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FDA’s OK for Roche’s Tecentriq for metastatic non-small cell lung cancer

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FDA’s OK for Roche’s Tecentriq for metastatic non-small cell lung cancer

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May 19, 2020: “Roche announced that the US FDA has approved Tecentriq® (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression (PD-L1 stained ≥ 50% of tumour cells [TC ≥ 50%] or PD-L1 stained tumour-infiltrating [IC] covering ≥ 10% of the tumour area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations.

“We are pleased to offer people with certain types of lung cancer a new chemotherapy-free option that can help prolong their lives and be administered on a flexible dosing schedule, including an option for once-a-month Tecentriq infusions,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development.
“Today marks the fifth approval of Tecentriq in lung cancer, as we remain committed to providing an effective and tailored treatment option for every person diagnosed with this disease.”

This approval is based on an interim analysis from the Phase III IMpower110 study, which showed that Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (median OS=20.2 versus 13.1 months; hazard ratio [HR]=0.59, 95% CI: 0.40–0.89; p=0.0106) in people with high PD-L1 expression (TC3/IC3-wild-type [WT]).
Safety for Tecentriq appeared to be consistent with its known safety profile, and no new safety signals were identified.
Grade 3–4 treatment-related adverse events (AEs) were reported in 12.9% of people receiving Tecentriq compared with 44.1% of people receiving chemotherapy.

Tecentriq is the first and only single-agent cancer immunotherapy with three dosing options, allowing administration every two, three or four weeks.
The supplemental Biologics License Application for the Tecentriq monotherapy was granted Priority Review, a designation given to medicines the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

In the US, Tecentriq has received four approvals across NSCLC, including as a single agent or in combination with targeted therapies and/or chemotherapies.
It is also approved in combination with carboplatin and etoposide (chemotherapy) for the first-line treatment of adults with extensive-stage small cell lung cancer.
RELATED NEWS:

Roche presents pivotal First Phase III cancer immunotherapy Tecentriq in combination with Avastin to show an improvement in liver cancer patients

Roche to present first clinical data on novel anti-TIGIT cancer immunotherapy tiragolumab at ASCO

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

IMpower110 is a Phase III, randomised, open-label study evaluating the efficacy and safety of Tecentriq monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in PD-L1-selected, chemotherapy-naïve participants with Stage IV non-squamous or squamous NSCLC.

The study enrolled 572 people, of whom 554 were in the intention-to-treat WT population, which excluded people with EGFR or ALK genomic tumour aberrations, and were randomised 1:1 to receive:
  • Tecentriq monotherapy, until disease progression (or loss of clinical benefit, as assessed by the investigator), unacceptable toxicity or death; or
  • Cisplatin or carboplatin (per investigator discretion) combined with either pemetrexed
    (non-squamous) or gemcitabine (squamous), followed by maintenance therapy with pemetrexed alone (non-squamous) or best supportive care (squamous) until disease progression, unacceptable toxicity or death.


The primary efficacy endpoint was OS by PD-L1 subgroup (TC3/IC3-WT; TC2/3/IC2/3-WT; and TC1,2,3/IC1,2,3-WT), as determined by the SP142 assay test. Key secondary endpoints included investigator-assessed progression-free survival (PFS), objective response rate (ORR) and duration of response (DoR).

NSCLC
Lung cancer is the leading cause of cancer death globally.

Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.

 Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.

 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors.

By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.”

https://www.roche.com/media/releases/med-cor-2020-05-19.htm

Bevespi Aerosphere approved in China for patients with COPD

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Bevespi Aerosphere approved in China for patients with COPD
May 18, 2020: “AstraZeneca’s Bevespi Aerosphere (glycopyrronium/formoterol fumarate)has been approved in China as a maintenance treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The approval by the National Medical Products Administration (NMPA) was based on positive results from the Phase III PINNACLE 4 trial in which Bevespi Aerosphere demonstrated a statistically significant improvement in lung function as measured by trough forced expiratory volume in one second (FEV1), compared to its monotherapy components and placebo, all administered twice daily via pressurised metered-dose inhaler (pMDI) in patients with moderate to very severe COPD.

The trial formed part of the broader PINNACLE clinical trials programme showing efficacy and safety and involving more than 5,000 patients across Asia, Europe and the US.

This was the first approval by the NMPA for a maintenance, fixed-dose, long-acting dual bronchodilator combination therapy in a pMDI, which uses the innovative Aerosphere delivery technology.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Chronic obstructive pulmonary disease affects almost 100 million people in China and presents a significant patient and public health burden.

The use of maintenance combination therapies in China is increasing year-on-year and the approval of Bevespi Aerosphere offers an important new treatment and choice of inhaler for patients, particularly those with limited lung function and advanced age who may benefit from using a pressurised metered-dose inhaler.”

Bevespi Aerosphere is already approved in the US, EU, Japan and other countries for the long-term maintenance treatment of moderate to very severe COPD.

The approval of Bevespi Aerosphere follows the recent approval of AstraZeneca’s triple-combination therapy, Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate), for the maintenance treatment of COPD in China.

COPD

COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness.

It affects an estimated 384 million people worldwide and approximately 100 million people in China.

COPD is the third leading cause of death globally.

 Improving lung function, reducing exacerbations and managing daily symptoms such as breathlessness are important treatment goals in the management of COPD.

PINNACLE

PINNACLE 1, 2 and 4 were randomised, double-blinded, multi-centre, placebo-controlled trials conducted over 24 weeks, which compared the efficacy and safety of Bevespi Aerosphere administered twice daily via a pMDI to its monotherapy components (glycopyrronium and formoterol fumarate) and to placebo.

In PINNACLE 1, open-label tiotropium was included as an active control.

 PINNACLE 3 was a multi-centre, randomised, double-blinded, parallel-group, chronic-dosing, active-controlled, 28-week safety extension trial of PINNACLE 1 and 2, which evaluated the long-term safety, tolerability and efficacy of Bevespi Aerosphere administered twice daily via a pMDI compared to its monotherapy components.

 All the trials were conducted in patients with moderate to very severe COPD.

Results from the PINNACLE 4 trial were published in the International Journal of Chronic Obstructive Pulmonary Disease.

Bevespi Aerosphere

Bevespi Aerosphere (glycopyrronium/formoterol fumarate) is a fixed-dose dual bronchodilator in a pMDI, combining glycopyrronium, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta2-agonist (LABA).

PMDIs are an important choice for COPD patients where limited lung function, advanced age and reduced dexterity or cognition are significant considerations for patients to achieve therapeutic benefits from their medicines.

 Bevespi Aerosphere is the only LABA/LAMA with Aerosphere delivery technology. Results from an imaging trial have shown that Bevespi Aerosphere effectively delivers medicine to both the large and small airways.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/bevespi-aerosphere-approved-in-china-for-patients-with-copd.html

AZ and Daiichi Sankyo’s third Breakthrough Therapy Designation for Enhertu

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AZ and Daiichi Sankyo’s third Breakthrough Therapy Designation for Enhertu
May 18, 2020: “AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a HER2 mutation and with disease progression on or after platinum-based therapy.

NSCLC is the most common type of lung cancer, and prognosis is particularly poor for patients with metastatic disease as only about 6-10% will be alive five years after diagnosis.

Approximately 2-4% of patients with NSCLC have a HER2 mutation.

The Food and Drug Administration (FDA)’s BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need.

The new medicine needs to have shown encouraging early clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.

José Baselga, Executive Vice President, R&D Oncology, said: “Today’s news is very welcome as we continue to evaluate the potential of Enhertu to help patients with this devastating type of lung cancer.

Targeted treatments and immunotherapies are demonstrating tremendous advancements, but there remains an unmet medical need for patients with HER2 mutations who are not benefiting from such therapies or for those whose cancer continues to progress.”

Gilles Gallant, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo, said: “We are encouraged by the promising evidence of activity seen with Enhertu in patients with advanced lung cancer and a HER2 mutation.

We look forward to working closely with the FDA on the potential for Enhertu to become the first HER2-directed therapy approved for non-small cell lung cancer.”

The FDA granted BTD based on data from the ongoing Phase II DESTINY-Lung01 trial currently testing Enhertu, a HER2-directed antibody drug conjugate (ADC),in patients with HER2-mutant (HER2m) metastatic NSCLC, and data from the Phase I trial published in Cancer Discovery.

An interim analysis from DESTINY-Lung01 will be presented during the 2020 American Society of Clinical Oncology ASCO20 Virtual Scientific Program, 29 to 31 May 2020.

The overall safety and tolerability profile of Enhertu in the ongoing DESTINY-Lung01 trial is consistent with that seen in the Phase I trial.

The most common adverse events to date (n=42) are gastrointestinal and haematological including nausea, alopecia, anaemia, decreased appetite and decreased neutrophil count.

There have been five cases of drug-related interstitial lung disease (ILD) and pneumonitis in patients with HER2m NSCLC, all of which were Grade 2. There have been no ILD-related deaths.

This is the third BTD granted for Enhertu in the US. Last week, Enhertu received BTD in patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab. 

Enhertu received BTD in 2017 for HER2-positive metastatic breast cancer and received approval in December 2019.

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours.

In some tumours, HER2 overexpression is associated with a specific HER2 gene alteration known as amplification and is often associated with aggressive disease and poorer prognosis.

Other HER2 gene alterations (called HER2 mutations) have been identified in NSCLC, specifically adenocarcinomas, as distinct molecular targets.

 Approximately 2-4% of patients with NSCLC have HER2 mutations, which have been independently associated with cancer cell growth and poor prognosis.

NSCLC

Lung cancer is the leading cause of cancer death among both men and women and accounts for about one-fifth of all cancer deaths.

In the US, it is estimated that 228,820 new cases of lung cancer will be diagnosed in 2020 and more than 135,000 people will die from the disease.

Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC. Within NSCLC, patients are classified as squamous, representing 25-30% of patients, or non-squamous, the most common type representing approximately 70-75% of NSCLC patients.

Stage IV is the most advanced form of lung cancer and is often referred to as metastatic disease.

For these patients with metastatic disease, prognosis is particularly poor, as only 6-10% will be alive five years after diagnosis.

 The introduction of targeted therapies and checkpoint inhibitors in recent years has improved outcomes for patients with advanced NSCLC; however, new approaches are needed for those who are not eligible for available treatments, or whose cancer continues to progress.

Currently, no medicine is specifically approved for patients with HER2m NSCLC.

DESTINY-Lung01

DESTINY-Lung01 is a global, Phase II, open-label, multicentre, two-cohort trial assessing the safety and efficacy of Enhertu in 170 patients with HER2m (n=90) or HER2-overexpressing, defined as IHC 3+ or IHC 2+, (n=80) unresectable and metastatic non-squamous NSCLC whose cancer has progressed after one or more systemic therapies (including chemotherapy, molecular targeted therapy or immunotherapy).

The primary endpoint is ORR. Key secondary endpoints include duration of response, disease control rate, progression-free survival and overall survival.

Enhertu (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the US) is a HER2-directed ADC and is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform.

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (“payload”) to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells.

Enhertu is approved in the US and Japan for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens based on the DESTINY-Breast01 trial.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/enhertu-granted-breakthrough-therapy-designation-in-the-us-for-her2-mutant-metastatic-non-small-cell-lung-cancer.html

For More News:

AstraZeneca’s US Breakthrough Therapy Designation for Enhertu

Phase II DESTINY-Gastric01 trial of Enhertu (trastuzumab deruxtecan) versus chemotherapy met primary endpoint

Daiichi Sankyo ENHERTU® is Now Available in the U.S. for the HER2 Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2-Based Regimens

ViiV HIV prevention trial stopped early on the efficacy

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ViiV HIV prevention trial stopped early on the efficacy

May 18, 2020: “ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders announced the interim analysis of the HIV Prevention Trials Network (HPTN) 083 study evaluating the safety and efficacy of investigational, long-acting, injectable cabotegravir for HIV prevention.

In the study, cabotegravir was found to be 69% more effective (95% CI 41%-84%) in preventing HIV acquisition in men who have sex with men (MSM) and transgender women who have sex with men when compared to the current standard of care, daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg (FTC/TDF) tablets.

The study achieved its primary objective of non-inferiority with the difference approaching superiority in favour of cabotegravir, pending final analysis.

The HPTN 083 study, with approximately 4,600 participants across more than 40 sites in North and South America, Asia, and Africa, is one of the first-ever clinical trials to directly compare two active prevention agents.

In a planned interim review, the independent Data and Safety Monitoring Board (DSMB) found the study data clearly indicated that long-acting injectable cabotegravir was highly effective at preventing HIV in the study population. 

Among the 50 people in the trial who acquired HIV, 12 were randomised to the long-acting cabotegravir arm and 38 were randomised to the daily, oral FTC/TDF arm.

This translated to an HIV incidence rate of 0.38% (95% confidence interval [CI] 0.20%- 0.66%) in the cabotegravir group and 1.21% (95% CI 0.86%-1.66%) in the FTC/TDF group.

Adherence to oral FTC/TDF was high, based on a random subset sampling that detected tenofovir (> 0.31 ng/ml) in 87% of all samples tested. Despite this high level of adherence to oral therapy, long-acting cabotegravir was 69% (95% CI 41%-84%) more effective than FTC/TDF in preventing HIV acquisition in the study population. 

Myron S. Cohen, M.D., Co-Principal Investigator of the HPTN and the Yeargan-Bate Distinguished Professor of Medicine, Microbiology and Immunology and Epidemiology at the University of North Carolina (UNC) at Chapel Hill, said: “Each year, an estimated 1.7 million people are newly diagnosed with HIV.

To lower that number, we believe more prevention options are needed in addition to currently available oral tablets for daily use.

If approved, a new injectable agent, such as long-acting cabotegravir administered every two months, could play an important role in reducing HIV transmission and helping to end the HIV epidemic.”

Safety was similar in the two groups. Most participants in the cabotegravir group (80%) reported pain or tenderness at the injection site, compared to only 31% of those in the FTC/TDF arm, who received placebo injections.

Discontinuation due to injection site reactions or injection intolerance in the cabotegravir arm of the study was 2% and there were no discontinuations due to ISRs in the FTC/TDF arm.

Following review of these findings, the DSMB recommended the blinded, randomised portion of the study be stopped early and results released.

Participants who were in the FTC/TDF arm will be offered CAB LA and participants in the CAB LA arm will continue to receive it.

Participants who do not want to receive CAB LA will be offered FTC/TDF until the end of the originally planned blinded component of the study.

The DSMB decision was approved by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), the study sponsor.

The HPTN 083 study enrolled HIV-negative men who have sex with men and transgender women who have sex with men, participants considered at risk for HIV acquisition.

Two-thirds of study participants were under 30 years of age, and 12% were transgender women. Half of the participants in the United States identified as black or African American.

“These study results demonstrate that long-acting injectable cabotegravir dosed every two months can successfully reduce HIV acquisition in at-risk MSM and transgender women,” said Kimberly Smith, M.D., Head of Research & Development at ViiV Healthcare.

“We are thrilled with the results not only because of the high efficacy of cabotegravir but also because we have demonstrated high efficacy in a study that adequately represents some of the populations most disproportionately impacted by HIV — black MSM in the US, young MSM globally and transgender women,” she said.

“We continue to be focused on the completion of the companion HPTN 084 study, which will give us important information about the effectiveness of cabotegravir in women.

New options are needed for HIV prevention that offer an effective alternative to daily oral PrEP.

If approved, this long-acting injectable has the potential to be a game-changer for HIV prevention by reducing the frequency of dosing from 365 days to six times per year.”

HTPN 083 was jointly funded by the U.S. NIAID, part of the NIH, and ViiV Healthcare, and was conducted by the HPTN. Study product was provided by ViiV Healthcare and Gilead Sciences.

The DSMB also reviewed data from HPTN 084, which began a year later than HPTN 083, and recommended that it continue as planned.

To date, more than 3,000 sexually active women in seven African countries have enrolled in HPTN 084, which is co-funded by NIAID, ViiV Healthcare and the Bill & Melinda Gates Foundation.

Detailed results from HPTN 083 will be presented at an upcoming scientific meeting. ViiV Healthcare plans to use the data from HPTN 083 for future regulatory submissions.

Cabotegravir has not yet been approved for the treatment or prevention of HIV as a single agent by regulatory authorities anywhere in the world.

About HPTN 083 (NCT02720094)
The HPTN 083 study is a phase IIb/III double blind study designed to evaluate the safety and efficacy of long-acting injectable cabotegravir for HIV prevention administered every eight weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg).

Each participant was to receive a maximum of three years of blinded study medication. The study opened to enrolment in November 2016.

HPTN 083 was conducted in approximately 4,600 men who have sex with men and transgender women who have sex with men at research centres in Argentina, Brazil, Peru, United States, South Africa, Thailand and Vietnam.

About HPTN 084 (NCT03164564)
The HPTN 084 study is a phase III double blind safety and efficacy study designed to evaluate the safety and efficacy of the long-acting injectable cabotegravir for HIV prevention administered every eight weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg) in 3,200 women who are at increased risk of HIV acquisition.

HPTN 084 opened to enrolment in November 2017 and is being conducted at research centres in Botswana, Kenya, Malawi, South Africa, Eswatini, Uganda and Zimbabwe.”

https://viivhealthcare.com/en-us/us-news/us-articles/2020/global-hiv-prevention-study-to-stop-early-after-viiv-healthcares/

NICE COVID-19 rapid guideline for chronic kidney disease

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NICE COVID-19 rapid guideline for chronic kidney disease
May 15, 2020: The purpose of this guideline is to maximise the safety of adults with chronic kidney disease during the COVID-19 pandemic.

It also aims to protect staff from infection and enable services to make the best use of NHS resources.

NICE has also produced  COVID-19 rapid guidelines on dialysis service delivery and acute kidney injury in hospital.

This guideline focuses on what you need to stop or start doing during the pandemic. Follow the usual professional guidelines, standards and laws (including those on equalities, safeguarding, communication and mental capacity), as described in making decisions using NICE guidelines.

This guideline is for:

  • health and care practitioners
  • health and care staff involved in planning and delivering services
  • commissioners.

The recommendations bring together:

  • existing national and international guidance and policies
  • advice from specialists working in the NHS from across the UK. These include people with expertise and experience of treating patients with chronic kidney disease during the current COVID-19 pandemic.

NICE has developed these recommendations in direct response to the rapidly evolving situation and so could not follow the standard process for guidance development. The guideline has been developed using the interim process and methods for developing rapid guidelines on COVID-19. The recommendations are based on evidence and expert opinion and have been verified as far as possible. We will review and update the recommendations as the knowledge base and expert experience develops.”

https://www.nice.org.uk/guidance/ng176

AveXis receives EC approval for Zolgensma® for spinal muscular atrophy

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AveXis receives EC approval for Zolgensma® for spinal muscular atrophy
May 19, 2020: “AveXis, a Novartis company announced the EC granted conditional approval for Zolgensma® (onasemnogene abeparvovec) for the treatment of patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA Type 1; or for patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to three copies of the SMN2 gene.

The approval covers babies and young children with SMA up to 21 kg according to the approved dosing guidance.

In Europe each year, approximately 550–600 infants are born with SMA, a rare, genetic neuromuscular disease caused by a lack of a functional SMN1 gene, resulting in the rapid and irreversible loss of motor neurons, affecting muscle functions, including breathing, swallowing and basic movement.

 Zolgensma is a one-time gene therapy designed to address the genetic root cause of the disease by replacing the function of the missing or nonworking SMN1 gene.

Administered during a single, intravenous (IV) infusion, Zolgensma delivers a new working copy of the SMN1 gene into a patient’s cells, halting disease progression.

According to Pediatric Neuromuscular Clinical Research (PNCR) natural history study of SMA, almost all patients under the age of five years of age will be under 21kg with some patients at 6, 7 or 8 weighing below 21 kg.

 AveXis is planning a product presentation that allows for treatment of patients weighing up to 21 kg and is working with the European Medicines Agency (EMA) to finalize supply timelines. 

“The EC approval of Zolgensma is a significant milestone for the SMA community, and further underscores the substantial clinical value of the only gene therapy for SMA, bringing new hope to those impacted by this rare, but devastating disease.” said Dave Lennon, president of AveXis.

“Even under the current pandemic conditions, the urgent need to treat SMA has resulted in access pathways in France and Germany for Zolgensma, a potentially life-saving medicine delivered in a single dose.

Additionally, we have met with more than 100 stakeholder organizations across Europe to discuss our “Day One” access program to enable rapid access with customizable options designed to work within local pricing and reimbursement frameworks.”

SMA is a significant burden to the healthcare system in Europe with cumulative estimated healthcare costs per child ranging between €2.5 to €4 million within the first 10 years alone.

 Zolgensma is a transformative and highly innovative one-time gene therapy for a devastating and progressive genetic disease and is consistently priced worldwide under a value-based framework, however final pricing and reimbursement decisions are determined at the local level.

Designed to work within existing, local pricing and reimbursement frameworks, the “Day One” access program offers ministries of health and reimbursement bodies a variety of flexible options that can be implemented immediately to support swift access and broad reimbursement.

The “Day One” access program ensures the cost of patients treated before national pricing and reimbursement agreements are in place align with the value-based prices negotiated following clinical and economic assessments.

The program maintains the integrity of the local pricing and reimbursement frameworks with a variety of customizable options including:

  • Retroactive rebates ensuring early access costs are aligned with negotiated prices following local clinical and economic assessment processes
  • Deferred payments and installment options allowing reimbursement bodies to manage budget impact during the early access phase
  • Outcomes-based rebates negotiated following clinical and economic assessments can be applied to patients treated during the early access period
  • Robust training for treating institutions on administration and follow-up care
  • Access to RESTORE, a global registry of patients who have been diagnosed with SMA that draws upon existing country registries

Immediate access to Zolgensma, aligned to the label, is available in France through the ATU framework and expected shortly in Germany.

“Today’s approval brings tangible progress in harnessing the transformational power of gene therapy,” said Dr. Eugenio Mercuri, Professor, Pediatric Neurology, Catholic University, Rome, Italy.

“The approval of Zolgensma represents an important new way for physicians to treat patients with SMA.

The results we have seen for Zolgensma to date from the STR1VE clinical trial show an impressive survival rate at the conclusion of the study, with the majority of patients achieving functional milestones, like sitting without support, that wouldn’t have been reached in untreated infants.”

“SMA Europe receives with deep excitement the news on the approval by the European Commission, of a gene therapy for treating a part of our community,” said Mencía de Lemus, President of SMA Europe.

“Many hopes have been put into this much awaited therapy. It will be now be up to all stakeholders involved to ensure that treating doctors, together with parents, can take the best therapeutic option based on the benefit that each of them can provide to each individual.

Gathering more data on how Zolgensma impacts in the lives of patients will be extremely important to better understand the potential of this new therapy on improving lives of those living with SMA.”

The EC approval is based on the completed Phase 3 STR1VE-US and Phase 1 START trials that evaluated the efficacy and safety of a one-time IV infusion of Zolgensma in symptomatic SMA Type 1 patients <6 months of age at dosing, who had one or two copies of the SMN2 backup gene, or two copies of the SMN2 backup gene, respectively.

STR1VE-EU, a comparable Phase 3 study is ongoing. Zolgensma demonstrated prolonged event-free survival; rapid motor function improvement, often within one month of dosing; and, sustained milestone achievement, including the ability to sit without support, crawl and walk independently – milestones never achieved in untreated Type 1 patients.6

Additional supportive data included interim results from the ongoing SPR1NT trial, a Phase 3, open-label, single-arm study of a single, one-time IV infusion of Zolgensma in pre-symptomatic patients (<6 weeks at age of dosing) genetically defined by bi-allelic deletion of SMN1 with 2 or 3 copies of SMN2.

These data demonstrate rapid, age appropriate major milestone gain, reinforcing the critical importance of early intervention in SMA patients.5

The most commonly observed side effects after treatment were elevated liver enzymes and vomiting. Acute serious liver injury and elevated aminotransferases can occur

Patients with pre-existing liver impairment may be at higher risk. Prior to infusion, physicians should assess liver function of all patients by clinical examination and laboratory testing.

And, they should administer systemic corticosteroid to all patients before and after treatment, and then continue to monitor liver function for at least 3 months after infusion.

There is limited experience in patients 2 years of age and older or with body weight above 13.5 kg. The safety and efficacy of Zolgensma in these patients have not been established.

AveXis has an exclusive, worldwide license with Nationwide Children’s Hospital to both the intravenous and intrathecal delivery of AAV9 gene therapy for the treatment of all types of SMA; has an exclusive, worldwide license from REGENXBIO for any recombinant AAV vector in its intellectual property portfolio for the in vivo gene therapy treatment of SMA in humans; an exclusive, worldwide licensing agreement with Généthon for in vivo delivery of AAV9 vector into the central nervous system for the treatment of SMA; and a non-exclusive, worldwide license agreement with AskBio for the use of its self-complementary DNA technology for the treatment of SMA.

About Zolgensma® (onasemnogene abeparvovec)
Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time IV infusion.

Zolgensma represents the first approved therapeutic in the company’s proprietary platform to treat rare, monogenic diseases using gene therapy.

 More than 500 patients have been treated with Zolgensma, including clinical trials, commercially and through the managed access program.

AveXis is pursuing registration in close to three dozen countries with regulatory decisions anticipated in Switzerland, Canada, Australia, Argentina, South Korea and Brazil in late 2020 or early 2021.1

In May 2019, the U.S. Food and Drug Administration approved Zolgensma for the treatment of pediatric patients less than two years of age with SMA with bi-allelic mutations in the SMN1 gene.

 In the U.S. nearly all on-label patients have been approved by their payer for access to Zolgensma.

On March 19, 2020, Zolgensma was approved by Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of SMA in patients under the age of two, including those who are pre-symptomatic at diagnosis.

 Today’s EC approval applies to all 27 European Union member states, as well as Iceland, Norway, Liechtenstein and the United Kingdom.”

https://www.novartis.com/news/media-releases/avexis-receives-ec-approval-and-activates-%22day-one%22-access-program-zolgensma-only-gene-therapy-spinal-muscular-atrophy-sma

Novo Nordisk’s wins big obesity ambitions take shape with semaglutide

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Novo Nordisk’s wins big obesity ambitions take shape with semaglutide
May 13, 2020: “Novo Nordisk announced headline results from STEP 4, the first completed phase 3a trial in the STEP programme. STEP 4 is a randomised, double-blind, multicentre, placebo-controlled, withdrawal trial exploring sustained weight management with semaglutide vs placebo.

The 68-week trial investigated the effect of once-weekly subcutaneous (sc) semaglutide 2.4 mg on body weight in 902 people with obesity or overweight with comorbidities.

After the 20-week run-in period, the 803 people reaching the target dose of semaglutide 2.4 mg had reduced their mean body weight from 107.2 kg to 96.1 kg and were randomised to continued treatment with either once-weekly sc semaglutide 2.4 mg or placebo for 48 weeks.

The trial achieved its primary objective by demonstrating that in all people randomised, continued treatment with sc semaglutide 2.4 mg for 48 weeks (after the run-in period) resulted in an additional mean weight loss of 7.9%, from a mean baseline body weight at randomisation of 96.1 kg, whereas people on placebo regained 6.9% of the body weight.

The treatment difference was statistically significant. People who received sc semaglutide 2.4 mg for 68 weeks (run-in period plus 48 weeks) achieved a total weight loss of 17.4%.

When evaluating the effects of treatment if taken as intended, people who continued treatment with sc semaglutide 2.4 mg achieved an additional mean weight loss of 8.8% whereas people on placebo regained 6.5%.

The treatment difference was statistically significant. People who stayed on sc semaglutide 2.4 mg for 68 weeks achieved a weight loss of 18.2%.

In the trial, sc semaglutide 2.4 mg appeared to have a safe and well-tolerated profile.

The most common adverse events among people treated with sc semaglutide 2.4 mg were gastrointestinal events.

As seen previously with GLP-1 receptor agonists, most events were transient and mild or moderate in severity.

“Achieving sustained weight loss without medical therapy is known to be very challenging.

STEP 4 shows that people continuing treatment with semaglutide achieved a further substantial weight loss while people switching to placebo, on the other hand, regained a significant amount of weight,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk and continues,

“this highlights that obesity is a chronic disease requiring sustained treatment, and we look forward to sharing additional results from the ongoing STEP programme”.

About obesity and sc semaglutide 2.4 mg for weight management
Obesity is a chronic disease that requires long-term management. It is associated with many serious health consequences and decreased life expectancy.

Obesity-related complications are numerous and include type 2 diabetes, heart disease, obstructive sleep apnoea, chronic kidney disease, non-alcoholic fatty liver disease and cancer.

Once-weekly sc semaglutide 2.4 mg is being investigated by Novo Nordisk as a treatment for adults with obesity.

Semaglutide is an analogue of the human glucagon-like peptide-1 (GLP-1) hormone. It induces weight loss by reducing hunger, increasing feelings of fullness and thereby helping people eat less and reduce their calorie intake.

About the STEP clinical programme
STEP (Semaglutide Treatment Effect in People with obesity) is a phase 3 clinical development programme with once-weekly sc semaglutide 2.4 mg in obesity.

The global clinical phase 3a programme consists of 4 trials, having enrolled approximately 4,500 adults with overweight or obesity.

STEP 1 – a 68-week safety and efficacy trial of sc semaglutide 2.4 mg versus placebo in 1,961 adults with obesity or overweight.

STEP 2 – a 68-week safety and efficacy trial of sc semaglutide 2.4 mg versus placebo and once-weekly sc semaglutide 1.0 mg in 1,210 adults with type 2 diabetes and either obesity or overweight.

STEP 3 – a 68-week safety and efficacy trial of sc semaglutide 2.4 mg versus placebo in combination with intensive behavioural treatment in 611 adults with obesity or overweight.

STEP 4 – a 68-week safety and efficacy trial of sc semaglutide 2.4 mg versus placebo in 803 adults with obesity or overweight who have reached the target dose of 2.4 mg after a 20-week run-in.”

https://www.novonordisk.com/media/news-details.2301466.html

Efficacy Vs Effectiveness

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Efficacy Vs Effectiveness
Many persons often get confused with efficacy and Effectiveness.  There is a very minute difference between the two. Firstly, let’s get familiar with both these terms then for better understanding, we will also discuss the difference between efficacy and effectiveness (efficacy Vs effectiveness).

Definition of Efficacy

“Efficacy = best possible results for a particular intervention, under perfect conditions;

Efficacy is the degree of success to which an intervention does more good than harm under ideal circumstances.

Efficacy studies are frequently conducted in large tertiary care which leans to have more specialized clinicians and better technical equipment than primary care facilities.

Efficacy study conducted in Phase II Trial as the number of patients less (100–300) with specific diseases.”

Convalescent Plasma for COVID-19 Close Contacts

Definition of Effectiveness

“Effectiveness = most likely results for a particular intervention under pragmatic or ‘real-life’ conditions (taking into account compliance, dropouts, withdrawals, the learning curve for surgical interventions, etc.) 

Effectiveness assesses whether an intervention does more good than harm when provided under usual circumstances of the healthcare practice.

Therefore, populations in primary care may be a tolerable subject group for effectiveness studies.

Effectiveness studies are conducted in Phase III Trial approx 300–3,000 patients with specific diseases.”

Efficacy and Safety of SHR3824 in Combination With Metformin in Subjects With Type 2 Diabetes

So, from the above definition, it can be concluded as “How well the treatment/ intervention/ Drug is performed in the small population” is termed as Efficacy and how well the treatment/ intervention/ Drug is performed in real-world is termed as Effectiveness.

When Efficacy study (performed in Phase II Trial) covers a large population then only it will be termed as Effectiveness studies (performed in Phase III Trial) as now it will be closer to the real world.

Efficacy Vs Effectiveness

“Efficacy is the effect in perfect conditions whereas effectiveness is the effect in the real world.

When a study assesses efficacy, it is looking at whether the drug given in the precise manner described in the study is able to influence an outcome of interest (e.g. tumor size) in the selected population (e.g. cancer patients with no other ongoing diseases).

When a study is assessing effectiveness, it is determining whether a treatment will influence the disease. In an effectiveness study, it is necessary that patients are treated as they would be when the treatment is prescribed indefinite practice.

That would mean that there should be no aspects of the study designed to increase patient compliance above those that would occur in routine clinical practice.

The outcomes in effectiveness studies are also easily applicable than in most efficacy studies (for example does the patient feel better, come to the hospital less or live longer in effectiveness studies as disparate to better test scores or lower cell counts in efficacy studies).

There is usually less stiff control of the type of patient to be included in the effectiveness studies than in efficacy studies, as the researchers are interested in whether the drug will have a broad effect in the population of the patients with the disease.”

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3726789/

Accuracy Vs Precision

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Accuracy Vs Precision

What is the Definition and Difference between Accuracy and Precision

Definition of Accuracy:

Accuracy refers to a value measured being close to a standard or known value.

The degree to which the measurement outcome conforms to the correct value or standards which basically corresponds to the closeness of the measurement to the value agreed upon.

For example When a weight measurement of 3.8 kg for a given material is achieved in the laboratory but the true or known weight is 11 kg, then the calculation is not correct. In this case, the known value isn’t similar to the calculation.

Definition of Precision

Precision refers to the closeness of two or more steps.

Or ‘the quality of being exact’ and refers to how close two or more measurements are to each other, in spite of whether those measurements are accurate or not. Precision measurements can be not accurate.

Using the example above If you weigh a given substance five times and each time you get 3.8 kg, then the calculation is very precise. Precision is equal to precision. As mentioned above you can be very precise but inaccurate. You should be accurate but imprecise too.

For example,
if on average the measurements are similar to the known value for a given material, but the measurements are far away from each other, then you have accuracy without precision.

Difference between Accuracy and  Precision

Just imagine a basketball player shooting baskets is a good analogy for understanding accuracy and precision. If the player is shooting correctly, his goal will always be to send the ball close or into the basket.

If the player shoots accurately, his aim will always take the ball to the same location that might or might not be close to the basket. A good player will be both precise and accurate by shooting the ball the same way each time and making it in the basket each time.

https://labwrite.ncsu.edu/Experimental%20Design/accuracyprecision.htm
https://www.precisa.co.uk/difference-between-accuracy-and-precision-measurements/

Pandemic Vs Endemic Vs Epidemic

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Pandemic Vs Endemic Vs Epidemic

What is the definition and difference between Pandemic Vs Endemic Vs Epidemic

Definition of Epidemic

According to WHO, Epidemic is the regional outbreak of an illness that spreads unexpectedly. It refers to an increase, often sudden, in the number of cases of disease outside what is normally expected in the population of an area.

AN EPIDEMIC is a disease which affects a large number of people within a community, population, or region

Epidemics come about when an agent and susceptible hosts are present in adequate numbers, and the agent can be efficiently conveyed from a source to the susceptible hosts.

More specifically, an epidemic may result from:

  • A current raise in amount or virulence of the agent,
  • The recent introduction of agent into a setting where it has not been before,
  • An enhanced mode of transmission so that more vulnerable persons are exposed,
  • A change in the weakness of the host response to the agent, and/or
  • Factors that boost host exposure or involve introduction through new portals of entry

Examples of epidemics in India in the past include the outbreaks of zika virus, chikungunya and dengue fever.

Definition of Pandemic

Pandemic refers to an epidemic that has stretched across countries and continents — the worldwide spread of a new disease.

A PANDEMIC is an epidemic that spread over multiple countries or continents.

“Pandemic is not a word to use lightly or carelessly,” warned Dr Tedros Adhanom Ghebreyesus, director-general of the WHO, and claimed the global health body had previously avoided using the term because it didn’t want to give the impression that coronavirus was unstoppable or uncontainable.

Dengue fever as an example:

“An example of this is dengue fever. There are parts of the world where dengue fever is endemic, meaning that there are mosquitoes that are carrying dengue fever and transmitting it from one person to another person.

 But some imported cases were also seen and imported outbreaks in the parts of the world where the disease is not endemic,” says Dr Tosh.

” Most recently we saw an outbreak in the Big Island of Hawaii where somebody, unknown, must have come in with dengue fever, got bitten by mosquitoes, and then you had local chains of transmission where those mosquitoes then bit other people, they got dengue fever, and so on and so on. 

In this case, dengue fever is not endemic in the Big Island, however, there was an outbreak due to an imported disease with the subsequent transmission.”

Definition of Endemic:
The term endemic refers to the constant presence and/or usual prevalence of a disease or infectious agent in a population within a geographic area. For example, chickenpox is considered endemic in the UK, but malaria is not.

After months of only referring to the coronavirus outbreak as an epidemic, the World Health Organization (WHO) Wednesday finally declared it a global pandemic.

Hyperendemic refers to the persistent, higher levels of disease prevalence in a particular place.

Definition of Outbreak:

The term ‘outbreak’ by definition means the same as an epidemic, but it is often used for a more limited geographic area. ‘Cluster’, on the other hand, refers to an aggregation of cases grouped in place and time that are suspected to be greater than the number expected.

AN OUTBREAK is a greater-than-anticipated raise in the number of endemic cases.

 Also, It can be a single case in a new area. If it’s not speedily controlled, an outbreak can become an epidemic.

Why call COVID-19 a pandemic now

After 118,000 positive cases of COVID-19 over 114 countries, it was clear that the virus has crossed the definition of an epidemic.

Illnesses are frequently considered pandemic when the disease-causing agents differ from strains at this time circulating among humans and have the ability to infect people easily.

Coronavirus has spread rapidly and no vaccines or treatment have been officially found yet. So, declaring it a global pandemic is of necessity to contain its spread.

What’s the difference between a pandemic, an epidemic, endemic, and an outbreak?

Not all words related to infectious disease are considered synonymous, but they are sometimes misused interchangeably.

The distinction between the words “pandemic,” “epidemic,” and “endemic” is regularly indistinct, even by medical experts. That is because each term’s meaning is dynamic, which evolves over time as illnesses become more or less widespread.

Although conversational usage of such terms does not require exact meanings, understanding the distinction is crucial to help you learn more news about public health and correct responses to public health.

Epidemic vs. Pandemic:

A pandemic is an epidemic that travels.

A simple way to know the difference between an epidemic and a pandemic is to memorize the “P” in the Pandemic, which means a pandemic has a passport.

Epidemic vs. Endemic

An epidemic is dynamically spreading; new cases of the disease significantly exceed what is expected. Broadly, it is used to describe any problem that’s out of control, such as “the opioid epidemic.”

An epidemic is often localized to a region, but the number of those infected in that region is considerably higher than normal.

For example, when COVID-19 was limited to Wuhan, China, it was an epidemic. The geological spread turned it into a pandemic.

On the other hand, Endemics are a constant presence in a specific location.

For example, Malaria is endemic to the parts of Africa. Ice is endemic to Antarctica.

Endemic vs. Outbreak

Moving a step forward will lead to an outbreak of an endemic and an outbreak will occur anywhere. The dengue fever outbreak in Hawaii last summer is a prime example.

Dengue fever is common in several parts of Africa, Central, South America, and the Caribbean. In these areas, mosquitoes bear dengue fever and pass it on from person to person.

But in 2019 there was an outbreak of dengue fever in Hawaii, where the disease is not endemic.

It was believed that an infected person visited the Big Island and was bitten by mosquitoes there. The insects then transferred the disease to the other individuals they bit, which created an outbreak.

https://theprint.in/health/pandemic-epidemic-endemic-what-these-mean-and-how-they-are-different-from-each-other/380224/

https://intermountainhealthcare.org/blogs/topics/live-well/2020/04/whats-the-difference-between-a-pandemic-an-epidemic-endemic-and-an-outbreak/

https://newsnetwork.mayoclinic.org/discussion/pandemic-versus-endemic-versus-outbreak-terms-to-know/

Beginner’s Guide to Clinical Research Coordinator

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Beginner’s Guide to Clinical Research Coordinator

“A clinical research coordinator (CRC) assists Principle investigator (PI) in many clinical trial site-related activities. The clinical research coordinator is also called Clinical trial Manager (CTM)”

Under the supervision of the Principal Investigator (PI), the Clinical Research Coordinator is responsible for performing the trials according to the GCP guidelines.

It should be noted that the PI has overall responsibility for performing the study, But CRC conducts many activities on behalf of PI

“Protect and ensure the well-being of the participants in the study” is the core responsibility of all Clinical research professionals”

Responsibilities of Clinical Research Coordinator

Budget :

Participate in the planning and management of budgets for the study and financial payments. It may include IRB fees over the life of the clinical trial, pharmacy costs, PI and CRC travel costs for attending investigator meetings, facilities, dedicated fax and computer lines and all other associated costs.

Feasibility

CRA completes the questionnaire form regarding the feasibility for the site. It is sent by a sponsor before starting a trial on any site. CRC has to provide information about the following component.

  • The patient population at the site
  • support staff availability
  • medical facilities availability
  • Updates about Equipment and other facility needed to successfully carry out the study protocol

Informed consent:

Clinical Research Coordinator Manage the recruitment of subjects by ensuring that informed consent is actually obtained and recorded.

Institutional Review Board (IRB) review the IRB the informed consent template and CRC acts as a liaison between IRB and Sponsor regarding informed consent related communication.

Contract with Sponsor

Each site has to sign a clinical trial agreement for the common understanding on confidentiality, publishing the data, intellectual property, insurance, data protection, injury to the subject, legislative protections, termination clauses etc.

CRC coordinate between site, Sponsor and PI.

Educate the subject:

CRC educates subject regarding all study aspects relevant to them such as nature of drug candidate, dose, formulation type, possible side effect, visit schedules etc

Entering of data into database

CRCs enter the subject’s data in the database (eDC) such as Lab data, any assessment data, dose administration data, adverse event data, visit schedule, medical history, concomitant medication data etc.

The electronic forms where data is entered (in an electronic database or eDC) is called the case report form.

CRF follows the Case report form completion guidelines to enter the data. Case report form (CRF) completion guidelines are drafted by the sponsor and provide the instruction to enter the data into the database (eDC)

Adverse event

The CRC reports all adverse events to the sponsor and all serious adverse events (SAE)  to the IRB (institutional review board) and sponsor.

Audit

A site audit is one of the key activities in clinical research that is done by study sponsors, regulatory authorities, or exclusively designated review groups. CRC should be ready with all the relevant documents and answer the queries on behalf of PI.

Queries

Clinical research coordinator responds to queries raised on Database (eDC system). Generally, these queries are raised by CRA (clinical research associate), Data management and safety team.

Interaction with CRA and record-keeping

CRA visits the site and CRC gives the updates about the recent changes, document status and share any ongoing issues with CRAs.

CRC manages all the documents such as drug dispensation records, collection, labelling, storage and shipment of samples, lab reports, visit record etc (Source documents).

CRA checks all the source documents maintained by CRC for its completeness and correctness as per protocol (Source data review)

CRA also checks the data entered in the database and check it against data present in source documents. This is called source data verification.

CRC answers all the queries raised by CRA after Source data verification.

CRC must comply with the Food and Drug Administration’s (FDA), ICH’s, and clinical trial agreement record-keeping policies.

Sometime CRC has to •Collect and manage biological samples, such as saliva and urine.(depend on the study)

Other

Prepare advertising and other educational materials and conduct campaigns to enrol subjects.

The CRC is responsible for subject recruitment once the trial begins, or must conduct campaigns to enrol subjects.

Arrange space for the equipment going to be used in the study and other material related to trials.

CRC maintains the record of all subject visits and contacts the subject and reminds them to come for a site visit

Dispense the investigational drug to a subject

Average Clinical Research Coordinator (CRC) Salary:

These are the common factors which decide your salary in any organizations:

  • Experience,
  • Qualifications,
  • Countries and
  • Type of Organisations.

Average Clinical Research Coordinator (CRC) Salary in India:

Up to 3 lakh/annum (0-1 years of experience).

Average Clinical Research Coordinator (CRC) Salary in Canada:

Up to $52000 (0-2 years of experience)

Average Clinical Research Coordinator (CRC) Salary in the US:

Up to $69000 (1-3 years of experience)

These above salaries based on various sources such as https://www.salary.com/research/salary/benchmark/clinical-research-coordinator-salary/ontario-ca
https://ca.indeed.com/salaries/clinical-research-coordinator-Salaries

How to become a clinical research coordinator:

You should have below combination of skills and education to become CRC.
  1. You should have a degree in Life science such as Pharmaceutical sciences, clinical research, biotechnology, nursing etc.
  2. Knowledge of GCP, ICH guidelines
  3. Basic knowledge of clinical research. Below are the important topics, you must read if preparing for CRC interview:
  4. Microsoft Excel, Word and PPT
  5. Communication skills
  6. The following bodies also conduct courses on various topics related to clinical research:

    https://lifepronow.com/blog/2020/05/01/free-but-best-clinical-research-courses-hurry-up/
    Association of Clinical Research Professionals
    National Institutes of Health
    Harvard Catalyst Clinical Research
    Oregon Health & Science University

Career path:

CRC role provides a great opportunity to learn about clinical research and the chance to interact with patients

  • Centralised monitoring and clinical data management are the departments which are always open to CRC
  • CRC can aim to become CRAs as well. Many CRCs tries to become CRA after 1-2 years of experience.
  • You can continue as CRC and can move into the ladder as per organization hierarchy.
Experienced CRC can establish his/her career as a freelancer as well

Example of CRC Job description:

The screenshot has taken from Naukari and other online portals.

Key skills

Keywords to be added in CRC-resume

Generally, recruiter sees the keywords in the resume while screening the resume of any job roles. You can add below keywords and learn about them.
Refer: Complete Guide for writing effective Pharma- Resume: Your First Impression

Clinical research,
GCP, ICH,
Excel, word and PPT
any relevant certificate


Complete Guide for writing effective Pharma- Resume: Your First Impression
Best Use of Naukari Portal for Pharma Jobs

Substantial investment needed to avert mental health crisis

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Substantial investment needed to avert mental health crisis
May 14, 2020: “The COVID-19 pandemic is highlighting the need to urgently increase investment in services for mental health or risk a massive increase in mental health conditions in the coming months, according to a policy brief on COVID-19 and mental health issued by the United Nations today. 

“The impact of the pandemic on people’s mental health is already extremely concerning,” said Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization.

“Social isolation, fear of contagion, and loss of family members is compounded by the distress caused by loss of income and often employment.”

Depression and anxiety are increasing

Reports already indicate an increase in symptoms of depression and anxiety in a number of countries. A study in Ethiopia, in April 2020, reported a 3-fold increase in the prevalence of symptoms of depression compared to estimates from Ethiopia before the epidemic. 

Specific population groups are at particular risk of COVID-related psychological distress. Frontline health-care workers, faced with heavy workloads, life-or-death decisions, and risk of infection, are particularly affected. During the pandemic, in China, health-care workers have reported high rates of depression (50%), anxiety (45%), and insomnia (34%) and in Canada, 47% of health-care workers have reported a need for psychological support. 

Children and adolescents are also at risk. Parents in Italy and Spain have reported that their children have had difficulties concentrating, as well as irritability, restlessness and nervousness.

Stay-at-home measures have come with a heightened risk of children witnessing or suffering violence and abuse. Children with disabilities, children in crowded settings and those who live and work on the streets are particularly vulnerable. 

Other groups that are at particular risk are women, particularly those who are juggling home-schooling, working from home and household tasks, older persons and people with pre-existing mental health conditions.

A study carried out with young people with a history of mental health needs living in the UK reports that 32% of them agreed that the pandemic had made their mental health much worse.

An increase in alcohol consumption is another area of concern for mental health experts. Statistics from Canada report that 20% of 15-49 year-olds have increased their alcohol consumption during the pandemic.

Mental health services interrupted

The increase in people in need of mental health or psychosocial support has been compounded by the interruption to physical and mental health services in many countries.

In addition to the conversion of mental health facilities into care facilities for people with COVID-19, care systems have been affected by mental health staff being infected with the virus and the closing of face-to-face services. Community services, such as self-help groups for alcohol and drug dependence, have, in many countries, been unable to meet for several months. 

“It is now crystal clear that mental health needs must be treated as a core element of our response to and recovery from the COVID-19 pandemic,” said Dr Tedros Adhanom Ghebreyesus.

“This is a collective responsibility of governments and civil society, with the support of the whole United Nations System. A failure to take people’s emotional well-being seriously will lead to long-term social and economic costs to society.”

Finding ways to provide services

In concrete terms, it is critical that people living with mental health conditions have continued access to treatment.

Changes in approaches to the provision of mental health care and psychosocial support are showing signs of success in some countries.

In Madrid, when more than 60% of mental health beds were converted to care for people with COVID-19, where possible, people with severe conditions were moved to private clinics to ensure continuity of care.

Local policy-makers identified emergency psychiatry as an essential service to enable mental health-care workers to continue outpatient services over the phone. Home visits were organized for the most serious cases.

Teams from Egypt, Kenya, Nepal, Malaysia and New Zealand, among others, have reported creating increased capacity of emergency telephone lines for mental health to reach people in need. 

Support for community actions that strengthen social cohesion and reduce loneliness, particularly for the most vulnerable, such as older people, must continue.

Such support is required from government, local authorities, the private sector and members of the general public, with initiatives such as the provision of food parcels, regular phone check-ins with people living alone, and organization of online activities for intellective and cognitive stimulation. 

An opportunity to build back better

The scaling-up and reorganization of mental health services that is now needed on a global scale is an opportunity to build a mental health system that is fit for the future,” said Dévora Kestel, Director of the Department of Mental Health and Substance Use at WHO.“

“This means developing and funding national plans that shift care away from institutions to community services, ensuring coverage for mental health conditions in health insurance packages and building the human resource capacity to deliver quality mental health and social care in the community.” 

https://www.who.int/news-room/detail/14-05-2020-substantial-investment-needed-to-avert-mental-health-crisis

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