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Medical writing is the making of scientific documents by specialized writers.
Generally, a medical writer closely works with scientists, doctors and other subject matter experts in order to create effective documentation that deeply defines research results and product’s usage.
As you already know, Medical writing involves writing scientific documents of different types which include regulatory and research-related documents, disease or drug-related educational and promotional literature, publication articles like journal manuscripts and abstracts, health-related magazines, content for healthcare websites or news articles.
The scientific facts found in such publications have to be interpreted to match the intended audience’s level of understanding, including patients or the general public, physicists or regulators.
Also, Medical writers require an understanding of the medical concepts and expressions, knowledge of suitable guidelines as regards the structure and contents of specific documents, and good writing skills.
Skills to become a Medical Writer
The basic requirement for becoming a medical writer is off course, familiarity with medical concepts and terminology.
Advanced training in one of the life sciences such as medicine or paramedic sciences such as pharmacy, microbiology, nutrition and dietetics, biochemistry, and biotechnology will have the right context to familiarize the writer with scientific principles and evidence from study.
Other important requirement is the ability to write. Since a medical writer’s basic necessity is to convey science knowledge to the target audience, some degree of command over the language, expressed by the ability to write grammatically correct text, and the ability to simply and succinctly articulate and present knowledge is most critical.
So, in this blog, we are going to understand “what are the various skills required to become a good medical writer?”
Familiarity with medical concepts and terminology is a must before proceeding on the way to become a medical writer.
Others skills that are important to be a medical writer are as follows:
- Knowledge of Scientific & therapeutic area.
- The drug development process, pharmacology, drug safety.
- Statistics. (interpreting or analyzing graphs)
- Any medical writer has to deal with schemes of randomization, confidence interval, P +values and t-tests.
- phases (I-IV) of clinical trials.
- Technical guidelines (ICH guidelines)
- Knowledge of Scientific & therapeutic area: Since the medical writer publishes information about medical science, it is needless to say that he / she knows the medical terms and principles.
Someone must also have strong grammatical skills and how to write an argument or description.
The writing of professional papers relating to particular medical areas, e.g. cardiology or neurology, may be greatly improved by information in this paper.
- The drug development process, pharmacology, drug safety: Medical writers dealing with the preparation of clinical research and regulatory documents such as trial protocols, investigator brochures, clinical trial results of different phases (I-IV) of clinical trials, effectiveness and safety summaries need a detailed understanding of the drug development cycle, clinical research and various recommendations relating to them.
Even those writing reports of early clinical development need a good pharmacology framework and an understanding of pharmacokinetic principles.
Similarly, health writers who write safety papers need to consider the mechanism of drug protection and the protection reporting standards imposed by specific regulators.
- Statistics: Medical writers come across statistics when they write about the clinical trials and the research studies they write.
The statistical results of the clinical research must be presented in a way that helps clinicians to determine the consistency and reliability of both the design of the analysis and any conclusions that could impact the clinical practice significantly.
Meta-analysis is a statistical technique for summarising the results of multiple studies in a quantitative manner
Any medical writer has to deal with schemes of randomization, confidence interval, P +values and t-tests. Effective medical writing includes an understanding of the facts.
Another way to know is by conducting conferences on medical statistics provided by qualified statisticians.
It is very useful for a medical writer to have the knowledge of different statistical methods, but it depends entirely on the type of industry / company in which you work. Yet if you’re able to read or evaluate diagrams, it will be a great benefit in the near future.
- Technical guidelines: The EU, the USA and Japan have developed a set of common guidelines on the drug development and registration (International Conference on Harmonization [ICH] guidelines).
ICH Stability Guidelines for Stability Conditions and Testing for Product Quality are followed around the world.
Knowledge of these guidelines is a “must” for every medical writer.
In addition, new guidelines emerge, old ones are revised but a medical writer has to keep up to date.
“Publication guidelines like Good Publication Practices, guidelines for reporting clinical trials (e.g. CONSORT), the International Committee of Medical Journal Editors’ (ICMJE) guidelines for manuscripts are available. Moreover, all medical journals have their own instructions for the authors.”
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use ( ICH) is an initiative which brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of the development and registration of pharmaceutical products.
The aim of the ICH is to promote public health through the creation of technical guidelines and specifications for the registration of pharmaceutical products.
The ICH guidelines are divided into the four categories below and ICH topic codes are assigned according to these categories.
Q: Quality Guidelines
“Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for the impurities testing and a more flexible approach to the pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.
S: Safety Guidelines
ICH has developed a comprehensive set of safety guidelines to identify potential risks such as cancer, genotoxicity and neurotoxicity.
A recent development has been a non-clinical research technique for determining the responsibility for QT interval prolongation: the most significant single cause of drug withdrawals in recent years.
E: Efficacy Guidelines
ICH ‘s research under the heading Efficacy deals with the design, behavior, health and reporting of clinical trials.
It also includes novel types of biotechnological-derived medicines and the use of pharmacogenetics / genomics techniques to develop better-targeted medicines.
M: Multidisciplinary Guidelines
Those are the cross-cutting subjects that do not fall directly into either of the categories of efficiency, health and efficacy.
It includes the ICH medical terminology (MedDRA), the The Technical Document (CTD), and the creation of regulatory knowledge transmission electronic standards (ESTRI).
Among all the ICHGuidelines, Efficacy Guidelines are available on how to write clinical study reports (ICH E3), investigator′s brochures, patient information leaflets, clinical overviews, periodic safety reports (ICH E2C) and other documents required for regulatory submission.
ICH E3: structure and content of clinical report
In November 1995 the ICH Harmonized Guideline was finalized under step 4.
This document describes the format and content of a report on a clinical study that will be acceptable to all ICH Regional regulators.
This consists of a central report suitable for all submissions and appendices that need to be made available but in all cases should not be submitted.
ICH E2C(E2A-E2F): Pharmacovigilance
E2C(R2): Periodic Benefit Risk Evaluation Report
The ICH Harmonised Guideline was finalised under Step 4 in November 1996.
The document includes guidelines on the format and content of security updates, which must be given to regulatory authorities at intervals after goods have been marketed.
The Guideline is intended to ensure that authorities are provided with maximum efficiency and prevent duplication of effort at specified times after promotion, with the worldwide safety experience.
E2F: Development safety update Report
The ICH Harmonised Guideline was finalised under Step 4 in August 2010.
The Development Safety Update Report (DSUR) proposed in this Guideline is intended to serve as a shared standard between the ICH regions for periodic reporting on drugs under clinical (including marketed drugs under further study).
The DSUR’s key focus is on evidence and results from interventional clinical trials (referred to as “clinical trials”) of the examined drugs and biologics, whether or not they have a marketing license.
Upon completion of the E2F Step 4 Guideline, the E2F EWG has produced DSUR Examples for commercial and non-commercial partners to assist with the application of the E2F Guideline.
It should be noted that these documents are the only examples and therefore did not go through the Formal ICH Procedure.
The Periodic Benefit-Risk Evaluation Report described in this Guideline is intended to serve as a common standard for periodic benefit-risk evaluation reports on branded products (approved drugs under further study) between the ICH regions.
This Guideline describes the structure and content suggested for a PBRER, and sets out the points to be included in the planning and presentation.
https://www.ich.org/page/efficacy-guidelines
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149406/
https://journal.emwa.org/statistics/statistics-for-medical-writers/
file:///C:/Users/Rahul/Downloads/mew-253-jacobs.pdfhttps://database.ich.org/sites/default/files/E2C_R2_Guideline.pdf
