Before understanding the difference between central lab and local lab, let’s understand about “why lab tests are conducted”
In Clinical trials, several lab tests need to be performed for each patient as per the protocol. These tests are needed to evaluate the following things:
- Inclusion/Exclusion criteria or eligibility check
- Safety checks
- Study drug dose determination
Sponsor or Pharmaceutical companies have two options-Central labs and Local labs to perform these tests.
What is the central lab in clinical research:
Central labs are the sponsor assigned well-equipped laboratories.
Samples are collected from different sites (hospitals) and they are sent to one lab (sponsor assigned) for testing purpose. Sites may be situated in different countries but the samples need to be sent to one special laboratory (which is called central lab).
What is the local lab in clinical research:
Local labs are the regular lab facilities that are available in the hospital or nearby location. Each site (hospital) will have their lab.
Sample of the patients on a particular site will be analysed in lab affiliated to that particular hospital.
Now the question comes, why there are two different kinds of labs
In the central lab, all the samples are processed by using the same analytical methods so that unintentional differences in laboratory results and reference ranges can be avoided.
For example, you can observe much difference in haemoglobin lab results if performed by different methods. Even different labs may use different ranges for haemoglobin.
Central Laboratories are equipped with better facilities which are not possible to provide at each hospital-associated lab (local lab).
For example, the central laboratory uses sophisticated software to record, track and transmit the lab results after analyzing the samples.
Central labs can conduct many different kinds of protocol-specific tests because they are maintained mainly for clinical trial-related work.
In general, Pharmacokinetic parameters such as the concentration of drug in blood from different time points, metabolites concentration, genetic mutations and another biomarker test on the tissue sample etc are performed in the central lab.
There are also issues with central labs and local labs need to be used in these cases. Let us discuss one by one:
lab test at Central lab is times consuming process as all sites sample has to reach one lab and it may take 4-7 days or more.
Sample stability may be compromised if any issue in transportation.
In the case of the adverse event, immediate lab tests are needed which can be done in the local lab only. Central labs are not feasible.
Related: Free Course on Clinical Data Management
Dosing of study drugs: Lab tests need to be performed in a short period.
In the case of oncology studies, drug dosing and adjustment of dose generally depend on blood biochemistry and Blood cells counts and these tests can be done easily in the local lab facility without wasting time.
Important Points for CRA and CRC
In the case of local labs, Clinical research coordinator (CRC) has to share the reference range manuals to clinical research associate (CRA) and clinical research associate enters the reference ranges in the clinical database (eDC).
(The document containing all the reference rages to be used in the local lab for a particular study is called local lab manual.)*
In the case of the central lab, manual data entries of reference ranges are not needed.
Local lab-results are manually entered in clinical databases (eDC) by the clinical research coordinator.
Form 1572, section 4 mentions about local lab facility. No need to mention about the central lab here.