WHAT IS A CENTRAL LAB?
Clinical trials and research are a developing and growing field. There was a need for a formal and rigorous way to collect, combine and report trial data from different clinical sites which helped develop the concept of a Central Laboratory for clinical trials. The main objective of a central lab was consolidation of the test results and data originating from different clinical sites. Thus, the central lab is the core of a clinical trial.
A central lab as the name suggests is the laboratory where all the samples from the different clinical sites involved in a trial are sent in order to carry out the clinical trial. The central Laboratory involved in clinical trials are different for clinical testing laboratories which test patient samples for routine tests. These laboratories specialize in analysis for clinical trials in accordance with clinical study related regulations
WHAT IS THE IMPORTANCE OF CLINICAL TRIALS?
Any new development in the medical field whether in prevention, diagnosis or treatment started with a clinical trial. Thus, highlighting the significance of clinical trials. Without clinical trials there will be no development in this field. Clinical trials are carried out in various phases in order to maintain safety and in accordance with guidelines for trials.
WHAT IS THE IMPORTANCE OF CENTRAL LAB IN CLINICAL TRIALS?
The central lab is the head laboratory and most important for a clinical trial. The following is the importance of the Central lab in clinical trial as it is the main lab involved in the
- Documentation (analytical planning and maintenance of manuals)
- maintenance of laboratory kits
- Sample management
- Logistics
- Online reporting
- Data management
- Biorepository
- Equipment management
WHAT IS THE DIFFERENCE BETWEEN A CENTRAL LABORATORY AND LOCAL LABORATORY?
| central laboratory | local laboratory |
| It is a laboratory where all the samples from the clinical sites involved in a trial are sent. | It is located close to the clinical trial site. Hence, each site will have a local lab for the testing |
| Due to the presence of a single lab for various sites there are logistic problems with samples | There are no logistic problems due to the presence of the lab in the vicinity. |
| As there is one lab running the tests from various sites it ensures consistent results and analyses | different local labs for different sites leads to inaccuracies due to different equipment; operating procedures; reference ranges; and reporting methods being used |
WHAT IS THE ROLE OF THE CENTRAL LAB IN CLINICAL RESEARCH?
The central lab is involved in the complete project management. It includes the following:
- Laboratory testing – routine and safety analysis, method development and validation, analytical expertise, quality maintenance
- Investigator support- dedicated and locally based staff, query resolution, training, lab manuals and help desks
- Sample management- study specific kits building, packaging and labels, quality control, in-house frozen logistics support, kits inventory monitoring
- Logistics- planning, tracking and reporting, temperature control,
- Data management and reporting –integrated single database, standardized reference ranges and units of measure, electronic data transfer
