Mitigating Risks for Biospecimen Management in Clinical Trials
During clinical trials, thousands of biological samples (biospecimens) are collected, usually at different places at different times. The samples are analysed either during the screening phase of the study, in order to include or exclude subjects, or after the administration of the product, in order to assess primary or secondary endpoints.
Flawless management of clinical trial biospecimens is therefore critical as correct handling has a big impact on both the course and the results of clinical trials: The correct management – handling, transport, and storage – of specimens is essential to guarantee their integrity and quality. Biospecimens often require specific conditions, such as controlled temperature, and time can be a factor when samples need to be analysed right after collection.
A documented chain of custody requires complete traceability of each biospecimen tube between the taking of the sample and the associated results.
The timely analysis of biological samples can be crucial for the progress of a clinical trial, especially in the screening phase.
Improper biospecimen management can involve missing or mixed up samples, missing data, delays in reporting results, and poorly organised biospecimen logistics. This mismanagement can dramatically affect the outcome of a clinical trial, leading to higher costs, patient drop-off, and other preventable problems.
THE BIGGEST CHALLENGES FOR BIOLOGICAL SAMPLE MANAGEMENT IN CLINICAL TRIALS
Proper biospecimen management requires several elements, any of which can pose challenges. These necessary elements include:
- Clear instructions that allow the collection, preparation, and shipment of the required samples at the required time points and in the required conditions
- Complete traceability of all samples and aliquots in a way that guarantees they are correctly identified on an individual basis
- A list of all the aliquots generated on different sites worldwide during a clinical trial
- Consolidation and verification of the data associated with that list of aliquots
- Transportation and storage of samples at defined packaging and temperature conditions
- Dispatch of samples to defined locations, such as analytical labs and storage facilities
- Management in compliance with good clinical laboratory practice (GCLP) requirements
While biospecimen management during clinical trials can be exacting and difficult, there are plenty of ways to surmount the obstacles through expert clinical supply services. The following are a few examples:
BIOLOGICAL SAMPLE COLLECTION KITS
Sample collection kits are designed specifically for each study and each visit, and can be supplied to clinical sites along with all the associated documentation. This helps ensure correct biospecimen collection, preparation, and handling. Also, all of the shipping materials may be supplied to meet regulatory or temperature requirements, with preprinted airway bills.
A clear and unambiguous identification of each tube generated can be designed with a label for specific information and a bar code for complete traceability. These tubes may also be prelabelled.
SHIPMENT AND DISPATCH OPTIMISATION
Shipment and dispatch of biospecimens can present costly challenges. Through an experienced clinical supply services provider, the process can be optimised to reduce the cost of transportation and improve overall trial efficiency.
Samples can be centralised before use to allow the generation of a consolidated and verified list. A well-planned logistics strategy for biomedical samples collected during clinical trials is essential to cutting costs and optimising quality.