Tissue sample collection is a key component of many clinical trials, with clinical trial samples providing a valuable resource for research. Human tissue includes anything derived from a human being e.g. tissue, cells, plasma, urine, faeces etc.
In the UK, clinical trial tissue samples can be collected and used within the lifetime of a specific project, or they can be collected and stored for potential ethically approved research beyond the timeframe of a specific project.
There is significant amounts of legislation surrounding the collection, processing and analysis, storage, disposal, import and export, and transportation of tissue samples in clinical trials. Therefore the processes necessary to comply with each of these, must be established prior to the start of the trial. It is likely that there will be country-specific regulations and requirements relating to the use of human tissue in clinical trials, so it is recommended that these are considered early in the trial planning stage so to prevent delays at site set-up.
- The rationale for the collection of tissue samples should be justified within the trial protocol.
- It should be clear whether or not the collection of tissue samples is mandatory for a site to participate in the trial or if a site can opt-out of sample collection, or if tissue collection will only be done at selected centres. At sites where sample collection is taking place, will this be optional for patients?
- Perform a feasibility assessment of sample collection for each collaborating site/country. If a particular number of samples are required, will this be achievable across participating sites who are able to provide tissue samples?
- The costs associated with sample collection should be included in the grant application.
Quality Assurance of Sample Collection
To try to ensure quality assurance of the tissue samples collected as part of a trial protocol, a ‘Trial Samples Protocol’ should be agreed by the Trial Management Group. This should detail the requirements for collection, processing, storage, transport, data protection etc. If sample collection involves a deviation from standard of care at any sites, oversight measures should be put into place to quality assure the process. This may include training of site staff to collect/process/ prepare the samples or the production of training materials to standardise the sample pathway.
Shipping requirements will depend on the type of tissue samples being collected, and the purpose of this. It may be that the samples have to be shipped in real time, or it may be possible to batch samples to send periodically. Adequate funding should be included within the grant application to cover the cost of shipping, and any specific packaging required to ship collected samples (and the subsequent return of residual material back to site if required).
A robust sample tracking pathway should be put into place. In most cases, tissue samples will be sent to a laboratory/biobank rather than directly to the main co-ordinating centre. Clear channels of communication will ensure the coordinating centre can confirm which samples are due and expected, and the receiving laboratory can confirm receipt of samples to allow the trial coordinating centre to chase any missing samples. It is recommended that there is a process in place to allow reporting of any issues with samples so these can be resolved with sites, in addition to sites being able to record reasons why samples may not have been sent.
Sample Custodian at the End of the Trial
The location for the storage of samples at the end of the clinical trial must be decided. This may include any unused sample material following analysis in the trial or samples collected to produce a research tissue bank. If the samples are to be stored in the UK, this must comply with the requirements of the Human Tissue Act.