Participation in a clinical trial or longitudinal study involves significant investment of a biobank’s resources. For example, in order to participate, biobankers must allocate storage space, create databases, develop sample collection protocols, etc. –and ultimately, the success of the clinical trial or longitudinal study depends on the thoughtful optimization of each of these steps.
For this blog post, let’s focus on just one aspect of participation: sample collection.
When the time comes to gather samples from participants in a study, it’s typically that staff on-site at the clinical trial that performs the actual collection (as opposed to trained scientists from the biobank). So, it’s the responsibility of the study design team to provide the clinical staff with all of the materials necessary for sample collection, as well as a protocol that is clear and easy to follow.
In general terms, there are two methods used to provide clinical staff with sample collection materials:
- bulk supplies and
- collection kits.
With the bulk supply method, large quantities of the materials necessary for sample collection are shipped to the clinical site. Then, the on-site staff breaks down the bulk containers and distributes the materials required for each individual collection. The bulk supply method is usually cost-effective and quick, but it relies heavily on the experience of the clinical staff.
Many biobankers prefer the collection kit method. With this method, individual kits containing everything needed for sample collection from a single study participant are prepared several weeks in advance. This makes the job of the clinical staff easier; they simply have to open a new kit for each participant. Collection kits ensure the right type and quantity of sample will be collected.
Since the success of any clinical trial or longitudinal study depends heavily on the quality of original material collected, biobankers need to find a balance between the cost-effectiveness of bulk supply and the quality guarantee of collection kits.
A recent Fisher Bio Services video blog outlines a few key questions you need to consider as you weigh the pros and cons of each method:
- What is the timeline?
Collection kits can take four to six weeks to assemble. If you need samples to be collected sooner, the bulk supply method may be optimal because bulk supplies can be sent to the collection site within a few days.
- How experienced is the staff at the collection site?
Bulk supplies can save you time and money. But if the on-site staff does have experience with gathering biosamples, collection kits may be necessary to ensure high sample quality.
- How complicated is the collection?
If several time points are needed in the study, collection kits can be helpful in keeping track of the different collections and protocols. Bulk supplies may be more appropriate for trials with only a single collection or follow-up.
- What is the margin of error allowed?
Collection kits can be designed with specific, barcoded supplies that can be tracked through the use of the sample. Is this kind of precision is necessary for your study? If so, collection kits may be the best choice.
- Are there non-standard supplies used in the collection?
Collection kits may be the best bet if a protocol calls for unique items that an on-site clinical staff member may not be familiar with.
In the end, it’s up to each trial or study review board to determine the best method for collection. Remember: Your needs are specific to your trial and your collection site, and it’s likely there are more factors to consider than the few listed here.