[Video] Sample Collection for Clinical Trials & Longitudinal Studies: Bulk Supplies VS. Collection Kits
When setting up a clinical trial or a longitudinal study, every decision revolving around sample management: collection, lab processing, storage, disssemination, and data management, is crucial to its success. For collection of clinical participants' biospecimens, one aspect that requires significant thought and planning is how the needed patient samples (e.g. whole blood, tissue) will be collected at the clinical sites. Sponsors, CROs, and clinical investigators must decide if they are going to provide their sites with the tubes and other supplies in bulk, or provide patient-specific or visit-specific collection kits. Below are five points to consider when making your decision:
- Your timeline for getting the trial up and running. No matter how well you plan, the set-up phase can come down to the wire. If you have four to six weeks to get your trial sites up and running, then you can consider building and distributing sample collection kits, and train site staff on how to use them. If time does not permit, the choice becomes very easy—bulk supplies. When getting supplies to the site speed is critical, shipping in bulk allows them to be there within a few days.
- Site experience in conducting clinical trials. Some hospitals are well versed in clinical trials, while others are less so. Clinical sites that are experienced in this process and have a track record of success may better understand the scope of your specimen collections and be more able to manage bulk supplies for your trial (the flip side of this is that a popular site may have a number of ongoing trials, and it may prove difficult for them to separate each trial and collection protocol). Sites with less experience may not have these study management systems in place, and sending clinical trial-dedicated kits with collection instructions will lessen the risk of error.
- Type of collections. If the protocol calls for different biospecimens to be collected from patients over time, then having visit-specific collection kits made and shipped to sites will help to ensure that the correct biospecimens are collected and in the correct manner. These specific kits will contain only the needed components for that patient visit, and in addition, the containers can be barcoded to tie the collections together to a specific patient, and will eliminate receiving the wrong specimen for a specific time point. If your protocol calls for only one follow-up collection, or the samples are the same at each follow-up visit, then bulk supplies may be the more cost-effective option.
- The need for absolute precision. It is important to examine the stringency of your collection process. As the clinical market moves toward personalized medicine, the importance of absolute accuracy has never been higher. For companies working on an autologous therapy, the need to match the patient, the biospecimens, and the doses of the resulting therapy demand a specific, barcoded kit that would encompass all the needed materials, specific instructions to ensure a "perfect" sample, and provisions to ensure proper labeling at collection and downstream. For trials that are collecting specimens for standard lab work and storage, there is still the need for an accurate sampling and tracking, but bulk supplies may suffice.
- Standard items vs. unique and difficult to replace. Many trial
protocols call for collection of blood samples in standard red top tubes, while others call for samples collected into specialized containers or using equipment that is not commonly found in a hospital or clinical site. Consider whether or not the staff members will be comfortable using these unique items, and whether or not a suitable replacement can be found if mistakes are made. You may decide to combine two options; send study-specific collection kits to each each site, supplemented with extra components sent in bulk for replacement purposes.
The decision of how to supply your study sites with biospecimen collection materials is not a simple one, and certainly has more than five points to consider. If you are interested in related information about this topic, please download our eBook on "Automating Your Sample Collection for Biobanking: 10 Things to Consider" by Kathleen Groover, Ph.D., Project Director.
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