With funding the way it is today, long gone is the era of producing unlimited DNA from study participants' cell lines. Many study coordinators are faced with the challenge of how to manage the limited amount of DNA collected from participants during a clinical trial. Through years of working with many clients involved in clinical trials and cohort studies, I've summarized some of the important considerations that can help you manage this invaluable resource.
Four things to consider for storage of the limited DNA collected during your clinical trial/cohort study:
- What are the downstream research applications? Consider your research audience and what they will be doing with the DNA collected. This will help you determine the best concentration of DNA in each aliquot, as well as the volume of the aliquot.
- What about automated downstream processing? Do you know if the researchers analyzing your cohort’s DNA will be using robotic equipment to run their assays? If so, consider using 2D bar-coded vials in an SBS (side by side) format for the child vials. This format is ideal for automated platforms.
- How many child aliquots should you create? Some people still believe that the fewer freeze thaw cycles the better. Creating as many child samples as possible up front will cut down on the freeze-thaw cycles associated with thawing a stock tube every time a researcher requests a sample. Consider creating one-time use samples of 50-70 micro-liters.
- Will you be able to recover any of your costs? It is critical to recover some of the costs associated with maintaining your study’s genetic biorepository. This can include charging researchers a fee for each aliquot of DNA requested and/or the cost of shipping the aliquots. We can invoice the researchers on behalf of the study and use those funds to offset the cost of maintaining the repository.
In the end it is all about the best stewardship of your cohort’s DNA. As today’s assays require less and less DNA, answering the above questions will allow you to provide the research community with the right amount of DNA, in the right format, to get the needed research results while conserving the DNA you spent so much time and effort to collect.
What are the challenges you have faced with limited DNA collection? Please share your comments below.