Sharing clinical trial data with researchers who weren’t involved in the original study maximizes the value of patients’ participation, allowing more research questions to be answered than those of the original study. However, figuring out what data should be shared and how to do it has proven to be difficult.
The most recent issue of the New England Journal of Medicine devoted three perspective articles and an editorial on the topic of data sharing. Perry Nisen, M.D., Ph.D., CEO of Sanford Burnham Prebys Medical Discovery Institute (SBP) answers questions about where we are with data sharing below.
Q: Why is data sharing at crossroads right now?Dr. Nisen: Today data are being made available through multiple separate systems, so researchers who want to analyze studies conducted by different institutions have to figure out all the different requirements to access the data. A single system would be much better, but who would pay for it and run it remains undecided.
Q: Why should research sponsors go to the expense in sharing data?Dr. Nisen: Clinical data sharing is the right thing to do for science and society. First, it increases transparency of clinical trial data. It maximizes the contribution of trial participants to new knowledge and understanding. This allows researchers to confirm or refute findings; and enables them to generate other hypotheses. Scientific research globally is moving toward more transparency in clinical trial reporting and this is an important step toward building trust.
Q: What are the challenges/concerns about a one-stop shop for sharing all clinical trials data?Dr. Nisen: Protecting patient privacy and confidentiality is a major concern. Also, ensuring the data are used for valid scientific investigation, preventing erroneous claims of benefit or risk, and controlling the cost associated with anonymizing data in formats investigators can utilize effectively. Other challenges inherent in data sharing include patient consent, data standards, standards for re-use, conflicts of interest, and intellectual property.
Q: Talk about the data sharing system you helped establish at GSK in 2013. Dr. Nisen: GlaxoSmithKline was a first mover in making anonymized patient level data available from clinical trials. In 2013, the Clinical Study Data Request (CDSR) was established. (www.clinicalstudydatarequest.com) the site is now managed by the Wellcome Trust, an independent, non-sponsor safe harbor. It includes more than 3,000 trials from 13 industry sponsors.
Q: What can be done to increase use?Dr. Nisen: We need to create a single system and a mechanism to pay for data entry and accessibility. We also need increased awareness, and that will take time. It’s critical that we ensure consistent data standards. Researchers need to provide a secure environment for data. The costs of submitting requests and analyzing data are a challenge that we need to reduce and either have the NIH or a foundation fund.
Q: Why is it important that research, academia and industry are joining forces on this call to action?Dr. Nisen: It is the right thing to do for patients and society. It creates transparency, and maximizes the utility of costly data collection.
If you'd like to interview Dr. Nisen, please contact Kristen Cusato at email@example.com
Link to NEJM article: http://www.nejm.org/doi/full/10.1056/NEJMp1608086#t=article