In January of 2015, the Institute of Medicine (IOM) made an historic call to increase the sharing of data gathered in clinical trials. The aim to increase knowledge and subsequently increase the rate of therapy development is clear.
How does this work? Collectively, sharing trial data would reduce cost and data leakage by eliminating duplicate efforts for sponsors. However, the barriers remain large. Barriers include maximizing value for primary investigators/sponsors as well as protecting the data itself.
First, the IOM laid out who is responsible for these issues, including: funders and sponsors of clinical trials, disease advocacy organizations, regulatory and research oversight agencies, research ethics committees or institutional review boards, investigators, research institutions and universities, academic journals, and membership and professional societies. These are a lot of cats to herd.
Beyond suggesting responsible stakeholders, the IOM also highlighted exactly when clinical trial data should be shared. The challenge is to encourage sharing with secondary investigators while affording primary investigators the opportunity to extract value. Presented more as a rule of thumb, the IOM recommends sharing data 18 months after trial completion. Further, when data sharing is delayed, the IOM takes an interesting step to make stronger recommendations for sharing data prior to 30 days after regulatory approval, or at worst case, 18 months after product abandonment.
So what should be considered next? First, we believe primary investigators will need to be rewarded, financially or scientifically—perhaps even tying compensation to the success of their secondary investigators. Second, technologies and processes for enabling secure delivery to secondary investigators must be considered, with an eye to the reality that downstream investigators may not have the same internal processes and culture of those who originally collected the data.
Learn more about how eBinders allows controlled document sharing between clinical research sites.
Has the IOM taken on too large of a challenge? While global sharing of clinical data is an idealistic scientific ecosystem, we’re not sure primary investigators are sufficiently motivated. Furthermore, we’re left unsure how all the data will be shared and who will lead the effort in each case. What do you think? Tell us in the comments.