Re-Use of Clinical Trial Data: An FDA Perspective
*Estelle Russek-Cohen, CBER FDA  

Keywords: Transparency; meta-analysis

Sponsors of clinical trials submit data to FDA on a regular basis. The datasets are submitted largely in support of a product they wish to market. The data is regarded as the intellectual property of the sponsor but re-use of data is useful in regulatory decision-making. Meta-analyses can assess consistency across a class of clinical trials. They can also be used to identify endpoints that are possible surrogate endpoints through meta-regression methods. Exploratory analyses are great for science and generate potential hypotheses. A subgroup identified as a result of an exploratory analysis would still need confirmation with additional studies but that doesn’t mean researchers shouldn’t look. I see tremendous opportunities for advancing our understanding of subgroups, and for precision/personalized medicine if we have access to the actual data used in trials. The main challenge with making data available for re-use by groups outside a regulatory setting is the need to protect patient privacy and to determine if anonymization will impact any of the conclusions. This is up to companies as FDA is still bound to maintain confidentiality but it doesn’t mean FDA cannot be supportive of the effort.