Miller J, Ross J, Wilenzick M, Mello M. Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices BMJ 2019; 366
Public expectations for transparency in the conduct and reporting of clinical trials continue to evolve. Today, the transparency discussion has shifted to new terrain: sharing of patient level clinical trial data. Evaluating and tracking progress on the implementation of data sharing among pharmaceutical companies is, however, difficult. Existing guidelines for what should be shared, how, and when vary widely and are often vague. As part of a larger project called the Good Pharma Scorecard, we developed a harmonized, practical set of measures and a tool for assessing sharing of participant level clinical trial data by research sponsors and applied them to measure policies and practices among large pharmaceutical companies with drugs newly approved by the FDA in 2015. We also evaluated the feasibility of the tool (a ranking system) in improving companies’ practices. We found 25% of large pharmaceutical companies fully met the data sharing measure. Given feedback and a chance to improve their policies to meet this measure, three companies made amendments, raising the percentage of companies in full compliance to 33%.