BioCentury
ARTICLE | Politics & Policy

EMA, Harvard, PhRMA publish perspectives on data transparency

October 23, 2013 12:48 AM UTC

In a pair of perspectives published in the New England Journal of Medicine on Tuesday, EMA reiterated its position on the "managed" release of patient-level clinical trial data while a working group comprised of researchers from Harvard University and the Pharmaceutical Research and Manufacturers of America provided a list of principles for data sharing systems. EMA staff including Executive Director and Senior Medical Officer Hans-Georg Eichler said access to full clinical trial datasets will improve the design and analysis of subsequent trials, which the agency said would ultimately benefit companies and researchers. EMA also said wider access will allow sponsors to present "more robust" comparative-effectiveness analyses without the cost of conducting head-to-head trials.

In a separate paper, the working group said sharing patient-level data will "help research sponsors and investigators make more informed decisions about where to invest resources," but cautioned about unintended consequences and included a list of principles for data sharing systems. The working group said data-sharing requirements should also apply to government, academic and not-for-profit trial sponsors and should apply to data for trials of all approved prescription drugs, medical devices and biologics. The group said rules should specify what and how data should be shared to prevent "underreporting, concealment, and incomplete or uninformative disclosures." Additionally, the authors said the identity, hypotheses and analytical plans of parties requesting patient-level data should be publicly disclosed...