Driving Improvements in Clinical Trial Results Sharing

The world’s leading medical journals now require authors to disclose whether or not they’ll be sharing clinical trial results, a public declaration that may nudge them toward further transparency.

The GlobalData Pharmaceutical Technology website reports on how a not-for-profit organization Bioethics International, along with researchers from Yale and Stanford, developed the Good Pharma Scorecard (GPS). An annual ranking of pharma companies’ ethical performance, the scorecard provides a standardized means of assessing data-sharing practices.

Dr Jennifer E Miller, Founder of Bioethics International and Assistant Professor at the Yale School of Medicine, tells GlobalData “Before this tool, we didn’t have a consistent set of measures or benchmarks you could use to understand how research sponsors were performing. It wasn’t clear what was really going on in the sector.”

Miller’s team developed a set of harmonized measures for responsible data-sharing in clinical research. Then they used these to benchmark the practices of 20 large pharma companies that had FDA-approved products in 2015.

The results, published in the BMJ, were fairly mixed. While four of the pharma companies (Novo Nordisk, Roche, Novartis, and Johnson & Johnson) met all the data-sharing measures, two companies did not have data sharing policies at all, and the median score for data sharing was a lukewarm 63%. However, once companies were given the chance to improve their policies, the average score jumped to 80% and three more companies acquired a perfect rating.

Miller explains that this is a great example of how the tool can motivate companies to change. “Not only does it recognize where there were best practices, but it also provides a catalyst for reform. What you’ll see is that 50% of the lowest-scoring companies improved their practices and policies within 30 days of receiving the low score. So it shows the GPS is a great vehicle for setting harmonized standards as well as recognizing best practices and, perhaps most importantly, catalysing improved behaviors where needed.”

The researchers plan on repeating the scorecard every year and want to expand the scorecard to include small and mid-sized pharma and biotech companies, as well as looking at biologics and medical devices.

Says Miller “Through repeating the data sharing measures every year, we can make sure we’re catalyzing consistent data sharing year after year across many companies. The more data that companies collect, the more we need to ask what responsible data collection looks like. We need to make sure there’s an accountability mechanism present so we can understand how companies are performing relative to a set of ethics standards.”

Visit GlobalData’s Pharmaceutical Technology: https://www.pharmaceutical-technology.com/features/sharing-clinical-trial-data/

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