Researchers at Yale University, Stanford University, and Bioethic International developed the Good Pharma Scorecard to provide rankings of companies and new medicines based on their level of clinical trial transparency and data-sharing.
The Good Pharma Scorecard provides these rankings while still considering ethics and legal standards regarding trial transparency. Jennifer Miller, assistant professor at Yale University School of Medicine, told us the tool was designed to be a set of new data sharing measures and a ranking intervention.
Existing guidelines for data sharing vary widely and are often vague and conflict, she said, adding, “There wasn’t a clear set of measures for what data should be shared, how, and when, before we developed our tool.”
The tool provides a “harmonized set of measures” that can be used to benchmark sponsors’ data sharing practices and applies the measures to benchmark the data sharing policies and practices of large companies with approved drugs, Miller explained.
Additionally, the scorecard introduced a ranking system in an aim to increase data sharing practices. It also made a concrete deadline for making data available: 6 months after US Food and Drug Administration (FDA) approval or 18 months after a trial is over.
“This was a critical addition, as many guidelines say data needs to only be shared after publication of trial results. This means that if a paper isn’t published on a trial, then no data sharing is necessary,” said Miller. “As many trials are never published in the medical literature, we needed to close this loophole and ensure that non-Phase I trials are generally sharing data.”
Topping the charts
Leading the industry in clinical trial transparency for 2019, Novo Nordisk and Roche/Genentech are tied in first with a transparency score of 100%. Novartis, Merck, Bristol-Myers Squibb, and Pfizer make up the rest of the top five on the Good Pharma Scorecard.
A score is given based on the public availability of results for trials conducted in patients, the company’s compliance with legal transparency requirements, and data sharing at the patient-level.
The final score a company represents an average based on all of its approved medicines for that year.
Evaluating transparency
As part of launching the scorecard, Miller said the researchers wanted to evaluate if ranking companies in this manner would improve their practices – after conducting a study to examine this, they determined that it has.
The researchers evaluated the importance of transparency and data sharing by applying the tool to large pharmaceutical companies with drugs approved by the FDA in 2015. Results of the study were published in the British Medical Journal and demonstrated that initially 25% of companies fully met standards for registering clinical trials, sharing data and study protocols publicly, and reporting requests for data on an annual basis.
Evaluators gave the companies the opportunity to improve scores by updating policies to report annually or add data sharing timelines. A few organizations responded to this chance and the rate of standards met rose to 33%.
Miller said that the group aims to publish rankings annually while also expanding its analysis. “Next we will benchmark all sized companies, not just large drug companies, and add biologics and devices to the evaluations,” she said.
Beyond the statistics, the study demonstrated that data sharing has benefits. Researchers found that transparency generated greater knowledge, promoted evidence-based guidelines, and maximized the use of data.
