Good Pharma Scorecard judges clinical trial transparency
Monday, December 11, 2017
Bioethics International announced the second publication of its Good Pharma Scorecard (GPS), an annual index ranking large pharmaceutical companies and new drugs on their clinical trial transparency, in BMJ Open. Bioethics International is a not-for-profit organization dedicated to raising the bar on ethics, trustworthiness, and patient-centricity in pharma.
Two of eleven ranked companies—Johnson & Johnson and Sanofi—achieved the highest overall clinical trial transparency scores, both scoring 100%. AbbVie, Celgene, Merck and AstraZeneca all scored at or above the industry median.
The 2017 GPS ranking evaluates clinical trial registration, results reporting, clinical study report synopsis sharing, and journal article publication rates for new drugs approved by the FDA in 2014 that were sponsored by large drug companies. Bioethics International is the first organization to consistently measure large pharma companies and their FDA-approved drugs on their clinical trial transparency performance. This learning system helps advance high-quality, patient-centric, and ethical healthcare innovation, medical evidence, and drug development.
The 2017 GPS shows meaningful progress has been made on several key metrics since the first Scorecard was released in 2015: the proportion of new drugs with all phase 2 or 3 trials disclosed from their NDAs went up from 50% in the 2015 rankings to 67%, and the public availability of results for trials conducted in patients for each drug, went up from a median of 87% to 96%, measured at 13 months post FDA approval. Disclosure rates for trials in patients were 65% at FDA approval and improved significantly by 3 months post FDA approval (85%).
There was little change in transparency levels for the “all trials” standard, which included evaluating phase I trials conducted in healthy volunteers; the median proportion of all trials with public results went from 65% to 68%.
“We created the GPS to help advance trustworthiness and ethics in the pharmaceutical sector, by setting clear ethics standards and benchmarking the performance of companies against those standards every year,” said Jennifer E. Miller, Ph.D., founder of Bioethics International and lead author on the paper. “This year’s Scorecard shows clear corporate leaders in clinical trial transparency and industry improvement on several metrics. We hope this improvement continues year after year, because clinical trial transparency is critical for advancing innovation, respect for trial participants, and patient health.”
Chief Medical Officer of Johnson & Johnson, Joanne Waldstreicher, M.D., said, “We’re honored to be recognized in the top spot for the Scorecard for the second year in a row. At Johnson &Johnson, we believe sharing clinical trial data honors the patients who participated in the trial, and contributes to improving patient care. The Good Pharma Scorecard transparency standards match our own standards, and we recognize the work Bioethics International is doing to shine a light on transparency in the industry.”
Joseph S. Ross, M.D., M.H.S., associate professor of medicine and public health at Yale School of Medicine, and co-author on the paper said, “Medical professionals depend on the reporting of clinical trial results to be complete and accurate to make the best decisions for their patients and properly prescribe medications. By not reporting these results, clinicians are left to make decisions based on a biased and selectively reported evidence base.”
Michelle Mello, Ph.D., professor at Stanford Law School and the Department of Health Research and Policy at Stanford University School of Medicine, and co-author on the paper, said, “The study highlights that companies are taking their legal obligations around clinical trial reporting seriously. We also found there are some emerging industry leaders that are going farther than the law requires in getting patients and doctors the information they need—and there are clear opportunities for other companies to do more.”