Since the late 1990s, new laws and regulations have expanded the necessity for pharmaceutical companies to enroll and report results from clinical trials. However, a few organizations don’t completely comply, and industry guidelines vary. To evaluate the data-sharing practices of large organizations, scientists at Yale University in collaboration with Stanford and Bioethics International, have developed a tool that can effectively measure and improve pharmaceutical companies’ clinical trial data-sharing policies and practices.
Scientists evaluated almost one-third of the organizations that satisfied guidelines for sharing data; others could be progressively transparent to the benefit of science and the public.
The specialists applied the instrument to large pharmaceutical companies with medications endorsed by the FDA in 2015. At first, the specialists found that 25% of companies were completely satisfied with their guidelines. Those benchmarks included enlisting clinical trials, sharing data and study protocols openly, and revealing requests for information on a yearly premise.
At the point when allowed the chance to improve their score, a few companies reacted, and the extent of those meeting the standard rose to 33%. They did so by refreshing their approaches to reporting every year or by adding timelines for data sharing.
Lead author Jennifer Miller said, “The findings show that this scorecard and ranking system work. It’s one tool we can use to set standards and catalyze change in the industry.”
“However, the study also found that some companies could go much further to share trial data in a timely and transparent way. Data sharing has many benefits, the researchers noted, including generating knowledge, promoting evidence-based guidelines, and maximizing the use of data.”
“Data sharing is important for advancing the development of new cures and therapies. The next step for the team is to make annual assessments of companies’ data-sharing and transparency performance and to expand the scorecard to address drug pricing and clinical trial design practices.”
Other study authors are Joseph S. Ross, M.D. of Yale, Marc Wilenzick, and Michelle M. Mello. This work was conducted as part of the Good Pharma Scorecard at Bioethics International, supported by a grant from Arnold Ventures.
The dataset for this study will be made available on Bioethics International’s website for the Good Pharma Scorecard.
Their study was published in The BMJ (British Medical Journal).