Clinical trial data helps in deciding prescriptions and is good for science, but a new study revealed that not many pharmaceutical companies are completely transparent with the development data for their products. The study also found that large companies are much more transparent than smaller ones.
The study, co-authored by Yale researchers and published in The BMJ Open, assessed the data-sharing practices of 42 pharmaceutical companies for clinical trials of 40 novel drugs and 22 biologics which received US Food and Drug Administration approval in 2016 and 2017. They were evaluated with the Good Pharma Scorecard, which consists of transparency measures and a ranking system.
The researchers found that only seven of the 42 companies (17%) entirely met the tool’s standards for transparency and sharing data, with smaller companies being particularly opaque.
“The non-large pharmaceutical companies are dragging down the sector, often failing to meet federal reporting requirements, much less voluntary standards,” said study co-author Jennifer Miller, assistant professor at Yale School of Medicine, founder of Bioethics International.
“The lack of transparency is a problem because access to robust clinical-trial data supports patient care and good science,” she added. “Full transparency allows scientists to learn from previous work and prevents people from being exposed to unnecessary experiments.”
From the late 1990s, requirements for pharmaceutical companies to register and report results from clinical trials have been increasing. However, not all companies fully comply with the rules and industry guidelines vary.
In a smaller 2019 study using the transparency scorecard, 25% of companies fully met the standards, which include registering clinical trials, sharing data and study protocol publicly, and annually reporting requests for data. When given a 30-day window to improve, 33% met the standard.
For the latest study, the researchers also included biologics and smaller companies. While 17% of companies had perfect scores, 58% of the companies assessed had publicly available results for all patient trials, 42% complied with federal reporting laws, and 26% met the scorecard’s data-sharing measure.
Non-large companies were less responsive than large companies when offered the 30-day window to fix errors and improve data-sharing practices. Four companies used the window to improve data-sharing procedures
“It’s not surprising that non-large companies lag behind large as they may have fewer resources and smaller staffs with less compliance experience,” Miller said. “Our findings suggest that large companies may benefit from reviewing the transparency procedures of smaller companies before partnerships, mergers, and acquisitions so they don’t inherit any deficiencies.”
The researchers did notice improvements among large companies between the 2019 study and the latest one. For example, the median data-sharing score for large companies increased from 80% for drugs approved in 2015 to 100% for products approved in 2017.
Source: Yale University
Journal information: Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis, BMJ Open (2021). DOI: 10.5061/dryad.r2280gbdb
