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    Access to transparent clinical-trial data helps doctors make informed decisions – New Study

    Access to transparent clinical trial data on medicine, vaccines is key to promote health and enabling the medical professionals to make informed decisions. According to a new study, published in The BMJ Open (British Medical Journal), which assessed the data-sharing practices of 42 pharmaceutical companies for clinical trials of 40 novel drugs and 22 biologics—products, such as vaccines, derived from living organisms—approved by the U.S. Food and Drug Administration in 2016 and 2017.

    Overall, only seven of the 42 companies, 17%, entirely met the tool’s standards for transparency and sharing data. Smaller companies are particularly opaque, according to the study.

    “The non-large pharmaceutical companies are dragging down the sector, often failing to meet federal reporting requirements, much less voluntary standards,” said Jennifer Miller, assistant professor at Yale School of Medicine, founder of Bioethics International—a nonprofit advocate for patient-centered medical innovation—and co-author of the study.

    “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.”

    Only 25% of large pharmaceutical companies fully met the data sharing measure – says the BMJ study

    In a 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. After companies received a 30-day window to improve their scores, the proportion of those meeting the standard rose to 33%.

    While 17% of companies achieved perfect scores, the assessment also found that 58% of the companies had publicly available results for all patient trials, 42% fully complied with federal reporting laws, and 26% fully met the scorecard’s data-sharing measure.

    The study authors found it feasible to develop a tool to measure data sharing policies and practices among large companies and have an impact in improving company practices. Using this measurement and ranking approach, they found some noteworthy efforts among large companies to share participant level trial data and a willingness by some of the companies to improve their policies when needed.

    They also found that 26% of the products evaluated had publicly available results for all clinical trials supporting their FDA approval, and 67% had public results for patient trials within six months after their FDA approval.

    Non-large companies were less responsive than large companies when offered the 30-day window to fix errors and improve data-sharing practices, the researchers said. Four companies used the opportunity to improve their data-sharing procedures, raising the median data-sharing score for all companies from 60% to 69%.

    The transparency discussion has shifted to new terrain: sharing of patient level clinical trial data – The Study says

    “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 evaluation. 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.

    Other study authors are Sydney Axson, Deborah Lincow, and Cary Gross of Yale; Michelle M. Mellow of Stanford University School of Medicine; and Catherine Yang of the University of Pennsylvania Perelman School of Medicine. (Source: The BMJ).

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