Be the first to like.

Share

A tool developed by researchers at Yale, Stanford, and Bioethics International can promote greater sharing of clinical trial data by pharmaceutical companies. While nearly one-third of the companies that the researchers assessed met standards for sharing data, others could be more transparent to the benefit of science and the public, the researchers said.

Their study was published in The BMJ (British Medical Journal).

Since the late 1990s, new laws and regulations have increased requirements for pharmaceutical companies to register and report results from clinical trials. Yet, some companies don’t fully comply, and industry guidelines vary. To assess the data-sharing practices of large companies, lead author Jennifer Miller and her collaborators developed a new tool consisting of a set of standards and a ranking system.

The researchers applied the tool to large pharmaceutical companies with drugs approved by the FDA in 2015. Initially, the investigators found that 25% of companies fully met their standards. Those standards included registering clinical trials, sharing data and study protocols publicly, and reporting requests for data on an annual basis.

When given the opportunity to improve their score, a few companies responded, and the proportion of those meeting the standard rose to 33%. They did so by updating their policies to report annually or by adding timelines for data sharing, the researchers said.

Be the first to like.

Share
Yale News

Leave a Reply