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July 11, 2019

Yale researchers develop new tool for clinical trial data sharing

Researchers at Yale University, Stanford University and Bioethics International have developed a new scorecard for better sharing of clinical trial data by pharmaceutical companies.

Researchers at Yale University, Stanford University and Bioethics International have developed a new scorecard for better sharing of clinical trial data by pharmaceutical companies.

The researchers assessed and revealed that nearly one-third of the companies met standards for sharing data. They said that other companies could be more transparent to the benefit of science and the public.

Many laws and regulations have been passed since late 1990s urging pharmaceutical companies to register and report results from clinical trials.

Despite the requirement, some companies do not fully comply with the standards, which results in the variation of industry guidelines.

Lead author Jennifer Miller and her partners developed a new tool comprising a set of standards and a ranking system to evaluate the data-sharing practices of pharmaceutical companies.

The partners involved in the research applied the tool to large pharmaceutical companies with FDA approved drugs in 2015.

Initially, they found that one-fourth of companies fully met their standards, including clinical trial registration, data sharing, and study protocols making publicly available.

The researchers gave the companies an opportunity to improve their score, to which only a few of them responded, increasing the proportion of companies that met standards to 33%.

Miller said: “The findings show that this scorecard and ranking system work. It’s one tool we can use to set standards and catalyse change in the industry.”

The study, however, also found that some companies could further enhance the sharing of trial data efficiently in a timely manner.

According to the researchers, data sharing has many benefits, including generating knowledge, promoting evidence-based guidelines, and maximising use of data.

Miller added: “Data sharing is important for advancing development of new cures and therapies.”

As a further step, the team plans to make annual analysis of the data-sharing and transparency performance of the companies, and to expand the scorecard to address drug pricing and clinical trial design practices.

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