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August 2, 2021

Yale University study finds low trial data transparency

Large pharmaceutical companies were observed to be more transparent about their trial data than smaller companies.

A study conducted by researchers at Yale University in the US found that only a few pharmaceutical companies are completely transparent regarding the data related to their products.

In the study, published in The BMJ Open, large companies were observed to be more transparent compared to smaller firms.

The study examined the sharing practices of 42 pharmaceutical companies for trial data of 40 drugs and 22 biologics that received the US Food and Drug Administration (FDA) approval in 2016 and 2017.

Good Pharma Scorecard was used to conduct the assessment.

A tool created by researchers at Yale, Stanford University and Bioethics International, the scorecard comprises transparency measures and a ranking system.

Of the total 42 companies assessed, seven or 17% completely met the tool’s transparency and data sharing standards. This 17% of companies had ‘perfect scores.’

Meanwhile, data from all their human trials were made available by 58% of companies and 42% had complete compliance with federal reporting laws.

According to the study, 26% of companies entirely met the data-sharing measure of the scorecard while 67% made results for their patient trials public within six months following the FDA approval.

Furthermore, 26% of the products assessed had public data for all trials backing their FDA approval.

On providing a 30-day timeframe to address errors and to improve data-sharing procedures, the researchers found non-large companies to be less responsive than large companies.

During the timeframe, four companies enhanced their data-sharing practices, in turn increasing the median data-sharing score from 60% to 69% for all companies.

Yale School of Medicine assistant professor Jennifer Miller said: “The lack of transparency is a problem because access to robust clinical-trial data supports patient care and good science.

“Full transparency allows scientists to learn from previous work and prevents people from being exposed to unnecessary experiments.”

A study of large companies in 2019 using the transparency scorecard revealed that 25% entirely met the standards, and following a 30-day window, the proportion reached 33%.

With the latest study, the team observed improvements among large companies versus the 2019 study.

The median score for data sharing by large companies increased from 80% for medicines approved in 2015 to 100% for drugs approved in 2017.

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