Pharma & drug development

Why is pharma so bad at sharing clinical trial information?

Since the 90s, the requirements for pharmaceutical companies to register and report results from clinical trials have increased. But analysis published in the BMJ indicates that large pharmaceutical companies could be doing much more when it comes to sharing data. Abi Millar finds out more.

Over the last few decades, pharma companies have been under ever-mounting pressure to report their clinical trial data. Beginning in 1997, when the US Food and Drug Administration (FDA) required certain trials to be registered, the expectations for transparency have steadily increased.
At first, the only trials that needed registering were those for potentially lifesaving drugs. And while companies needed to record that the trial had taken place, they didn’t need to release any of the data.

It wasn’t until 2007, when the FDA implemented its Amendments Act (FDAAA), that registration requirements were applied to all trials. At the same time, certain trials were also required to post their results, a mandate that was extended to all trials ten years later.

Today, the industry is in a position where pharma companies are not only reporting their results, they’re also going a step further and discussing whether to share de-identified patient data. Since January this year, the world’s leading medical journals have required authors to disclose whether or not they’ll be sharing this information, a public declaration that will likely nudge them towards further transparency.

Unfortunately, it can be hard to gauge how much progress has truly been made. The guidelines for what should be shared, and how it should be shared, are often vague, and it isn’t always clear what constitutes good practice. A 2017 study, which looked at 42 pharma companies’ policies on trial transparency, showed high variability in what they understood by this.

Read the rest of this article in the October 2019 edition of Pharma Technology Focus 


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