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Brazen Scofflaws? Are Pharma Companies Really Completely Ignoring FDAAA?

Placebo Control

If a sponsor gets approval from FDA to delay reporting (as is routine for all drugs that are either not approved for any indication, or being studied for a new indication – i.e., the overwhelming majority of pharma drug trials ), but doesn't post that approval on the registry, the JCO authors deem that trial “noncompliant”.

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How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

Drug development is already a difficult endeavor, with the vast majority of R&D efforts failing to produce a market-worthy product. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S. Food and Drug Administration approval.

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Bayer-led project on AI in trials eyes ‘virtual’ placebo groups

pharmaphorum

” Conducting this kind of research in Finland makes sense, as it has a sophisticated healthcare system but a small population, which can make it challenging to carry out clinical research using traditional approaches. . “On the other hand, [they] should be able to tell a user if they are no longer reliable.”

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Treatment for all: the key steps to better representation in pharma

pharmaphorum

In the UK, research found that even among people working within the healthcare sector, there was greater vaccine hesitancy among every minority of healthcare workers (HCW) than among white HCWs. In 2020, 53 novel medicines were approved by the FDA and of the patients who took part in trials, just 8% were black and 6% were Asian.