FDA approval = Market success

Yajat G -

Hi everyone,

Over the past week I have been working on my literature review and focusing on looking for the importance of diversity in clinical trials. I have been searching for quantitative data to directly compare two clinical trials, but many have too many other extraneous variables to effectively compare without the bias of trying to prove that diversity is a defining factor into FDA approval. Although I have not found any direct comparison, during my literature review I found a Harvard study that said “For pharmaceutical companies seeking FDA approval, getting the drug approved by the FDA may be difficult if the clinical studies are not representative of all ethnic groups. And it’s not good enough to say you tried, according to Dr. Ajay Singh.” He has a background in clinical research specifically relating to anemia and chronic kidney disease so he is well-versed in research studies and clinical trials as well as how to effectively get a drug into the market. Another great example of how diversity was necessary in clinical trials was when assessing the Alzheimer’s drug Aduhelm. Although the FDA had approved the drug it was not able to successfully enter the market because it was rejected for broad coverage by Medicare and was sent back more representative trials. So even with FDA approval being somewhat of a gold standard result of a clinical trial, market success is not confirmed without representative trials that allows insurance policies to subsidize the use of the drugs for all their users. Thanks again for reading and I will get even more information about clinical trials and diversity next time.

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    Mr. Crane
    Fascinating stuff! What’s really interesting is the relationship between the FDA and other insurance agencies. Especially in this case, where both the FDA and Medicare are government entities, and yet still disagree on the necessary standards of clinical trial reliability.
    Hi Yajat! The importance of diversity in trials is super interesting; does the FDA have particular racial or ethnic diversity quotas that must be met?

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