FDA issues final guidance to improve diversity in clinical trials

fda issues final guidance to improve diversity in clinical trials

Sumary of FDA issues final guidance to improve diversity in clinical trials:

  • Food and Drug Administration on Monday released final guidance on improving diversity among participants in clinical trials..
  • “To further promote and protect public health, it is important that people who are in clinical trials represent the populations most likely to use the potential medical product,”.
  • The FDA has been working for several decades to promote enrollment more reflective of the population, “challenges to participation in clinical trials remain, and certain groups continue to be underrepresented in many clinical trials,”.
  • Food and Drug Administration on Monday released final guidance on improving diversity among participants in clinical trials.<br>.
  • (iStock) Diversity among participants in ongoing clinical trials for coronavirus vaccines has been a significant point of discussion..
  • Earlier last month, for example, Reuters reported that Moderna hired contractors had not enrolled enough trial participants from minority groups to see how well the vaccine works in these populations..
  • The FDA said it’s “important that people who are in clinical trials represent the populations most likely to use the potential medical product.”(iStock) In contrast, Black Americans account for roughly 13% of the U.S..
  • population but are among only 5% of clinical trial participants, according to Pfizer, one of the leading companies developing a coronavirus vaccine, which cited U.S..
  • Pfizer announced on Monday that its coronavirus vaccine was found to be 90% effective in a trial that includes more than 43,000 participants, “with 42% having diverse backgrounds,”.
  • Recommendations included specific definitions of intended trial participants (also known as exclusive criteria), while broadening patients allowed to partake in trials’ Phase 2, and enrolling clinically relevant populations (like kids, teens and enough women, among others)..
  • Also, those running trials should determine which populations will clear a drug differently earlier on to adjust doses and be able to study the drug safety and efficacy across different groups, the agency advised..
  • A recent example of an adaptive trial would be the World Health Organization’s multi-country Solidarity trial, which dropped certain coronavirus treatments (hydroxychloroquine and lopinavir) over the summer over futility…

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