Food and Drug Administration responds to pressure for expanded drug access.

@article{Brower2014FoodAD,
  title={Food and Drug Administration responds to pressure for expanded drug access.},
  author={Vicki Brower},
  journal={Journal of the National Cancer Institute},
  year={2014},
  volume={106 6},
  pages={
          dju171
        }
}
  • V. Brower
  • Published 1 June 2014
  • Biology
  • Journal of the National Cancer Institute
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Allowing children who are not eligible for a clinical trial and for whom there are no known effective therapies may obtain access to investigational agents, including drugs under development for adults, is recommended.
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[Compassionate use of drugs].
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  • Medicine
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It is found that patients and their families experience mixed results, but still gravitate towards the use of online campaigns out of desperation, lack of reliable information about treatment access options, and in direct response to limitations of the current fragmented structure of expanded access regulation and policy currently in place.
The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials
TLDR
It is argued first that excluding vulnerable subjects from participation in pragmatic clinical trials can be harmful by preventing acquisition of data to meaningfully inform clinical decision-making in the future, and second that protections for vulnerable subjects in traditional clinical trial settings may not be translatable, feasible, or even ethical to apply in pragmaticclinical trials.