For some reason when I googled "deaths in clinical trials" a page from a rather obscure (to me) US NGO "Center for Responsible Science" popped on the first page of results. It claims (and seems to have filed a lawsuit against the FDA on that basis as well) that there was a

Dramatic Rise in Treatment-Related Deaths in Clinical Trials

And seemingly based on this data

Clinical Trial Treatment-Related Deaths

2016-2017 – 143+

2014-2015 – 10+

2012-2013 – 1+

Is this data accurate?

N.B.: the lawsuit was covered by Bloomberg Law in 2018; however that coverage doesn't extend to the [veracity of the] statistics claimed by CRS, only to their defeat in court because they seemingly didn't have standing to sue the FDA on that basis: "The center failed to sufficiently claim it had been injured by the FDA’s refusal to add more disclosures to the consent forms for clinical trial participants, the court said."

  • Interesting, and despite the outcome of the lawsuit (which doesn't approach the correctness of the claim, only the fact that the claimant hasn't suffered the injury they claim to have suffered, which makes sense as they're still alive) it is surprising. Though it could of course be easily explained by a surge in trials, or by a redefinition of some statistic. I simply don't have the data or time to look into that, but that's probably an avenue of research for someone who does have the references and time.
    – jwenting
    Oct 27, 2021 at 9:16
  • 2
    I don't feel much up to taking the effort to fully research the available data here, but for at least one of the studies on the lawsuit, the 19 "treatment related deaths" appears to be all of the deaths in one arm of the study. The study was halted for this reason, but there were also 9 deaths in the control group, and the study population overall was cancer patients. Definitions vary by study, but it seems like the most charitable assumption is they're using the "deaths during treatment" as treatment-related definition, which is misleading at best in this context. Oct 27, 2021 at 23:25
  • 1
    143 deaths in two years in the treatment arm during all cancer studies sounds quite reasonable to me, and not suggestive of general lack of safety of the study drugs, rather suggestive of lack of safety of having cancer. 1 death in 2012-2013 does not really seem reasonable. Oct 27, 2021 at 23:25


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