Disclosure in Phase 1 Cancer Trials

Followers of this blog may recall my continuing concern with the way informed consent is obtained in phase 1 trials involving patient-volunteers (typically, these patients have exhausted standard care options and enter phase 1 trials as a final shot at managing their disease). Language used by investigators in these studies is often suggestive of therapeutic benefit, even though meta-analyses of phase 1 studies show that chances of major clinical benefit in phase 1 studies are exceedingly low. In previous posts, I described my own experience with an ethics review committee that actually defended giving patients vague and almost meaningless information about the therapeutic benefits of phase 1 trial participation. Meantime, evidence from surveys indicate that phase 1 cancer patient-volunteers tend to overestimate the probability of therapeutic benefit.

2009 October 26 | Leave a comment | Tags: Informed Consent Phase 1

@Manual{stream2009-83,
    title = {Disclosure in Phase 1 Cancer Trials},
    journal = {STREAM research},
    author = {Jonathan Kimmelman},
    address = {Montreal, Canada},
    date = 2009,
    month = oct,
    day = 26,
    url = {http://www.translationalethics.com/2009/10/26/disclosure-in-phase-1-cancer-trials/}
}