Tuesday, July 22, 2008

Ethics, Phase 1 Trials, and the Developing World

Under what conditions is it ethical to perform phase 1, translational clinical trials in low and middle-income countries? Together with lead author Alex John London (Carnegie Mellon, Philosophy), I attempt to answer that question in the July 5 issue of Lancet ("Justice in Translation: From Bench to Bedside in the Developing World").

The article makes three main points. First, we note that much discussion about international research has centered on post-trial access to interventions (that is, should patients enrolled in trials be provided with free drug even after a trial is completed?) However, we argue that this question is irrelevant for phase 1 studies, which test safety rather than efficacy.

Second, we note that most major national and international ethics codes indicate that trials conducted in disadvantaged communities should be responsive to local health needs. We suggest that this is the appropriate standard for determining whether phase 1 trials are consistent with international standards of fairness for clinical research.

Third, we attempt to specify what international policies actually mean by responsiveness. We suggest that a trial is responsive if it addresses an urgent, umet health need of a host community, and if it is part of a process of developing knowledge that can reasonably be projected to be applied in a host community. (photo credit: VCU Tompkins-McCaw Library Collections, 2008)

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