The myth of equipoise in phase 1 clinical trials.
Phase 1 clinical research trials using healthy volunteers are conducted for the sole purpose of serving the public good (a utilitarian concept). The literature on equipoise analysis does not exclude phase 1 trials with controls or healthy volunteers from the claim of being in "equipoise." The continued perpetuation of this ethically and scientifically invalid concept undermines the ethics of research with human subjects.
Shamoo
Adil E
AE
Department of Biophysics, University of Maryland School of Medicine, Baltimore, Maryland, USA. ashamoo@umaryland.edu
D035843:Biomedical Research / Q000941:ethics*; D017321:Clinical Trials, Phase I as Topic / Q000941:ethics*; D019317:Evidence-Based Medicine / Q000941:ethics*; D009229:Mythology; D018570:Risk Assessment / Q000941:ethics*; D012307:Risk Factors; D014481:United States