Learning from our patients: one participant's impact on clinical trial research and informed consent.
This Perspective includes an essay on modifying phase I clinical trials, written by George Zimmer, who was a professor of English and a commentary on that essay. Professor Zimmer was a cancer patient who participated in the phase I clinical trial program at the University of Chicago. His ideas are eloquently expressed and have had a profound effect on our investigational research for anticancer agents. Although at times his suggestions may seem radical, Professor Zimmer urges us to reconsider the 50-year-old Nuremberg paradigm that participants in human research are ignorant and vulnerable and must be protected. Although we must protect patients who have life-threatening diseases from coercive inducements and misplaced hopes, we must also listen carefully and thoughtfully to our patients. This is particularly true when, as research participants in the face of sacrifice and the threat of a life-ending diagnosis, they have made the effort to express their concerns. With the effect of the acquired immunodeficiency syndrome movement on clinical studies and on drug research and development, a precedent has been set that allows patients to reshape their role as participants in research trials. On a personal level, the essay by Professor Zimmer has had a significant effect on our research methods and, indeed, the focus of our research efforts. Thus, it is with a sense of respect and honor that we share George Zimmer's thoughts and our comments about the influence he has had on our research practices.
Daugherty
C K
CK
University of Chicago, Illinois, USA.
Siegler
M
M
Ratain
M J
MJ
Zimmer
G
G
D000163:Acquired Immunodeficiency Syndrome / Q000523:psychology / Q000628:therapy; D017321:Clinical Trials, Phase I as Topic; D032882:Comprehension; D035061:Control Groups; D036262:Empirical Research; D035082:Federal Government; D033161:Government Regulation; D006801:Humans; D007258:Informed Consent; D009369:Neoplasms / Q000523:psychology / Q000628:therapy; D026706:Paternalism; D010344:Patient Advocacy; D010358:Patient Participation; D026684:Personal Autonomy; D009272:Persons; D012107:Research Design; D035842:Research Subjects; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration; D035862:Vulnerable Populations