LEARNING FROM OUR PATIENTS - ONE PARTICIPANTS IMPACT ON CLINICAL-TRIAL RESEARCH AND INFORMED CONSENT

This Perspective includes an essay on modifying phase I clinical trial s, written by George Zimmer, who was a professor of English and a comm entary on that essay. Professor Zimmer was a cancer patient who partic ipated in the phase I clinical trial program at the University of Chic ago. His ideas are eloquently expressed and have had a profound effect on our investigational research for anticancer agents. Although at ti mes his suggestions may seem radical, Professor Zimmer urges us to rec onsider the 50-year-old Nuremberg paradigm that participants in human research are ignorant and vulnerable and must be protected. Although w e must protect patients who have life-threatening diseases from coerci ve inducements and misplaced hopes, we must also listen carefully and thoughtfully to our patients. This is particularly true when, as resea rch participants in the face of sacrifice and the threat of a life-end ing diagnosis, they have made the effort to express their concerns. Wi th the effect of the acquired immunodeficiency syndrome movement on cl inical studies and on drug research and development, a precedent has b een set that allows patients to reshape their role as participants in research trials. On a personal level, the essay by Professor Zimmer ha s had a significant effect on our research methods and, indeed, the fo cus of our research efforts. Thus, it is with a sense of respect and h onor that we share George Zimmer's thoughts and our comments about the influence he has had on our research practices.