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 out investigational research for anticancer agents.
Although at times his suggestions may seem radical, Professor Zimmer urges us to reconsider the 50-yearold Nuremberg paradigm that participants in human research are ignorant and vulnerable and must be protected.
Although we must protect patients who have lifethreatening diseases from coercive inducements and misplaced hopes, we must also listen carefully and thoughtfully to out 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 out research methods and, indeed, the focus of out research efforts. (...)
Mots-clés Pascal : Essai clinique, Relation médecin malade, Protocole expérimental, Consentement éclairé, Cancérologie, Méthodologie, Motivation, Homme, Organisation santé, Ethique
Mots-clés Pascal anglais : Clinical trial, Physician patient relation, Experimental protocol, Informed consent, Cancerology, Methodology, Motivation, Human, Public health organization, Ethics
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 97-0331164
Code Inist : 002B30A09. Création : 12/09/1997.