[Phase I clinical trials in oncology: ethical issues].
The scientific goal of phase I clinical trials in oncology is to determine and optimise the drug dose and schedule on the basis of the toxicity profile. These trials also respond to a need: they offer the chance of early access to a new therapy for cancer patients who are characterised by both the lack of a therapeutic option and a desire to fulfil personal ambitions. The therapeutic relationship in this context must reconcile unreasonable hopes and anxiety regarding death and follow the same rules as in other doctor-patient relationships, with the triple requirement being that it should be genuine, therapeutic and empathetic.
Goldwasser
François
F
Unité d'Oncologie Médicale, Service de Médecine Interne, Hôpital Cochin, Paris, France. francois.goldwasser@cch.ap-hop-paris.fr
D017321:Clinical Trials, Phase I as Topic / Q000941:ethics* / Q000592:standards; D005602:France; D006801:Humans; D008495:Medical Oncology / Q000941:ethics* / Q000592:standards*