PATIENTS IN PHASE-I TRIALS OF ANTI CANCER AGENTS IN JAPAN - MOTIVATION, COMPREHENSION AND EXPECTATIONS

We attempted to characterize the motivation, comprehension and expecta tions of patients who had given informed consent to participate in pha se I trials of anti-cancer agents at the National Cancer Center of Jap an. Thirty-three patients were given a simple multiple-choice question naire and asked to return it at a later date. The completed survey was returned by 32 patients. The patients were surveyed before they had r eceived any investigational phase I agents. Nineteen per cent of patie nts were motivated to participate in the phase I trials by the possibi lity of therapeutic benefit, 9% because participation seemed a better choice than no treatment and only 6% for altruistic reasons. Most pati ents comprehended the major features of a phase I trial, namely its in vestigational nature, the unknown effects of the agent investigated an d the unclear benefit to the patients themselves. Fifty-nine per cent of the patients anticipated that they might suffer severe or life-thre atening side-effects if they participated in the phase I trial, and 43 % were able to indicate accurately the purpose of the phase I trial as a dose determination study. Although only a minority of the patients indicated that their motivation to participate was possible treatment benefit to themselves, when answering questions regarding expectations , more than half indicated that there might be personal benefits of va rying degrees by participation.