Patient motivation and informed consent in a phase I study of an anticancer agent

Rodenhuis, S.; Heuvel, W.J.A. van den; Annyas, A. A.; Koops, Heimen Schraffordt; Sleijfer, Dirk; Mulder, Nanno

doi:10.1016/0277-5379(84)90229-3

Cited by 84 publications

(66 citation statements)

References 16 publications

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“…Rodenhuis et al (1984) reported that half of the patients studied were motivated by the hope of improvement of their disease and that 2 of 10 patients believed the treatment to have been effective (Rodenhuis et al, 1984). In our study, however, only about one-fifth of the patients were motivated to participate because they perceived that the treatment would be of benefit to them.…”

Section: Discussioncontrasting

confidence: 61%

“…Although almost all investigators and institutional review boards agree as to the importance of informed consent (Kodish et al, 1992) and the guiding concept in ethical clinical research is informed consent, which is meant to guarantee the voluntary Received 31 May 1996 Revised 25 November 1996 Accepted 11 December 1996 Correspondence to: K Itoh nature of participation in clinical trials, there have been only a few reports from the viewpoint of the patients in phase I clinical trials of anti-cancer agents (Rodenhuis et al, 1984;Tomamichel et al, 1995;Daugherty et al, 1995). Furthermore, it is of interest to learn whether the patients' perception of these studies in Japan differs from that of patients in the United States and Europe.…”

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confidence: 99%

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Patients in phase I trials of anti-cancer agents in Japan: motivation, comprehension and expectations

Itoh

Sasaki²,

Fujii³

et al. 1997

Br J Cancer

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Summary We attempted to characterize the motivation, comprehension and expectations of patients who had given informed consent to participate in phase I trials of anti-cancer agents at the National Cancer Center of Japan. Thirty-three patients were given a simple multiplechoice questionnaire and asked to return it at a later date. The completed survey was returned by 32 patients. The patients were surveyed before they had received any investigational phase agents. Nineteen per cent of patients were motivated to participate in the phase trials by the possibility of therapeutic benefit, 9% because participation seemed a better choice than no treatment and only 6% for altruistic reasons. Most patients comprehended the major features of a phase trial, namely its investigational nature, the unknown effects of the agent investigated and the unclear benefit to the patients themselves. Fifty-nine per cent of the patients anticipated that they might suffer severe or life-threatening side-effects if they participated in the phase trial, and 43% were able to indicate accurately the purpose of the phase 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 varying degrees by participation.

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Section: Discussioncontrasting

confidence: 61%

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confidence: 99%

Patients in phase I trials of anti-cancer agents in Japan: motivation, comprehension and expectations

Itoh

Sasaki²,

Fujii³

et al. 1997

Br J Cancer

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“…Empirical studies find that phase I oncology trial subjects are highly optimistic about their chance of personal benefit (17, 32, 34, 39, 41 -44) and are motivated by hope for clinical improvement (32, 34, 36, 40, 43 -47). Altruism, on the other hand, is much less frequently identified as driving their decision to enroll (34,36,40,43,45); when cited as a motivating factor, it typically is not the main reason for participation (32,39,46,47). In one study, 61% of phase I oncology subjects were doubtful that altruism would motivate advanced cancer patients to enroll in nonbeneficial research (34), and several phase I subjects in another study indicated ''surprise'' at the idea of participation based solely on altruism (45).…”

Section: Ethics Of Phase I Oncologytrialsmentioning

confidence: 99%

The Ethics of Phase 0 Oncology Trials

Abdoler

Taylor

Wendler

2008

Clinical Cancer Research

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Recent guidance from the Food and Drug Administration supports the conduct of a new type of exploratory clinical trial, commonly called phase 0 clinical trials. Proponents argue that phase 0 clinical trials have the potential to expedite the development of new oncology drugs while exposing fewer research subjects to the risks of experimental treatments. At the same time, phase 0 oncology trials raise important ethical concerns that have received little attention. In particular, there is a question of whether it is ethical to enroll individuals in research that offers them no potential for clinical benefit. Further concern focuses on the inclusion of terminally ill and consequently vulnerable cancer patients in these trials. To evaluate these concerns, this article considers relevant empirical data from phase 1 oncology trials and develops several recommendations regarding the conduct of phase 0 clinical trials in oncology.

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“…The published literature on patient motivation to participate in clinical trials suggests that altruism may not be the sole motivating factor; self-interest is also important (Penman et al, 1984;Rodenhuis et al, 1984;Kodish et al, 1992;Daugherty et al, 1995;Itoh et al, 1997;Yoder et al, 1997). A recent systematic review, however, has questioned whether participation in clinical trials is of any benefit to participants (Peppercorn et al, 2004).…”

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confidence: 99%

Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy

et al. 2005

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Successful advances in the treatment of advanced malignant diseases rely on recruitment of patients into clinical trials of novel agents. However, there is a genuine concern for the welfare of individual patients. The aim of this study was to examine motives of patients entering early clinical trials of novel cancer therapies. Questionnaire survey with both open- and close-ended questions. The patients were surveyed after they had given informed consent and before or during the first cycle of treatment. In all, 38 phase I/II trial patients participated and completed the survey. Obtaining possible health benefit was listed by 89% as being a ‘very important' factor in their decision to participate, with only 17% giving reasons of helping future cancer patients and treatment. Other items cited as a ‘very important' motivating factor were ‘trust in the doctor' (66%), ‘being treated by the latest treatment available' (66%), ‘better standard of care and closer follow-up' (61%), and ‘closer monitoring of patients in trials' (58%). Only 47% patients indicated that someone had explained to them about any ‘reasonable' alternatives to the trial. In total, 71% strongly agreed that ‘surviving for as long time as possible was the most important thing (for them)'. Nearly all (97%) indicated that they knew the purpose of the trial and had enough time to consider participation in the trial (100%). In this survey, most patients entering phase I and II clinical trials felt they understood the purpose of the research and had given truly informed consent. Despite this, most patients participated in the hope of therapeutic benefit, although this is known to be a rare outcome in this patient subset. Trialists should be aware, and take account of the expectations that participants place in trial drugs.

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Patient motivation and informed consent in a phase I study of an anticancer agent

Cited by 84 publications

References 16 publications

Patients in phase I trials of anti-cancer agents in Japan: motivation, comprehension and expectations

Patients in phase I trials of anti-cancer agents in Japan: motivation, comprehension and expectations

The Ethics of Phase 0 Oncology Trials

Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy

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