Informed consent for phase I studies: Evaluation of quantity and quality of information provided to patients

Tomamichel, Michele; Sessa, Cristiana; Herzig, Stefan; Jong, J. de; Pagani, Olivia; Willems, Yvonne; Cavalli, F.

doi:10.1093/oxfordjournals.annonc.a059185

Cited by 67 publications

(48 citation statements)

References 26 publications

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“…A paper by Tomamichel et al [26] provides an objective report of investigator communication and the ICP of P1 trials. Analysis indicated that in more than half of the 32 taped consultations, the investigator scored on the lower half of the scale in terms of assessing patient understanding at the end of the consultation.…”

Section: Resultsmentioning

confidence: 99%

“…Of concern is Tomamichel et al's [26] report that only 11 of 32 taped consultations advised of the possibility of study withdrawal or treatment refusal. An analysis of 272 consent forms [23] found only 65% of consent forms mentioned the alternative of receiving no treatment, and only 56% mentioned supportive or palliative care as an alternative.…”

Section: Resultsmentioning

confidence: 99%

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Communication and informed consent in phase 1 trials: a review of the literature

Cox

Fallowfield

Jenkins

2006

Support Care Cancer

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Phase 1 (P1) trials are vital to the development of cancer treatments; however, the patients involved in these trials are unlikely to receive any therapeutic benefit, and there are significant possibilities that they will experience serious side effects. Ethical requirements stipulate that patients must be adequately informed before they consent to participate in P1 trials. This review focuses on studies that have measured patient comprehension of information given during the informed consent process of P1 cancer trials. Patients consenting to participate in P1 trials currently have a limited understanding of trial purpose, an unrealistic expectation of the benefits and risks associated with trial participation and a questionable appreciation of their right to abstain or withdraw. Health care professionals recruiting to P1 trials need clear and practical guidelines and training packages designed to ensure that all details of P1 trials are communicated effectively to eligible patients.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Communication and informed consent in phase 1 trials: a review of the literature

Cox

Fallowfield

Jenkins

2006

Support Care Cancer

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“…[1][2][3][4][5][6][7][8][9][10][11] A particular concern is that some patients do not have the requisite skill, numeracy, to understand and manipulate quantitative information about uncertain outcomes. For example, in a study of highly educated adults, Lipkus et al 12 found low levels of numeracy, with no more than one-third of respondents able to answer all 10 items correctly on the authors' numeracy scale.…”

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confidence: 99%

Understanding of an aggregate probability statement by patients who are offered participation in Phase I clinical trials

Weinfurt

DePuy

Castel

et al. 2004

Cancer

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BACKGROUNDThere is concern that patients with poor numeracy may have difficulty understanding the information necessary to make informed treatment decisions. The authors sought to characterize a special form of numeracy among patients with advanced cancer who were offered participation in Phase I oncology clinical trials.METHODSSurveys were administered to 328 cancer patients who were considering Phase I trials. Their frequency‐type numeracy was assessed using a multiple‐choice question involving a hypothetical scenario in which a physician stated that an experimental treatment would control cancer in “40% of cases like yours.” In univariate and multivariable analyses, patient characteristics that were associated with better numeracy were identified.RESULTSThe correct frequency‐type interpretation was selected by 72% of respondents. Fourteen percent of respondents incorrectly selected a belief‐type answer, “The doctor is 40% confident that the treatment will control my cancer.” In a multivariable model, patients who answered incorrectly tended to have less formal education and less experience with experimental therapies.CONCLUSIONSBecause the misunderstandings some patients demonstrated may influence their treatment decision making adversely, it is critical to identify such patients and to give them special consideration when communicating information about potential risks and benefits of treatment. Cancer 2004. © 2004 American Cancer Society.

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“…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%

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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Informed consent for phase I studies: Evaluation of quantity and quality of information provided to patients

Cited by 67 publications

References 26 publications

Communication and informed consent in phase 1 trials: a review of the literature

Communication and informed consent in phase 1 trials: a review of the literature

Understanding of an aggregate probability statement by patients who are offered participation in Phase I clinical trials

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

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