Attitudes of patients to randomised clinical trials of cancer therapy

Fallowfield, Lesley; Jenkins, VA; Brennan, Carol; Sawtell, Mary; Moynihan, Clare; Souhami, R. L.

doi:10.1016/s0959-8049(98)00193-2

Cited by 114 publications

(95 citation statements)

References 25 publications

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“…Within the field of cancer, there has been a longstanding interest in the recruitment of patients into clinical trials. 24 This relatively positive and open environment for the recruitment of patients into trials culminated recently in the establishment of the National Cancer Research Network (NCRN) in England and Wales, which was created to improve the infrastructure within the NHS for clinical research in cancer and to ensure that research is better integrated with cancer care. The NCRN was established by the Department of Health in April 2001 to support prospective trials of cancer treatments and to support research undertaken by cancer charities (most of the trials included in this study had completed recruitment before this initiative was established).…”

Section: Discussionmentioning

confidence: 99%

Recruitment to randomised trials: strategies for trial enrolment and participation study. The STEPS study

Campbell

Snowdon²,

Francis³

et al. 2007

Health Technol Assess

396

403

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Section: Discussionmentioning

confidence: 99%

Recruitment to randomised trials: strategies for trial enrolment and participation study. The STEPS study

Campbell

Snowdon²,

Francis³

et al. 2007

Health Technol Assess

396

403

View full text Add to dashboard Cite

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“…This was reported as one of the less appealing aspects of randomized trials in previous research (Slevin et al, 1995). The emphasis given to chance in the explanation of the concept of randomization is another cause of unease amongst patients and the general public (Corbett et al, 1996;Fallowfield et al, 1998;Featherstone and Donovan, 1998).…”

Section: Discussionmentioning

confidence: 99%

Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy

2000

Self Cite

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Summary This paper reports on the reasons why patients agreed to or declined entry into randomized trials of cancer following discussions conducted by clinicians in both District General and University Hospitals. Two hundred and four patients completed a 16-item questionnaire following the consultation, of these 112 (55%) were women with breast cancer. Overall results showed that 147 (72.1%) patients accepted entry to a randomized clinical trial (RCT). The main reasons nominated for participating in a trial were that 'others will benefit' (23.1%) and 'trust in the doctor' (21.1%). One of the main reasons for declining trial entry was that patients were 'worried about randomization' (19.6%). There was a significantly higher acceptance rate for trials providing active treatment in every arm 98 (80.6%) compared with those trials with a no treatment arm 46 (60.5%), χ 2 test P = 0.003. The study outlines a number of factors that appear to influence a patient's decision to accept or decline entry into an RCT of cancer therapy. An important factor is whether or not the trial offers active treatment in all arms of the study. Communication that promotes trust and confidence in the doctor is also a powerful motivating influence.

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“…[2][3][4] Studies have shown that many people with cancer believe that patients should be asked to take part in medical research. 5,6 Nevertheless, accrual remains low, thus slowing the introduction of better treatments and compromising the generalizability of results. 7 Several reasons have been cited for recruitment difficulties, including attitudes of both physicians 8 -10 and patients.…”

mentioning

confidence: 99%

Ethical communication in clinical trials

Loh¹,

Butow²,

Brown³

et al. 2002

Cancer

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BACKGROUNDInformed consent has been proposed as the optimal method for ensuring the ethical entry of patients into clinical trials. However, it is known that problems with informed consent exist from the perspective of both patients and physicians. This has led to the suggestion that a third party, such as a research nurse or data manager, should be responsible for obtaining informed consent. The objective of this study was to explore the views of data managers concerning the nature, challenges, and rewards of their role and the similarities and differences between their role and that of physicians in obtaining informed consent.METHODSFour focus groups in three large teaching hospitals were conducted. Twenty‐one data managers who were involved in cancer or pain clinical trials participated. The focus groups were audiotaped, transcribed, and subjected to content analysis to identify themes.RESULTSData managers identified three primary roles complementary to that of physicians: information provision, quality assurance of the informed consent process, and ongoing support during the trial. Despite expressed concern that medical and drug company interests may lead to subtle coercion of the patient, participants did not support the notion that they may be solely responsible for the consent process. Participants described a range of ethical dilemmas they confronted, including patients asking them for medical details they could not provide and situations in which they felt that informed consent was compromised in some way, for example, dealing with situations in which the patient appeared to be entering the trial for the wrong reasons due to misunderstanding, need, or passivity. Effective functioning of the multidisciplinary team assisted data managers in performing their role. A range of training needs were identified, particularly communication skills training and trial start‐up briefing.CONCLUSIONSThe issues raised by these data managers have important implications for the successful conduct of clinical trials, particularly the need for an integrated, multidisciplinary approach at all levels of the informed‐consent process. Cancer 2002;95:2414–21. © 2002 American Cancer Society.DOI 10.1002/cncr.2002;10994

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Attitudes of patients to randomised clinical trials of cancer therapy

Cited by 114 publications

References 25 publications

Recruitment to randomised trials: strategies for trial enrolment and participation study. The STEPS study

Recruitment to randomised trials: strategies for trial enrolment and participation study. The STEPS study

Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy

Ethical communication in clinical trials

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