Volunteers or victims: patients' views of randomised cancer clinical trials

Slevin, M. L.; Mossman, Jean; Bowling, Allen C.; Leonard, Riley J; Steward, William P.; Harper, Patricia H.; McIllmurray, M B; Thatcher, Nick

doi:10.1038/bjc.1995.245

Cited by 109 publications

(76 citation statements)

References 15 publications

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“…Patients are attracted to a clinical trial by 'being treated by a doctor with a specialist interest in the disease and encouraged by the possibility that their progress will be monitored closely' (Slevin et al, 1995). High-quality care and closer monitoring are realistic expectations for phase I and phase II trials.…”

Section: Discussionmentioning

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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Section: Discussionmentioning

confidence: 99%

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

et al. 2005

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“…Fifty-one per cent of those who agreed to a trial indicated that they would have preferred the doctor to choose the treatment. 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%

“…The UK Co-ordinating Committee on Cancer Research working party identified several factors affecting clinician participation, particularly for those doctors practising in non-teaching hospitals. Among these were time constraints and lack of support staff to help discuss and coordinate the pragmatic aspects of randomized trials (Slevin et al, 1995;Smyth et al, 1994).…”

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confidence: 99%

“…Among the factors that have been identified for acceptance of trial participation are the hopes that the new treatment will be of benefit to them, and that it will be of benefit to others (Penman et al, 1984;Kardinal, 1994;Slevin et al, 1995). Reasons for declining participation include a preference for a specific treatment arm and fear of randomization (Penman et al, 1984;Llewellyn-Thomas et al, 1991;Jenkins et al, 1999).…”

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confidence: 99%

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

2000

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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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“…This literature has identified the values and characteristics of individual participants (e.g. Fry & Dwyer 2001), people's perceptions of the benefits of participation, such as the possibility of securing better treatment and specialist attention (Slevin, Mossman, Bowling, et al 1995;Wendler et al, 2008), risks, costs and benefits of participation (Lowton 2005) and aspects of information (Ellis, 2000: Jenkins andFallowfield, 2000 ) that are relevant to such decisions. But participation is distinct from cooperation.…”

Section: Introductionmentioning

confidence: 99%

Why do people cooperate with medical research? Findings from three studies

Dixon‐Woods

Tarrant

2009

Social Science & Medicine

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In this paper, we distinguish decisions about cooperation from decisions about research participation. We offer an empirical and theoretical exploration of why people in three different UK-based medical research projects chose to cooperate. Data analysis of the accounts of 128 participants across the three studies was based on the constant comparative method.Participants' cooperation was engaged by a perception that they would be contributing to the 'public good', but they also wanted to justify their decision as sensible and safe. Critical to their cooperation was their belief that researchers would fulfil their side of the cooperative bargain, by not exposing participants to risks of harm or exploitation. Although participants were generally unaware of the details of the regulatory regime for research, they demonstrated a generalised reliance on regulation as a feature of everyday life that would provide a safe context for cooperation. In their assessment of particular projects, participants made judgements about whether to cooperate based on more specific cues, which acted as signs to assure them that researchers shared their cooperative intentions. These cues included organisational and professional credentials, the role identities and perceived trustworthiness of those involved in recruiting to research, and visible signs of reasonable practice mandated by regulatory systems. Thus participants drew on their understandings of an institutional field that was much broader than that of research alone. We propose that the social organisation of research is fundamental to the judgements people make about cooperation with research. Cooperation may be a more useful way of thinking about how people come to engage in collaboratively oriented actions such as research participation, rather than currently dominant individualistic models. Attention to the institutional context of research is critical to understanding what makes cooperation possible, and has important implications for the design of regulatory regimes for research.3

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Volunteers or victims: patients' views of randomised cancer clinical trials

Cited by 109 publications

References 15 publications

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

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

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

Why do people cooperate with medical research? Findings from three studies

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