Clinicians' attitudes to clinical trials of cancer therapy

Fallowfield, Lesley; Ratcliffe, Denise; Souhami, Robert L.

doi:10.1016/s0959-8049(97)00253-0

Cited by 103 publications

(96 citation statements)

References 11 publications

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“…Motivating the consistent use of these possibly underutilized skills is a much more taunting task, and this issue likely relates to previous arguments suggesting that successful accrual to clinical trials requires extra time and commitment. 16,31 The CRAs felt even more convinced that their own communication skills were important to the success of recruitment. These skills were seen as key to ensuring high levels of information transfer.…”

Section: Discussionmentioning

confidence: 99%

Factors that influence the recruitment of patients to Phase III studies in oncology

Wright

Crooks

Ellis

et al. 2002

Cancer

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BACKGROUNDThe multiple determinants of a patient's decision to enter into a clinical trial have been explored largely from the perspectives of patients and their physicians. Little research has involved clinical research associates (CRAs) formally, despite their central role in the process of recruitment. The current study was initiated to explore the factors that influence the decision of patients with cancer regarding clinical trial entry, specifically from the perspective of the CRA.METHODSTwo focus groups of CRAs from the Hamilton Regional Cancer Center were organized. A skilled facilitator guided both groups through exploratory and subsequent confirmatory phases of discussions, which were audiotaped for review and coding using a process of consensus employing intercoder triangulation.RESULTSThe two groups identified a number of factors that they believed influenced the recruitment process. Numerous physician and patient factors were reaffirmed, such as the impression of the scientific merit of a study or the sense of personal benefit, respectively. More uniquely, CRAs identified information transfer within the informed consent process as a major aspect of their specialized role. It was believed that full disclosure of information, in terms of both the content and the techniques and styles of delivery, was an important predictor of recruitment success. The groups quickly reached consensus on which factors they believed were the most important overall with respect to influencing study recruitment.CONCLUSIONSCRAs appear to have a unique role in the process of recruiting patients to active clinical trials. They believe that they have an important influence on recruitment success. Further research to validate this impression is required, because, ultimately, a greater understanding of the relative roles of physician and patient factors and, potentially, CRA factors will be important in the development of ethical and supportive strategies to optimize the recruitment of patients with cancer into randomized clinical trials. Cancer 2002;95:1584–91. © 2002 American Cancer Society.DOI 10.1002/cncr.10864

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Section: Discussionmentioning

confidence: 99%

Factors that influence the recruitment of patients to Phase III studies in oncology

Wright

Crooks

Ellis

et al. 2002

Cancer

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“…Of the 18 studies eligible for review, 3 were published before 1993, 10-12 2 were published between 1993 and 1999, 13,14 and 13 were published in 2000 or later (Table 1). [15][16][17][18][19][20][21][22][23][24][25][26][27] The study designs included a randomized controlled trial (n ¼ 1), concurrent controlled trial (n ¼ 1), casecontrol (n ¼ 1), and descriptive (n ¼ 15), with 4 of the studies also using qualitative techniques to facilitate in-depth assessments of physician attitudes and perceptions.…”

Section: Yield Of Literature Searchmentioning

confidence: 99%

“…[15][16][17][18][19][20][21][22][23][24][25][26][27] The study designs included a randomized controlled trial (n ¼ 1), concurrent controlled trial (n ¼ 1), casecontrol (n ¼ 1), and descriptive (n ¼ 15), with 4 of the studies also using qualitative techniques to facilitate in-depth assessments of physician attitudes and perceptions. Fourteen studies reported recruitment into treatment trials only [10][11][12][13][15][16][17][18][19][20][21][22]24,26 ; 3 studies reported recruitment into both prevention and treatment trials 14,25,27 ; and 1 study reported recruitment to a prevention trial (Table 1). 23 Because these results were so heterogeneously reported with a diversity of target populations and study designs, a formal quantitative 12 and records of actual patient enrollment into trials (Table 1).…”

Section: Yield Of Literature Searchmentioning

confidence: 99%

Provider roles in the recruitment of underrepresented populations to cancer clinical trials

Howerton

Gibbons

Baffi

et al. 2007

Cancer

152

127

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BACKGROUND.Providers play a vital role in the successful recruitment of underrepresented patients to cancer clinical trials because they often introduce the opportunity of clinical trials. The purpose of the current systematic review was to describe provider‐related factors influencing recruitment of underrepresented populations to cancer clinical trials.METHODS.To find original studies on the recruitment of underrepresented populations to cancer clinical trials, electronic databases from January 1966 to December 2005 were searched; hand‐searched titles in 34 journals from January 2003 to January 2006; and reference lists were examined of eligible articles. Title and abstract reviews were conducted to identify relevant studies. Potential articles were then abstracted using a structured instrument and a serial review process by 2 investigators.RESULTS.Eighteen studies were eligible for review: 13 targeted healthcare providers, 3 targeted patients/participants, and 2 targeted both providers and patients. The study designs included randomized controlled trial, concurrent controlled trial, case‐control, descriptive, and qualitative. A lack of available protocols and/or a lack of provider awareness about clinical trials prevented providers from discussing the opportunity of clinical trials in 2 studies. In 14 studies, patient accrual was affected by provider attitudinal barriers relating to patient adherence to the study protocol, patient mistrust of research, patient costs, data collection costs, and/or patient eligibility. Providers' communication methods were barriers in 5 studies and promoters in 1 study.CONCLUSIONS.A heterogeneous body of evidence suggests that several provider‐related factors influence recruitment of underrepresented groups to clinical trials. Future recruitment efforts should address these factors. Cancer 2007;109:465–476. © 2007 American Cancer Society.

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“…Studies examining the reason for low recruitment note that nonparticipation is influenced by factors affecting both the physician and the patient, as well as the eligibility criteria in strict trial protocols (Taylor and Kelner, 1987;Cook-Gotay, 1991;Fallowfield et al, 1997). 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.…”

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confidence: 99%

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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Clinicians' attitudes to clinical trials of cancer therapy

Cited by 103 publications

References 11 publications

Factors that influence the recruitment of patients to Phase III studies in oncology

Factors that influence the recruitment of patients to Phase III studies in oncology

Provider roles in the recruitment of underrepresented populations to cancer clinical trials

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

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