Recruitment to a prospective breast conservation trial: why are so few patients randomised?

Abstract

Objective-To investigate the rate of recruitment to early breast cancer trials and elucidate the reasons for ineligibility and refusal to participate among patients otherwise suitable for these trials.Design

Effects of patient selection on the applicability of results from a randomised clinical trial (EORTC 10853) investigating breast-conserving therapy for DCIS

“…The applicability of the trial results is highly dependent on the selection that occurs in each step. Entry rates of patients for RCTs and the reasons for non-entry have been studied by a number of groups (McCusker et al, 1982;Lee and Breaux, 1983;Martin et al, 1984;Anonymous, 1986;Jack et al, 1990;Fentiman et al, 1991;Gorst and Johnson, 1992;Kotwall et al, 1992;Kober and Torp-Pedersen, 1995;Partonen et al, 1996;Licht et al, 1997) but the effect of selection on the applicability of the trial results has been investigated in only a few, mainly pharmaceutical studies (Anonymous, 1986;Gorst and Johnson, 1992;Kober and Torp-Pedersen, 1995;Licht et al, 1997). To our knowledge, the effect of patient selection on applicability of results in surgical/radiotherapy trials has never been fully analysed.…”

“…Other studies report rates of eligible but non-entered patients of 25 -73% (Lee and Breaux, 1983;Jack et al, 1990;Kotwall et al, 1992). The five institutes selected for our study are all specialised cancer centres and the physicians have put much effort into randomisation of suitable cases with only a few patients not being considered for entry.…”

“…This may account for the lower proportion of eligible but non-entered patients compared with other studies. Three factors known to influence the entry of eligible patients in RCTs are problems with informed consent, and doctors' and patient's preference for one of the treatment arms in certain subgroups of the eligible patients (Taylor et al, 1984;Anonymous, 1986;Jack et al, 1990;Gorst and Johnson, 1992;Kober and Torp-Pedersen, 1995;Partonen et al, 1996;Licht et al, 1997) The reported rates of patient refusal vary from less than 10% to almost half of the eligible patients (McCusker et al, 1982;Lee and Breaux, 1983;Martin et al, 1984;Jack et al, 1990;Kotwall et al, 1992). This variation is highly dependent on the type and stage of the disease, type of treatment, the patients' occupational level and the physicians' skills of informing the patient about the trial (McCusker et al, 1982).…”

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

“…32,33 They can also be affected by pre-existing factors such as the beliefs of the collaborating clinicians 34 and patient preferences. 35,36 Several such factors have been reported as barriers to recruitment by trialists 37,38 and identified in empirical studies. 15,39,40 These forces create a complex microclimate in which a trial can flourish, struggle, or do both.…”

Managing clinical trials in Asia: Issues, threats, opportunities and approaches

“…Trials conducted in the UK showed that 45% failed to reach 80% of the target and it is more worrying that less than half of participating physicians succeeded in recruiting any patients. 10,11 Clinical trials conducted in the UK between 1971 and 2000 (n-333) revealed that just over one-half failed to recruit the desired sample size, one-fifth recruited at least 75% of the target sample, while a further fifth recruited 25% of the planned number of patients. 12 Another concern is that the number of physicians pursuing a career in research has also declined.…”