Barriers to recruitment in cancer trials: no longer medical oncologists’ attitudes

To the Editor: Participation by patients in cancer clinical trials is low. Doctors’ reluctance to participate in clinical trials has been reported as a key barrier to recruitment.1

The Physician Orientation Profile (POP) examines doctors’ attitudes to and behaviour regarding randomised clinical trials.2 In the context of a 2010 cluster-randomised trial to assess the impact of a consumer-friendly cancer clinical trials website (http://www.australiancancertrials .gov.au), we asked medical oncologists to complete the POP and identify barriers they faced when recruiting patients to trials. The option of providing a comment on barriers identified was included.

The sociodemographic characteristics of the 28 medical oncologists who participated in the trial and the barriers to recruitment reported are shown in the Box. Twenty-one doctors reported that they faced barriers when recruiting patients to clinical trials. The most common barriers identified included poor organisational infrastructure, insufficient time, slow and bureaucratic ethics approval processes, and lack of staff (medical oncologists and clinical trials coordinators). This was associated with the feeling that it is too hard to do trials.

However, in contrast to studies reported during the 1990s in the United States and the United Kingdom,1,2 we found that doctors were strongly supportive of clinical trials. A high proportion gave answers consistent with the attitudes of “researchers” (practice guided by published data) rather than “clinicians” (practice guided by clinical experience). For example, if there was uncertainty about treatment, most saw this as an opportunity to do a randomised trial (26 of 28), and most believed that clinical trials were central to a medical oncologist’s practice (24 of 28).

We acknowledge our small sample size and the likelihood of selection bias. However, the doctors in our study were experienced in recruiting patients to clinical trials and had firsthand knowledge of barriers to recruitment in the Australian medical system.

Our findings suggest that, rather than negative attitudes of doctors, issues regarding organisational infrastructure, staffing, time and ethics approval processes are now significant barriers to recruitment of patients to cancer clinical trials. The participating doctors’ comments about the challenges of ethics and governance processes are consistent with recent publications which highlight that multisite studies are under threat because of onerous ethics review and regulatory requirements.3,4 These issues are also addressed in the first rec-ommendation of the Australian Government’s Clinical Trials Action Group report, which is “to improve the timeliness of ethics and research governance review”.5 Our results support the importance of this recommendation.