The purpose of studying interventions through clinical trials is to provide a definitive method to identify treatment efficacy, risks and benefits of those treatments. Unfortunately, only about 5% of adults newly diagnosed with cancer participate in clinical trials. Barriers to patient participation in clinical trials include additional medical appointments and procedures required by many trial protocols and the concomitant travel time and costs; uncertainty about the goals of medical research; and clinical trial options not offered by the physician.1
Limited information exists regarding the profile of physicians who recruit patients onto trials and the clinical practice settings in which they work. A population-based assessment of specialty physicians in a subset of institutions that are already involved in clinical research who recruit and refer patients to clinical trials has been published by Klabunde and colleagues.1
The researchers analyzed data from the Cancer Care Outcomes Research and Surveillance Consortium. The study included 1533 specialty physicians who cared for colorectal and lung cancer patients (496 medical oncologists, 228 radiation oncologists, and 809 surgeons) and completed a survey conducted during 2005–2006 (response rate = 61%). Descriptive statistics were used to characterize physicians’ personal and practice characteristics, and regression models were used to examine associations between these characteristics and physician participation in clinical trials.1
- A total of 87.8% of medical oncologists, 66.1% of radiation oncologists, and 35% of surgeons reported referring or enrolling one or more patients in clinical trials during the previous 12 months.
- The mean number of patients referred or enrolled by these physicians was 17.2 (95% confidence interval [CI] = 15.5 to 18.9) for medical oncologists, 9.5 (95% CI = 7.7 to 11.3) for radiation oncologists, and 12.2 (95% CI = 9.8 to 14.6) for surgeons (P < .001).
- Specialty type, involvement in teaching, and affiliation with a Community Clinical Oncology Program (CCOP) and/or a National Cancer Institute–designated cancer center were associated with physician trial participation and enrolling more patients (all Ps < .05).
- Two-thirds of physicians with a CCOP or National Cancer Institute–designated cancer center affiliation reported participating in trials.
The authors concluded those more likely to participate in a clinical trial were medical or radiation oncologists (vs surgeons), were in larger practices, had academic appointments, saw a higher volume of lung or colorectal cancer patients, and attended weekly tumor board meetings. Recommendations of the authors include: promote a culture of research and encourage a professional responsibility to support clinical research within the medical and professional schools that train clinicians and reach out to a broader base of clinicians beyond oncologists or those affiliated with research institutions to increase physician participation in clinical trials.1
The results of this survey study may be somewhat surprising to oncology healthcare professionals (HCPs) working in academic or regional cancer centers, where clinical trials are an integral part of daily practice. Many smaller facilities decline clinical trial participation because of the unreimbursed cost for additional visits, tests and time spent during informed consent and patient follow-up. The authors do not comment on the role of research nurses, advance practice nurses (APNs) or physician assistants (PAs) in conducting clinical trials. Clinical research personnel can greatly reduce the physician burden, increase patient comfort and confidence, and serve as liaisons between clinical practice and the clinical trial sponsor. Stepan et al3 describe an initiative to standardize clinical trial education; their findings may provide direction for nurses challenged to increase clinical trial participation in their practice3 as may an earlier article by Connolly and colleagues.4 We support expanding roles of research nurses, APNs and PAs in community and academic settings in order to meet future clinical trial needs.
- Fouad M, Lee J, Kiefe CI, Catalano P, Vogt T. Why do cancer patients rarely participate in clinical trials? J Clin Oncol 2008; 26:(abstr 6561). Link to abstract http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=55&abstractID=35578
- Klabunde CN, Keating NL, Potosky AL, et al. A population-based assessment of specialty physician involvement in cancer clinical trials. J Natl Cancer Inst. 2011; 103:384–397. doi:10.1093/jnci/djq549 Link to abstract http://jnci.oxfordjournals.org/content/early/2011/02/11/jnci.djq549.abstract
- Stepan KA, Gonzalez AP, Pyle ND, et al. Initiative to Standardize a Clinical Trial Educational Program. Oncol Nurs Forum 2010; 37: 535-539. doi:10.1188/10.ONF.535-539
- Connolly NB, Schneider D, Hill AM. Improving enrollment in cancer clinical Trials. Oncol Nurs Forum 2004; 31:610-614. doi: 10.1188/04.ONF.610-614