JNCI: Spurt in cancer trial enrollment essential for improved care
A large proportion of physicians do not participate in clinical cancer trials, with a lack of funding and underdeveloped hospital infrastructures and IT preventing nearly half of cancer specialists from enrolling patients in research trials, according to a study published Feb. 11 in the Journal of the National Cancer Institute.

Fifty-seven percent of oncologists, radiation oncologists and surgeons reported enrolling at least one patient in cancer trials within a 12-month period. Academic and larger institutions, as well as patient-focused physicians were significantly more likely to enroll more patients, while surgeons accrued just over half as many patients as the average physician in the study.

According to the National Cancer Institute (NCI), approximately 8,000 clinical trials are currently seeking U.S. participants, while studies estimate that 2 to 4 percent of cancer patients participate in such trials. Although a number of barriers stifle enrollment, “Physicians have an important role in making patients aware of clinical trials, informing them of the benefits and risks of trial participation, and facilitating referral or enrollment for those who are willing to consider participating in a trial,” noted Carrie N. Klabunde, PhD, of the Applied Research Program, division of cancer control and population sciences at the National Cancer Institute in Bethesda, Md., and co-researchers.
Moreover, little is known on the meta-level about enrollment of patients in cancer trials: particularly sparse is information about patient accrual based on physician and provider context, the authors observed.

Klabunde and colleagues examined enrollment in clinical trials among oncologists, radiation oncologists and surgeons participating in the Cancer Care Outcomes Research and Surveillance Consortium (CanCORS), including physicians working in a variety of geographic locations as well as private, academic and Veterans Administration hospitals. A total of 4,188 of 6,871 physicians responded to the survey, which queried about patients with colorectal or lung cancer.

Fifty-seven percent of physicians reported enrolling at least one patient in the previous 12 months into a clinical trial, including 88 percent of medical oncologists, 66 percent of radiation oncologists and 35 percent of surgeons. The mean number of patients referred or enrolled was 17.2 for medical oncologists, 9.5 for radiation oncologists and 12.2 for surgeons.

Referrals by surgeons varied considerably according to subspecialty: mean enrollment for general surgeons was 6.7 patients, 17.8 for thoracic surgeons, 9.4 for colorectal surgeons, 26.1 for surgical oncologists and 11.8 for other surgical subspecialists.

The authors found that physicians working at hospitals affiliated with the NCI or Community Clinical Oncology Program (CCOP), which provide funding and other support to hospitals for cancer programs and research, were significantly more likely to refer or enroll patients in trials.

“Given that a lack of infrastructure to support physicians’ involvement in clinical trials is frequently cited as a barrier to patient accrual to clinical trials, our results underscore the positive influence of NCI’s investment in infrastructure to support clinical trials, including the designated cancer centers program, which began in the 1960s, and CCOP, which was established in 1983 to increase the involvement of community physicians in trials,” the authors wrote. “Nevertheless, in this study, only two-thirds of physicians with a CCOP or NCI-designated cancer center affiliation reported involvement in clinical trials.”

Physicians working at practices with six or more other doctors, as well as those involved in academics, doctors who spend 60 or more minutes with newly diagnosed cancer patients and physicians who reported attending weekly tumor board meetings were also significantly more likely to enroll patients in clinical trials. In addition, nonsurgical specialists that reported income increases resulting from enrolling patients in trials referred, on average, 20 percent more patients than non-incentivized clinicians.

Surgeons older than 60 years, female doctors and physicians who earned their medical degrees in the U.S. or Canada were also more likely to refer patients for trials.

“Low and slow accrual to cancer clinical trials limits the availability of state-of-the-art therapies in routine clinical practice,” the authors argued. “The role of physicians in recruiting patients to clinical trials is pivotal.”

Klabunde and colleagues emphasized the role of IT, including clinical trial databases and EMRs, as well as improved reimbursement and incentive systems as important for stimulating accrual to clinical trials.

An accompanying editorial argued, however, that these improvements would not be sufficient. Putting stock in recent requirements that medical students be instructed in clinical trial enrollment and research, the editorial authors argued that “34 percent of physicians affiliated with an organization designed to support clinical trial participation are not actively participating in the research. It appears that ‘the desire is present, but the body is unwilling,’” according to Lori M. Minasian, MD, and Ann M. O’Mara, PhD, MPH, RN, of the Community Oncology and Prevention Trials Research Group, division of cancer prevention at the National Cancer Institute in Bethesda, Md.

Klabunde and colleagues said that closer examination of nonparticipating physicians would be critical for identifying incentives and improving enrollment, emphasizing that “[c]ontinued monitoring of physician participation in cancer clinical trials will be essential.”