Accrual to Clinical Trials: Let’s Look at the Physicians

Lori M. Minasian 0 1 Ann M. O'Mara 0 1 0 Institute, National Institutes of Health , 6130 Executive Blvd, EPN, MSC-7340, Bethesda, MD 20892-7340 ( 1 Affiliation of authors: Division of Cancer Prevention, National Cancer Institute , Bethesda, MD (LMM, AMO) JNCI | Editorials 357 - Clinical trials have long been recognized as the definitive way to identify efficacious treatments and to understand the risks and benefits of those treatments. Unfortunately, only a small fraction of cancer patients participate in clinical trials and limited information exists regarding the profile of physicians who recruit patients onto trials and the clinical practice settings in which they work. The population-based assessment of specialty physicians who recruit and refer patients to clinical trials by Klabunde et al. (1) in this issue of the Journal provides an important description of the types of physicians who are recruiting patients to cancer clinical trials in a subset of institutions that are already involved in clinical research (1). The study by Klabunde et al. (1) included 1533 medical oncologists, radiation oncologists, and surgeons who were involved in the care of patients with colorectal or lung cancer. The investigators identified physician and infrastructure factors associated with clinical trial participation within the Cancer Care Outcomes Research and Surveillance Consortium, a partnership of academic and Veterans Administration hospitals with community outreach that are funded to do clinical research on cancer outcomes (2). Among the more telling findings: Physicians who saw a higher number of patients and who spent more time with each new patient had higher clinical trial accrual rates. Specifically, the majority of medical oncologists (59.4%) saw more than 20 colorectal or lung cancer patients per month, whereas the majority of surgeons (65%) saw fewer than five of these patients per month. The majority of medical oncologists (63.5%) and radiation oncologists (84%) spent 60 minutes or more with a new cancer patient visit, whereas the majority of surgeons (81.4%) spent less than 60 minutes. Factors that may facilitate discussion of treatment options with other physicians, such as teaching medical students or residents and attending tumor board meetings, were found to be associated with a higher likelihood of accruing or referring patients to trials. As expected, frequent participation in tumor board meetings (ie, weekly or monthly) was associated with higher rates of accrual, most likely because patients could be promptly referred to trials with specific eligibility requirements. However, participation in discussion formats is only a small part of the story, given that only 869 (56.7%) of physicians in the study had accrued or referred at least one patient to a clinical trial during the previous 12 months. Clinical trials require additional work beyond the usual practice of cancer care. Physicians who participate in clinical trials do not necessarily do so for their own financial gain, as supported by this study. Specific resources in the form of trained staff such as research nurses, staff to handle institutional review board issues, jnci.oxfordjournals.org and investigational pharmacists and resources, such as physical space and information technology support, are essential to incorporate clinical trials into daily practice. Physicians who were affiliated with a National Cancer Institutedesignated cancer centers (3) or a Community Clinical Oncology Program (4), two programs designed to provide that infrastructure, were associated with more accrual and referral. And yet, the research support is not sufficient: As Klabunde et al. (1) show in their secondary analysis, 34% 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. What are the barriers to active participation by these physicians who have agreed (implicitly or explicitly) to participate? Are physicians inadequately trained for the additional responsibilities required of them to participate in clinical trials? Is it the additional work at a time when so many demands are made of them inhibiting their participation? What are reasonable expectations of physicians with regard to participation in clinical trials? The American public continues to value investment in medical research. In 2010, more than 70% of the general public were likely to consider participating in a clinical trial, but only 6% of their physicians offered that participation (5). A recent survey of patients seen at the Mayo Clinic showed that 76% of patients expected their treating physician to inform them about current trials (6). A more in-depth evaluation of the physicianpatient encounter noted that of those patients who were offered participation in a cancer clinical trial, 75% agreed to participate, but only 20% of all of the patients (who were potentially eligible) were explicitly offered participation in a trial (7). If patients are in fact looking to their physicians to initiate the discussion about clinical trials, and given the finding by Klabunde et al. (1) that one-third of the physicians who were affiliated with a supportive clinical trial infrastructure are not actively engaged in the research process, then efforts at enhancing that engagement are needed. One example is the recent addition of a new standard by the Liaison Committee on Medical Education, which is the accrediting body for programs leading to the M.D. degree in the United States and Canada. Effective in 2008, medical students must be introduced to the basic principles of clinical and translational research, including how such research is conducted, evaluated, explained to patients, and applied to patient care (8). Not every physician should be expected to actively accrue patients onto clinical trials, but all physicians should understand the value of clinical trials and know how to refer patients. If we want research to inform practice, we need a workforce of physicians who value the research and understand how to incorporate research results into their practice. Much of the American public looks to their physicians to do that. References (...truncated)