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

Abstract

ogists, 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, 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 affil iated with a National Cancer Institute–designated 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 physician–patient 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).