‘Lack of Study Volunteers Hobbles Cancer Fight’, reads the headline from a New York Times article published in August 2009.1 Clinical trials are an essential tool for evaluating medical technologies, and they are required to garner treatment approvals. Too often, though, an insufficient number of participants enroll in these trials, often preventing fully informative results across the spectrum of research from being obtained. This is especially true for cancer. In the United States, only 3% of adult cancer patients are recruited into trials, although an estimated 20% are eligible.2,3 As a result, oncology drugs take more time to develop compared to nononcology drugs. Studies show that clinical development times were 10 months longer for oncology drugs in the United States. One factor accounting for this discrepancy is the extra time needed to recruit and evaluate patients in clinical trials.4
To gauge interest on the subject, a quick Google search on ‘barriers to clinical trial participation’ leads to pages of resources to draw upon. There is by no means a lack of awareness of the problem from various stakeholders. Whether one is a community oncologist, a clinical investigator, or part of an academic medical center, low patient accrual rates slow the advancement of scientific discoveries, and that affects everyone. This stagnancy delays and likely prevents the development of new treatment options for patients. We know it leads to longer and more costly clinical trials that contribute to higher drug prices. Estimates put the costs of delaying a phase 3 study at $1 million per day.5 Understanding the barriers to recruiting patients and implementing policies to overcome them should be a high priority for researchers, policymakers, physicians, and patients.
Identifying the Barriers
Findings from various polls and research studies that sought to identify these barriers were reviewed. Across multiple studies and polling data, common themes were seen in the responses from both prospective or active patients and investigators. One study conducted a systematic review from the results of other ‘barriers to participation’ investigations that included 12 qualitative and 21 quantitative studies.6 Understandably, common patient-related barriers emerging from this study included ‘feelings of uncertainty’, ‘an inconvenience to every-day life’, ‘the potential for side effects’, ‘uncomfortable with experimentation’, ‘increased anxiety’, and ‘transport or distance to trial site’.
Using data cited from various sources, some of the more common physician-related barriers have been categorized as being financial, practical, or psychosocial in nature, and are summarized below.
The cost burden For various reasons, cost remains a strong barrier. For physicians, it is the belief that participating in a clinical trial adds a large administrative and cost burden–and they are right.7 According to a survey conducted by the American Society of Clinical Oncology (ASCO) in 2000, the most significant barriers to patient enrollment included the intensity of paperwork collection and filing, and the extra time needed to train staff in the completion of enrollment and data collection forms.8 Managing a protocol also takes time. In addition, many physicians are rightly concerned that they will incur additional costs that might not be reimbursed by third party insurers.7 As noted by Dr. Karen Hagerty, Director of Reimbursement Policy in ASCO’s Cancer Policy & Clinical Affairs Department of the ASCO, at a recent Institute of Medicine (IOM) workshop on the National Cancer Clinical Trials System, “discussing options with patients and then enrolling and following them in trials requires significant commitment to time on the part of physicians – time that largely goes uncompensated”.9