Practical Barriers

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Lack of awareness Polling data suggest that many physicians are generally unaware that clinical trials are available as potential treatment options. And when they are aware, they rarely recommend them. Studies have shown that while 44% of people find out about studies through the media, only 14% gain the information from their physicians.10 According to a recent IOM workshop, some physicians said they would enroll more patients if they had a convenient tool to alert them, such as electronic health records.9

Psychosocial Barriers

Losing the ability to help Some physicians fear they may lose the chance to treat their patient should they enter into a clinical trial.7 Perhaps that explains, in part, a recent questionnaire of 1,000 patients who cited discouragement from their oncologist as a reason not to participate in a trial.11 Additionally, some physicians have expressed concern about a patient’s reaction to the mere suggestion of a clinical trial, while others believe that the treatment patients receive in clinical trials is not as good as standard therapy.7  

Policy Review

This short summary of physician-related barriers provides a glimpse into the challenges facing researchers today. But this problem extends way beyond the physician. There are issues unique to each stakeholder (ie, patients, payers, policymakers, physicians, and drug sponsors). But addressing each barrier individually is like treating the symptoms and not the disease.  

Consider this: over the past four decades, survival rates have quadrupled in childhood cancers. Yet in most adult cancers, we have seen relatively modest gains in survival. A major factor for this progress in survival has been the introduction of effective new therapies, the result of faster evaluation of medical technologies made possible by a much higher level of patient and physician participation and engagement in clinical research. In the United States, 90% of children with cancer receive care from a cooperative clinical research group, and more than 60% of childhood cancer patients are enrolled in clinical trials.12 Compare this to adult participation rates of around 3%, and it helps explain in part the disparity. There is an opportunity being missed here, as multiple polls suggest that many more patients would participate if they were made more aware of clinical trials as potential treatment options.10  

While we have seen incremental improvement in trial recruitment through the work of various institutions, including ongoing efforts by both public and private interests that seek to facilitate participation in clinical trials, there is an underlying reality holding back substantial progress. Without the proper financial incentives for community physicians (who care for most patients) or for academic medical settings to invest in the clinical trial infrastructure necessary to conduct clinical research, advancement will remain hindered. In a recent study coauthored by the chair of the Patient Centered Outcomes Research (PCORI) Methodology Committee, cultural shifts, economic incentives, and infrastructural changes are necessary for real modification.12 Such changes include a call for the integration of clinical trials into the foundation of clinical practice and the creation of a learning health system that informs the delivery of care.