Update: APOR

Abstract

Recruitment and retention of subjects in clinical trials by American investigators is suboptimal compared with that of many other nations, and the cost of trials is often greater here than elsewhere. Increasing difficulties in recruitment and retention of US participants means that an increasing proportion of important clinical studies recruit subjects from abroad. The number of non-US authored clinical trials published in the journal Blood has increased from 21% 25 years ago to 56% in 2010, and most of these studies recruited all or most of their participants outside the United States. Comparable figures for the Journal of Clinical Oncology are 12% and 39%, respectively. Does this trend place at risk America’s position as the undisputed leader in clinical and translational research in the world? There are many reasons for the increased clinical research productivity in other countries. Larger numbers of patients may be accrued into important clinical trials in a shorter period of time overseas than in the United States. Why? An important recent development is that most potential candidates for clinical trials in the United States are cared for in private practice environments where the emphasis is often not on research.1 In addition, America is a multicultural, diverse society. But in some American racial and ethnic groups, trust of medical research may not be as great as it is in some other countries. In Taiwan, for example, almost 90% of cancer patients expressed a willingness to participate in a clinical trial when presented with the option.2 Reimbursement of physicians and medical facilities for participation in clinical trials not sponsored by industry, especially investigator-initiated studies, rarely covers the cost of such participation in this country. There are other impediments to performing clinical trials in the United States, including institutional review board (IRB) costs and delays. For example, it is not unusual for multicenter studies sponsored by the NIH that have already undergone extensive peer review to require 3–6 months or more for local IRB approval. At present, only 2–3% of all cancer patients participate in clinical trials in this country. Some of the causes for this low participation rate have been and are being addressed. The National Cancer Institute’s (NCI) Cancer Clinical Oncology Program (CCOP) and Minority-Based CCOP efforts, along with similar programs, have modestly enhanced accrual to cancer clinical trials.3 The current effort to transform the NCI’s clinical trials system by merging various study groups into fewer, larger ones may eliminate competitive duplication that may impede progress in refining cancer treatment. On the other hand, fewer national studies means fewer protocol chairs, and fewer opportunities for interested physicians to develop clinical trials expertise and careers. It seems to me that there are at least two major impediments to enhancing accrual to major, potentially ground-breaking clinical trials in our country. Perhaps the most significant obstacle is that there is inadequate reimbursement to physicians for expenses associated with entering patients into innovative clinical trials not sponsored by the pharmaceutical industry. It seems highly unlikely that more government funding will be available in the near future to support such trials. However, even token assistance would be encouraging. Federal and state governments should consider tax incentives for institutions and private practices that participate in approved clinical trials. The second major problem is the lack of interest in enrolling patients into clinical trials on the part of many physicians in private practice. This reflects in part concerns about the additional administrative oversight required to carry out such trials. I have a simple proposal that might help, and would not cost a penny to implement: require state medical and nursing licensing authorities to provide continuing medical education (CME) credits to physicians and nurses for enrolling and maintaining patients in approved clinical trials. Additional CME credits should be provided for enrolling patients in studies that require extra work and resources, such as those requiring provision of pharmacokinetic samples or submission of tissues or blood to central laboratories or tissue banks. Such CME credit, in addition to its practical value to physicians, would signal that the medical community and the country as a whole consider clinical research participation to be an integral component of good general medical practice. It should be a national priority for clinical trials to be conducted, completed, and analyzed in a more timely fashion than currently is the case. The above proposals should be seriously considered as we work to accomplish that goal.