AOA Symposium. Barriers (threats) to clinical research.

Abstract

Clinical research encompasses a wide range of scientific investigations including case reports on a single patient, case series, retrospective studies, prospective studies, and multicenter randomized clinical trials. These activities aim to enhance our understanding of medical conditions with the intention of helping patients. Clinical research is time-consuming, challenging, and expensive, and with current practice pressures, it can be a daunting task. An increasing number of regulatory obstacles produce further challenges to performing clinical research. Both evidence and opinion indicate that these regulatory obstacles have adversely affected the conduct of clinical research. Ninety-one percent of the audience who attended the symposium at the 2007 Annual Meeting of the American Orthopaedic Association (AOA; a clinical meeting of senior orthopaedic surgeons) in Asheville, North Carolina, characterized this threat as moderate or severe. When the attendees were presented with three negative statements about their institutional review board, which described it as (1) cumbersome, bureaucratic, and difficult to deal with; (2) more interested in protecting the institution than the patient; and (3) causing delays and unnecessary costs, 66% felt that all three applied to their board. This reflects the deep sense of frustration many clinicians have with the current regulatory process and their belief that institutional review boards are clearly obstructive to clinical research. This symposium explores the barriers and obstacles to clinical research provided by the Health Insurance Portability and Accountability Act (HIPAA) and by institutional review boards and presents the position that change is necessary to minimize the problems and the expense they create. Clinical research requires substantial funding, particularly for large-scale multicenter trials, which limits the number and quality of these important clinical experiments. Issues related to the funding of orthopaedic trials from the perspective of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) are reviewed. Finally, high-quality clinical research needs clinician researchers trained in the methods of large clinical trials, and this type of expertise must be developed, mentored, and financially supported with protected time.