Pediatric Rheumatology Online Journal → August 2003 → Health-Care Delivery → Abstract #180

BARRIERS TO PARTICIPATION IN CLINICAL RESEARCH WITHIN THE US PEDIATRIC RHEUMATOLOGY COMMUNITY

E. H. Giannini,¹ C. A. Wallace,² H. I. Brunner,¹ the Childhood Arthritis and Rheumatology Research Alliance

¹Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States; ²Division of Immunology and Rheumatology, University of Washington and Children's Hospital and Regional Medical Center, Seattle, WA, United States

Purpose: To determine the nature of barriers that exist within pediatric rheumatology centers that precluded effective participation in clinical research programs and trials.
Methods: In 2001, a random sample of 93 physicians of the ACR Pediatric Rheumatology Section were sent a questionnaire that inquired about 5 domains: demographics, motivation, barriers to participation, corrective resources or interventions, resources available within their institutions.
Results: 62 of the 93 (67%) physicians responded. Most of them work in small centers with only 1-2 full-time physicians (range 1-8), but treated a median number of 400 pts/yr. Only 28% of the centers had participated in 1 clinical studies during the last 5 yrs. The chief motivation for doing clinical research was to provide state-of-the-art pt care. Lack of time, support staff, and inadequate reimbursement were the most frequent barriers to doing studies. 66% stated that their ability to participate in studies would be much improved if a network coordinating center was present to handle regulatory and financial affairs, develop patient materials, and manage the overall study. Sponsor-supported funding for on-site clinical research coordinators (CRCs) was identified as the most important site-specific need. Centers that "made money" on trials had more patients, performed more trials with fewer physicians, and participated in fewer investigator-initiated protocols.
Conclusions: Most pediatric rheumatology centers have 1-2 physicians with no time to participate in studies and no funding to support infra-structure needed to conduct research. A network that facilitates overall performance of clinical sites would likely result in more sites being able to participate in studies and assure enrollment and successful completion of vital research. Adequate funding for on-site CRCs to assist in study initiation, patient recruitment, clinical documentation and patient follow-up is crucial.