AmerisourceBergen Specialty Group Overcoming the Challenges of Clinical Trials in Community-Based Practices Sharon Jameson, RN, BSN, MBA VP, Clinical Research International Oncology Network, an AmerisourceBergen Specialty Group company Clinical trials in community-based practices allow physicians to gain first-hand experience with the latest therapies. These trials provide participating physicians with a marketing edge — a differentiator in the increasingly competitive healthcare environment. At the same time, manufacturers can evaluate how their products perform in the real world and patients gain access to the newest and most advanced care. But for all the benefits of conducting clinical trials in community-based practices, there remain several challenges that must be recognized and addressed to pave the way for trial success. Practice Commitment A productive clinical trial relies on the commitment from an entire practice, not just the clinical research coordinator (CRC). Three elements stand out as crucial to building this commitment and maintaining it throughout the duration of the clinical trial: • Physician sponsorship. CRCs need assistance from everyone within a practice to effectively manage a clinical trial. Physicians must support these efforts through their attitudes and behaviors. Their nurses and support staff must understand the crucial role that clinical trials play in advancing medicine. • Long-term expectations. Practices should view clinical trials as an investment for the future. Before they can expect any return from clinical trials, physicians have to demonstrate a willingness to spend capital on staff, training, systems, and equipment. • Clear communications. When physicians and their staffs execute a coordinated and systematic communication plan for a clinical trial, patients feel more comfortable about participating. Program Expense Expenses related to personnel salaries and benefits, equipment and services, storage fees for documents, and trial drugs add up to make clinical trials a capital-intensive undertaking. Practices can ensure program quality by carefully monitoring two factors: • Overhead costs and budgeting. By understanding the costs for phones, faxes, copy machines, computers, and other items vital to a clinical trial, practices can develop more accurate budgets, manage their costs more efficiently, and direct the program toward financial success. • Adequate staffing. Practices typically ask each CRC to manage 25 to 30 active patients, depending on the circumstances of the clinical trial. Successful practices understand that they can’t overburden their CRCs, but also know they can’t afford to overstaff. They are realistic in their expectations and plan for growth with the help of professional organizations and industry publications. Trial Selection With the time and money required for each clinical trial, it makes sense for practices to be selective before diving right in. An experienced and knowledgeable CRC can guide a practice toward the right trial by evaluating whether the potential trial matches with the practice in four essential areas: • Patient population. The practice must possess an adequate patient pool from which it can recruit. These patients also must be open to the idea of participating in Phase I/II clinical trials. • Physician support. All practice physicians must support the scientific rationale, otherwise, the practice won’t accrue enough patients for the trial. • Adherence ability. The practice must be able to adhere to the study procedures within its normal infrastructure. • Staffing. The practice needs to hire appropriately to ensure that it can adequately manage the clinical trials it conducts. Managing for Success Above all, practices need to understand that managing a successful research program involves more than just patient accrual. Patient accrual will always be an essential part of the effort to recover costs, but sustainable programs also require practices to address issues such as physician and patient expectations, operational expenses, and staffing needs. For programs to be successful, pharmaceutical company sponsors must recognize these factors, act as partners to participating practices, and compensate practices accordingly. So long as all parties know their responsibilities and enter into research programs well-prepared, clinical trials in community-based practices can be a winning scenario for everyone involved — for physicians, manufacturers, and particularly patients. A productive clinical trial relies on the commitment from an entire practice, not just the CRC. AmerisourceBergen specialty group, Addison, Texas, provides the comprehensive resources needed to effectively launch, market, support, and deliver specialty pharmaceuticals to providers and patients. For more information, go to absg.com. The Trial Proccess June 2006 VIEW on Clinical Services

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