The vast majority of clinical research performed in this country is industry-sponsored. Although this sort of research is not designed to address basic science or thought-provoking issues, it is critical to the ultimate delivery of safe and effective therapies. For excellent reasons, the regulatory milieu in which such research is conducted demands a strict adherence to protocol, and thorough evaluation of subjects rights and protection, and a careful and open analysis of outcomes.
There is, therefore, an inherent problem in the practical conduct of such research. The fundamental question that the manufacturer, the clinician and the public want answered is how well will this therapy work (risks, benefits, effectiveness, side-effects, cost, etc.) when applied in a broad range of clinical settings. However, the exigencies of the conduct of the research limit the available researchers to those in academic settings or those with such large practices that they can afford the infrastructure necessary to make such research feasible. The vast majority of excellent clinicians, even if they have the interest and intellect for research, are simply incapable of performing the work. This limitation results in the virtually inevitable post-approval learning process as the therapy transitions from clinical trial to clinical practice.
It is in this critical area that community hospitals have the opportunity to fill the void. The hospital obviously has infrastructure and resources beyond that of all but the most exceptional clinical practices. By establishing an office of clinical trials within the hospital setting, the hospital can bring the necessary professional and regulatory expertise to the service of the physician. Obviously, only the highest quality of individuals with appropriate expertise would be eligible.
Sounds great, except, not that the hospital minds being such a “nice guy”, but, in a time of extremely tight operating budgets, why would the hospital be willing to risk such expense and potential liability? And even if they would, many physicians in private practice are averse to treating their patients as “guinea pigs.”
Fortunately, with an appropriate focus on quality, the economics can fall into line very nicely. Obviously, the study sponsors (manufacturers) need competent and productive sites for their studies and are willing to pay for the additional work and risk involved in product testing. The more research being conducted at a given site, the more economy of scale is achieved for the resources expended. Moreover, the more active the research site, the better it is able to attract and negotiate more lucrative contracts. An equitable distribution of funds between the hospital for its services in study coordinators, regulation and protocol compliance, IRB services, data collection and management and reporting, and the physicians for their patient enrollment will increase the profitability of both groups. Physicians, in an era of dramatically dropping reimbursement, are eager to find new income streams from the same patient volume.
Research, properly conducted, not only addresses this critical financial need, but does so in a manner that advances medicine and ultimately leads to improved patient care. Both the physician and the hospital become part of the process of advancing the profession. Moreover, the hospital now has a “value-added” mechanism to attract physicians to its facilityif Dr. A admits the patient to hospital X, he can potentially enroll that patient in a study, play a viable role in the field of research, and enhance his bottom line. Any savvy hospital administrator will confirm that, all things being equal, patients beget patients. The efficiency of the institution is dependant on filling beds. The more time more doctors spend seeing more patients in their hospital, the more likely the hospital is to benefit. The return for the hospital is not merely the fee for services from the research sponsors, but the increased physician connection and patient volume, as well as the added prestige of being a site of leading-edge research. For the community hospital, for the doctors, and ultimately for the patients, this is a very good deal.
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