The impact of clinical trial protocols on patient care in a community hospital.

Although clinical research is essential in cancer control, less than 5% of cancer cases in community hospitals are entered in clinical trials. Phase III studies comprise the bulk of clinical research at our community hospital. Potential research protocols are selected by the Community Clinical Oncology Program Therapeutic Investigations Committee for referral to affiliated institutional review boards. Selection criteria include assessments of the scientific validity, relevance, and importance of the research, the match between the proposed protocol and research interests and experience of the investigators, priorities of the research bases for patient accrual, and resource availability for conduct of the study. There are serious impediments to the performance of clinical trials in the multiethnic, multilingual urban community hospital setting. These include diminution of the potential patient pool for trial entry due to language barriers and other difficulties associated with patient accrual; escalating costs (insurance coverage from some carriers in not available for clinical trial participation, and some therapies may be excluded by third-party payers); underinsurance or lack of insurance in many segments of the potential patient population; declining financial support for clinical research and the variability of payments, with restrictions even for standard or conventional treatments; the widespread belief that investigational studies are too costly or are of unproven value; potential liabilities associated with withholding cancer therapy; the unresolved legal quagmire surrounding cancer care for patients just under 18 years of age; and the potential for scientific misconduct related to the performance of clinical trials.