Clinical Concerns and the Validity of Clinical Trials

Abstract

Background: The validity of results from clinical trials depends on both clinical researchers and participants consistently and strictly following research protocols. However, clinical trial researchers are also expected to provide excellent medical care to the participants. These two commitments may conflict under some circumstances. Methods: A questionnaire previously used for a national Internet-based survey was adapted to conduct in-depth, semistructured interviews in order to further explore reported attitudes and/or behaviors that indicated that patient well-being sometimes took precedence over strict adherence to the study protocol. We conducted 96 interviews with researchers working on Phase II and/or Phase III clinical trials in a variety of medical fields at four major academic medical centers. Results: Due to concerns for the welfare of their patients, the researchers we interviewed described decisions that involved “individualized” rather than protocol-driven decisions about recruitment, protocol implementation, and termination. The individualized decisions could threaten the validity of the trials. Conclusions: Clinical researchers should be strongly encouraged to carefully document and report selective recruitment, implementation, and termination decisions so that it will be easier to evaluate to whom the results of research studies apply. Those who design clinical trials should be careful to construct them so that the clinicians who carry them out will not feel that implementing the protocol will violate their commitments to good clinical care.