Competing Commitments in Clinical Trials‪.‬

Scholars of the ethics of clinical trials have long recognized a tension between the therapeutic obligations (1) of clinicians (physician, nurses, and other health professionals) and the scientific demands of clinical trials. (2) The basis for this concern is clear: clinical care is focused on improving the condition of the presenting patient, while clinical research seeks valid, generalizable information to help future patients. Although in principle both the investigational and control arms of clinical trials are designed to have an equal likelihood of efficacy for the typical patient, in many situations research and clinical goals may nonetheless be in conflict. For example, during the recruitment process for a clinical trial, clinicians may have to decide whether to offer participation to a patient who might benefit from the study intervention, but who does not meet the trial's eligibility requirements. (3) And once a patient enrolls in a trial, clinicians have to decide whether to deviate from protocol requirements (e.g., dosage of study medication, use of adjunctive medications, or procedures to collect required study data) for the purpose of promoting the patient-subject's best medical interests. Finally, clinicians involved with clinical trials may have to decide whether to keep a participant in a trial who, despite technically meeting a termination criterion, seems to be benefiting from ongoing participation. Whatever the scope of a therapeutic obligation concerning clinical trials, the potential for the clinical commitments of physicians, nurses, and other health professionals to undercut the requirements of a research protocol has largely been ignored. With few exceptions, (4) ethical and policy discussions of this issue have centered on how research imperatives may interfere with clinical care, not how clinical imperatives may lead to decisions that could compromise the validity of research results. The scant literature on gaps between protocol design and adherence to the protocol assumes that protocol violations are matters of research integrity motivated by selfish interests, (5) rather than matters related to therapeutic obligation. This is not just a theoretical issue. In some circumstances, clinicians' decisions that are motivated by concerns about a patient-subjects' medical interests may threaten the validity of the research, waste the financial resources invested as well as the efforts of researchers and subjects, and lead to invalid data entering the medical knowledge base.