Rigor in Monitoring Clinical Trials Is Ethical

Abstract

Wells focuses our attention on confidentiality of preliminary data in ongoing clinical trials. Based on his views of circumstance, regulation, and ethics, he concludes “. . . the medical and scientific community is being dishonest with patients and research subjects. . . engaging in unethical research practices and undermining ethical standards of research.” Restriction of information has the potential to be a thorny problem. However, current clinical trials principles and practices do not sink to the level of damnation suggested by Wells. In 1865, Claude Bernard said: Man is by nature metaphysical and arrogant. Accordingly, he thinks that the idealistic creations of his mind, which correspond to his feelings, are identical with reality. From this it follows that the experimental method is not really natural to him. . . This view is apposite to the spirit and foundations of Wells’ criticisms. Since the early 1980s when I began as a clinical trialist, we have seen the emergence and wide application of formal administrative and quantitative methods for monitoring trials to minimize errors of interpretation. Clinical trials have permeated nearly every area of medicine, encountering numerous circumstances that require the needs of society to be balanced with the rights of research subjects. Rigorous trial monitoring methods, including restraints on data dissemination, have evolved to improve the balance of needs and the ethics properties of studies rather than to aggravate them. The proper view of such matters hinges on four points: (1) the unreliability of early information, (2) the fact that research subjects are not disadvantaged by a temporary lack of access to preliminary data, (3) the ethics imperatives for good design and investigator competence, and (4) the obligation of physician scientists to acquire definitive information and make it available to everyone. I will return to these topics after a critical review of Wells’ arguments.