Financial ties as part of informed consent to postmarketing research. Attitudes of American doctors and patients.

Postmarketing research, often called phase IV trials, is intended to familiarise doctors and patients with newly approved drugs. La Puma and colleagues, in Chicago, studied doctors' and patients' attitudes to whether doctors should receive payment for taking part in such research. We asked for commentaries on their findings from four ethical experts, who put the study in a British context, present the views of patients, and examine some methodological assumptions. The attitudes of doctors and patients about financial ties as part of informed consent to research have not been studied. Neither the United Kingdom's quadripartite regulations1 nor new research guidelines in the United States2 require financial disclosure to patients. Postmarketing (phase IV) research is part of the $10.9bn the American pharmaceutical industry spends annually on research.3 Ordinarily uncontrolled observational cohort studies of outpatients,4 phase IV trials are often intended to familiarise doctors and patients with new drugs approved by the Food and Drug Administration. In the United States phase IV trials and postmarketing surveillance (seeding studies) are generally indistinguishable. Industry sponsors pay doctors to …