Opinion 2.075 - The Use of Placebo Controls in Clinical Trials
Placebo controls are an important part of medicine’s commitment
to ensuring that the safety and efficacy of new drugs are
sufficiently established. Used appropriately, placebo controls
can safely provide valuable data and should continue to be
considered in the design of clinical trials. The existence of an
accepted therapy does not necessarily preclude the use of such
controls; however, physician-investigators should adhere to the
following guidelines to ensure that the interests of patients
who participate in clinical trials are protected. (1)
Investigators must be extremely thorough in obtaining informed
consent from patients. To the extent that research is dependent
upon the willingness of patients to accept a level of risk,
their understanding of the potential harms involved must be a
top priority of any clinical investigation. The possibility
presented in some studies that patients often do not fully
understand the research protocol and ther