Author Affiliations: Department of Adult Oncology, Dana-Farber Cancer Institute, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.
Of the 1.3 million individuals diagnosed with cancer each year in the
United States,1 a substantial minority participate
in clinical trials.2,3 When patients
agree to enter these trials, they expect their physicians to provide full
and detailed information about the study. In addition, the success of the
research may be influenced by how well patients are informed.4
Following completion of a clinical trial, participants are not routinely informed
about the aggregate study results unless this information would influence
their future care. However, anecdotal experience suggests that many patients
who participate in clinical trials are interested in the experience of other
patients enrolled in the study and in learning about the aggregate results.
A recent consensus conference recommended that the results of clinical trials
should be made available to participants and suggested that providing participants
with results, both positive and negative, should be considered the "ethical
norm."5 Currently, there is clear disparity
between this recommendation and what actually occurs. This article examines
the implications of offering trial results to study participants and the steps
necessary before results could be routinely provided. Clinical trials of cancer
therapies are used as an example, although the issues may extend to many types
of clinical research.
Partridge AH, Winer EP. Informing Clinical Trial Participants About Study Results. JAMA. 2002;288(3):363-365. doi:10.1001/jama.288.3.363