TY  - JOUR
T1  - INforming clinical trial participants about study results
AU  - Partridge AH, Winer EP
Y1  - 2002/07/17
N1  - 10.1001/jama.288.3.363
JO  - JAMA
SP  - 363
EP  - 365
VL  - 288
IS  - 3
N2  - 
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.

SN  - 0098-7484
M3  - doi: 10.1001/jama.288.3.363
UR  - http://dx.doi.org/10.1001/jama.288.3.363
ER  -