PARTICIPANTS IN CLINICAL TRIALS FOR HEART
DISEASE TREATMENTS ARE OFTEN HEALTHIER THAN
PATIENTS THE INVESTIGATIONAL DRUGS TARGET, A
NEW STUDY CONFIRMS. THE STUDY ALSO FINDS THAT
THE GENERALIZABILITY OF CLINICAL TRIAL RESULTS
SUFFERS BECAUSE OF LOW PARTICIPATION.
Review of Clinical
Trials Participation
Spotlights
Need for Higher
Enrollment
By Michael Ferguson
A
UTHORS OF THE 2014 study,
published in The Journal of the
American Medical Association,
set out to analyze the extent
of the recognized phenomenon that
clinical trial participants aren't fully
representative of patient populations
treated in routine clinical practice.
During a four-yea r study period,
researchers tracked participation in
randomized clinical trials of patients
who had suffered acute myocardial
infarction. They found that participants
were younger, had fewer prior bouts
of cardiovascular disease and were
hospita lized for shor ter durations.
They were also more frequently treated
w it h ev idence-ba sed t herapy t ha n
nonparticipants were. These factors
contributed to lower risk profiles and
more favorable prognoses compared
with those of the broader population
with myocardial infarction, who the
study noted are often prevented from
participating in clinical trials due to
factors such as uncontrolled hypertension,
severe anemia or cardiogenic shock
(42, 15 and 14 percent of the
time, respectively).
