Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2009. For permissions please email: journals.permissions@oxfordjournals.org.
Clinical trial participation: are we studying the patients we are trying to treat?
1 Robert Wood Johnson Clinical Scholars Program, Department of Medicine, Yale University School of Medicine, New Haven, CT, USA
2 Section of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, CT, USA
3 Section of Health Policy and Administration, School of Public Health, Yale University School of Medicine, New Haven, CT, USA
4 Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA
* Corresponding author. Tel: +1 203 7645885, Fax: +1 203 7645653, Email: harlan.krumholz@yale.edu
This editorial refers to Is taking part in clinical trials good for your health? A cohort study by Andrew L. Clark et al. on page 1078
| The first 10% of the full text of this article appears below. |
A cardiologist reads an article in a leading journal which reports positive findings for a randomized clinical trial testing a novel pharmaceutical agent for use in patients with heart failure. The trial is well designed and the results suggest a clinically relevant improvement in mortality and morbidity. Later that day, during a routine office visit, a patient reports worsening symptoms related to her heart failure, despite being on appropriate medications. She meets all of the inclusion criteria and none of the exclusion criteria listed in the study. Is this patient an appropriate candidate for this novel drug?
Many of the improvements in outcomes for the treatment of cardiovascular disease are based on results of randomized clinical trials over the past 30 years. The scenario described above is an example of what most would describe as a reasonable
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Related articles in Eur J Heart Fail:
- Is taking part in clinical trials good for your health? A cohort study
- Andrew L. Clark, Michael J. Lammiman, Kevin Goode, and John G.F. Cleland
Eur J Heart Fail 2009 11: 1078-1083.[Abstract] [Full Text]