Abstract
Prior exposure to one of the randomized treatments has been a routine design element of large-scale trials in patients at high cardiovascular risk. A run-in feature has allowed our trials to be more realistic; it has strengthened their ability to estimate the true treatment effect; and it has never undermined the validity of a trial's findings. Those who suggest that run-in periods distort the results of large-scale trials should become more familiar with our history of drug development and our standards of clinical practice. Physicians use run-in periods every day in real life, and trialists have used run-in periods for decades to reliably establish the role of new cardiovascular drugs. Those who reflexively criticize the trials because of their inclusion of a run-in period need to carefully reexamine how medicine is practiced and how it advances.
Original language | English (US) |
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Pages (from-to) | 697-699 |
Number of pages | 3 |
Journal | Journal of Cardiac Failure |
Volume | 23 |
Issue number | 9 |
DOIs | |
State | Published - Sep 1 2017 |
Keywords
- Clinical trial design
- drug efficacy studies
- heart failure trials
- run-in periods
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine