Efficacy and Safety in Clinical Trials in Cardiovascular Disease

Jay N. Cohn

Research output: Contribution to journalReview articlepeer-review

11 Scopus citations

Abstract

Mortality and morbid events are insensitive guides to the efficacy and safety of interventions in chronic cardiovascular disease (CVD). To enhance the ability to find new and effective long-term treatments, especially for the early stages of CVD, a revised strategy for clinical trials should emphasize efficacy on disease progression while monitoring symptoms and quality of life as guides to clinical benefit. Mortality, which is uncommon except in acute or advanced disease, provides at best a crude guide to net efficacy and safety. It must be monitored to support demonstrated efficacy on disease progression without adverse safety effects. This revised approach, made possible by our enhanced ability to monitor the progression of disease, should make it possible to study earlier disease and to improve cardiovascular health while reducing health care costs.

Original languageEnglish (US)
Pages (from-to)430-433
Number of pages4
JournalJournal of the American College of Cardiology
Volume48
Issue number3
DOIs
StatePublished - Aug 1 2006

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