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Multidisciplinary research team led by Tufts CTSI proposes new model for clinical trials
Date:3/19/2014

BOSTON (March 19, 2014) Experts across academia, industry and government propose a new method for health care providers to get the right treatments to the right patients at the right time. This new approach, A Proposal for Integrated Efficacy-to-Effectiveness (E2E) Clinical Trials, published in Nature Clinical Pharmacology & Therapeutics, recommends a seamless transition from controlled experiments to real-world comparative effectiveness trials. This continuum will improve the accuracy of treatment selection and better determine how those treatments work on different groups of people.

Efficacy trials are conducted in optimal conditions with patients who have similar characteristics. These trials are typically used to secure regulatory approval for a drug.

Effectiveness trials are conducted in more typical clinical settings, with patients who have varying characteristics. These trials are designed to determine whether treatment effects identified in efficacy trials carry over to more typical uses of drugs in practice.

Currently, efficacy and effectiveness trials are conducted separately, and effectiveness trials may occur years later or not at all. In the E2E model, an effectiveness trial starts immediately after the efficacy trial is completed (or as soon as possible, depending upon a predetermined approval process). Data derived from the efficacy trial can be used to formulate questions to investigate during the effectiveness trial; data derived from the effectiveness trial can then be used to assist patients and providers in making individual treatment decisions.

Development of the E2E approach was led by Harry P. Selker, MD, MSPH of Tufts Clinical and Translational Science Institute (CTSI) and Tufts Medical Center's Institute for Clinical Research and Health Policy Studies (ICRHPS), with assistance from Aaron Kirby, MSc, T
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Contact: Amy West
awest@tuftsmedicalcenter.org
617-636-6025
Tufts Clinical and Translational Science Institute
Source:Eurekalert

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