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

ufts CTSI's Manager of Project Administration. The research team includes:

  • Kenneth A. Oye, PhD, Massachusetts Institute of Technology (MIT)
  • Hans-Georg Eichler, MD, MSc, European Medicines Agency
  • Norman L. Stockbridge, MD, PhD, US Food and Drug Administration, Center for Drug Evaluation and Research
  • Cyrus R. Mehta, PhD, Harvard School of Public Health
  • Kenneth I. Kaitin, PhD, Tufts Center for the Study of Drug Development
  • Newell McElwee, PharmD, MSPH, Merck & Co.
  • Peter K. Honig, MD, MPH, AstraZeneca
  • John K. Erban, MD, Tufts Cancer Center
  • Ralph B. D'Agostino, PhD, Boston University; Harvard Clinical Research Institute

"The E2E approach represents a fundamental shift in a drug development model that has remained basically unchanged for over fifty years," suggests Kenneth I. Kaitin, PhD, director of the Tufts Center for the Study of Drug Development and research professor at Tufts University School of Medicine. "Although adoption of the approach is not without its challenges, there are likely to be many winners: industry, who will gain better understanding of a drug's utility, enabling differentiation from competitors; regulators, who will have greater understanding of the drug's safe and effective use in heterogeneous populations; payers, who will be able to make more informed reimbursement and coverage decisions; and of course physicians and patients, who will benefit from real-world data on the benefits and risks of new medicines."

"There is growing realization that the difference between efficacy and effectiveness is not just a challenge for drug regulation, but also an underutilised learning opportunity," says Hans-Georg Eichler, MD, MSc, of European Medicines Agency, "the heterogeneity of real-life treatment populations may help identify non-responders or non-tolerators, and such insights may not be gained from the rather homogenous clinical trial populations. Realizing this learn
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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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