Efficacy and Effectiveness Too Trials: Clinical Trial Designs to Generate Evidence on Efficacy and on Effectiveness in Wide Practice

Author:

Selker Harry P.12,Eichler Hans‐Georg3,Stockbridge Norman L.4,McElwee Newell E.5,Dere Willard H.6,Cohen Theodora12,Erban John K.7,Seyfert‐Margolis Vicki L.8,Honig Peter K.9,Kaitin Kenneth I.10,Oye Kenneth A.11,D'Agostino Ralph B.1213

Affiliation:

1. Tufts Clinical and Translational Science InstituteTufts University Boston Massachusetts USA

2. Institute for Clinical Research and Health Policy StudiesTufts Medical Center Boston Massachusetts USA

3. European Medicines Agency London UK

4. US Food and Drug Administration Center for Drug Evaluation and Research Silver Spring Maryland USA

5. Boehringer Ingelheim Ridgefield Connecticut USA

6. Department of Internal MedicineUtah Center for Clinical and Translational ScienceUniversity of Utah School of Medicine Salt Lake City Utah USA

7. Cancer CenterTufts Medical Center Boston Massachusetts USA

8. My Own Med, Inc. Bethesda Maryland USA

9. Collegeville Pennsylvania USA

10. Tufts Center for the Study of Drug DevelopmentTufts University Boston Massachusetts USA

11. Massachusetts Institute of Technology Political Science and Center for Biomedical Innovation Cambridge Massachusetts USA

12. Department of Mathematics and StatisticsBoston University Boston Massachusetts USA

13. Baim Institute for Clinical Research Boston Massachusetts USA

Funder

National Institutes of Health

National Center for Advancing Translational Sciences

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

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