Assessing the Scope and Predictors of Intentional Dose Non-adherence in Clinical Trials.

Journal: Therapeutic innovation & regulatory science
Published Date: May 4, 2020

Abstract

BACKGROUND: Although there is broad agreement that the accurate estimation of non-adherence rates in clinical trials is essential to determining the dose-response relationship, treatment safety and efficacy effects, no accurate estimates have ever been produced.

Authors

  • Kenneth Getz
    Tufts Center for the Study of Drug Development, Tufts University School of Medicine, 75 Kneeland Street, Suite 1100, Boston, MA, 02111, USA. Kenneth.getz@tufts.edu.
  • Zachary Smith
    Tufts Center for the Study of Drug Development, Tufts University School of Medicine, 75 Kneeland Street, Suite 1100, Boston, MA, 02111, USA.
  • Laura Shafner
    From the Montefiore Medical Center, Bronx, New York (D.L.L., M.R.G., D.V.); and AiCure, New York, NY (L.S., A.H.). laura.shafner@aicure.com.
  • Adam Hanina
    From the Montefiore Medical Center, Bronx, New York (D.L.L., M.R.G., D.V.); and AiCure, New York, NY (L.S., A.H.).

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