The life cycles of six multi-center adaptive clinical trials focused on neurological emergencies developed for the Advancing Regulatory Science initiative of the National Institutes of Health and US Food and Drug Administration: Case studies from the Adaptive Designs Accelerating Promising Treatments Into Trials Project-Reference-Cited by-同舟云学术

The life cycles of six multi-center adaptive clinical trials focused on neurological emergencies developed for the Advancing Regulatory Science initiative of the National Institutes of Health and US Food and Drug Administration: Case studies from the Adaptive Designs Accelerating Promising Treatments Into Trials Project

Published:2017-10-16 Issue: Volume:5 Page:205031211773622
ISSN:2050-3121
Container-title:SAGE Open Medicine
language:en
Short-container-title:SAGE Open Medicine

Author:

Guetterman Timothy C¹,Fetters Michael D¹,Mawocha Samkeliso²,Legocki Laurie J¹,Barsan William G²,Lewis Roger J³,Berry Donald A⁴,Meurer William J²⁵

Affiliation:

1. Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA

2. Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA

3. Department of Emergency Medicine, Harbor-UCLA Medical Center, Los Angeles, CA, USA

4. Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

5. Department of Neurology, University of Michigan, Ann Arbor, MI, USA

Publisher

SAGE Publications

Subject

General Medicine

Link

http://journals.sagepub.com/doi/pdf/10.1177/2050312117736228

Reference18 articles.

1. Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012

2. Clinical development success rates for investigational drugs

3. Advancing Regulatory Science

4. An Overview of the Adaptive Designs Accelerating Promising Trials Into Treatments (ADAPT-IT) Project

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