Abstract

The use of randomized clinical trials to evaluate drugs and medical devices is a complex and increasingly expensive process, which is plagued by disappointingly low rates of success. Innovations in clinical trial methodology, and specifically adaptive clinical trials, can address many ofthe limitations of conventional trial designs and have the potential to improve the efficiency and success rates of clinical research, the quality of resulting scientific data, and the protection of human subjects. Optimal approaches-including both statistical methods and organizational processes-iforthe collaborative development and implementation of confirmatory, adaptive clinical trials remain unclear. This project will address that gap. The process of clinical trial development within the NINDS-supported Neurological Emergencies Treatment Trials (NETT) networl

Public Health Relevance

(See Instructions): Randomized clinical trials are the cornerstone for acceptance of new therapies by regulatory agencies and clinicians. Currently, this process is slow and cumbersome and may lead to false conclusions about the utility of new treatments. This project will identify effective processes for the design and initiation of high-quality, confirmatory, adaptive clinical trials. These methods can be used to accelerate the evaluation of promising new therapies, conserve resources and support public health by improving the rate and quality of drug and device development.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01NS073476-03
Application #
8323322
Study Section
Special Emphasis Panel (ZRG1-ETTN-A (50))
Program Officer
Morris, Jill A
Project Start
2010-09-27
Project End
2014-08-31
Budget Start
2012-09-01
Budget End
2014-08-31
Support Year
3
Fiscal Year
2012
Total Cost
$566,876
Indirect Cost
$162,150

  Institution

Name
University of Michigan Ann Arbor
Department
Emergency Medicine
Type
Schools of Medicine
DUNS #
073133571
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109

  Publications

Guetterman, Timothy C; Fetters, Michael D; Mawocha, Samkeliso et al. (2017) 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 Adap SAGE Open Med 5:2050312117736228
Mawocha, Samkeliso C; Fetters, Michael D; Legocki, Laurie J et al. (2017) A conceptual model for the development process of confirmatory adaptive clinical trials within an emergency research network. Clin Trials 14:246-254
Meurer, William J; Legocki, Laurie; Mawocha, Samkeliso et al. (2016) Attitudes and opinions regarding confirmatory adaptive clinical trials: a mixed methods analysis from the Adaptive Designs Accelerating Promising Trials into Treatments (ADAPT-IT) project. Trials 17:373
Guetterman, Timothy C; Fetters, Michael D; Legocki, Laurie J et al. (2015) Reflections on the Adaptive Designs Accelerating Promising Trials Into Treatments (ADAPT-IT) Process-Findings from a Qualitative Study. Clin Res Regul Aff 32:121-130
Legocki, Laurie J; Meurer, William J; Frederiksen, Shirley et al. (2015) Clinical trialist perspectives on the ethics of adaptive clinical trials: a mixed-methods analysis. BMC Med Ethics 16:27
Connor, Jason T; Broglio, Kristine R; Durkalski, Valerie et al. (2015) The Stroke Hyperglycemia Insulin Network Effort (SHINE) trial: an adaptive trial design case study. Trials 16:72
Meurer, William J; Barsan, William G (2014) Spinal cord injury neuroprotection and the promise of flexible adaptive clinical trials. World Neurosurg 82:e541-6
Zahuranec, Darin B; Lisabeth, Lynda D; Sánchez, Brisa N et al. (2014) Intracerebral hemorrhage mortality is not changing despite declining incidence. Neurology 82:2180-6
Bleck, Thomas; Cock, Hannah; Chamberlain, James et al. (2013) The established status epilepticus trial 2013. Epilepsia 54 Suppl 6:89-92
Johnston, S Claiborne; Easton, J Donald; Farrant, Mary et al. (2013) Platelet-oriented inhibition in new TIA and minor ischemic stroke (POINT) trial: rationale and design. Int J Stroke 8:479-83

Showing the most recent 10 out of 14 publications