July 21-27, 2012
Vail Marriott Mountain Resort & Spa
Vail, Colorado
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The NINDS Clinical Trial Methods Course

This is an intensive, interactive clinical trials training program for fellows and faculty in the clinical neurosciences. The program will introduce investigators to the essentials of effective clinical trial design and implementation. During the program, investigators will develop their own pilot clinical trial protocol.

Program Goals

The mission of the National Institute of Neurological Disorders and Stroke (NINDS) and the broader neuroscience research community is to develop effective therapies that will lessen the burden of neurological disease. However, translating discoveries made in the laboratory into therapeutics has proven difficult. One reason for this difficulty is an insufficient number of well-trained clinical trialists to design and conduct scientifically sound and feasible clinical trials. Errors in trial design and conduct can lead to the abandonment of promising interventions and the further pursuit of interventions that are unlikely to be successful. Early and middle development trials (phases I and II) are critical steps in translation and pose unique challenges in neurology. These pilot trials will be the main focus of this course. The specific goals of the workshop are to improve the efficiency of clinical trials and development of interventions in the neurosciences by:
  • Introducing investigators to the fundamentals of effective clinical trial design and conduct. Investigators will learn from an experienced, multidisciplinary team of clinical trialists from neurology and other fields. The course will cover key topics in phase I and II clinical trials and will emphasize how early trials provide the foundation for later comparative efficacy studies.
  • Developing scientifically sound and feasible pilot clinical trial protocols. Investigators will work closely with faculty members to develop their own clinical trial idea into a protocol that they will conduct after the course. Designing a study and writing a protocol will give investigators the chance to synthesize the course information. A well-crafted study will also provide a sound footing for further career development.
  • Building a cohort of well-trained clinical researchers who will enhance the conduct of clinical trials nationally. This will in turn foster more efficient clinical development programs and will lead to improved treatments for patients with neurological diseases.

Program Formats

Protocol Development Sessions: during these sessions investigators will work in small groups and one-to-one with faculty to develop a protocol by the end of the course. Investigators must start the course with a clinical trial idea, as part of their application to the course. The focus of the protocol development sessions will mirror the lectures and discussion sessions and will allow investigators to synthesize and apply the material they have learned. These sessions are the core activity of the course and investigators will receive extensive critiques on their proposed studies from the experienced scientists.

Lectures and panel discussions: these sessions cover fundamental areas of clinical trial methodology. Lectures will cover the core principles needed for the design and conduct of efficient clinical trials. There will be ample time for questions and discussion.


Supported by the National Institute of Neurological Disorders and Stroke NINDS Logo

Jointly Sponsored by:
UR Sponsorship