July 21-27, 2012
Vail Marriott Mountain Resort & Spa
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.
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.
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.
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.
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
APPLICATIONS DUE BY 4/20/2012 at 5:00PM EST
ACCEPTED PARTICIPANTS WILL RECEIVE FULL SCHOLARSHIPS FOR TUITION AND EXPENSES
Supported by the National Institute of Neurological Disorders and Stroke