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NINDS clinical trials in stroke: lessons learned and future directions
1National Institute of Neurological Disorders and Stroke, National Institutes of Health, 6001 Executive Blvd, Rm 2216, Rockville, MD 20892, USA. marlerj@ninds.nih.gov
Stroke
|October 27, 2007
Summary
The National Institute of Neurological Disorders and Stroke (NINDS) has sponsored 28 phase 3 stroke trials, leading to beneficial treatments. Future trials will be larger, simpler, and focus more on cognitive and quality-of-life outcomes.
Area of Science:
- Neurology
- Clinical Trials Methodology
- Cerebrovascular Disease Research
Background:
- The National Institute of Neurological Disorders and Stroke (NINDS) has a long history of sponsoring stroke clinical trials.
- Over 44,000 patients have been randomized in 28 phase 3 trials since 1977.
- These trials have successfully identified beneficial and cost-effective treatments for cerebrovascular disease.
Purpose of the Study:
- To review the impact and evolution of NINDS-sponsored phase 3 stroke trials.
- To outline future directions for stroke clinical trial design and outcome measures.
- To highlight the importance of continued research and participation in advancing stroke treatment.
Main Methods:
- Review of 28 completed and ongoing phase 3 clinical trials sponsored by NINDS.
- Analysis of patient randomization numbers and geographical scope.
- Identification of trends in trial design and outcome assessment over time.
Main Results:
- NINDS stroke trials have established a strong evidence base for effective cerebrovascular disease treatments.
- Successful identification of beneficial and cost-effective therapeutic interventions.
- Significant patient enrollment across numerous international trials.
Conclusions:
- Future stroke trials are expected to increase in size and adopt simpler designs for broader patient inclusion and reduced data collection per patient.
- Emphasis on cognitive outcomes, executive function, disability scales, and quality-of-life measures will grow.
- Continued scientific discovery, innovative trial methodologies, and increased clinical trial participation are crucial for future advances in stroke treatment.
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