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Published on: January 17, 2013
Advances in clinical trials for movement disorders
Karl Kieburtz1, C Warren Olanow2
1University of Rochester School of Medicine, Rochester, New York, USA.
Abstract:
In the past several years, there have been several innovations in the design of clinical trials assessing new therapies for patients with movement disorders. These include attempts to address difficulties in conducting clinical trials in treated patients in the advanced stages of their illness, demonstrating disease-modifying effects or a reduction in the development of cumulative disability, and assessing the effects of interventions in patients in the premanifest state of their disease. In addition, there have been advances in clinical trial methodologies and changes in regulatory guidelines that permit the performance of more efficient studies, with a reduction in the cost and duration of the development period. These will be reviewed in the present article. © 2015 International Parkinson and Movement Disorder Society.
Insights
Innovations in clinical trial design for movement disorders aid in assessing new therapies for advanced and premanifest stages. Methodological advances and regulatory changes enable more efficient, cost-effective, and timely drug development.
Area of Science:
- Neurology
- Clinical Trials
- Movement Disorders
Background:
- Clinical trials for movement disorders face challenges in advanced disease stages.
- Demonstrating disease modification and assessing premanifest interventions are key difficulties.
Purpose of the Study:
- To review recent innovations in clinical trial design for movement disorders.
- To discuss advancements in methodologies and regulatory guidelines for efficient studies.
Main Methods:
- Review of recent innovations in clinical trial design.
- Analysis of methodological advancements.
- Examination of changes in regulatory guidelines.
Main Results:
- New trial designs address challenges in advanced disease stages.
- Methods now allow for assessment of disease modification and premanifest interventions.
- Regulatory changes facilitate more efficient and cost-effective studies.
Conclusions:
- Recent innovations have significantly improved clinical trial design for movement disorders.
- Methodological and regulatory advancements streamline drug development, reducing cost and duration.
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