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Published on: January 15, 2017
A strategic plan to accelerate development of acute stroke treatments
1National Institute of Neurological Disorders and Stroke Acute Stroke Study Group, National Institutes of Health, Rockville, Maryland, USA. johnmarler@verizon.net
Abstract:
In order to reenergize acute stroke research and accelerate the development of new treatments, we need to transform the usual design and conduct of clinical trials to test for small but significant improvements in effectiveness, and treat patients as soon as possible after stroke onset when treatment effects are most detectable. This requires trials that include thousands of acute stroke patients. A plan to make these trials possible is proposed. There are four components: (1) free access to the electronic medical record; (2) a large stroke emergency network and clinical trial coordinating center connected in real time to hundreds of emergency departments; (3) a clinical trial technology development center; and (4) strategic leadership to raise funds, motivate clinicians to participate, and interact with politicians, insurers, legislators, and other national and international organizations working to advance the quality of stroke care.
Insights
To improve acute stroke treatments, we propose a new clinical trial strategy. This plan involves large-scale trials with thousands of patients, aiming for faster and more effective stroke care interventions.
Area of Science:
- Neurology
- Clinical Trials
- Public Health
Background:
- Acute stroke research requires innovation to accelerate new treatment development.
- Current clinical trials often lack the scale to detect small but significant treatment effects.
- Timely intervention post-stroke is crucial for maximizing treatment efficacy.
Purpose of the Study:
- To propose a transformative plan for acute stroke clinical trials.
- To enable large-scale trials involving thousands of patients.
- To expedite the development and implementation of effective stroke treatments.
Main Methods:
- Establishing free access to electronic medical records.
- Creating a national stroke emergency network and coordinating center linked to emergency departments.
- Developing a dedicated clinical trial technology center.
- Implementing strategic leadership for funding, clinician engagement, and stakeholder interaction.
Main Results:
- The proposed plan facilitates large-scale, real-time clinical trials.
- It enhances the potential to identify subtle yet significant treatment improvements.
- It aims to accelerate the translation of research findings into improved patient care.
Conclusions:
- A paradigm shift in clinical trial design is necessary for acute stroke research.
- The proposed four-component plan provides a framework for successful large-scale trials.
- This initiative will accelerate the development of novel and effective acute stroke therapies.
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