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Neurological clinical trials in developing countries are growing exponentially, with strong contributions from Asia. However, there
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Area of Science:
- Neurology
- Clinical Trials
- Global Health
Background:
- Clinical trials in neurology are expanding in developing nations.
- No prior reviews have comprehensively analyzed these trials' evolution, distribution, or validity.
- Evaluating the quality of neurological clinical trials in these regions is crucial.
Purpose of the Study:
- To systematically review and describe neurological clinical trials conducted in developing countries.
- Specific objectives include detailing pathological fields, evaluating methodologies, and assessing trial validity.
Main Methods:
- A systematic literature review was performed.
- Databases searched included PubMed, Pascal, ScienceDirect, African Journal Online, and the Virtual Library of African Neurology.
- 145 studies were included in the analysis.
Main Results:
- Identified an exponential increase in the number of neurological clinical trials.
- Asia, Africa, and Latin America are key geographical contributors.
- A wide range of pathological fields are covered, including noncommunicable diseases, with diverse intervention types.
- A notable lack of early-phase trials (Phase I and IIa) was observed.
- Several methodological areas require improvement.
Conclusions:
- There is a need to establish dedicated structures for early-phase human intervention studies.
- Sustained development of clinical research methodology structures and training courses on good clinical practice are essential.
- Improvements in methodological quality, data management, and statistical analysis are necessary for neurological trials in developing countries.