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Journal of neurosurgery · Nov 2023
ReviewClinical trial implementation: a primer for neurosurgeons.
- Adrian E Jimenez, Rupesh Kotecha, and Debraj Mukherjee.
- 1Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.
- J. Neurosurg. 2023 Nov 1; 139 (5): 143914451439-1445.
AbstractIn the current landscape of evidence-based medicine, prospective clinical trials are an important avenue through which to establish the efficacy and safety of biomedical treatments compared with standard-of-care interventions. Depending on their scope and aims, clinical trials can be extremely costly and time intensive, and significant coordination is needed to ensure optimal utilization of healthcare resources, adherence to the principles of biomedical ethics, and appropriate interpretation of study results. This review highlights the core principles for designing and implementing clinical trials within neurosurgery, with the aim to provide clinicians with a framework for implementing both investigator-initiated and industry-sponsored trials.
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