Clinical trial implementation: a primer for neurosurgeons

Abstract

In 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.

Why are clinical trials of deep brain stimulation terminated? An analysis of clinicaltrials.gov

“…There are lessons to be learned from successful and unsuccessful trials to optimize future clinical study and limit the lost financial, administrative, and physical investment associated with unsuccessful clinical trials. 15 Here, we review successful and unsuccessful DBS-related clinical trials and assess causes of early trial termination to identify factors associated with unsuccessful trials. We also review trials that highlight the current state of DBS for neuropsychiatric conditions.…”