Clinical Trials in Neurology
This chapter provides extensive coverage of concepts related to controlled clinical trials in neurology. It describes the main issues in clinical trial design, conduct, and analysis, by examples from neurological research. It begins with a summary of the objectives of Phase I through Phase IV trials, followed by a discussion of the commonly used study designs for clinical trials (parallel group design, factorial design, crossover design, N-of-one design). It then describes important principles for the conduct of clinical trials, including methods for recruitment and retention of clinical trial subjects, approaches to minimizing bias due to unblinding, and techniques for monitoring compliance and adverse events. It discusses methods of randomization and choice of primary and secondary measures of treatment outcome and summarizes statistical approaches to clinical trial data, including intent-to-treat analyses, explanatory analyses, per protocol analyses, and on-treatment analyses. Methods for subgroup analyses and planning of interim analyses are also discussed. One section of the chapter is devoted to ethics of controlled clinical trials.
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