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This chapter describes the planning process for a clinical trial. Successful clinical trials rely on scientific, clinical, and operational excellence, and discuss the example of large, global studies. Most study management models in the pharmaceutical industry rely on a study or project manager (PM). Efficient communication across the entire study team is a requisite for successful execution of clinical trials. Investigator-initiated studies often try to obtain investigational medicinal product (IMP) directly from the manufacturer at no-cost. Most project teams or PMs use a countdown approach where the main goal is identified as the final task. The FDA has established classifications for approximately 1700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. The Maintenance and Support Services Organization reviews and maintains MedDRA on a regular basis. Drafting the Statistical Analysis Plan (SAP) typically begins shortly after the protocol synopsis is finalized.
This chapter discusses the basic ethical principles and practices for human experimentation. It touches on the related subject of regulatory and legal issues in neurological research. Disorders of the central nervous system (CNS) present a number of challenges for specifying core principles and practices of research ethics. In CNS research, the tensions between regulation and ethics are greatest around the use of placebo controls. Phase 1 trials of new CNS interventions, as with all interventions, generally present a high degree of risk and uncertainty. Many trials involving neurological disorders show evidence of placebo responses. Many CNS drug trials involve brain imaging, in one report, brain abnormalities, like malignancies or vascular malformations, were detected in as many as 18% of healthy volunteers. Issues of justice arise with particular frequency whenever CNS trials involve placebos. Researchers should also attend to various non-verbal or affective elements of communication that shape public expectations.