ABSTRACT
Clinical trials are the key interfaces of basic science findings, product development, rationalization of existing therapies, and their translation into effective clinical therapy (see Chapter 1). Thus, all translational research depends upon clinical trial data. However, clinical trial design is a specialty field in its own right and few basic scientists, clinician investigators, and clinicians have formal training in this field, particularly in neurosurgery and orthopedics. The performance of clinical trials and
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the outcomes of those trials form the most severe bottleneck of new therapy development, particularly in surgical fields and device development, where many alternative pathways for product introduction exist and no specific criteria are available for trial format.1,2 Thus, particularly in product development (unlike drug development), the manufacturer may omit clinical trials of efficacy determination altogether to focus only on safety issues, rather than risk a failed clinical trial that could doom FDA approval because alternative pathways to approval exist.
