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International Clinical Trials

Clinical Complexities

Industry-wide, clinical trials are becoming vastly more complicated and costly as investigational therapies develop in sophistication, and the amount of data needed not only for regulatory approval, but also for commercial success (ie, market access and adoption), expands exponentially.

Rising complexity is particularly acute in central nervous system (CNS) clinical trials, where industry-wide challenges are compounded by the unique intricacies associated with research in neurologic, analgesic, and psychiatric disorders. It continues to rise at a big cost. According to a 2014 report from the Tufts Center for the Study of Drug Development, the overall clinical approval success rate for CNS compounds from 1995 to 2007 was just 6.2% and less than half the 13.3% rate for non-CNS drugs (1).

CNS clinical trials are difficult and becoming more so because, in large part, the understanding of neurobiology is incomplete and the pathology of many CNS disorders is unknown. Many endpoints used in CNS studies – eg, pain, mood, or cognitive improvement or decline – are inherently subjective, and signal detection is more difficult in the absence of objective measures for diagnosis and treatment response. Novel and objective study endpoints are being explored, and assessment tools are becoming more sensitive – but also are more difficult to administer without proper training. Newer, targeted drug delivery methods, such as those involving ultrasonography, may require patient adherence to a comprehensive set of procedures, compounding the already significant problem of adherence in CNS clinical trials. Moreover, the placebo response is high in CNS trials; new, more complex study designs are being employed in the effort to minimise this, often increasing the burden on clinical sites. Advances in technology capable of facilitating real-time monitoring and measurement – and eventually even ‘site-less’ clinical trials – are starting to make inroads into CNS study design and implementation while also raising the stakes for scientific rigor and technological know-how.

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Tom Zoda is Executive Vice President and General Manager, Clinical Development, CNS, for Syneos Health. Syneos Health, created through the merger of two industry leading companies – INC Research and inVentiv Health – is the only fully integrated end-to-end biopharmaceutical solutions organisation and is purpose-built to accelerate customer performance to address modern market realities.
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