Neuroscience Trials of the Future Proceedings of a Workshop (2016) / Chapter Skim
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1 Introduction
1 Introduction
Pages 1-4
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. In addition, even in the hands of experienced investigators, poor assay sensitivity2; the lack of reliable, validated, and clinically meaningful endpoints; high placebo or non-specific responses; high variability among participants and sites; poor treatment adherence; and inadequate recruitment and retention have adversely affected pharmaceutical and device development (Ereshefsky et al., 2016; Gupta, 2012; Silberman, 2009)
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approved 19 drugs in oncology and 9 in neuropsychiatry, suggesting greater efficiency in the neuroscience area, said Perry Nisen, chief executive officer of Sanford Burnham Prebys Medical Discovery Institute. Quite apart from the business perspective, the fact that many earlystage clinical trials misleadingly provide a false-positive signal (a type I error)
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Chapter 2 provides an overview of the challenges and opportunities for 21st century neuroscience clinical trials noted by many workshop participants. Chapter 3 outlines novel research and clinical trial design approaches to address heterogeneity and expedite the development of biomarkers and other drug development tools, including clinically meaningful outcome measures.
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The workshop will bring together key stakeholders to consider ways to advance therapeutic development for nervous system disorders by using inno vative clinical trial designs; improving patient selection, engagement, and retention; and enhancing clinical monitoring to help decrease the failure rate of drugs and devices in development. Presentations and discussions will be designed to: • Examine assay sensitivity challenges in clinical trials for nervous system disorders, including causes of poor signal detection and type II error.
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