Neuroscience Trials of the Future Proceedings of a Workshop (2016) / Chapter Skim
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2 Neuroscience Clinical Trials: An Overview of Challenges and Potential Opportunities
2 Neuroscience Clinical Trials: An Overview of Challenges and Potential Opportunities
Pages 5-14
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From page 5... ...
Drew Schiller, chief technology officer and co-founder of Validic, suggested embracing failure and exploiting it as an avenue to find answers to questions that may not even have been asked. While some of the challenges, barriers, and opportunities discussed at the workshop were specific to neuroscience clinical trials, many were general to trials across therapeutic areas.
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From page 6... ...
. 1 These lists highlight topics discussed throughout this workshop, but should not be construed as reflecting a consensus of workshop participants or any endorsement by the National Academies of Sciences, Engineering, and Medicine or the Forum on Neuroscience and Nervous System Disorders.
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From page 7... ...
A few partici pants stated that companies need more clarity from regulators on what information to collect as part of their clinical trial submis sions. For example, data on non-serious adverse events or measures obtained as part of routine clinical care on every pa tient enrolled in a large pivotal trial are not useful to regulators and expensive to collect (Califf)
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From page 8... ...
For example, in 2012, Buckholtz and Meyer-Lindenberg proposed that common symptoms arise from common circuit dysfunction, suggesting a different way of thinking about potential treatment targets that might be specific to a symptom, but not to a particular condition. Developing more rel evant animal models will facilitate translation of fundamental dis coveries into effective treatments (Romano)
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From page 9... ...
. • Applying machine learning techniques to clinical trial data may help to identify fraudulent data, which are frequently introduced by underperforming clinical trial sites (de Vries)
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. Building Innovative Research Programs • Building a more agile research methodology may help to rapidly and efficiently test various technologies and conduct feasibility testing (Rodarte)
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From page 11... ...
. • Leveraging consumer engagement achieved by electronics com panies that have created wearable devices and apps with new models of collecting information, as well as social media plat forms that have been used to successfully recruit participants for clinical trials, will be important for trials of the future (Schiller)
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From page 12... ...
. • With regard to concerns about "phishing," that is, searching data bases for personal information to be used for nefarious purposes, several workshop participants urged reasonableness and social responsibility, commenting that these concerns may be over blown and prevent valuable research (Chiauzzi, Koski, Rockhold, and Snowberg)
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From page 13... ...
. Meeting Regulatory Requirements • Innovative technologies may provide a novel approach for providing "substantial evidence" of effectiveness for regulators, if investigators can show that a device generates data that can be quantitatively linked to an element of disease progression (de Vries)
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