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International Clinical Trials

Outcome Solutions in Medical Research

In central nervous system (CNS) clinical research, pharmaceutical sponsors pursuing CNS indications encounter numerous challenges stemming from the subjective nature of many CNS endpoints, variability of placebo response, and from measurement errors due to inconsistency in a site investigators’ assessment processes. CNS clinical trial sites also face formidable challenges related to recruiting and retaining appropriate patients, tight budgets, and increasing respondent burden due to the increasing number of endpoints, measures, and techniques required by modern protocols. Variability in rater experience, patient eligibility requirements, and the task of integrating multiple vendors and technology applications create additional hurdles to trial success.

A key challenge facing clinical trials in many CNS indications is in designing studies to optimise the opportunity to demonstrate efficacy by obtaining a true drug-placebo difference. For example, high placebo response rates in Parkinson’s disease, depression, mania, anxiety, and negative symptoms of schizophrenia are suspected to be a key reason for study failure.

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About the Authors

Dr Bill Byrom serves as Vice President of product strategy and innovation at Signant Health, where he also leads a team of ePRO scientists. He has worked in the pharma industry for 30 years and is the author of over 70 publications and two industry textbooks on ePRO. Bill provides independent eClinical commentary via LinkedIn and Twitter (@billbyrom).

Dr Denis Curtin is Principal, eCOA and Patient Engagement, in the science and medicine practice at Signant Health. Denis’s experience includes more than 20 years in pharma industry roles leading drug and vaccine clinical development and commercial brand management, product lifecycle and franchise portfolio strategic planning, and clinical trial design and management.

Dr David Daniel is Signant Health’s Senior Vice President and Chief Medical Officer, and Clinical Professor of Psychiatry at George Washington University, US. He has over 25 years’ experience in supervising and conducting rater training and data quality management programmes in multi-site industry, government, and academic settings. David has received patent protection for new treatment approaches he invented in epilepsy, anxiety disorders, and motor side effects of antipsychotic treatment.

Dr Alan Kott is based in Signant Health’s Prague office and, until recently, was Senior Clinical Manager for Europe. Having led the development of the data analytics programme for Signant Health, he has overseen the design and reporting of data analytics in multiple large schizophrenia studies. For the past seven years, he has also provided training to investigators as an Expert Trainer. Alan has been responsible for the design and implementation of multiple in-study data quality programmes and served as a Product Business Owner for rater reliability statistical measures application.

Dr Gary Sachs is an internationally recognised expert clinical trialist with extensive experience in rater training and clinical trial methodologies for mood and anxiety disorder research. He has been instrumental in developing technology-based solutions for randomised controlled trials that identify correlates of high placebo response, improve signal detection, and reduce the risk of failed trials. As Principal Investigator of the National Institute of Mental Health sponsored Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD), Gary led the largest treatment study ever conducted for bipolar disorder.
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