Webinar reviews science and safety advantages of ePRO for episodic and preventative treatment strategies

The webinar is designed for professionals involved in Protocol Development, Regulatory Affairs, Health Outcomes, Clinical Operations, Medical Affairs, Data Management, and CNS.

Migraine and headache patient diary compliance is an important component for obtaining accurate and high-quality clinical research data. Patient reported outcome (PRO) and electronic PRO (ePRO) measures are standard tools for directly eliciting the patient experience for Clinical Outcome Assessments (COAs). The 2009 FDA Guidance for Industry Patient Reported Outcome Measures: Use in Medical Product Development to Support Label Claims highlights the importance of PROs and other Clinical Outcome Assessment (COAs) in clinical research.

PRO and ePRO are increasingly becoming an important part of migraine and headache clinical trials especially with regard to collecting information around migraine/headache frequency, duration, and severity. The electronic diary can be used as a daily record of migraines and headaches in prophylactic treatment studies or used to measure the effect of a treatment at distinct intervals after study drug administration in episodic treatment studies.

The webinar will focus on the current use of COAs in migraine and headache studies, including review of:

• Published papers comparing electronic to paper data collection;
• Patient compliance with assessments in treatment compared to other therapeutic areas;
• Patient compliance of PRO/ePRO assessments to determine the appropriate frequency of administration for electronic diaries to obtain accurate and high-quality clinical trial data.

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Dr. Susan Dallabrida has 20+ years of experience in clinical trial design, strategy, and research and product development in a wide range of therapeutic areas. She is an experienced senior scientist and project leader in R&D and has led multiple cross-functional drug discovery and product development teams and collaborations. Dr. Dallabrida has 20 peer-reviewed articles, 14 grants, 3 patents, 22 abstracts, 31 conference presentations, and 17 awards. She received a B.A. in Chemistry and a B.S. in Biology, both cum laude, from Bloomsburg University; and a Ph.D. in Biochemistry and Molecular Biology from Pennsylvania State University.

Dr. Jill Platko is an expert in laboratory information system management and clinical research systems with more than 16 years of advanced training in molecular biology at Cornell University, Genome Therapeutics Corporation, Whitehead Institute Center for Genome Research and Harvard Medical School. She provides scientific guidance and review of all clinical trial protocols to determine ePRO data collection design and project complexities; and creates demonstration versions of software customized for each sponsor’s clinical trial protocol.