How to optimize patient and clinician reported outcome assessment data (COA) in early phase clinical trials
In this webinar, our team of expert panelists will answer key questions around Clinical Outcome Assessment (COA) data collection in early phase clinical trials. Chris Vogel, Clario’s Executive Director for eCOA Solutions, will steer the discussion taking a deep dive into frequently asked questions around effective COA collection strategies including the debate between paper vs. electronic diaries, eCOA collection in decentralized and hybrid trials, regulatory requirements and guidance on patient-reported data, benefits to real-time data access and more.
Key Takeaways:
- Understand the importance of capturing Clinical Outcome Assessment (COA) data and what global regulators require
- Gain insight into the pitfalls with paper diaries and their impact on trial data quality, timelines, and cost
- Impact of electronic COA capture on data quality and patient burden
- Understand what a decentralized or hybrid trial is and how this impacts COA collection
- Why real-time data is valuable in early phase trials
Session Information:
Title: How to optimize patient and clinician reported outcome data (COA) in early phase clinical trials
Date: Friday, October 28th 2022
Time: 9:30 a.m. EDT / 3:30 p.m. CET
Join Clario’s VP of Science, Bryan McDowell, Pharma Consultant, Donna Reed and Principal Scientific Advisor, Kelly Dumais for ‘How to optimize patient and clinician outcome assessment data (COA) in early phase clinical trials’ to explore issues which impact data quality and patient burden for biotechs, pharma and CROs.
Speakers
Kelly Dumais, PhD
Principal Scientific Advisor at Clario
Dr. Dumais is a scientist with over 13 years of experience in behavioral and life science research. She has expertise in the implementation of electronic clinical outcome assessments (eCOA) and the development and validation of patient reported outcomes (PROs) to support labeling claims. She is currently a Principal Scientific Advisor at Clario, a global data and technology company that helps to minimize risk in clinical trials. She consults on best practices for questionnaire design and eCOA design/use to drive data integrity and patient engagement and develops custom site rater training and participant training for improving accuracy in COA reporting and improving inter-and intra-rater reliability.
Bryan McDowell, MSc, MBA
Vice President eCOA Clinical Science & Consulting at Clario
In his role as VP, eCOA Science and Consulting, Bryan brings extensive experience and expertise to achieve smarter drug development, clinical trial design and execution (including decentralized and remote trials) to vastly expand the reach and access of trials to more patients, provide improved patient experience and data quality to deliver accelerated drug and device development programs. Bryan is a thought leader and recognized strategist and visionary and continues to influence, drive and deliver on the pharma wide industry necessity for smarter drug and device development and life cycle management.
Donna L Reed
Consultant to the pharma industry
Donna was a graduate of Elizabethtown College (Biology/Chemistry Medical Technology) and York Hospital Med Tech certification. She had her first introduction to clinical research at the University of Penn women’s health in 1980 exploring biomarkers for tumor metastasis. After that Donna joined DuPont Life sciences, researching inflammation and virology as a protein chemist before joining their HIV research team (1985) which led to the discovery of new diagnostic tools. After moving to Geneva, Switzerland, in 1988 to launch HIV diagnostics in Europe, Middle East, Asia and Africa she developed Rapid tests, ELISA and Western Blot products with a start up company based in Singapore. From 1997-2000 Donna was a Strategic Account Manager for Covance Central Lab and joined PHT Corporation (eCOA) to expand their market into Europe where she worked closely with the product management and science teams to optimize solutions. She is now a consultant within the pharma industry.
Chris Vogel
Executive Director, eCOA Solutions at Clario
Chris Vogel is an eClinical Solutions leader focused on helping improve the clinical research experience through patient-centered technology. For the past 16 years, he’s focused on evolving the role of eCOA within the clinical trial ecosystem and specializes in consulting on eCOA lifecycle and solution design. As Executive Director of eCOA Solutions, Chris and his team help sponsors and CROs review protocol requirements to determine the optimal way to collect key eCOA study endpoints taking into consideration regulatory and therapeutic area best practices on a global scale.