Clinical Outcome Assessments (COA): Diving deeper, applying scientific rigor and good instrument design
The bedrock of a successful trial is a well-designed protocol with reliable measurements of biomedical and health-related outcomes to satisfy regulatory standards. There is a knowledge gap between the field of clinical trials and other relevant scientific disciplines on fundamental methodological principles that should govern the collection of clinical outcome assessments (COA) data. This webinar takes a deep dive into how scientific rigor can be applied to COA even though they are subjective. The featured speakers will synthesize the scientific practices underpinning good instrument design and COA data collection methods and recommend next steps for addressing data collection challenges.
Join this webinar to learn more about applying scientific rigor and good instrument design to clinical outcome assessments.
Who should attend?
Senior Professionals from Biotech, Pharma and CROs, including:
- CEOs
- Clinical Operations, Clinical Development, Clinical Research
- Clinical Scientists
- Regulatory Affairs
- Procurement
- Outsourcing
- Clinical Data Managers
- Clinical Drug Development
- Clinical Program/Project Manager
- Clinical Trial Lead
- Sr. Manager, Trial initiation
- Data Science
- Digital Health
- Digital Operations
What you will learn
- Best practices to use when designing an instrument, especially in the context of homegrown diaries
- Characteristics for well-designed data collection instruments such as structure, content and presentation
- Strategies for instrument design that improve the quality of the data and ensure the data meets regulatory standards
- The pitfalls of poor instrument design
Speakers
Lindsay Hughes, Ph.D.
Director, eCOA Science & Consulting, eCOA Science at Clario
Dr. Lindsay Hughes is a scientist & leader with 15+ years of experience in behavioral and life sciences. She has held key national leadership roles including advisor within the Obama/Biden administration’s global HIV response team, advisor to United Nations leadership and instructor at the Centers for Disease Control and Prevention (CDC) and the United States Agency for International Development (USAID). An international speaker, Dr. Hughes is responsible for a team of scientific experts who provide guidance and analysis services related to the creation of electronic data collection systems for clinical trials.
Jowita Marszewska, Ph.D.
Scientific Advisor, eCOA Science & Consulting at Clario
Jowita Marszewska, Ph.D. is a Scientific Advisor at Clario, a global data and technology company that helps minimize risk in clinical trials. Dr. Marszewska has experience with electronic data capture and data management in clinical research. She advises on eCOA best practices, diary and instrument design and training for participants, caregivers and raters. Dr. Marszewska earned her M.Sc. and Ph.D. degrees in the field of chemistry and has authored 10 publications. She has been an advocate for STEM education throughout her career.