Presentation at DIA 2014 – Moving Beyond the Traditional Psychometric Validation of New Phase 3 Clinical Outcome Assessments
Cheryl Coon, Associate Director from our Endpoint Development & Outcomes Assessment practice will be presenting at the DIA 2014 50th Annual Meeting in San Diego on June 19th.
The session titled ‘Moving Beyond the Traditional Psychometric Validation of New Phase 3 Clinical Outcome Assessments’ will be on June 19, 9:00AM – 10:30AM (Pacific Standard Time) and chaired by Lisa A. Kammerman, PhD, MS, Senior Principal Scientist, AstraZeneca, United States. Fellow panelists include: Rima Izem, PhD, Lead Mathematical Statistician, Office of Translational Science, CDER, FDA, United States, and Laura Lee Johnson, PhD, Statistician, National Center for Complementary & Alternative Medicine (NCCAM)
The discussion will cover challenges faced by those who evaluate the results of randomized controlled trials that are designed to evaluate the performance of new clinical outcome assessments and identify strategies beyond psychometric validation techniques.
“I am honored to be invited to speak at this prestigious event and alongside such prominent people in the field” said Cheryl Coon. “Psychometric validation is a fundamental part of achieving regulatory success. It is an area I am passionate about and have specialized in for the last 10 years.”
For anyone planning to attend the session, you can expect to:
- Identify clinical outcome assessment (COA) properties that should be evaluated in a phase 2 randomized clinical trial prior to the COA’s use in a phase 3 trial
- Discuss classical and modern psychometric methodology limitations to evaluating COAs used in medical intervention trials
- Describe other approaches that can be used to evaluate some of these properties.
According to their website, the DIA 2014 50th Annual Meeting is the largest multidisciplinary event that brings together a community of life sciences professionals at all levels and across all disciplines involved in the discovery, development, and life cycle management of medical products all with a common goal to foster innovation that will lead to the development of safe and effective medical products and therapies to patients.
If you will be attending the meeting we’d love to meet with you.
Email us to set up a meeting in advance, or meet with Cheryl after the presentation on the 19th June.