Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Bethesda North Marriott Hotel and Conference Center

Mar 18, 2014 8:30 AM - Mar 20, 2014 4:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Beginning with the End in Mind – Study Endpoints: Targeting Patient-Centered Outcomes

Conceptualization and Generation of a Draft Measure

Session Chair(s)

Elektra  Papadopoulos, MD, MPH

Elektra Papadopoulos, MD, MPH

Director, Patient Experience Data and Strategy, AbbVie, United States

Along with a clearly defined context of use, clear conceptualization provides the foundation for the process of instrument development. This is particularly important in clinical trials for regulatory purposes because the concept of interest becomes the labelling claim. Once there is clarity in conceptualization, the qualitative research process may begin.

Speaker(s)

Donald L Patrick, PhD, MPH

Spoke 1: Conceptualization and Making the Case for Content Validity

Donald L Patrick, PhD, MPH

Professor, Health Services, School of Public Health, University of Washington, United States

Ashley F. Slagle, PhD, MS

Spoke 2: Interview, Qualitative Analysis, and Item Development Techniques

Ashley F. Slagle, PhD, MS

Principal, Scientific and Regulatory Consulting, Aspen Consulting, LLC, United States

James P. Stansbury, PhD, MPH

Spoke 2: Interview, Qualitative Analysis, and Item Development Techniques

James P. Stansbury, PhD, MPH

Social Science Analyst, Division of Non-Prescription Clinical Evaluation, CDER, FDA, United States

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.