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

Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

Defining the Treatment Effect of Interest in Regulatory Submissions: Estimands and ICH E9R1 Final Guidance

Session Chair(s)

Yongman  Kim, PhD

Yongman Kim, PhD

Lead Mathematical Statistician, OB, OTS, CDER

FDA, United States

Describe ongoing pilot efforts by statistical and clinical reviewers at FDA to create ‘default’ estimands for different therapeutic areas. Clinical and statistical teams’ experience on estimands in pulmonary-allergy and other areas will be discussed.

Learning Objective : Discuss the Agency’s pilot experiences and opinions on estimands in a few clinical settings from the regulatory perspective; Demonstrate the value to statisticians and clinicians for clearly understanding medical questions by defining appropriate estimands.

Speaker(s)

Munish  Mehra, PhD, MS, MSc

Estimands and ICH E9 (R1): Adoption and Challenges - 3 Years Later

Munish Mehra, PhD, MS, MSc

Quantum Biopharma, United States

Managing Director and Sr. Principal Biostatistician

David M. Petullo, MSc

Estimands Approach Taken in Analgesia and Thoughts for the Future

David M. Petullo, MSc

FDA, United States

Mathematical Statistician, OB, OTS, CDER

Rekha  Jhamnani, MD, MSc

Why Clinicians are Interested in Estimands: How it Helps Their Reviews and What They Wish to Achieve

Rekha Jhamnani, MD, MSc

FDA, United States

Medical Officer, DNPDI, OND, CDER

Susan  Mayo, MS

Estimands Approach Taken in Pulmonology-Allergy-Critical Care Statistics at CDER FDA

Susan Mayo, MS

FDA, United States

Senior Mathematical Statistician, CDER Office of Biostatistics

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.