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Wednesday, June 28 • 4:00pm - 5:00pm
#364: Can Pragmatic Trials Simultaneously Meet the Needs of Regulators, Payers, and Clinical Care?

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Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-23-643-L04-P; CME 1.00; RN 1.00

After regulatory approval, products still need coverage and clinical adoption. We will assess trial design elements and examples of pragmatic trials to understand whether pragmatic trials may simultaneously meet the needs of all three.

Learning Objectives

Define features of pragmatic and explanatory trials; Identify advantages and disadvantages of pragmatic and explanatory trials for regulatory bodies and payers; Discuss downstream impacts on different trial designs on choice of therapy in clinical practice, particularly providing personalized care tailored to individual patient characteristics and circumstances.

Chair

Elise Berliner, PhD

Speaker

Pragmatica-Lung: A New Paradigm for Phase III Cancer Trials
Konstantin Dragnev, MD

Optimizing Trial Design with the GetReal Trial Tool
Mira Zuidgeest, PharmD, PhD, MSc

"Pragmatic" Trials: Some Regulatory Considerations
Peter P. Stein, MD


Speakers
avatar for Elise Berliner

Elise Berliner

Global Senior Principal for Real World Evidence Strategy, Cerner Enviza, United States
avatar for Konstantin Dragnev

Konstantin Dragnev

Associate Director for Clinical Research, Dartmouth Cancer Center, United States
Konstantin H. Dragnev, MD, is Professor of Medicine, Medical Oncology, at Dartmouth Health. He is the Associate Director for Clinical Research at the Dartmouth Cancer Center, a NCI-designated Comprehensive Cancer Center. Dr. Dragnev specializes in the diagnosis and treatment of solid... Read More →
avatar for Peter Stein

Peter Stein

Director, Office of New Drugs, CDER, FDA, United States
Dr. Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions... Read More →
avatar for Mira Zuidgeest

Mira Zuidgeest

Associate Professor, University Medical Center Utrecht, Netherlands
Mira Zuidgeest is an Associate Professor at the University Medical Center Utrecht. Trained both as pharmacist and epidemiologist and with a PhD in pharmacoepidemiology in the field of paediatric asthma, her current work focuses on clinical trial innovation, both methodological and... Read More →

Wednesday June 28, 2023 4:00pm - 5:00pm EDT
Room 254 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  02: ClinTrials -ClinOps, Forum
  • Level Basic
  • Level Basic
  • Credit Type ACPE, CME, RN
  • Tags Forum