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Smarter Clinical Trials with Real World Evidence Data

Track:
How Can We Enable Clinical Research in Europe Further?

Day & Time:
April 19, 8:30AM - 10:00AM (Central Europe Standard Time)

Session Number:
S0904

Type:
Session

Title:
Smarter Clinical Trials with Real World Evidence Data

Chair(s):
Holger Maria Rohde, PhD, MBA, MSc
Director Regulatory Project Management
Merck KGaA, Germany

Description:
In the session we will discuss innovative ways to leverage RWD/RWE to optimise clinical trial design, such as the fine-tuning of a targeted population, improvement of site selection and patient recruitment, but also to complement traditional development in changing (or increasing?) regulatory requirements. How can we increase efficiency of clinical trial design, mitigate against avoidable delays and costs, and unlock advanced “what if” scenario planning options in the trial design process? What kind of data and design can complement evidence from clinical trials, in which situations this could be helpful to fulfil regulatory requirements?

Presentation(s) & Speaker(s):
How Can Real World Data Improve the Early Clinical Development Process?
Michel Francois Denarie, MBA
Sr. Principal, Data Scientist
IQVIA, United States

Will RWE Replace Evidence Coming from Clinical Trials in the Future?
Patrice Verpillat, MD, PhD, MPH
Corp. Dept. Global Epidemiology
Boehringer Ingelheim GmbH, Germany

The Role of Real World Data in the Regulatory Setting
Anne Louise Svendsen, MSc
Chefkonsulent Biostatistik
Danish Medicines Agency, Denmark