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Activity Number:
201 - Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee)
Type: Roundtables
Date/Time: Monday, July 30, 2018 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract #327296
Title: Challenges in Oncology: Pragmatic Trials Using Real-World Evidence
Author(s): Zhe Zhang*
Companies: Pfizer
Keywords: Oncology; Pragmatic trial; Real-world evidence; EHR

Traditional randomized controlled trials (RCTs), conducted under carefully controlled ideal conditions, have served as the main source of clinical evidence supporting market authorization decisions of new drugs. In recent years, pragmatic clinical trials (PCT) have received increasing attention in the regulatory and industry setting to using real world evidence (RWE) for new drug approval or label expansions. While tackling from a different angle on effectiveness of interventions, i.e., benefit under routine clinical practice maximizing generalizability, PCTs have encountered challenges in design, conduct and analyses. In this roundtable session, we will discuss some of the common issues from PCT in an oncology setting including 1) How to select and define real-world trial endpoints; 2) How to leverage accuracy and completeness of data captured from the electronic health record (EHR) with low level of interference under routine clinical practice; 3) Intent-to-treat vs. per-protocol analyses; 4) Measure adherence while drug accountability is not enforced; 5) Non-inferiority study in the PCT setting.

Authors who are presenting talks have a * after their name.

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