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Tuesday, June 26 • 8:00am - 9:15am
#205: Best Practices for Implementing Lay Summaries and Communicating Results to Patients

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-18-558-L04-P; CME 1.25; IACET 1.25; RN 1.25

Chief concerns from regulators and patient/public/advocate communicates are that trial results summaries (lay language summaries) are non-promotional, unbiased and not misleading. This session presents case studies and reviews strategies to address these concerns in lay summary content including: narrative content, visual content, process and policy and review.

Learning Objectives

Evaluate strategies to ensure lay language summaries are non-promotional, unbiased and not misleading; Analyze case studies to identify key takeaways to develop your own internal lay summaries program and processes.


Behtash Bahador


Preparing for the Clinical Trial Report Lay Summary
Barry Drees, PhD

Beyond Lay Summaries: A Vision for Comprehensive Post-Trial Communications
Paulo Moreira

Promotional and Misleading Lay Summaries: Addressing the Elephant in the Room
Behtash Bahador

avatar for Behtash Bahador

Behtash Bahador

Senior Manager, Quality and Compliance, CISCRP
Behtash Bahador is a Senior Manager at the non-profit CISCRP. With a background in health communication, Behtash leads quality and compliance assurance on CISCRP’s program that provides non-promotional and unbiased trial results summaries in an easy-to-understand format for patients... Read More →
avatar for Barry Drees

Barry Drees

Senior Partner, Trilogy Writing & Consulting, Germany
Barry holds a Ph.D. in molecular genetics. Following his postdoctoral work as a fellow of the NIH, he worked as a medical writer in the pharmaceutical industry for 12 years, and leading several regulatory submission teams. Barry is a frequent speaker on medical writing, statistics... Read More →
avatar for Paulo Moreira

Paulo Moreira

Vice President, Global Clinical Operations, Head of External Innovation, EMD Serono, Inc.
Paulo Moreira is a Clinical Development executive with 25+ years of experience in Clinical R&D. He has been with EMD Serono for the last 17 years. Presently serves as the Head of GCO External Innovation overseeing Clinical Innovation and Patient Centricity in Clinical Operations... Read More →

Tuesday June 26, 2018 8:00am - 9:15am EDT
Room 210C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  04: MedAffairs-SciComm, Session