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#460: Is There an Urgent Need for Global Alignment on External Controls in Clinical Trials?
Monday June 15, 2026 4:00pm - 5:00pm EDT
203AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-553-L04-P; CME 1.00; RN 1.00

This session will focus on use of external controls, including historical cohorts and real-world data, in clinical trials across drug development, focusing on the gaps and need for alignment between regulators from different regions

Learning Objectives

Explain the current guidance and reflection papers on the use of external controls from leading regulatory agencies (FDA, PMDA, MHRA) and discuss recent progress within the EU on this topic; Analyze the key similarities and differences in regulatory recommendations for study design, and describe the rationale for greater alignments across agencies.

Chair

Gracy G Crane, MS

Speaker

Panelist
Motiur Rahman, PHD, MPHARM, MS

Panelist
Denise Umuhire, MBA, MSC

Panelist
Tricia Luhn, PHD, MPH


Speakers
avatar for Gracy Crane

Gracy Crane

Policy Lead, Roche, United Kingdom
Gracy holds a Ph.D. in Molecular Oncology from King’s College Hospital, an M.Sc. in Biomedical Research from King’s College. She did her postdoctoral training at Oxford (UK) and at MIT (USA). Gracy brings broad experience in clinical research, medical affairs and health outcomes... Read More →
TL

Tricia Luhn

RWD Oncology, Genentech, United States
TL

Tricia Luhn

RWD Oncology, Genentech, A Member of the Roche Group, United States
avatar for Motiur Rahman

Motiur Rahman

Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States
Dr. Motiur Rahman is a Senior Epidemiologist and Policy Advisor in Real-World Evidence (RWE) Analytics within the Office of Medical Policy at CDER, FDA. He leads the consult service for reviewing RWD study submissions, leads international regulatory collaborations including ICH initiatives... Read More →
DU

Denise Umuhire

Pharmacoepidemiologist and Real-World Evidence Specialist, European Medicines Agency, Netherlands
I am a pharmacoepidemiologist & RWE specialist within the Data Analytics and Method Taskforce at the Europea Medicine Agency (EMA). I am part of the RWE workstream that provides support on RWE related matters to different evaluation committees, delivering rapid analyses of RWD to... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Forum |   02: ClinicalTrialOps-Innovation, Forum
  • Audience Intermediate
  • Area Evidence Innovation
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Development & Operations
  • Feature Topics Evidence Innovation
  • Tags Forum

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