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#519: Patient Registries: Basket Trial or Basket Case?
Tuesday June 16, 2026 10:15am - 11:30am EDT
116
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-568-L04-P; CME 1.25; RN 1.25

Akin to basket trials which study a single treatment for multiple conditions, patient registries enroll people with similar conditions, look for safe and effective treatments and disease management strategies, and are used to guide decision-making by clinicians, regulators and payers. Yet the very nature of real-world evidence requires that patient registries be nimble and opportunistic -- desirable attributes to maintain relevance, but ones that inevitably raise questions about data quality and completeness, transparency, provenance and Fitness for Use. Recent guidance documents from regulators and professional societies hint that real-world data from patient registries may be viewed more favorably than other, less traceable and auditable sources of real-world data. This session will illustrate key attributes of high quality, trustworthy patient registries, the criticisms and barriers they generally face and what they do to bolster trust.

Learning Objectives

Explain the value of RWE on population groups that may not be fully representative of all cases, and who may have some missing data; Explain expectations for quality, transparency and provenance; Describe key values of patient registries and common approaches to bolster trustworthiness.

Chair

Nancy Dreyer, MPH, FISPE

Speaker

How registries are changing with technology and AI, and what that means for quality
Richard Gliklich, MD

Gauging registry quality according to its intended use
Mike D'Ambrosio

Life in the trenches of a patient registry: navigating the reality of RWD
Angela Dobes, MPH


Speakers
avatar for Mike D'Ambrosio

Mike D'Ambrosio

Parexel, United States
22 Years Industry experience at top 5 CRO’s including in RWE/RWD general manager roles, leading RWE/RWD and medical affairs cross functional teams. Currently leads Parexel's Real World Research (RWD/RWE) business franchise - Helping customers build innovative RWD/RWE solutions to... Read More →
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Angela Dobes

SVP, IBD Plexus, Crohn's & Colitis Foundation, United States
Angela Dobes is the senior vice president of IBD Plexus, a real-world data platform and biorepository that redefines how researchers study inflammatory bowel disease to advance precision-medicine strategies and cut years off the R&D timeline. She strives to elevate the important role... Read More →
avatar for Nancy Dreyer

Nancy Dreyer

Founder, Dreyer Strategies LLC, United States
Nancy Dreyer brings her experience as Chief Scientific Officer at IQVIA Real World Solutions and SVP roles at IQVIA, Quintiles, Outcome Sciences Inc and UnitedHealth Group to independent consultancy. Her work focuses on advancing the use of real-world evidence for safety, effectiveness... Read More →
avatar for Richard Gliklich

Richard Gliklich

Founder & Director, OM1, United States
Dr. Richard Gliklich is the Founder of OM1, Inc., a data, outcomes and technology company focused on using data and AI to accelerate medical research and improve clinical decision making. OM1 accelerates and lowers the cost of prospective and retrospective studies and registries for... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
116 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
  • Feature Topics Evidence Innovation
  • Interest Area Data Management & Data Standards,Biostatistics
  • Tags Forum

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