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Patient Registries: Basket Trial or Basket Case?
Session Chair(s)
Nancy Dreyer, MPH, FISPE
Founder
Dreyer Strategies LLC, United States
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 Objective : 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.
Speaker(s)
Gauging registry quality according to its intended use
Mike D'Ambrosio
Parexel International, United Kingdom
Senior Vice President and Global Head, Real World Research (RWD/RWE)
Life in the Trenches of a Patient Registry
Angela Dobes, MPH
Crohn's & Colitis Foundation, United States
SVP, IBD Plexus
How registries are changing with technology and AI, and what that means for quality
Richard Gliklich, MD
OM1, United States
Founder
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