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You are here: Home / Webinars / Patient Registries and Medical Publications

Patient Registries and Medical Publications

Event Date: Jun 12, 2019

Patient registries have been defined as “an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes.” They represent a powerful approach to gather real-world evidence on patient outcomes, natural history of diseases, and the effectiveness and safety of healthcare products and services.

Registries are usually designed to address multiple questions of interest, often over long periods of time. They are often used as a source of evidence to understand the natural history of rare and chronic diseases, or to fulfill specific regulatory requirements for post-marketing studies monitoring long-term safety of licensed treatments. However, registries can provide insights into patient outcomes, patterns of treatment and healthcare resource utilization that are difficult to obtain from other study methodologies, and so are increasingly being mandated by regulators and payers for ongoing monitoring of the effectiveness of health interventions.

Medical publications professionals typically encounter patient registries from the perspective of supporting a pharma company sponsor. It is therefore important to understand that publications and communications based on registry data present challenges that are different to those posed by traditional randomized controlled trials. These include issues of governance (which may be complex and involve academic institutions, scientific bodies and other external stakeholders), mandated requirements for data analysis and dissemination, and publication planning for evolving longitudinal datasets.

At the end of this session, participants should be able to:

  • Define why and when registries may be established, what outcomes they may assess, and what questions they can address.
  • Understand how registries are set up and managed, and how data are collected, analyzed and communicated.
  • Identify potential challenges for registry publications and communications and know how to address them

Click here for additional information and registration details.



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