SOURCE: Xtalks

Xtalks Webinars

February 25, 2016 06:30 ET

Pragmatic Studies for Real World Evidence -- Lifting the Veils, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - February 25, 2016) - Regulators, healthcare payers, prescribers and Health technology assessment (HTA) agencies are increasingly seeking clinical and economic evidence to better understand the impact of a new product in the real-world, outside of a trial. As such, real-world evidence (RWE) is an increasingly critical component in drug development and commercialization that impacts the success of approval and reimbursement over a product's lifecycle.

As payers and regulators aim to understand how a drug will perform for their beneficiaries, a new approach is the need for the development of high-quality widely applicable RWE. Trail data is often limited to select populations and doesn't provide insights that can be tailored to a target population of interest to key decision makers. More and more the industry is turning to "pragmatic trials" which are designed to evaluate the effectiveness of therapies in real-life routine practice conditions.

This webinar, featuring experts from inVentiv Health, describes and explains pragmatic studies and discusses why key Late Stage stakeholders are increasingly interested in pragmatic studies -- and why, nevertheless, pragmatic approaches are still relatively rare in the area of RWE. The panel outlines operational modifications and adaptations of the main pragmatic study approach, such as community based studies, cluster randomized approaches, and 'stepped wedge' designs.

The panel also discusses both current and future regulatory considerations such as the new EU Clinical Trials Regulation. An outlook into the future of pragmatic study types will be provided, and strategic options for potential design modifications will be assessed. We will close our evaluation of pragmatic studies and their nuances by assessing evidence validity from pragmatic approaches with others, primarily analytic methods minimizing bias in observational settings.

The webinar's key learning objectives:

  • What is 'Real World Evidence'?
  • Understand RWE needs of Late Stage stakeholders
  • Understand why stakeholders are asking for pragmatic approaches and why they are still rarely performed
  • Understand internal / external validity and efficacy vs. effectiveness
  • Discuss nuances of pragmatic approaches such as cluster randomization, community based designs, or stepped wedge approaches
  • Learn about the regulatory considerations when planning and conducting pragmatic studies
  • Understand analytic considerations for evidence validity in pragmatic designs, versus non-interventional approaches using analytic techniques such as regression methods, propensity score matching, instrumental variables.

Join inVentiv Health for an informative session on Thursday, March 17, 2016 at 11am EDT (3 pm GMT). To learn more visit: Pragmatic Studies for Real World Evidence -- Lifting the Veils

About inVentiv Health

inVentiv Health is a top-tier professional services organization that accelerates the clinical and commercial success of biopharmaceutical companies worldwide. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) help clients improve their performance to deliver much-needed therapies to market. With 14,000 employees providing services to clients in 70 countries, inVentiv Health designs best practices, processes and systems to enable clients to successfully navigate an increasingly complex environment. inVentiv Health, Inc. is privately owned by inVentiv Group Holdings, Inc., an organization sponsored by affiliates of Thomas H. Lee Partners, L.P., Liberty Lane Partners and members of the inVentiv Health management team. For more information, visit

About Xtalks

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, health care centers, etc.) turn to Xtalks for access to quality content. Xtalks helps life science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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