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Location:

WebCast Only

The Food and Drug Administration (FDA, the Agency), Center for Biologics Evaluation and Research, Office of Vaccines Research and Review (OVRR) is announcing the following public workshop entitled, "Considerations for the Use of Real-World Evidence (RWE) to Assess the Effectiveness of Preventive Vaccines."

Purpose of the Workshop:

The purpose of this online symposium is to exchange information with stakeholders from industry, academia, and government about the scientific, clinical, and regulatory challenges and opportunities in using RWE to assess the effectiveness of preventive vaccines.

Background:

The 21st Century Cures Act directs the FDA to establish a program to evaluate the potential use of real-world evidence (RWE) to a) support the approval of a new indication for a drug approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act; and b) to support or satisfy post-approval study requirements.  Details on the framework for FDA’s RWE Program are available here:  https://www.fda.gov/media/120060/download.

Objectives:

• Clarify the FDA's current thinking and the regulatory framework that informs the use of RWE in vaccine development and licensure.  Provide context and illustrate the importance of RWE in vaccine development, including through a review of relevant case examples.
• Focus on observational studies:
  • Identify and discuss features of RWE studies (design/methodology, study conduct, analysis, fitness of the data for proposed study populations, and endpoints) that would tend to increase (or decrease) confidence in conclusions about vaccine effectiveness.
  • Discuss the potential uses of methods to identify, measure, and/or correct the effect of bias and confounding.
• Identify challenges and opportunities for incorporating RWE into innovative trial designs (e.g., cluster-randomization, decentralized trials, “pragmatic” or “large simple trials”) that maintain randomization.
• Discuss emerging infectious diseases (e.g., coronavirus, Ebola, influenza pandemics) and other scenarios (e.g., maternal immunization to prevent disease in infants through the use of licensed/recommended vaccines) in which traditional clinical trials could be impractical or ethically unacceptable.  Consider the role of RWE approaches in these scenarios.
• Understand stakeholders' perspectives/priorities/expectations concerning the use of RWE for preventive vaccine development, licensure, and implementation.

REGISTRATION:

Persons interested in attending this public meeting must register online at https://www.eventbrite.com/e/real-world-evidence-to-assess-the-effectiveness-of-preventive-vaccines-tickets-110151323574.

This public meeting will be held via webcast only.

Webcast information will be provided upon completion of registration.

If you need special accommodations due to a disability, please contact Loni Warren Henderson or Sherri Revell no later than August 28, 2020, [email protected] (subject line: RWE Workshop)

MEETING AGENDA

A full agenda will be made available approximately one week before the meeting.

RECORDINGS

Day 1 Recording - Considerations for the Use of Real-World Evidence to Assess the Effectiveness of Preventive Vaccines Workshop
Day 2 Recording - Considerations for the Use of Real-World Evidence to Assess the Effectiveness of Preventive Vaccines Workshop

FOR FURTHER INFORMATION CONTACT:

Loni Warren Henderson or Sherri Revell, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1118, Silver Spring, MD 20993, 240-402-8010, [email protected] (subject line: RWE Workshop).

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