- July 26, 2019
FDA White Oak Campus
Building 31, Room 1503A – Great Room
10903 New Hampshire Ave.
Silver Spring, MD 20993
FDA Campus Information
Federal Register Notice
If you plan to attend the meeting in person or through webcast, you must register online here by July 24, 2019 at 3 PM, Eastern Time.
Onsite Registration and Check-In
8 AM - 10 AM
* Online registration is strongly encouraged, seats may be limited
The Food and Drug Administration is holding a public workshop entitled “Endpoints for Drug Development in Heart Failure." The purpose of this public meeting is to bring the stakeholder community together to discuss clinical endpoints for trials in heart failure that could be used to support FDA approval of drugs. The workshop will focus on endpoints related to symptoms and physical function. In addition, there will be discussion of the need to assess mortality effects of drugs under development for heart failure.
FDA is interested in soliciting feedback on a number of topics:
- Consider and discuss endpoints related to symptoms and physical function, e.g., patient-reported outcome instruments, exercise tests, data from electronic monitors;
- Consider the best ways to count multiple hospitalizations;
- Discuss when the nature and clinical importance of a treatment effect for a particular endpoint may justify deferral or omission of outcomes studies;
- In setting an upper bound for a mortality risk to be ruled-out, discuss how the boundary may be influenced by a drug’s demonstrated benefits and risks;
- Discuss the advantages and disadvantages of all-cause vs. cardiovascular-specific endpoints, e.g., hospitalizations and deaths;
- Discuss the advantages and disadvantages of adjudicating causes of deaths and hospitalizations.
Requests for Oral Presentations
On the day of the meeting, a sign-up sheet will be made available for those who wish to speak during the public comment session. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their comments. On the meeting day, based on demand, we will determine the amount of time allotted to each presenter and the approximate time each comment is to begin.
Please note this will be oral comment only; no slides or other presentation material is permitted. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.
- Webcast Recording - Part I
- Webcast Recording - Part II
- Webcast Recording - Part III
- Webcast Recording - Part IV
If you need special accommodations due to a disability and/or need more information regarding this meeting, please contact Meg Pease-Fye no later than July 1, 2019, via email at Meg.PeaseFye@fda.hhs.gov or by phone at (301) 796-2240.
|Endpoints for Drug Development in Heart Failure Agenda
|pdf (167.22 KB)
|pdf (161.76 KB)