REGISTRATION UPDATE:

Thank you for your interest in FDA's upcoming PFDD workshop on October 15-16th. At this time, we are at capacity for in-person registration. We have opened a first-come, first-serve wait list. The wait list will close on October 10, 2018 at 11:59pm EST. To be placed on the waitlist, please email patientfocused@fda.hhs.gov and you will be notified if space for in-person attendance becomes available.

WEBCAST INFORMATION:

The link to join the webcast for both days is: https://collaboration.fda.gov/pfdd1018. The meeting agenda and discussion information are available on the meeting webpage: https://www.fda.gov/Drugs/NewsEvents/ucm607276.htm

The link will begin working approximately one hour before the start of the meeting. When prompted, you may identify yourself as a “guest” and type in your first and last name (or simply write “anonymous”). Technicians will be monitoring the webcast for any technical difficulties. We recommend joining the webcast at least 15 minutes early to allow for any technical issues.

Patient-Focused Drug Development Guidance: Methods to Identify What is Important to Patients and Select, Develop or Modify Fit-for-Purpose Clinical Outcome Assessments

2 Day Workshop Format:

Day 1: October 15th: 9am-5pm
Day 2: October 16th: 9am-5pm

On October 15-16th, the Food and Drug Administration (FDA) is hosting a two-day public workshop to convene a discussion on: 1) methodological approaches that may be used to develop and identify what is most important to patients and caregivers with respect to burden of disease, burden of treatment, and the benefits and risks in the management of the patient’s disease; and 2) best practices for selecting, developing or modifying fit-for-purpose Clinical Outcome Assessments (COAs) to measure the patient experience in clinical trials. This workshop will inform development of patient-focused drug development guidance as required by Section 3002 of the 21st Century Cures Act of 2016, and as part of commitments made by FDA under the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI).

The purpose of this public workshop is to obtain feedback from stakeholders on considerations for:

(1) Methods to identify what is important to patients with respect to burden of disease, burden of treatment, and the benefits and risks in management of the patient’s disease

(2) Best practices for eliciting information on which aspects of disease symptoms, signs, impacts and other issues are important and meaningful to patients

(3) Measuring symptoms, signs, impacts and other issues of a disease or condition in a meaningful way

(4) Selecting, developing or modifying fit-for-purpose clinical outcomes assessments (COAs) to measure the patient experience in clinical trials

FDA is seeking information and comments from a broad range of stakeholders, including patients, patient advocates, academic and medical researchers, expert practitioners, drug developers, and other interested persons. FDA will publish discussion documents outlining the topic areas that will be addressed in the draft guidance(s) approximately 1 month before the workshop. FDA will seek information and comments on the approaches proposed in the discussion documents. FDA also will seek input on examples to include in the draft guidance(s) where the approaches proposed in the discussion document have been successfully applied.

Workshop updates, agenda, and discussion documents will be made available at: https://www.fda.gov/Drugs/NewsEvents/ucm607276.htm prior to the workshop. For additional questions email us at PatientFocused@fda.hhs.gov

Patient-Focused Drug Development Guidance: Methods to Identify What is Important to Patients and Select, Develop or Modify Fit-for-Purpose Clinical Outcome Assessments

Follow this organizer to stay informed on future events