Events

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

Monday

Oct 15, 2018 – 9:00 AM

10903 New Hampshire Ave. , Building 31, Room 15...
Silver Spring, MD Map

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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 FDA will publish discussion documents outlining the topic areas that will be addressed in the draft guidance(s) approximately 1 month before the workshop.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  

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