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

Patient-Focused Drug Development Guidance: Methods to Identify What is Important to Patients and Select, Develop or Modify Fit-for-Purpose Clinical Outcome Assessments is organized by U.S. Food and Drug Administration (FDA) and will be held from Oct 15 - 16, 2018 at FDA Building 22, Silver Spring, Maryland, United States of America.

Conference Description :
This two-day public workshop to convene a discussion on :
• 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.
• Best practices for selecting, developing or modifying fit-for-purpose Clinical Outcome Assessments (COAs) to measure the patient experience in clinical trials.

The purpose of this public workshop is to obtain feedback from stakeholders on considerations for :
• 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.
• Best practices for eliciting information on which aspects of disease symptoms, signs, impacts and other issues are important and meaningful to patients.
• Measuring symptoms, signs, impacts and other issues of a disease or condition in a meaningful way.
• Selecting, developing or modifying fit-for-purpose COAs to measure the patient experience in clinical trials.

Additional details will be posted as soon as they are available.