Patient-Reported Outcomes in Clinical Drug Development

February 27, 2019
1:00 EST | 7:00PM CET | 6:00PM GMT - 1 hour in duration
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Speakers: Annette Champion, BS Mathematics & Psychology, MBA

Patient-reported outcomes (PROs) from clinical trials are critical to understanding how patients feel and function during treatment for a disease or condition. PROs report patient health status directly, without interpretation, providing information that supplements clinician-reported, observer-reported, and performance outcomes. When PRO results are in the drug label, the information can be used in promotion. In any case, PRO results can be shared in scientific communications, and incorporated in health technology assessments, Academy of Managed Care Pharmacy dossiers, and other similar submissions.

This presentation will examine the role of PROs in clinical drug development from the HEOR perspective, focusing on:

  • US regulatory environment,
  • Comparisons with Europe,
  • Differences by therapeutic area, and
  • Practical considerations for clinical trial study design and communication.

This is a Members ONLY webinar.

Members will receive an official member invitation via Email.

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Speakers:

Annette Champion, BS Mathematics & Psychology, MBA
President,
Healthcare Research Insights, Inc.
Lake Forest, IL

Please note: On the day of the scheduled webinar, the first 500 registered participants will be accepted into the webinar. For those who are unable to attend, or would like to review the webinar at a later date, the full-length webinar recording will be made available at the ISPOR Educational Webinar Series webpage approximately 2 weeks after the scheduled Webinar.

Reservations are on a first-come, first-served basis for all ISPOR members.

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