12th Annual Patient-Reported Outcome Consortium Workshop
Register Now for This Virtual Workshop!
On April 14-15, 2021, the 12th Annual Patient-Reported Outcome Consortium Workshop will be held in a virtual format. We encourage you to attend both days. Please register separately for each day by simply clicking the appropriate button and completing the brief form. You will receive a confirmation email message for each day as well as an option to add the event(s) to your calendar.
The agenda for the 2-day workshop, including session objectives, is below. The workshop begins each day at 11:00 AM Eastern Time (US).
|Agenda – April 14, 2021|
|11:00 – 11:20 am ET (20 min)||Welcome and Patient-Reported Outcome Consortium Update
Provide a high level summary of the recent accomplishments and ongoing activities within the Patient-Reported Outcome (PRO) Consortium
|11:20 – 12:30 pm ET (70 min)||Session 1: FDA Update
Provide an update on FDA’s Clinical Outcome Assessment (COA) Qualification Program and other FDA initiatives
|12:30 – 12:50 pm ET (20 min)||Break – 20 min|
|12:50 – 2:20 pm ET (90 min)||Session 2: Migraine: A Tale of Two Paths to PRO-Based Product Labeling
Discuss the experience of two pharmaceutical firms’ different paths to obtaining FDA-approved PRO-based label claims for novel migraine drugs
|2:20 – 2:35 pm ET (15 min)||Day 1 close out|
|Agenda – April 15, 2021|
|11:00 – 11:20 am ET (20 min)||eCOA: Getting Better Together Initiative Update
Provide a brief update on the eCOA: Getting Better Together Initiative, an ongoing collaboration between the PRO Consortium and Electronic Patient-Reported Outcome (ePRO) Consortium
|11:20 – 12:50 pm ET (90 min)||Session 3: Where Are We Headed with Activity Monitors in Clinical Trials?
Discuss practical considerations associated with the use of activity monitors to measure efficacy endpoints in clinical trials
|12:50 – 1:10 pm ET (20 min)||Break – 20 min|
|1:10 – 2:40 pm ET (90 min)||Session 4: Identifying COAs for Use in Rare Disease Treatment Trials
Provide an update regarding the establishment and goals of the Rare Disease COA Consortium and present results of work accomplished by the PRO Consortium’s Rare Disease Subcommittee
|2:40 – 2:45 pm ET (5 min)||Workshop close out|
Session presentations will be recorded and posted to the PRO Consortium’s web page following the workshop.
Posters summarizing the status of the PRO Consortium’s working groups, the Rare Disease Subcommittee activities, and the ePRO Consortium are available below: