April 13–14, 2022
On April 13–14, 2022, the 13th Annual Patient-Reported Outcome Consortium Workshop was held in a virtual format.
The following Workshop Agenda provides an overview of the two-day meeting as well as links to the session recordings and slide decks. Links to posters summarizing the status of the PRO Consortium’s working groups and highlighting the activity within the eCOA Consortium and the Rare Disease COA Consortium are located after the agenda.
Agenda – Day 1
| 11:00–11:20 am | Welcome and Patient-Reported Outcome Consortium Update Overview: Provide a high-level summary of the recent accomplishments and ongoing activities within the Patient-Reported Outcome ConsortiumPresenter: Sonya Eremenco, MA– Director, Patient-Reported Outcome (PRO) Consortium, Critical Path Institute (C-Path) |
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| 11:20–12:30 pm | Session 1: FDA Update Overview: Provide an update on FDA’s Clinical Outcome Assessment Qualification Program and other FDA initiativesModerator: Michelle Campbell, PhD – Senior Clinical Analyst for Stakeholder Engagement and Clinical Outcomes, Office of Neuroscience (ON), Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA) Presenters: Robyn Bent, RN, MS – Director, Patient Focused Drug Development Program, CDER, FDA Selena Daniels, PharmD, PhD – Clinical Outcome Assessment Team Leader, Division of Clinical Outcome Assessment, FDA Laura Lee Johnson, PhD – Director, Division of Biometrics III, Office of Biostatistics, Office of Translational Sciences, CDER, FDA David S. Reasner, PhD – Division Director, Division of Clinical Outcome Assessment, ODES, OND, CDER, FDA Q & A |
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| 12:30–12:50 pm | Break – 20 min | |
| 12:50–2:20 pm | Session 2: Advancing the Use and Interpretation of Meaningful Within-Person Change Thresholds Overview: Examine three examples that advance the use of meaningful within-person change thresholdsModerator: Rebecca M. Speck, PhD, MPH – Clinical Outcome Assessment Scientist, Clinical Outcome Assessment Program, C-Path Presenters: Carla Mamolo, PhD – Director, Health Economics & Outcomes Research, Pfizer, Inc. Johannes Giesinger, PhD – Assistant Professor, Medical University of Innsbruck Margaret Vernon, PhD – Senior Vice President, General Manager, Evidera, Inc. Josephine Norquist, MS – Executive Director, Patient-Centered Endpoints & Strategy Lead, Merck & Co., Inc. Panelists: Selena Daniels, PharmD, PhD – Clinical Outcome Assessment Team Leader, Division of Clinical Outcome Assessment, FDA Lili Garrard, PhD – Lead Mathematical Statistician, Division of Biometrics III, Office of Biostatistics, Office of Translational Sciences, CDER, FDA Q & A |
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| 2:20–2:30 pm | Day 1 Wrap Up |
Agenda – Day 2
| 11:00–11:20 am | eCOA: Getting Better Together Initiative Update Overview: Provide a brief update on the eCOA: Getting Better Together Initiative, an ongoing collaboration between the PRO Consortium and eCOA ConsortiumPresenter: Scottie Kern, BSc (Hons) – Executive Director, Electronic Clinical Outcome Assessment (eCOA) Consortium, C-Path |
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| 11:20–12:50 pm | Session 3: Using Digital Health Technology to Measure What Matters Overview: Discuss how digital health technology can be used to measure what is importantModerator: Maria Mattera, MPH – Scientific Director, PRO Consortium, C-Path Presenters: Maria Mattera, MPH – Scientific Director, PRO Consortium, C-Path Rebecca M. Speck, PhD, MPH – Clinical Outcome Assessment Scientist, Clinical Outcome Assessment Program, C-Path Kai Langel – Senior Director, Strategy and Innovation, Global Regulatory Policy and Intelligence, Janssen Jessie P. Bakker, PhD, MS – Executive Vice President of Medical Affairs, Signifier Medical Technologies (presenting on behalf of the Digital Medicine Society) Panelists: Michelle Campbell, PhD – Senior Clinical Analyst for Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER, FDA Anindita Saha, BSE – Assistant Director, Digital Center of Excellence, Center for Devices and Radiological Health, FDA Q & A |
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| 12:50–1:00 pm | Workshop Wrap Up |  |
Posters summarizing the status of the PRO Consortium’s working groups and highlighting the activity within the eCOA Consortium and the Rare Disease COA Consortium are available below:
