Partners in Progress: Sharing the Vision,
Shaping the Future
April 27 – 28, 2016
Sheraton Silver Spring Hotel
8777 Georgia Avenue
Silver Spring, MD 20910
On April 27-28, 2016 the SEVENTH ANNUAL PATIENT-REPORTED OUTCOME CONSORTIUM WORKSHOP was held in Silver Spring, Maryland. The overall Workshop objectives were to:
• Provide updates on FDA’s Clinical Outcome Assessment (COA) Qualification Program and COA Compendium
• Discuss progress made within the PRO Consortium, with particular focus on the development of the Symptoms of Major Depressive Disorder Scale (SMDDS) by the Depression Working Group
• Discuss ways of generating evidence to support the content validity of performance outcome (PerfO) measures used to assess efficacy endpoints in clinical trials
• Provide examples of the development and implementation of COA tools in pediatric clinical trials
• Describe NCI’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and some of the methodological considerations for its implementation in trials
• Build on last year’s workshop presentation titled Interpreting Change in Scores on COA Endpoint Measures by discussing emerging approaches to estimating meaningful change on COA (particularly PRO) measures
The following Workshop Agenda provides an overview of the day-and-a-half-long meeting as well as links to the slide sets and posters presented.
Workshop Agenda – Day 1
April 27, 2016
|
7:30 – 8:30 am |
Registration and Continental Breakfast – Cypress Ballroom |
| Day 1 Morning Moderator: Michelle Campbell, PhD – Reviewer and Scientific Coordinator, Clinical Outcome Assessments (COA) Qualification Program, COA Staff, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA) | |
|
8:30 – 8:50 am |
Welcome and Patient-Reported Outcome Consortium UpdateStephen Joel Coons, PhD – Executive Director, Patient-Reported (PRO) Outcome Consortium, Critical Path Institute |
|
8:50 – 10:20 am |
Session 1: Update from FDA Regarding the Clinical Outcome Assessment Qualification Program and the COA CompendiumModerator: Michelle Campbell, PhD – Reviewer and Scientific Coordinator, COA Qualification Program, COA Staff, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)
Presenters: Elektra Papadopoulos, MD, MPH – Acting Associate Director, COA Staff, OND, CDER, FDA Q & A |
|
10:20 – 10:45 am |
Break – 25 min |
|
10:45 – 12:15 pm |
Session 2: Assessing the Content Validity of Performance Outcome (PerfO) MeasuresModerator: Elizabeth (Nicki) Bush, MHS – Research Scientist, Global Patient Outcomes and Real World Evidence, Eli Lilly and Company
Presenters: Rachel Ballinger, PhD – Lead Outcomes Researcher, Clinical Outcome Assessment, ICON Clinical Research Panelists: Michelle Campbell, PhD – Reviewer and Scientific Coordinator, COA Qualification Program, COA Staff, OND, CDER, FDA Q & A |
|
12:15 – 1:15 pm |
Lunch – Elm I, Elm II and Magnolia Ballroom |
| Day 1 Afternoon Moderator: Stephen Joel Coons, PhD – Executive Director, Patient-Reported Outcome Consortium, Critical Path Institute | |
|
1:15 – 2:45 pm |
Session 3: Addressing Key Challenges in Developing, Testing and Implementing Clinical Outcome Assessments in Pediatric TrialsModerator: Linda Abetz-Webb – Paediatric PRO Expert, CEO/Senior Research Director, Patient-Centered Outcome Assessments, Ltd. (P-COA)
Presenters: Linda Lowes, PT, PhD – Clinical Therapies Research Director, Nationwide Children’s Hospital Panelists: Laura Lee Johnson, PhD – Associate Director, Division of Biometrics III, Office of Biostatistics, Office of Translational Sciences (OTS), CDER, FDA Q & A |
|
2:45 – 3:10 pm |
Break – 25 min |
|
3:10 – 4:40 pm |
Session 4: NCI’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE): Selecting Items and Assessment Frequency for Cancer TrialsModerator: Sandra A. Mitchell, PhD, CRNP – Research Scientist and Program Director, Outcomes Research Branch, National Cancer Institute (NCI)
Presenters: Paul G. Kluetz, MD – Associate Director of Clinical Science, OHOP, OND, CDER, FDA Panelist: Selena R. Daniels, PharmD, MS – Reviewer and Acting Team Lead, COA Staff, OND, CDER, FDA Q & A |
|
4:40 – 4:55 pm |
A Review of FDA PRO Labeling (2011 – 2015)Ari Gnanasakthy, MSc, MBA – Head, Patient Reported Outcomes, RTI Health Solutions |
|
4:55 – 5:00 pm |
Day 1 Closing Remarks Adjourn |
|
5:30 – 7:00 pm |
Reception and Poster Session – Magnolia Ballroom |
Workshop Agenda – Day 2
April 28, 2016
|
7:30 – 8:30 am |
Registration and Continental Breakfast – Cypress Ballroom |
| Day 2 Moderator: Katarina Halling, MSc – Global Head Patient Reported Outcomes, AstraZeneca and Industry Co-Director, Patient-Reported Outcome Consortium | |
|
8:30 – 10:00 am |
Session 5: Developing the Symptoms of Major Depressive Disorder Scale (SMDDS): From Patient Input to Final InstrumentModerator: Elizabeth (Nicki) Bush, MHS – Research Scientist, Global Patient Outcomes and Real World Evidence, Eli Lilly and Company
Presenters: Elizabeth (Nicki) Bush, MHS – Research Scientist, Global Patient Outcomes and Real World Evidence, Eli Lilly and Company Panelists: Stephen Joel Coons, PhD – Executive Director, Patient-Reported Outcome Consortium, Critical Path Institute Q & A |
|
10:00 – 10:25 am |
Break – 25 min |
|
10:25 – 11:55 am |
Session 6: Expanding Our Understanding of Meaningful Change from a Patient PerspectiveModerator: Cheryl D. Coon, PhD – Principal, Outcometrix
Presenters: Mona Martin, RN, MPA – Executive Director, Health Research Associates, Inc. Panelists: Wen-Hung Chen, PhD – Reviewer, COA Staff, OND, CDER, FDA Q & A |
|
11:55 – 12:15 pm |
Closing Remarks Adjourn |
