Session III: Standarization and Governance (4:47 )
Background and Session Objectives by Frank Rockhold, Session Co-Chair and Lynn Hudson, Session Co-Chair
The workshop's chair, Sharon Terry welcomes participants and introduces Panel I.
Background and Session Objectives
Fundamentals and Benefits of Sharing Participant-Level Clinical Trial Data
Pooling Data from Multiple Clinical Trials to Answer Big Questions
Brief introduction of panel participants before Panel Discussion
1) Data sharing – what does it mean from your perspective? 2) Considering the benefits...
Panelists answer questions from audience participants
The Limits of Summary Data Reporting: Lessons from ClinicalTrials.gov
Models that Increase Access and Use of Data from Individual Clinical Trials/ The...
Models that Increase Access and Use of Data from Individual Clinical Trials/...
Models that Foster Pooling and Analysis of Data/ FNIH Biomarkers Consortium Adiponectin...
Novel Methods Leading to New Medications in Depression and Schizophrenia (NEWMEDS)...
Challenge #1: Permissions
Challenge #3: Culture
Challenge #2: Techniques and Methodologies [via video conference]
Discussion among speakers, panelists, and audience
Panelists answer questions from the audience members.
Keynote Presentation
Richard Platt answers questions from the audience.
Background and Session Objectives by Frank Rockhold, Session Co-Chair and Lynn Hudson,...
PDUFA Update on Data Standards
CDISC Efforts to Support Clinical Research Data
HL7 Efforts to Support Clinical Care Data
Health Information Technology Perspective on Clinical Research Data Standards
Cost-Benefit Analysis of Retrospective vs. Prospective Data Standardization
Critical Path Institute and Coalition Against Major Diseases (CAMD) Alzheimer’s Clinical...
Translational Medicine Mart (tranSMART)
Panelist presentation
Day 2 Introduction
Clinical Trial Data Transparency: European Medicines Agency Perspective
Clinical Research Data Sharing Practices and Attitudes
Overview of Data Sharing Policies: Research Funders and Publishers
Academic Perspectives
Federal Research Funder Perspective
Facilitating Patient Ownership of Clinical Trial Data: Technical Challenges and...
Session I Chair Reports
Session II Chair Report
Session Chair Reports
Session III Chair Report
Session IV Chair Report
Closing Discussion with Session Chairs, Panelists, and Audience Led by Workshop Chair
Closing remarks of the workshop
Keck Center500 Fifth St. NWWashington, DC 20001