Clinical Trials Disclosure and Transparency Summit Presentations

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DAY ONE: TUESDAY, JULY 23, 2013

9:45 a.m. – 10:15 a.m.

Keynote: CDER’s Views on Clinical Trial Disclosure and Transparency

Dr. Richard Moscicki, Deputy Center Director for Science Operations, CDER, FDA

10:15 a.m. – 11:00 a.m.

Keynote: Open Clinical Trial Data for All?

Sir Alasdair Breckenridge, M.D., Chair, Emerging Science and Bioethics Advisory Committee, Department of Health, UK

11:30 a.m. – 1:15 p.m.

Interactive Panel Discussion: Got Registered Trials? Seeking Common Ground Between Medical Journal Editors and Industry (No slides for this session)

Moderator: Peter Pitts, President, Co-founder, Center for Medicine in the Public Interest

Panelists:

  • Dr. Gregory Curfman, Executive Editor, New England Journal of Medicine
  • Dr. Jose Merino, Research Editor, British Medical Journal
  • Dr. Phil Fontanarosa, Executive Editor, JAMA
  • Dr. Christine Laine, Editor, Annals of Internal Medicine
  • Dr. Bruce Haffty, Associate Editor, Journal of Clinical Oncology

2:30 p.m. – 3:30 p.m.

Trial Transparency and Participant Level Data

Dr. Deborah Zarin, Director, ClinicalTrials.gov

3:45 p.m. – 5:30 p.m.

Interactive Panel Discussion: Beyond Basic Research — Understanding Patient Advocacy And The Push To Help Shape The Process (No slides for this session)

Moderator: Peter Pitts, President, Co-founder, Center for Medicine in the Public Interest

Panelists:

  • Jessica Gilbart, Director of Patient Services, Lupus Foundation of America
  • Bray Patrick-Lake, Director of Stakeholder Engagement, Clinical Trials Transformation Initiative
  • Diane Dorman, Vice President of Public Policy, National Organization for Rare Disorders (NORD)
  • Dr. Mark Lim, Program Manager, Medical Research Innovation, FasterCures

DAY TWO: WEDNESDAY, JULY 24, 2013

9:45 a.m. – 10:30 a.m.

Understanding Data Sharing And Investigator Databanks To Improve Clinical Research

Dr. Garry Neil, Partner, Apple Tree Partners; formerly Corporate Vice President, Science & Technology, Johnson & Johnson

10:30 a.m. – 11:15 a.m.

Yale University Open Data Access Project (YODA) — A Model for Dissemination and Independent Analysis of Clinical Trial Program Data

Dr. Joseph Ross, Co-Investigator, Open Data Access Project, Yale University

11:30 a.m. – 12:15 p.m.

Automating Data Uploading From Company/Academic Databases/Spreadsheets Into Clinicaltrials.gov And Other Clinical Trial Registries

Christopher Dedels, Global Product Manager, Clinical Trial Disclosure Solutions, Virtify