Clinical Trials Data Transparency Toolkit

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Project Overview

This project is exploring the evolving global landscape of clinical trial transparency and will showcase the existing and emerging global requirements and best practices relating to clinical study submission requirements. The team have produced a poster on the global view of clinical trial transparency and disclosure events for a single study and product submissions which they presented at CSS 2018. This lead the team to develop a white paper investigating the evolving global landscape of clinical trial transparency and disclosure, focusing on submission related requirements.

Project Leads & Members

Name Role Organization
Anne Cutting Co-Lead GSK
Christa Polidori Participant Regeneron
George Allen Participant Janssen Pharmaceuticals
Helle Gawrylewski Participant Hawkwood Consulting LLC
Julie Holtzople Participant AstraZeneca
Liz Roberts Co-Lead UCB
Lora Killian Participant Pfizer
Mark Gummel Participant Jazz Pharma
Nate Root Participant Ionis Pharmaceuticals
Praveen Kumar Participant Geninvo
Raina Agarwal Participant kinapse
Rene Allard Participant Industry
Renee Entzminger Participant Industry
Sherry Meeh Participant JNJ
Stephen Bamford Participant Janssen Pharmaceuticals
Teresa Armstrong Participant Lilly
Tom Bosch Participant J&J
Wendy Wimmer Participant Merck

Project Updates

Poster Presented at CSS 2018 - Global View of Clinical Trial Transparency and Disclosure Events for a Single Study and Product Submissions

Objectives and Timelines

Project Activities

Objective Timeline
Communication tool/visual of all disclosure items required for a study and for a submission Q1 2018
A descriptive document that provides written content and explanation of the visuals Q2 2018
A helpful hints guide highlighting proactive wiring tips Q4 2018