Project Scope 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. |
ProjectLeadLeads | |
|---|---|
Anne Cutting |
Key Milestones
| Objective | Timeline |
|---|---|
| ||||||
|---|---|---|---|---|---|---|
| Evolving to reformat deliverable |
| Resources | |
|---|---|
| Poster Presented at CSS 2018 | Global View of Clinical Trial Transparency and Disclosure Events for a Single Study and Product Submissions |
| Best Practices Guide | Clinical Trials Data Transparency Toolkit Best Practices Guide |
| White Paper | Clinical Trials Data Transparency Toolkit White Paper V2 |
Project Members | Organisation |
|---|---|
| Anne Cutting | GSK |
Christa Polidori | Regeneron |
George Allen | Janssen Research & Development |
Helle Gawrylewski | Hawkwood Consulting |
Julie Holtzople | AstraZeneca |
Lora Killian | Pfizer |
Mark Gummel | Jazz Pharma |
| Nate Root | Ionis Pharmaceuticals |
| Praveen Kumar | Geninvo |
| Raina Agarwal | Kinapse |
| Rene Allard | Industry |
| Renee Entzminger | Industry |
| Sherry Meeh | Janssen Research & Development |
| Stephen Bamford | Janssen Research & Development |
| Teresa Armstrong | Eli Lilly |
| Tom Bosch | Janssen Research & Development |
| Wendy Wimmer | Merck, Sharp & Dohme |