Requirements & strategy considerations within clinical trial transparency

Clinical trial transparency practices in a changing landscape

The clinical trial disclosure (CTD) landscape has changed significantly over the past decade, with more expansion likely in the coming years. Numerous national regulations and policies require clinical trials to register protocol information and post clinical trial results on publicly accessible databases. The shift towards transparency — including an increased focus on data sharing and anonymisation by journals, patient advocacy groups and other organisations — contributes additional CTD considerations. For sponsors that wish to demonstrate scientific integrity and communicate important scientific findings to patients and the public, implementing proactive transparency policies is a priority.

Read the whitepaper to explore:

  • An overview of current CTD requirements
  • Global harmonisation of databases and registries
  • Considerations for planning for public disclosure
  • Future changes in the transparency landscape