Clinical Trial Disclosure - Requirements & Strategy Considerations within Clinical Trial Transparency

Summary

Clinical Trial Disclosure (CTD) is a compliance requirement mandated by various national laws and policies, and is at the heart of a paradigm shift towards greater trial transparency. CTD consists of registering protocol-related information and posting clinical trial study results on publicly-accessible databases. By disclosing information, sponsors provide a record of a study’s design, objectives, and results, and demonstrate scientific integrity to regulators, scientific journals, and trial participants.

Trial disclosure requirements exist for most trials in patients. The US and EU governments maintain registries where protocol information is submitted, maintained, and updated from a study’s initial approval through study completion. Many other countries maintain local registries, requiring oversight for ensuring global harmonization and compliance. The introduction of data sharing and anonymization, now becoming a focus of scientific journals, patient advocacy groups, and other organizations, further broadens the transparency landscape, and reinforces the need for sponsors to proactively implement transparency policies.