Clinical Trial Disclosure: A Complete Overview

By: Nathalie Borckmans, Technical Expert Coordinator

Introduction

Clinical Trial Disclosure (CTD) is one of many compliance requirements that face life sciences organizations around the world. These regulations have been put in place to improve science with the goal of eliminating selective publication and cherry picking results, which skewed what trials were being disclosed and what medicines were being prescribed.

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.

Beyond the US and EU, there are over 100 databases globally and growing.
Each new database requires planning for submission timelines and global harmonization with content disclosed on ClinicalTrials.gov and other registries.

 

Do you want to find out more about the current regulatory environment in the US & EU (and UK)? Read the full blog post below!

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Artboard 2 Copy 6Clinical Trial Disclosure 2