REGULATORY PUBLIC DISCLOSURE (RPD) - July

Health Canada issues notices of nonconformance

In recent months, HC placed identical notices on submissions packages from Lilly, Novartis, Seattle Genetics and Gilead which state that in respect of CSR narratives there are

'...extensive redactions to the patient information... redactions do not conform to HC guidance which encourages... other transformation methods...'

Read the full Lilly notice here as an example.

In the absence of change from retrospective redaction to the proactively anonymised authoring of CSR narratives that is actively encouraged in CORE Reference, we can surely expect to see similar notices on future submissions.

Adoption of Anonymization for Innovation

This d-wise White Paper describes "...a third party research study covering areas transparency sponsors consider highest priority, where they’re at currently with transparency efforts, and how they plan to meet different regulatory requirements and deadlines – now and in the future."

Objectives of the Research are as follows:

• Determine state of transparency adoption processes
• Assess how sponsors plan on meeting regulatory deadlines, both currently and in future
• Identify pain points around data transparency

Patient preferences when searching clinical trial registry

This TransCelerate publication in PLoS One  titled 'Patient preferences when searching for clinical trials and adherence of study records to ClinicalTrials.gov guidance in key registry data fields' offers useful pointers in creating more patient-friendly clinical trial summary results for posting in public registries.

PHUSE Clinical Trial Transparency Resources

The PHUSE Data Transparency Workstream have published two new resources on the PHUSE website:

• An update to the Clinical Trial Transparency & Disclosure - A Global View White Paper

A summary of updates to the original document are on page 3.

• A Global View of the Clinical Transparency Landscape—Best Practices Guide

This new guide is information dense and comes with an invaluable 'Quick Navigation Guide' on page 2

All PHUSE White Papers are available on the main site.

Proposal to Update CTIS Application Date

EMA have proposed to fix the go-live date of their Clinical Trials Information System (CTIS) to December 2021. Read these highlights of EMA's June 2020 Management Board Meeting for details.

Important EudraCT Updates

A new webpage (Registering a trial and updating its information) has been introduced to inform sponsors of the steps related to registering a trial in EudraCT and updating its information in the EU CTR.

The webpage CTA and results documentation contains useful links related to protocol and results information.

Tutorials for results posting are also available.