REGULATORY PUBLIC DISCLOSURE (RPD) - April
EudraCT and EU Clinical Trial Register - Updated FAQs
EudraCT & EU CTR Frequently Asked Questions were updated on 16 April 2021. There is plenty of interest about publication in the CTR, and on results postings.
CTIS Major Milestone
EMA confirmed that the clinical trial EU Portal and Database, one of the main deliverables of the Clinical Trial Regulation and the key component of the Clinical Trial Information System (CTIS), is now fully functional and on track to go live by 31 January 2022. Read all about it in this press release.
ICH E6 R3 Draft Guidelines
On 19 April 2021, the International Council for Harmonisation (ICH) Management Committee released the first draft document from the ICH’s GCP E6(R3) renovation process. The GCP principles document (dated March 2021) is not issued for public consultation but has been published as a work in progress in order to facilitate transparency and understanding. The document states that the “overarching principles provide a flexible framework for clinical trial conduct. They are structured to provide guidance throughout the lifecycle of the clinical trial. These principles are applicable to trials involving human participants, i.e., healthy volunteers or patients. The principles are interdependent and should be considered in their totality to assure ethical trial conduct and reliable results”. The ICH E6(R3) Expert Working Group is organising a web conference on 18–19 May 2021 to present the current draft of the GCP principles and E6(R3) development.
[Credit to CQAdvisor Newsletter 22 April 2021 for the above summary].
Section 10.7 states: “The transparency of clinical trials in drug development includes registration on publicly accessible and recognized databases, and the public posting of clinical trial results.”
Public Web Conference to Provide Progress Update on ICH E6 Guideline for Good Clinical Practice
Regional regulators are to be present at a free public web conference convened by the ICH E6 Expert Working Group on 18 and 19 May 2021. The meeting will provide a status update on revisions to the ICH E6 Guideline for Good Clinical Practice. Registration is now open for Tues 18 May 2021 or Wed 19 May 2021.
FDA Name and Shame for ClinicalTrials.gov Postings Failures
FDA announced that action is being taken for Sponsor failures to submit the required summary clinical trial results postings on ClinicalTrials.gov
The first ‘Notice of Noncompliance’ was issued to Acceleron Pharma on 27 April 2021.The Sponsor has 30 days to submit results for a study of dalantercept and axitinib in patients with advanced renal cell carcinoma. Interestingly, there is a link to a publication on ClinicalTrials.gov under results for this study (NCT01727336). The FDA reiterate that they are authorised to seek civil money penalties if Acceleron do not comply.