April 2021: US Regulatory Update

FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.gov 

FDA issued a press release on April, 28th FDA Takes Action for Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov announcing that a Notice of Noncompliance which was sent to Acceleron Pharma  for failing to submit required summary results information to ClinicalTrials.gov. The company’s applicable clinical trial evaluated the safety and effectiveness of the drug dalantercept in combination with axitinib in patients with advanced renal cell carcinoma.

The prenotice was issued on July 20, 2020, alerting Acceleron to potential noncompliance with the requirement to submit clinical trial results. The Notice of Noncompliance gives Acceleron 30 days to submit the required summary results information. The FDA is authorized to seek civil money penalties for Acceleron’s violation, including additional civil money penalties if Acceleron fails to submit the required information within the 30-day period of issuance of this notice.

The Notice of Noncompliance has also been posted to the FDA’s website and information about the noncompliance will be posted on the study record on ClinicalTrials.gov by NIH. NIH will continue to update the ClinicalTrials.gov records for applicable clinical trials that are the subject of a Notice of Noncompliance with information regarding whether the noncompliance has been corrected and the amount of civil money penalties assessed, if any.

April 2021: Clinical Trial Information System Portal Update

Clinical Trials Information System Reaches Major Milestone Towards Go-Live

As per the latest update posted on 21 April 2021, EMA’s Management 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.

The Board confirmed that it has verified that the system meets the agreed requirements during an extraordinary meeting held on 21 April following an independent audit of the new IT system.

April 2021: What’s New on EudraCT

The below update was posted on EudraCT What’s New section, on April 16, 2021:

A new version of the Frequently Asked Questions is now available for users and more detailed instructions are now provided in the tutorials on posting results.

Changes:

  • Q. 30: Provides more information regarding a third country trial
  • Q. 55: Provides an additional reference for contents of results information to be included in a summary attachment
  • Q. 67: Question updated to add ‘user or delegated preparer
  • Q. 70: Provides information for a sponsor to directly upload a PDF document; previously, the NCA was to be contacted who would then upload the document
  • Q. 78: Statement added ‘A link to the old version will remain published in the EU CTR to keep track of the changes and for transparency reason.
  • Q. 81: Addition of statement about errors and warning
  • Minor grammatical and typographical corrections

March 2021: UK MHRA Pilots Patient Involvement In New Applications

The MHRA has announced a new pilot, which will request, on a voluntary basis, applicant companies of new active substances and new indications to provide evidence of the patient involvement activities they undertook when developing their product.

For clinical trials, whilst additional information won’t be requested at this early exploratory stage of the pilot, the MHRA will be documenting in medical assessment reports if there is evidence of patient involvement in clinical trial applications in order to better understand the current scope of activities.

In considering how patient involvement is integrated into the approvals process, the MHRA hopes to learn from any patient-related activities that take place during development, and use this knowledge to improve the quality of clinical drug development and health outcomes in the future. During the pilot, the information provided by the applicants will be voluntary and will not alter the outcome of their application. However, in future, the agency hopes that a successful pilot will lead to patient involvement playing a greater role in the final assessment process, when clinical trials are approved, or medicines are licensed.

The agency will undertake a detailed analysis of the evidence submitted. This crucial patient-focused pilot supports the ambitious vision of The Future of UK Clinical Research Delivery. As a partner, the MHRA is proud to be part of strengthening and contributing to this project.

For more information, please click here.

March 2021: EMA Medical Terms Simplifier

EMA published a document “EMA Medical Terms Simplifier” on March 19, 2021.

This compilation gives plain-language descriptions of medical terms commonly used in information about medicines.  The list includes side effects and similar terms in summaries of product characteristics and
public assessments of medicines but does not extend to the terms that are used only rarely.

EMA will update the document periodically.

March 2021: EMA Management Board Meeting

The EMA Management Board meeting took place on March 11, 2021, and the highlights for the same were published on March 12, 2020.

As noted in the report, the Board agreed to revise the go-live date to 31 January 2022. This go-live date is the aspiration of the Board, being without prejudice to verification of the final audit outcome and full functionality of CTIS by the Management Board, and the subsequent decision process of the European Commission. The final go-live will take place exactly six months after the publication of the Commission decision in the Official Journal of the European Union.

March 2021: CTIS Training Webinars Update

Day 2 of the SME and academia Clinical Trials Information System (CTIS) two-part training webinar arranged by EMA took place on March 04, 2021. EMA has made available the presentations from Day 2 of this CTIS training webinar on March 03, 2021.

March 2021: What’s New on ClinicalTrials.gov PRS

The below update was posted on the What’s New section of ClinicalTrials.gov PRS for March 04, 2021:

PRS Guided Tutorials
The PRS Guided Tutorials have new and updated content and features to make them more useful in response to feedback obtained through focus groups and survey responses over the past year. Enhancements include updated images and improved zoom functionality, additional study examples from materials developed for the behavioral sciences community, and revisions to the Introduction and tutorial content for added clarity and guidance. Two new sections have also been added: Quick Start Guides are designed to help users get the most from the tutorials, and the PDF Library has all of the tutorial content in a single place, readily available for download. Please note that audio narration has been removed.

February 2021: European Regulatory Update

TranspariMed published an article How will national regulators in Europe impose fines for missing clinical trial results?

In this article, TranspariMED’s legal analyst Muhammad Dwistaraifa Rasendriya explains the legal context and how the process will work. As a summary, even though national medicines regulators will get clear legal powers to impose fines and other sanctions on European companies and institutions that fail to make the results of their drug trials public, there will be variation in the amount/type/applicability of the penalty depending on what act/law is passed in each EU country.

Click here for the original article.

February 2021: ClinicalTrials.gov Modernization Update

The following updates were communicated by NLM with respect to ClinicalTrials.gov modernization, on February 10, 2021:

Progress Towards a Modernized ClinicalTrials.gov
ClinicalTrials.gov acting director Rebecca Williams, PharmD, MPH, has authored a guest post on the National Library of Medicine Musings from the Mezzanine blog. Read the post to learn more about the progress to modernize ClinicalTrials.gov.

Webinar on ClinicalTrials.gov Modernization
Reminder to mark your calendars for an update on the ClinicalTrials.gov modernization effort on February 18, 2021, from 3 to 4 p.m. ET. Please register via the ClinicalTrials.gov
webinar registration page to attend the live event. A recording and the presentation slides will be posted after the webinar.