April 2021

EMA and Health Canada publish Moderna COVID-19 vaccine data

Openness and transparency are key to building confidence in COVID-19 vaccines. On 02 March 2021, EMA and Health Canada collaboratively published the full clinical data reviewed as part of their authorisations of the Moderna COVID-19 vaccine.

This international partnership highlights the shared commitment of both organisations to ensure the public has as much information as possible to make decisions regarding vaccination. Increasing access to clinical data can also have widespread benefits for the health care system and the research community. EMA and Health Canada are the only two jurisdictions in the world publishing this comprehensive information.

The two agencies have committed to a similar "...open data approach for all other COVID-19 vaccines".

Read the full press release here.

EMA’s COVID-19 Regulatory Information

EMA’s Exceptional Measures for COVID-19 Medicines page contains all the linked pages you will need to keep up to date with the current pandemic and clinical data publication. My summary for mid-March 2021 gleaned from these pages is that current rolling reviews include CVnCoV, NVX-Cov2372 and Sputnik V. Currently remdesivir is approved for COVID-19. Two mRNA vaccines (Comirnaty and Moderna); two adenovirus vector vaccines (Oxford-AstraZeneca and Janssen/J&J one-dose) are conditionally approved. Dexamethasone is endorsed.

The Comirnaty documentation on the EMA site is here. The Moderna documentation - including anonymization report, clinical overview, protocol and protocol amendments, statistical analysis plan, summary tables and figures, narratives, and summary safety and immunogenicity reports) - is publicly disclosed by Health Canada. It’s a fast-changing picture, so remember to check these pages yourself regularly for updates.

Read more about the EMA’s conditional marketing approval of COVID-19 vaccines in this 30 Jan 21 Lancet paper.

EMA and Health Canada Enhance Collaboration on COVID-19 Observational Research

ICH Regulators emphasised the importance of international collaboration on observational studies of real-world data in facilitating regulatory decision-making on vaccines and treatments for COVID-19. During a workshop on 25 January 2021 convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) and co-chaired by Health Canada and the European Medicines Agency, meeting participants shared information on ongoing initiatives on observational studies derived from real-world data. Key learnings from these activities and opportunities for international collaboration were identified. Regulators also discussed international cohort building; pregnancy studies; and vaccine surveillance and vigilance.

As COVID-19 vaccines are being authorised and rolled out across the world, regulators must ensure the continuous monitoring of their safety and effectiveness, especially when used by special populations. Real-world evidence (RWE) from observational research is critical to understanding the benefits and risks of medicines in everyday use for the prevention and treatment of COVID-19. The meeting built on previous ICMRA workshops on COVID-19 observational research in 2020 and was attended by participants from 28 regulatory authorities and experts from the World Health Organization. The main findings are summarised in this ICMRA report (published 8 February 2021).

It is also heartening that non-ICH Regulators have been contributing to the EMA’s COVID-19 Pandemic Task Force since Dec 2020, and support these assessments.

FDA Issues Annual Snapshot of US Trial Participation 

On 10 February 2021, the FDA’s Center for Drug Evaluation and Research (CDER) published its Drug Trials Snapshots Summary Report for 2020. Data include demographic summary information on trial participants for approved products, including breakdown by product. 

EMA Delays CTIS Launch to 31 Jan 2022

Due to technical difficulties, EMA has postponed the launch of it’s Clinical Trials Information System (CTIS) to 31 Jan 2022. Full details are on the CTIS page. Remember that full functionality of CTIS is actually linked to full application of the European Clinical Trials Regulation EU No 536/2014. So only 8 years behind the CTR being adopted and entered into force (2014) and it being fully applicable (2022 possibly), and with a global pandemic and the associated innovations in clinical trial design, conduct, reporting, and authorisation in between. Merely an observation… 

PHUSE Summer 2021 Data Transparency Event

The PHUSE Data Transparency Event will be held 22 to 24 June 2021.

Join an innovative, informative and inclusive space where knowledge is shared across all pharma companies, vendors and software companies. The event looks to meet the ongoing needs of data transparency within the clinical development arena and will showcase thought-provoking presentations from industry leaders.

This event is free to attend and open to all individuals passionate about the Data Transparency field – register here!

Clinical Data Disclosure, Transparency and Plain Language Summaries Virtual Course, 10 to 12 May 2021

Globally, there are numerous regulations and requirements on the transparency of clinical trials, depending on the local laws and the type of studies. This 3-day ‘Clinical Data Disclosure, Transparency & Plain Language Summaries’ virtual event will present the implementation of Global Clinical Transparency Regulations, what impact it will have on Data Sharing, and companies' experience. Agenda here. Register here. ‘Industry’ are able to attend for free.

EMA Medical Terms Simplifier

EMA have published a Medical Terms Simplifier. This plain-language description of medical terms related to medicines use is a boon for medical writers preparing patient-facing texts, including the Plain Language Summary (PLS) and Patient Information Sheet/Informed Consent Form (PIS/ICF). The resource is housed here on the patient pages of the EMA website.

MHRA Pilots Patient Involvement in New Medicines Applications

The UK Medicines and Healthcare Regulatory Agency (MHRA) is piloting a project that puts patient involvement at the heart of clinical trials and medicine development. Although at an exploratory stage, this initiative should serve patients better and increase transparency within clinical trials. It is certainly one to watch…

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.

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