COVID-19 opens a new era for clinical trials and pandemic preparedness in Europe

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Herman Goossens and his colleagues
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  • Goossens H
  • Derde L
  • Horby P
  • Bonten M
The European clinical research response to optimize the treatment of patients with COVID-19: lessons learned, way forward and recommendations.

call for structures and partnerships to enable clinical research and identify regulatory hurdles among the challenges for clinical trials. As European regulators, we recognize the need to optimize the clinical trial environment in Europe. Here we describe tools to address the challenges and highlight a new EU initiative, Accelerating Clinical Trials in the EU (ACT EU), which will enable faster, larger and more robust clinical trials.

From January 31, 2022, the way clinical trials are conducted in the EU will change significantly due to the application of the Clinical Trials Regulation (CTR) number 536/2014.
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EU
Regulation (EU) No. 536/2014 of the European Parliament and of the Council of April 16, 2014 on clinical trials of medicinal products for human use and repealing Directive 2001/20/EC.

The authorization of clinical trials will remain a competence of the Member States, but the new legal system puts in place a robust and agile evaluation procedure, increases transparency, streamlines and reinforces safety control.

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EU
Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down detailed rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards the establishment of rules and procedures for cooperation of Member States states in assessing the safety of clinical trials.

The Clinical Trials Information System will serve as a single point of entry for applications. The CTR introduces the concept of low-intervention trials and includes other options for risk adaptation, including the absence of additional labeling for authorized drugs (article 67 of the CTR) and targeted safety reports.

In April 2020, the European Commission, together with the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMAs), published guidance
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European Commission
Guidance on managing clinical trials during the COVID-19 (coronavirus) pandemic.

with regulatory flexibilities and simplifications for rapid authorization of COVID-19 trials and to support ongoing trials. Flexibilities include the ability for remote monitoring and verification, and direct shipment of investigational drugs to patients.

EMA’s Emergency Task Force (ETF) was activated at the start of the COVID-19 pandemic. As well as being responsible for the ongoing review of marketing authorization applications for COVID-19 vaccines and treatments, the ETF is also providing fast-track and free scientific advice for COVID trials. -19. At the beginning of 2022, the competence of EMA ETF will be extended
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EU
Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on an enhanced role of the European Medicines Agency in crisis preparedness and management for medicines and medical devices.

include support for cooperation between sponsors to enable large-scale platform trials in public health emergencies.

As part of the global effort to deliver more efficient clinical trials, European regulators are contributing to the ongoing review of the International Conference on Harmonization of Good Clinical Practice and supporting the work within the International Coalition of Regulators drug regulatory framework to facilitate the international acceptability of large scale platform trials.

In January 2022, the European Commission, EMA and HMA launched ACT EU to transform the way clinical trials are conducted.
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EMA
Accelerating Clinical Trials in the EU (ACT EU): Implementation of a clinical trial transformation initiative in the EU.

As part of ACT EU, we are committed to modernizing clinical trial methods and oversight and bringing together the clinical research stakeholder community through a series of multi-stakeholder workshops that will focus on achieving more effective clinical trials involving researchers from all over Europe, benefiting from the wealth of EU biomedical research. potential. By working together, we believe we can energize the clinical trials environment in the EU for the benefit of patients and improve knowledge and innovation.

We declare no competing interests.

The references

  1. 1.
    • Goossens H
    • Derde L
    • Horby P
    • Bonten M

    The European clinical research response to optimize the treatment of patients with COVID-19: lessons learned, way forward and recommendations.

    Lancet Infect Dis. 2021; ()

  2. 2.

    Regulation (EU) No. 536/2014 of the European Parliament and of the Council of April 16, 2014 on clinical trials of medicinal products for human use and repealing Directive 2001/20/EC.

  3. 3.

    Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down detailed rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards the establishment of rules and procedures for cooperation of Member States states in assessing the safety of clinical trials.

  4. 4.

    Guidance on managing clinical trials during the COVID-19 (coronavirus) pandemic.

  5. 5.

    Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on an enhanced role of the European Medicines Agency in crisis preparedness and management for medicines and medical devices.

  6. 6.

    Accelerating Clinical Trials in the EU (ACT EU): Implementation of a clinical trial transformation initiative in the EU.

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