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Coronavirus: Fast tracking the regulatory approval process for COVID-19 Clinical trials


United Kingdom

In unprecedented medical situations such as the pandemic effects of the coronavirus, a clinical trial to help identify and provide medicinal treatment will typically focus on key priority questions in order to improve public health. 

We are all navigating unchartered waters as business and society faces up to the impact of COVID-19.  We very much hope you and your loved ones remain in good health. 

 Please be assured that Fieldfisher is continuing to work with clients to navigate COVID-19 related issues and on business as usual needs.  Do get in touch with us if you would like to chat anything through.

These questions are:
  • Does the medicine reduce mortality rates?
  • Does the medicine reduce the time a patient is in hospital?
  • Do patients receiving the medicine need ventilation and intensive care unit treatments?
In an effort to fast track the clinical trials approval process yet ensure patient safety is maintained as best it can, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has stated that it currently has procedures in place for the provision of rapid scientific advice, study reviews and priority approvals for COVID-19 clinical trials which are submitted in efforts to support manufactures, researchers and other regulators.

The MHRA could potentially authorise the initiation of a Phase I clinical trial in as little as one week following the receipt of appropriate documentation. In the event that the Phase I trial results are positive in animal studies, researchers could move to conducting tests in humans within a matter of months.

The primary challenge for researchers and regulatory authorities will be to balance potential trial risks against the benefits for the speedy release of a medicine. Notwithstanding the ability to fast track trials researchers will still be required to adhere to the UK Medical Research Council (MRC) guidelines for good clinical practice (GCP) and undergo extensive testing to ensure its efficacy and safety prior to obtaining regulatory approval.

 The MHRA has published a guidance document for Clinical trials applications for Coronavirus (COVID-19) which can be read here.

Working alongside the MHRA in an attempt to fast track the COVID-19 regulatory approvals process for clinical studies, the UK's Health Research Authority (HRA) which protects and promotes the interests of patients and the public in health and social care research will also expediently process research applications.  This means that researchers receive trial approval to begin much more quickly than the usual timelines, sometimes in a matter of hours. Whilst emergency applications are still subject to a robust ethics review. The Director of the Approvals Service can either arrange for an existing Research Ethics Committee (REC) to hold an extraordinary meeting, or for a new REC to be formed to consider a particular application.

On a global scale, the World Health Organization (WHO) last week announced a large global trial, called SOLIDARITY, to find out whether any can treat infections with the new coronavirus for the dangerous respiratory disease. It’s an unprecedented effort—an all-out, coordinated push to collect robust scientific data rapidly during a pandemic. The study, which could include many thousands of patients in dozens of countries, has been designed to be as simple as possible so that even hospitals overwhelmed by an onslaught of COVID-19 patients can participate.

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