ICMRA seeks international alignment on COVID-19 product assessment

COVID-19 drugs, vaccines and diagnostics that are developed and tested within new international guidelines can expect rapid assessment and authorisation.

The criteria, set out in a statement from the International Coalition of Medicines Regulatory Authorities (ICMRA) published last week, aims to help get lifesaving products to the people who need them as quickly as possible.

“ICMRA members have an important role to play in supporting the worldwide effort to fight the COVID-19 pandemic,” said the statement.

“[They] have stepped up their global collaboration to facilitate and expedite the development and evaluation of diagnostics and therapeutics, including possible vaccines, against SARS-CoV-2.”

Global collaboration is the key to success and becomes ever more important as the pandemic dynamics shift, said the organisation, which has been holding meetings on the international alignment of COVID-19 policies every two weeks.

“While the pandemic is accelerating in some countries, it is decreasing in others after the first wave of infections, serious illnesses and deaths…

“The virus is not gone, nor is there herd immunity. The development of, and widespread access to, safe and effective vaccines and therapeutics will further contribute to our efforts to reduce the spread of the virus and infections.”

Emerging challenges

So far, progress has been swift. Potential vaccines, which previously would have taken years or even decades to develop, are already into phase II and III trials just months after the advent of the pandemic.

Repurposed drugs, such as remdesivir and dexamethasone, have been shown to be safe and effective and have started to be used in clinical practice, and researchers are learning more all the time.

“New information about the pathogenesis of the disease is helping to understand the potential mechanism of action of some therapeutics.

“As further information becomes available, there is a need for early monitoring of patients, and provision of information to clinicians.”

But as the pandemic accelerates in some countries and decreases in others, the global emergency response faces challenges, said the ICMRA.

“Where the number of cases of COVID-19 infections have decreased, ongoing clinical trials are now at risk because participant enrolment is slowing down, meaning the statistical power of the trial may not be enough to reach robust conclusions,” said the statement.

“In addition, the pandemic is making it difficult to recruit, manage and follow participants due to restrictions on visits, sometimes travel, and when visits create risks for both the participants and the healthcare professionals involved in the trial.”

Regulators have worked to “anticipate these issues as much as possible” and provide “regulatory agility”, said the statement.

“Regulators are committed to supporting investigators and healthcare professionals so that participants can continue to be enrolled in priority trials that will provide the robust and reliable results needed to support regulatory decisions”, said the authors.

Defining priorities

The statement describes the key characteristics of “priority” clinical trials, describing them as those most likely to generate the conclusive evidence regulators need to quickly approve products.

It sets out how stakeholders should collect, analyse, and report the data needed to determine safety and efficacy, and highlights the importance of sharing results with the global research community.

“The COVID-19 pandemic requires treatments whose quality, efficacy and safety are based on robust evidence. The main way to obtain reliable evidence is through well-designed randomised controlled trials,” it said.

“Observational studies and real-world evidence may supplement this evidence, especially if employed to support the use of repurposed medicines, or for hypothesis generation, and can provide key safety information.”

According to the statement, priority trials are well-designed confirmatory studies that “address unmet medical need” and have sufficient power to conclude with reliable results.

They must have a realistic recruitment and completion capacity, and address some of the most severe complications of COVID-19, such as acute respiratory lung injury or cytokine storm.

Priority trials are those that test products with a greater chance of success, such as repurposed drugs or those in a more advanced stage of development, and that could benefit the greatest number of people.

“They test therapeutics with simpler routes of administration and shorter treatment duration, in particular in view of the needs of low- and middle- income countries with less robust healthcare systems,” explained the ICMRA.

Free-flowing information

Sharing information is a key theme of the statement, which encourages investigators and healthcare professionals to ensure that all trials are completed, analysed, and reported, and that results are shared with participants.

Investigators should provide full access to data from both positive and negative trials, and engage in “enhanced collaboration” to ensure trials meet their objectives during this “unprecedented time of investment in medical research”.

Ultimately, the group believes, delivering therapeutics, vaccines and diagnostics that have the potential to end the SARS-CoV-2 pandemic relies on the strategic coordination of international efforts.