After two days of intense talks at the G7 Health Ministers’ meeting in Oxford, UK, a new clinical trials charter has been developed.
The Therapeutics and Vaccines Clinical Trials Charter is designed to make it easier and quicker to share results from vaccine and therapeutic trials to tackle Covid-19 and any future threats to global health.
The agreement is part of a global commitment from industry leaders to protect the population from future health threats “and slash time to develop and deploy new diagnostics, therapeutics and vaccines to just 100 days.”
The charter will be “rapidly implemented” and will help deliver high-quality, reliable and comparable evidence from international clinical trials to speed up worldwide access to approved treatments and vaccines.
The charter calls for enhanced collaboration of large international trials to allow for a broader diversity of participants, including children and pregnant people, two groups who have been historically left out of many areas of clinical research.
By breaking down barriers of siloed clinical knowledge the charter will also help to avoid unnecessary duplication of unsuccessful trials.
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“The landmark agreements we’ve reached in Oxford – which has been at the heart of the global response – show our commitment, not just to getting through the COVID-19 crisis, but also to make we’re better prepared for future threats,” said UK Health and Social Care Secretary Matt Hancock.
“It contains a series of measures to make us all safer by improving clinical trials, quicker and wider access to safe vaccines, better use of data, more accurate health surveillance tools and greater collaboration between countries. We are determined that, working together, we will beat this virus and build back better.”
A “One Health” approach
The G7 ministerial discussions also saw leaders come to agreements around digital health, particularly the development of testing and vaccination certificates for G7 countries ensuring that “processes and national certification policies do not disadvantage certain groups of people, including participants in vaccine clinical trials.”
Additional efforts will be made to standardise minimum datasets for patients’ health information to enable the simple sharing of personal health data with other countries. Processes for artificial intelligence (AI) algorithms used for clinical evaluation are also set to undergo review to allow for cross-border sharing.
In the name of global health security, the charter calls for better coordination and collaboration across complex systems, which the UK government says are “key drivers of a strengthened One Health approach towards global health security surveillance.”
“The collaboration on One Health intelligence will provide an interim report by the end of 2021 on how the WHO, FAO, OIE and UNEP can collectively deliver consistent, reliable and comprehensive data on emerging human, animal, plant and environmental health threats,” outlines a government release.
This ‘One Health’ approach will also see a commitment to collaborate with environment ministries, industry and regulators to develop standards to curb levels of antimicrobial manufacturing waste that are released into the environment – a practice that has spurred on antimicrobial resistance (AMR) over the past few decades.
The charter will see the development of policies to “assess the value of innovation in access to and good stewardship of novel antibiotics, with a view to these being applied to new incentive mechanisms.” The need to work together to better understand antimicrobial supply chains was recognised in the hope that this will enable the reduction of drug shortages and supply insecurities.
The discussions also saw G7 leaders commit to the strengthening of the World Health Organization’s role in preparation and response to health emergencies, as well as the sharing of vaccine doses with developing countries through COVAX when domestic situations allow.
The Therapeutics and Vaccines Clinical Trials Charter ushers in a new and much-needed approach to clinical research and drug development and comes just weeks after the EMA announced the EU Clinical Trial Regulation set to come into force in early 2022. The new regulation also aims to boost efficiency and knowledge sharing while helping avoid clinical trial duplication or repetition.
This renewed commitment to sharing new disease data, focus on improving pandemic surveillance systems and measures to improve the security of antibiotics will all play pivotal roles in preventing and combatting global health crises for decades to come.