Science
EMA sets out proposals to reform EU’s clinical trials framework
The European Commission, EMA and national regulators within the EU have launched an initiative to change the way
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The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.
The broad strokes of the proposals are laid out in a document entitled Accelerating Clinical Trials in the EU (ACT EU) that lists priority actions that will be taken, including measures to allow greater use of innovative clinical trial designs.
One objective is to increase the number of larger, multinational trials – specifically in the academic setting – that can take advantage of the scale afforded by organisations across member states acting together.
The paper notes that the COVID-19 pandemic has exposed that there are relatively few multi-member state trials, with most still being carried out at a national level, as well as “disharmony” between regulatory requirements between EU countries.
The result is slower trial authorisations, and higher costs, which may be the reason why analyses of centralised marketing authorisation applications have revealed a fall in the inclusion of trial results generated within the EU, it suggests.
“The aim is to further develop the EU as a focal point for clinical research, further promote the development of high quality, safe and effective medicines, and to better integrate clinical research in the European health system,” according to the EMA.
Top of the list of recommendations is to develop a new governance strategy for studies, drawing on existing initiatives if possible, and to develop key performance indicators and a dashboard that can be used to track the performance of the EU clinical trial environment.
The aim is to bring as many voices into the discussion as possible, including patients, says the document.
There’s also a proposal for the EMA and other EU regulators to work on new guidance for innovative trials designs, such as those that use artificial intelligence and machine learning, as well as complex and decentralised designs.
The initiative will build on the EU’s 2014 Clinical Trials Regulation (CTR) and the launch of the Clinical Trials Information System (CTIS), which will come into force at the end of this month, having been delayed from its earlier deadline of September 2018.
The CTIS – which is operated by the EMA – will contain the centralised EU portal and database for clinical trials covered by the CTR, is designed to make it easier for trials to be conducted in across EU member states and to increase transparency around studies for the public.
“ACT EU will strengthen the European environment for clinical trials, whilst maintaining the high level of protection of trial participants, data robustness and transparency that EU citizens expect,” said the EMA.
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European outbreak of monkeypox: what you need to know
There are some concerns of human-to-human transmission.

Four new cases of monkeypox have been reported in the UK, bringing the total number of confirmed cases to seven. The UK Health Security Agency (UKHSA) is urgently looking for the source of the outbreak.
The first case in the current outbreak was confirmed on May 6. But this is not the first time monkeypox has been reported in the UK. Three cases were also reported in 2021 and one in 2018. However, these infections are rarely seen in the UK and are overwhelmingly linked to international travel from endemic areas, including parts of west and central Africa.
On May 18 five cases of monkeypox were reported in Portugal, with investigations into 20 further suspected cases. On the same day, the Spanish health authorities reported eight suspected cases in men who have sex with men.
This is the largest monkeypox outbreak ever seen in Europe. It is not known if the cases are linked.
Misnomer
Monkeypox, as the name suggests, was first found in laboratory monkeys in the late 1950s. However, scientists aren’t sure if monkeys are the main animal reservoirs (carriers of the virus), so the name may be a bit of a misnomer. The latest thinking is that the main reservoir is probably smaller animals, such as rodents.
Unlike COVID, monkeypox does not spread easily from human to human. It typically requires interaction with animals that carry the virus, or being in very close contact with infected people, or having contact with “fomites” (such as contaminated clothes, towels or furniture). Also unlike COVID, monkeypox is not known to spread asymptomatically. However, the evidence on monkeypox is thin, and the current outbreaks will provide new knowledge around its impact and transmission.
Monkeypox belongs to the same family of viruses as smallpox, but is less transmissible. People who catch it typically develop a fever and a distinctive rash and blisters. The disease is usually self-limiting, with symptoms disappearing after a few weeks. However, monkeypox can cause severe illness, with outbreaks typically showing a case-fatality rate (the proportion of people with the disease who die from it) of between 1% and 15%, with severe disease and death more likely among children.
Sexually transmitted?
The UKHSA says that some cases in the May 2022 outbreak cannot be explained by recent international travel, suggesting that there has probably been some “community transmission”. Four of the seven cases are in people who identify as gay, bisexual or other men who have sex with men. A UKHSA epidemiologist tweeted that this is “highly suggestive of spread in sexual networks”. The cases in Spain may also fall under similar consideration.
So the transmission here may be a little unusual compared with previous outbreaks. While there is a lot we don’t know about monkeypox, we do know the virus can be transmitted via close contact, for example, including prolonged skin-to-skin contact.
There is no evidence that it is a sexually transmitted infection in the manner of HIV or chlamydia. It’s more that, in the UK outbreak, the close contact during sexual or intimate activity may have been a key factor during transmission.
This may be the first time transmission of monkeypox via sexual contact or intimate activity has been documented. But the implications are not so significant in that we know close contact is required for transmission. The social dynamics around the transmission of infectious diseases means this finding may be most useful for the public health teams involved in “contact tracing” – finding other people who may have been exposed to the virus.
Very low risks for the general public
The monkeypox risks to the wider UK public are extremely low, and the NHS has specialist units that focus on treating these sorts of tropical infections. And, thankfully, there are ways of bringing the virus to heel.
The US Centers for Disease Control and Prevention highlights how the smallpox vaccine, cidofovir (an anti-viral drug), and vaccinia immune globulin can be used to control a monkeypox outbreak.
However, beyond the smallpox vaccine, there is no specific vaccine to protect against monkeypox. Some experts have suggested that stopping widespread vaccination against smallpox might have lowered population immunity against monkeypox, thus making cases and outbreaks more likely.
A 2019 meeting at Chatham House in London suggested that an unintended consequence of smallpox eradication could be that “emergent or re-emergent human monkeypox might fill the epidemiological niche vacated by smallpox”.
However, these imported monkeypox cases and other tropical infections (such as Ebola, malaria and Lassa fever) indicate a wider burden of disease elsewhere in the world, typically in low-income countries with limited access to healthcare. It may be that in a post-pandemic environment, we should give more consideration to understanding the local and global implications of Lassa, monkeypox, Ebola and other rare but serious pathogens.
Michael Head has received funding from the Bill & Melinda Gates Foundation and the UK Department for International Development.
disease control pandemic vaccine spread confirmed cases new cases transmission africa european europe uk spainScience
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