Clinical trial reforms have become abundant across the global pharmaceutical industry as regions look to stake their claim in attracting the next waves of drug research.
Amid a surge in research and development (R&D) activity from China – now responsible for one-fifth of pipeline drugs globally – many regions have revitalised clinical trial frameworks in a bid to maintain competitiveness. The US, UK, and European Union (EU) have all announced wide-ranging reforms over recent years that are designed to create a more attractive landscape for sponsors undertaking studies.
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The US Food and Drug Administration (FDA) launched a pilot for real-time clinical trials (RTCT) in April 2026. The aim of the initiative is to accelerate regulatory decisions and streamline the drug development timeline.
However, reforms in the European Union (EU) and UK are more pertinent given the plateau of trial activity regions. According to GlobalData’s Pharma Intelligence Centre, the number of clinical trials in Europe has only slightly risen in the past decade, contrasted with the surge in growth powered by China in Asia-Pacific.
Recent reforms in the EU and UK – alongside incentives introduced by other countries – were examined at the Outsourcing in Clinical Trials Europe 2026 Conference, held in Barcelona on 6 and 7 May.
Europe aims for golden era in 2030
The EU is currently in the middle of significant clinical trial regulatory transformations. Chief among these is the EU Clinical Trials Regulation (EU CTR), which came into force in early 2022. This framework aims to harmonise clinical trials via a single, streamlined application process for multinational trials.
There is also the Joint Clinical Assessment (JCA), a harmonised process designed to allow EU member countries to review data in parallel. Finally, the proposed EU Biotech Act – a wide-ranging framework to boost the bloc’s biotech and biomanufacturing sector, is in discussion phases.
Speaking on a panel about the European biotech landscape, Astrid Pañeda Rodríguez, senior director of clinical operations at Forge Biologics said Europe continues to face regulatory fragmentation.
“Phase III clinical trials need to come into Europe. But unfortunately, the fragmentation is not helping to make this a reality from the beginning,” said Pañeda Rodríguez. “Spain is one of the countries making good business on conducting early-stage trials. There are lots of advantages here in Europe.”
While ongoing trial reforms will harmonise much of this, a change in broader economic strategy could also be advantageous, according to Kamil Sitarz, chief operating officer at Ryvu Therapeutics. “If more countries see a connection between helping the health system and a way of levelling up the economy, that will help a lot,” he said.
Sitarz added that countries should do more to showcase their strategic advantages to sponsors, including patient availability, investigator networks, and site expertise.
“If you have a clinical development plan in place, with an indication, pool of patients, inclusion and exclusion criteria – you can draw a beautiful map, not only of countries, but of individual sites, with investigators, key opinion leaders. This is the strategy story that needs to be told,” he said.
Indeed, life sciences remain critical to the European economy. In a recent report, the European Federation of Pharmaceutical Industries and Associations (EFPIA) stated that a further €4bn ($4.72bn) a year in funding could come into Europe if targets are met.
The European Commission (EC) has set an 11% growth target for clinical trials to help the region recover from its slump. By 2030, the body aims to position Europe as the world’s most attractive destination for life sciences.
UK sets ambitions
Following Brexit in 2016, the UK is also on a mission to raise the profile of its life sciences industry with its own clinical trials regulations. A recent report by trade body Association of the British Pharmaceutical Industry (ABPI) said the UK is at risk of losing its world-leading life sciences status due to investment being captured elsewhere on the international stage.
Intertwined with this has been a lacklustre capture of international sponsors conducting clinical trials. However, there has been growth since the Covid-19 pandemic, as per ABPI. Looking to continue this momentum, the UK Government has initiated a large-scale reform of clinical trials. The new regulations, which aim to speed up and fast-track studies, were formally adopted shortly before OCT Europe.
Joanna Calvert, senior programme manager at the National Institute for Health and Care Research (NIHR), discussed the 150-day study set-up directive – one of these recent transformations. The framework helps accelerate clinical trial set-up times and is already producing successful results.
Speaking to Clinical Trials Arena, Calvert said: “A snapshot of data from October 2025 to April 2026 shows that the median setup time was 122 days. This was down from 169 days, which was the figure pre-150-day metric implementation.”
To achieve this, the NIHR Industry Hub is acting as a single, coordinated point of entry for commercial research. The body has established several workflows to streamline trial pathways and reduce fragmentation. The 150-day metric is a headline commitment of the government’s Life Sciences Sector Plan and is reinforced in the 10 Year Health Plan for England.
Calvert added: “We’re directly working on at least two of the actions within the UK Government’s Life Sciences Sector Plan. It is our aim to make the UK an investable place to attract global research.”
Australia entices with incentives
Australia is known for its strengths in early-stage trials – particularly Phase I – due to fast regulatory approval times and centralised populations. According to Sam Vohra, CEO of contract research organisation (CRO) Avion, Australia has an attractive life sciences scene for sponsors looking to commence clinical research.
Speaking on a panel at OCT Europe, Vohra explained: “Australia offers a low friction entry point for people looking to conduct their trials and for companies to commence their clinical development. Often, it’s acting as a springboard to more global trials and obviously that can continue, including expanding in Australia as well. I think our ecosystem works well together.”
Australia represents a country that not only has a favourable regulatory landscape but also incentive-driven offerings. The government’s R&D tax relief scheme is the most effective of these. The framework, which applies to all industries, allows companies a 43.5% refundable tax offset for eligible activities such as clinical trials up to Phase III.
The panel highlighted the importance of this flexible tax environment, allowing companies to establish early-stage research in Australia even if they later change their mind and conduct further studies elsewhere. First introduced in 1985, the programme is now both mature and powerful.
As countries jostle to attract the upcoming waves of cutting-edge drug research, it will therefore likely be a balance of reforms and incentive that yield the most success.
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