Revitalizing clinical trials in Europe: Germany's response to a declining landscape

What is the current landscape of clinical trials in Europe?

Recent data has illuminated a concerning trend: the number of commercially sponsored clinical trials in Europe has dwindled significantly over the past decade, dropping from 2,424 starts in 2013 to 1,978 in 2023¹. During this period, China has grown its share of global trials from 9% in 2018 to 18% in 2023, whereas the European Economic Area (EEA) has seen its share fall from 18% in 2018 to just 12% in 2023.

This shift can be largely attributed to China's streamlined regulatory environment and increased accessibility to research funding — particularly impacting Phase I and cell and gene therapy (CGT) trials. The human cost is also significant: the decline in EEA trial activity translates to 60,000 fewer patients able to access a trial involving an EEA country¹.

This decline in European clinical trial activity has raised concerns about the region's ability to attract and retain investment in pharmaceutical research and development. To proactively address this challenge, Germany — recognizing the potential economic impact on its own medical research ecosystem — has introduced significant legislative changes aimed at revitalizing clinical trials in Germany, and the general clinical trial landscape.

To do this, the German government is seeking to reduce bureaucracy for new trials, and to make it easier for new trial concepts like decentralized trials and trials for innovative therapies like CGTs and radiopharmaceuticals, with their complex supply chain needs, to take place in the country.

Germany is not the first EU country to streamline pharmaceutical development and clinical trial requirements. But taking these steps can influence more European countries to take a similar approach to attract new investment in research and accelerating the development of innovative therapies.

What factors are leading to the decline in European clinical trials?

This reduction in clinical trials in Europe can be attributed to several factors:

 

Lengthy approval processes and complex regulatory requirements

The implementation of the EU Clinical Trials Regulation (CTR), intended to harmonize clinical trial processes, has faced challenges and delays. This has contributed to a downturn in trial starts. It has also led some sponsors to consider alternative regions for conducting their trials, due to extensive negotiation times, stringent data protection laws, and rigid regulatory requirements.

 

Obstacles specific to CGTs and radiopharmaceutical trials

The complex manufacturing processes, stringent regulatory requirements, and the need for specialized logistics and infrastructure pose challenges for conducting clinical trials in Europe.

 

Increased competition from regions with more streamlined regulatory environments

China's clinical trial ecosystem has expanded rapidly, with total trial registrations reaching 5,215 in 2025. That is a 6.4% year-on-year increase and the first time the country has surpassed 5,000 annual registrations². CGT trials alone grew by nearly 30% in the same year. Faster approval timelines and an increasingly sophisticated domestic R&D environment are making China an attractive destination for sponsors seeking efficient pathways to trial initiation. This creates competitive pressure for Europe, as sponsors weigh cost, speed, and regulatory complexity when deciding where to conduct their trials.

Challenges in patient recruitment and retention

Increasing trial complexity, coupled with challenges in finding suitable patients, has contributed to a slowdown in patient recruitment in Europe. This slowdown can lead to delays in trial completion and increased costs for sponsors. Data access limitations for patient-finding in niche populations may further restrict recruitment speed, hindering the progress of clinical research in Europe.

Clinical trials in Germany: a legislative response which fosters innovation and streamlines regulations

The German Medical Research Act was officially published in the Federal Law Gazette on October 29, 2024³. It is focused on streamlining regulations and fostering innovation, and includes changes for decentralized clinical trials (DCTs), radiopharmaceutical and CGT trials. These areas represent significant growth drivers in the clinical trial sector but also face distinct challenges that the new legislation seeks to address.
Key changes include:

 

Labeling flexibility

Investigational and auxiliary medicinal products for clinical trials can now be labeled in English if administered directly by a physician or a member of the trial team. This change reduces the administrative burden for international trials and aligns with global practices — potentially accelerating the initiation of clinical studies.

 

Direct-to-patient (DtP) deliveries

The legislation supports DtP deliveries of investigational medicinal products (IMPs), a key aspect of DCTs. This provision allows for greater flexibility in trial design and can improve patient access and convenience. The German medicinal product act will be adapted to provide a legal basis for the dispensing of IMPs to participants in clinical trials.

 

Support for CGT trials

The legislation introduced several provisions specifically aimed at supporting CGT trials — including the creation of an indication-specific register for CGTs and the authorization for federal authorities to issue recommendations for interpreting good manufacturing practice (GMP) guidelines for CGTs. These measures aim to streamline the regulatory process, enhance transparency, and provide greater clarity for CGT developers.

Learn more about our cell and gene therapy logistics

Support for radiopharmaceutical trials

To increase the number of clinical trials in Germany for the development of radiopharmaceuticals and radioactive diagnostics, various legal changes for an easier approval process and to accelerate these clinical trials are implemented.

Learn more about our radiopharma logistics

Potential impact of Germany's clinical trials on the European clinical trial landscape

While these legislative changes are specific to Germany, they have the potential to significantly influence the broader European clinical trial landscape. By following other EU countries like Denmark in streamlining regulations and fostering innovation, Germany is incentivizing other European countries to adopt similar measures. This potentially creates a more harmonized and attractive environment for clinical trials across the EEA. This harmonization can benefit both sponsors, by simplifying regulatory processes, and patients, by accelerating the development and availability of new therapies.

Germany's approach is likely to attract more investment in clinical trials, benefiting the entire European research ecosystem. Clinical trials bring substantial economic benefits, with a multi-billion euro impact.

Enhancing the growth of clinical trials in Europe

The recent legislative changes in Germany represent an important step towards revitalizing the clinical trial landscape in Europe. By addressing key operational challenges and providing greater support for DCTs, RP and CGT trials, these changes can significantly impact the declining trend of clinical trial activity in the region.

As the clinical research landscape continues to evolve, stakeholders must adapt and embrace innovative approaches to ensure the continued advancement of medical science and the delivery of life-saving treatments to patients worldwide.

FAQs for clinical trials in Germany

Is Germany a good place for clinical trial research?

Germany can offer a compelling environment for clinical trial research. It has one of Europe's most advanced medical infrastructures, with a dense network of academic hospitals and specialist research centers. The country also has a large and diverse patient population — supporting recruitment across a wide range of therapeutic areas. Combined with the regulatory reforms introduced under the German Medical Research Act, Germany is increasingly well-positioned to attract both domestic and international clinical trial investment.

 

How is the clinical trial landscape changing in Europe?

The European clinical trial landscape is undergoing meaningful change. Key developments include:

• A unified regulatory framework — the EU Clinical Trials Regulation (EU-CTR) aims to simplify the approval process across member states and reverse Europe's declining share of global trials.
• Decentralized and digital trials — adoption of remote monitoring, eConsent, and direct-to-patient delivery is accelerating, making trials more accessible for patients.
• Faster set-up times — regulators and sponsors are increasingly focused on reducing the time between trial approval and first patient enrolment.
• A more patient-centric approach — trial design is evolving to reduce the burden on participants and improve retention rates across the region.