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

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 the 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 (RPs), 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 accelerate the development of innovative therapies.

Addressing the decline

This reduction in European clinical trials can be attributed to several factors, including:

• 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, contributing to a downturn in trial starts. This has led some sponsors to consider alternative regions for conducting their trials due to the extensive negotiation times, stringent data protection laws, and rigid regulatory requirements.
• Obstacles specific to CGT and RP trials: The complex manufacturing processes, stringent regulatory requirements, and the need for specialized logistics and infrastructure pose challenges for conducting these trials in Europe. 
• Increased competition from regions with more streamlined regulatory environments, such as China: China's favorable regulatory environment, including factors such as the National Reimbursement Drug List (NRDL) expansion, a large pool of treatment-naïve patients, and an increase in China-headquartered companies sponsoring trials have attracted a significant portion of clinical trials, particularly Phase 1 and CGTs². This creates a competitive disadvantage for Europe, as sponsors seek faster and more cost-effective pathways for conducting their trials, potentially delaying patient access to novel therapies.
• 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.

Germany’s legislative response fostering innovation and streamlining regulations

The new legislation, the German Medical Research Act, was officially published in the Federal Law Gazette on October 29, 2024³. It focuses on streamlining regulations and fostering innovation and includes changes for decentralized clinical trials (DCTs), radiopharmaceutical (RP) 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 new legislation supports DtP deliveries of investigational medicinal products, 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 investigational medicinal products (IMPs) to participants in clinical trials.
• Support for CGT trials: The legislation introduces 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.
• Support for RP trials: In order to increase the number of clinical trials for development of radiopharmaceuticals and radioactive diagnostics various legal changes for an easier approval process and to accelerate these clinical trials are implemented.

Potential impact 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, potentially creating 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 clinical trial growth in Europe

The recent legislation 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.