How Germany is boosting Clinical Research: Part 1 - Standard Contractual Clauses
HOW GERMANY IS BOOSTING CLINICAL RESEARCH: PART 1 - STANDARD CONTRACTUAL CLAUSES
Author: Ariane Helfrich, PhD
Germany, once Europe's leader in clinical trials with 641 clinical trials initiated by pharmaceutical companies in 2016¹, dropped to 519 clinical trials in 2023 and now ranks second behind Spain (591 trails in 2023)². Yet, Germany is ready for a spirit of optimism, thanks to the government, which has recognized the importance of research-based pharmaceutical companies as a key industry. It aims to reduce the bureaucratic burden in order to become a more attractive location for clinical trials again.
Clinical trials are very important to give patients access to new innovative therapies years before regular market availability. Insights from clinical trials can enhance patient care quality, thereby improving patient outcomes across various therapeutic areas. Simultaneously, clinical trials conducted in Germany contribute to the German economy and foster research and development in a country known for its academic excellence.
Despite all of this, Germany lost ground in the past, even though the total number of clinical trials worldwide is increasing. Within one year, the number of registered clinical trials increased from 477,208 in 2023 to 520,885 in 2024, and continues to rise³. How can it be that the number of globally registered clinical trials is growing while decreasing in Germany?
A major issue has been the contract negotiation with study centers, which is a critical phase in clinical trial initiation across Europe, with a significant impact on study timelines and operational efficiency. In EU countries it takes 183 days (median) to a have fully signed contract (measured at 78 sites in 2020-2023). It took between 2020 and 2023 double the time (median 379 days) in Germany to have a fully signed contract (measured at 8 sites)⁴. However, the average contract negotiation time differs from site to site and is dependent on the complexity of the bureaucracy of the site, as is usual at universities.
Several other factors may influence contract negotiation at German study sites and have cause delays in the past. One is the translation of a Clinical Trial Agreement (CTA): German study sites prefer a German or at least bilingual CTA. Second is the conflicts in country-specific legal terminology and variations in sponsorship and insurance requirements. These factors contribute to operational challenges and delay the contract negotiation⁵. Quite often, in multinational studies, a delay in contract conclusion means that German investigators lack time to recruit a sufficient number of participants, or, by the time of contract signature, the recruitment phase has already been stopped by the sponsor.
To avoid contract negotiation delays in the future, the Federal Government has enacted the German Medical Research Act on 30 October 2024. The German Medical Research Act aims to streamline the process and thus also incentivize sponsors to conduct clinical trials in Germany. One hurdle can be taken by implementing the standard contractual clauses. The implementation of standard contractual clauses across European clinical trial settings has demonstrated significant potential for timeline acceleration. Contract standardization success manifests most prominently in environments with robust implementation policies that specifically discourage deviations. France (time to signed CTA 24-76 days), Spain (61-111 days), and the UK (78-134 days) exemplify this approach, having a lower contract completion time through standard contractual clauses, which have been in place there for years⁶,⁷. The draft of the German standard contractual clauses can be improved, as the Federal Association of Contract Research Organisations (BVMA) commented on 10th March 2025 on the draft bill for an ordinance to simplify the conduct of clinical trials. It was highlighted that standard contractual clauses do not cover e.g., the most common contract scenarios which are used: 2-sided (sponsor-trial center), 3-sided (sponsor-CRO-trial center), and 2-sided (CRO-trial center)⁸ and should be considered to be implemented. Additionally, most studies are initiated by international sponsors, therefore an English version of the standard contractual clauses is highly recommended by the BVMA to accelerate contract negotiation as much as possible. By July 14th, 2025 the Federal Council has approved a corresponding ordinance that binding standard contractual clauses for contracts between companies and medical institutions for the conduct of clinical trials can be introduced⁹. This approval should lead to significantly accelerated contract negotiations as it was seen in France since 2014, for example. France introduced a mandatory national contract template as well as a harmonized budgeting process, which resulted in a reduction of contract negotiation time by over 40%⁷.
As soon as the Federal Ministry of Health will bring the ordinance into force, it will advance the study location Germany and will pave the way to shorten contract negotiation timelines, initiate studies faster, and bring innovations without delay to patients. In the near future, we will be able to evaluate how much the standard contractual clauses will reduce negotiation time and speed up study initiation.
Nevertheless, to accelerate clinical trial initiation in the meantime, FGK involves the study sites at an early stage and can directly communicate between legal teams on both sites, helping to resolve issues quickly. FGK improves efficiency by supporting negotiations in parallel with other study trial start-up activities. If sponsors need a contract template, FGK already offers a well-accepted template, which is based on the German - Joint Model-Contract-Clauses 2.0 published by The Deutsche Hochschulmedizin (German University Medicine), the KKS network, the pharmaceutical associations vfa and BPI and the CRO association BVMA.
References:
2 vfa. (7. November, 2024). Anzahl klinischer Studien forschender Pharmaunternehmen nach ausgewählten Ländern von 2019 bis 2023 [Graph]. In Statista. Zugriff am 10. Juli 2025, von https://de.statista.com/statistik/daten/studie/278264/umfrage/anzahl-industrie-initiierter-klinischer-pharmastudien-nach-laendern/
3 ClinicalTrials.gov. (June 16, 2025). Total number of registered clinical studies worldwide since 2000 (as of June 2025) [Graph]. In Statista. Retrieved July 10, 2025, from https://www.statista.com/statistics/732997/number-of-registered-clinical-studies-worldwide/
4 van Hout D, Mouncey P, Harrison D, Bonten M, Derde L, REMAP-CAP European Regional Investigators. Hurdles for the Delivery of Multinational Randomized Clinical Trials. JAMA Netw Open. 2025;8(7):e2518503. doi:10.1001/jamanetworkopen.2025.18503
5 Gumber L, Agbeleye O, Inskip A, Fairbairn R, Still M, Ouma L, Lozano-Kuehne J, Bardgett M, Isaacs JD, Wason JM, Craig D, Pratt AG. Operational complexities in international clinical trials: a systematic review of challenges and proposed solutions. BMJ Open. 2024 Apr 15;14(4):e077132. doi: 10.1136/bmjopen-2023-077132. PMID: 38626966; PMCID: PMC11029458.
6 New law to speed up clinical trials https://european-biotechnology.com/latest-news/new-law-to-speed-up-clinical-trials/
7 IQVIA (2025). White Paper: Optimizing Clinical Trial Startup Times: Competing on Contracting Efficiency. March 2025
8 BVMA (2024). BVMA-Umfrage zu Nutzung und Weiterentwicklung der Mustervertragsklauseln (MVK). n=20. Juni /Juli 2024.
9 https://transkript.de/hintergrund/2025/bundesrat-stimmt-verordnung-zu-standardvertragsklauseln-zu/
