{"id":8722,"date":"2026-01-20T14:53:34","date_gmt":"2026-01-20T13:53:34","guid":{"rendered":"https:\/\/fgk-group.com\/?post_type=knowledge-hub-mag&p=8722"},"modified":"2026-01-20T15:04:29","modified_gmt":"2026-01-20T14:04:29","slug":"how-germany-is-boosting-clinical-research-specialized-ethics-commitee","status":"publish","type":"knowledge-hub-mag","link":"https:\/\/fgk-group.com\/de\/knowledge-hub\/magazin\/how-germany-is-boosting-clinical-research-specialized-ethics-commitee\/","title":{"rendered":"How Germany is boosting Clinical Research: Part 3 \u2013 Specialized Ethics Commitee for Special Procedures (SEKbV)"},"content":{"rendered":"\t\t
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Centralized review for all ATMP, FIH, Master Protocol and EMA ETF studies: The new Specialized Ethics Committee for Special Procedures is adding value to Germany\u2019s clinical research landscape. Picture by FGK generated with AI<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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HOW GERMANY IS BOOSTING CLINICAL RESEARCH: PART 3 - SPECIALIZED ETHICS COMMITTEE FOR SPECIAL PROCEDURES (SEKbV)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Author: Ariane Helfrich, PhD<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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Conducting clinical trials is essential to have innovative therapies available. Trial participants benefit from new treatment methods, improving the medical care. However, regulation, monitoring, and evaluation of clinical trials are important to protect the rights, safety, dignity, and well-being of trial participants, as well as to ensure the reliability and robustness of the data obtained in clinical trials. In the past, the regulatory body took a long time to decide on a clinical trial project. Submission was paper-based, causing slow processing. Nowadays, the Clinical Trial Regulation, using the Clinical Trials Information System (CTIS<\/a><\/strong>) for complete digitalization accelerates approval time across Europe. This regulation has already proved success, with average reduction of 25 days in approval timelines across member states1<\/sup>.<\/p>

To streamline the submission process even more and to reduce bureaucracy for clinical trials, the Federal Government of Germany has enacted the Medical Research Act as of 30 October 2024. One component of the Medical Research Act is the Specialized Ethics<\/em> Committee for Special Procedures (SEKbV<\/em>). On 1st<\/sup> of July 2025 the Specialized Ethics Committee started to work. This body is intended to supplement the existing ethics committees (ECs) under state law. It will be responsible in particular for highly complex procedures: The Specialized Ethics Committee, consisting of 98 members, is tasked with reviewing clinical trials in which new drugs are tested on humans for the first time, clinical trials in the context of advanced therapy medicinal products (ATMPs<\/a><\/strong>), and trials that follow a master protocol, such as platform, basket, or umbrella trials.<\/p>

In 2024, one third of the 174 clinical trials initiated in Germany were phase I trials2<\/sup>. The main objective of first-in-human studies is to evaluate the pharmacokinetics, tolerability, and safety of the drug. This category of clinical trials applications is now exclusively reviewed by the Specialized Ethics Committee to accelerate the submission process. The second category which falls under the responsibility of the Specialized Ethics Committee is master protocol studies.<\/p>

Master protocol studies reflect the pharmaceutical industry’s commitment to innovative methodological approaches that increase research efficiency while maintaining rigorous scientific standards. Originally established in oncology, these sophisticated designs are now also being used for various indications such as schizophrenia, Crohn’s disease, Alzheimer’s disease, and pediatric Gaucher disease3<\/sup>. Master protocols enable multiple tests on different patient populations or diseases under a unified design. Basket and umbrella designs are the most commonly utilized types of master protocols. 2023 showed a strong focus on oncology, with 298 compounds in various clinical phases in Germany4<\/sup>, underscoring the importance of prioritization and outsourcing to the Specialized Ethics Committee.<\/p>

ATMPs, as a third category comprising cell, gene, and tissue-engineered therapies also fall within the scope of the Specialized Ethics Committee. ATMPs are an evolving option for unmet medical needs, which is reflected in the number of 27 ATMPs4<\/sup> that received market authorization in 2023 and the seven initiated trials in Germany5<\/sup> (various Phases; 01-06\/2025).<\/p>

Overview responsibilities of the Specialized Ethics Committee<\/strong>6<\/sup>:<\/p>