How Germany is boosting Clinical Research: Part 3 – Specialized Ethics Commitee for Special Procedures (SEKbV)

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) 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.

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 Committee for Special Procedures (SEKbV). On 1^st 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), and trials that follow a master protocol, such as platform, basket, or umbrella trials.

In 2024, one third of the 174 clinical trials initiated in Germany were phase I trials². 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.

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. 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, underscoring the importance of prioritization and outsourcing to the Specialized Ethics Committee.

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 that received market authorization in 2023 and the seven initiated trials in Germany⁵ (various Phases; 01-06/2025).

Overview responsibilities of the Specialized Ethics Committee⁶:

• Clinical trials for which, at the time of application, advice or scientific support has been provided by the European Medicines Agency (EMA) Emergency Response Team.
• Clinical trials that follow a comprehensive protocol comprising several sub-studies with one or more medicinal products and with patients with the same or different diseases.
• Clinical trials in which new medicinal products are tested on humans for the first time.
• Clinical trials of advanced therapy medicinal products (ATMPs).

The Specialized Ethics Committee supplements the existing ethics committees under state law. The office of the Specialized Ethics Committee was established at the Federal Institute for Drugs and Medical Devices (BfArM) and supports the committee in all organizational matters and in advising on clinical trials.

It aims to ensure the protection of study participants while also accelerating procedures and promoting scientific progress. The Specialized Ethic Committee is competent for the above mentioned types of clinical trials, all other clinical trials will be assessed by the ethics committees of the federal states.

An additional element of the Medical Research Act is the newly introduced authority for the Association of Medical Ethics Committees in Germany to issue binding policies that all ethics committees must adhere to. This measure will contribute to greater harmonization of the approval process and offer clear benefits to all applicants.

The extent to which the Specialized Ethics Committee and the harmonizing procedures will strengthened Germany’s position in the field of clinical trials can be evaluated in the upcoming years.