With the implementation of the Clinical Trials Regulation 536/2014 (CTR) and the Clinical Trials Information System (CTIS) on 31st of January 2022, the European Union has embarked on a transformative journey to streamline and harmonize clinical trial processes across its member states. This comprehensive regulatory framework, designed to replace the previous Clinical Trials Directive, represents a significant leap forward in promoting efficiency, collaboration, and transparency in the realm of clinical research. However, this change has also brought challenges and longer timelines for the submission of mononational trials.
In the dynamic landscape of clinical research, the speed at which trials can be initiated and conducted plays a pivotal role in advancing medical breakthroughs. One significant development is the notable reduction in approval times for mononational clinical trials by the German Federal Institute for Drugs and Medical Devices (BfArM):
Since October 2023, BfArM and the Working Group of the German Medical Ethics Committees (Arbeitskreis Medizinischer Ethik-Kommissionen, AKEK) have ensured that validated authorization applications will be processed within 26 calendar days. In case of no deficiencies the final trial authorization is granted within 31 days at the latest.
“Validated clinical trial applications for mononational clinical trials are assessed within 26 days at BfArM. In case of no deficiencies the final trial authorization is granted within 31 days at the latest. The Working Group of the German Medical Ethics Committees (Arbeitskreis Medizinischer Ethik-Kommissionen, AKEK) agreed to follow these timelines as well.” [1, 2]
It applies to all mononational (mono- and multicentric) trials which run through the German approval processes. This improvement is a game changer for researchers, sponsors, and ultimately, patients waiting for groundbreaking treatments. For us here at Profil and for our sponsors, this means even shorter timelines and faster approvals for our clinical trials. Combined with our rapid recruitment capabilities, we are able to offer our partners timelines that are second to none.
The recent shift towards significantly shorter approval times for mononational clinical trials is a result of streamlined processes and a proactive approach by regulatory authorities. By focusing on efficient evaluation mechanisms, BfArM has managed to cut down the time required for approval without compromising the rigorous standards necessary for ensuring the safety of the trial participants and data integrity.
In addition, an initiative of the Working Group on Applied Human Pharmacology (AGAH), together with BfArM, the Paul-Ehrlich Institute and AKEK is underway to harmonize scientific standards for the assessment of clinical research projects. The aim is to reduce the number of deficiencies (requests for information) within the clinical trial application process and thus significantly streamline the approval process.
These changes will greatly improve the approval process for clinical trials in Germany.