Clinical Research Magazine

To streamline the clinical trial 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).

The German Medical Research Act allows pharmaceutical manufactures that have recruited at least 5% of participants in Germany to be exempt from additional discounts and price caps that were decided in 2022.

To pave the way for accelerated clinical trial initiation, the submission, assessment and monitoring processes for clinical trials in the EU have been harmonized through the Clinical Trial Regulation as of January 31st 2022, using the Clinical Trials Information System (CTIS) deployed by EMA. This regulation has already been successful, with average reduction of 25 days in approval timelines across member states.

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, for example by enshrining Standard Contractual Clauses into German law.

The 30 year old ICH E6 guideline is completely revamped, resulting in the 2025 version called ICH E6 (R3), which will probably be completed until 2026 with Annex 2. Come with us on a journey through the depths of the GCP jungle in search of truths … and puns.

In summary, we see tracks of improvements of the criteria used for Essential Documents in the new ICH E6 (R3), but we have to see how ICH E6 (R3) Annex 1, Appendix C is handled in the practice of audits and inspections.

While the mid-90ies version of ICH E6 depicted the informed consent with pen and paper the brand new ICH E6 (R3) shows that it can handle cutting edge technology with ease. In line with this, the “investigators” are released from their vintage study centers…

ICH E6 (R3) features an inconspicuous, but troublesome concept called “certified copy” but does not define what “the original” is and for many documents it is hard to classify them as originals or copies.

Does ICH E6 (R3) protect participants more than the EU Clinical Trials Regulation against rogue documents? Come with us on a bumpy ride from ICH GCP to the EU rules and back.

Although ICH E6 (R3) does not feature a fully comprehensive checklist of all possible and all necessary protocol elements, it contains the most widely employed description of general protocol content.

Usually sponsors and investigators confirm compliance by signing on a dotted line beneath this very statement. But do they actually comply with ICH GCP, are they enabled to comply, and could they know how to comply?

ICH E6 (R3) has a completely new chapter, which is called “Data governance – investigator and sponsor”. You might wonder whether this new chapter was added to ICH GCP to address issues that emerged as being critical in real life – or if it was added to codify an emerging practice.

ICH GCP is not dead, even in Germany it is alive and kicking. In 2024, the inspection reports of a German authority for a clinical trial that is subject to the CTR made numerous references to ICH E6, but none to the CTR (!). Let’s dissect the applicability of ICH GCP as far as possible.

Explore the insights of Maya Zlatanovas podcast “Trials with Maya Z” with FGK Research CEO Martin Krauss on “How Germany’s care standards impact clinical trials”.

Ursula Türcke shares strategies to overcome patient recruitment challenges in clinical trials, emphasizing collaboration, early planning, and patient-centered solutions.

Read the interview with Ursula Türcke & Cornelia Grossrubatscher as part of the “European Pharmaceutical Contractor” section in the magazine “International Clinital Trials”.

Discover this interview on modern approaches to management with Ursula Türcke as part of the “Women in Pharma” articles in the magazine “International Clinital Trials”.