EUCROF conference in Prague – Our conference highlights

The EUCROF conference took place in Prague on February 19th and 20th. The main topics of the program were artificial intelligence (AI), Regulation (EU) No. 536/2014 including the Clinical Trial Information System (CTIS), Decentralized Clinical Trials (DCTs) and the empowerment of patients in clinical trials.

Laura Pioppo from the European Medicines Agency (EMA) kicked things off, giving an insight into regulatory changes. International cooperation is taking place to standardize regulatory requirements. A combination of real-world data with clinical trials is also sought. In the end clinical trials should result in better, faster and optimized trials since the majority of clinical trials are completed too slowly. Due to high costs, there are indications in which more clinical trials are urgently needed. In the future, clinical trials should be better planned, and the full spectrum of available data should be able to be exploited. New paths should be taken together with relevant stakeholders and patient representatives.

As an introduction to the world of AI, Lisa Moneymaker from Saama gave an overview of AI-supported technology that is ushering in a turning point. In conclusion AI helps to carry out clinical trials more quickly.

Afterwards, the experiences of the last two years with Regulation (EU) No. 536/2014 and the CTIS were exchanged. It became clear that the CTIS is not yet functioning optimally and that there are still challenges in harmonizing the member states. There is still room for improvement. The CTIS should be continuously improved, and the Question & Answer document must also be continuously updated. It was positively highlighted that the transparency rules had been updated. The training material and the response time of the EMA helpdesk were also praised.

The afternoon was divided into different streams. In the AI stream, Lina Gaggi from Viedoc reported on the status quo of using AI in clinical trials. She talked about regulatory requirements and the Artificial Intelligence (AI) Reflection Paper issued by the EMA. Phases of clinical trials in which AI is valuable were also listed. Another point of consideration was the validation of AI. It was concluded that the use of AI in clinical research can offer significant additional benefits. However, the regulatory requirements still need to be adjusted. Regulatory authorities of the US and Europe are already monitoring and allowing the use of AI. Corresponding regulations are already being developed in other regions as well. The providers of AI-controlled systems are currently experiencing major hurdles in getting the systems approved and certified by the regulatory authorities.

Furthermore, Rich Davies of CluePoints reported on the increasing use of technology and AI to manage the growing volume and complexity of data. The corresponding challenges were highlighted, including possible solutions and an outlook for the future.

The second day started with, among other things, news about the update of the ICH E6 (R3) guideline. Gabriele Schwarz from the Federal Institute for Drugs and Medical Devices (BfArM) and Rebecca Stanbrook from Novartis emphasized that new strategies and tools were used. The most important points have been listed. About Annex 1, the primary focus was on the changed structure: ethics committee (IRB/IEC), investigator, sponsor and data processing sections. Furthermore, an overview of the glossary, the appendices and Annex 2 was given. In conclusion the guideline was revised in order to adapt it for the future of clinical research and to update it in relation to the current clinical study landscape. Furthermore, the possibility of adapted actions (keyword risk management) should be included. In addition, diversity in clinical trials was considered. Ultimately, patients should also be more involved. The general rule is that clinical trials must be carefully planned. Finally, reference was made to the public consultation on Annex 2, which will begin this year.

In the Insights Stream, Gero zur Hellen from GCP Service International spoke about data protection and AI, among other things. AI is a powerful tool. However, data security must not be overlooked. Because AI is fed with a lot of data, and currently it is not clear how this data is used. Ultimately, data protection serves to protect critical business data and financial savings. In summary, AI is a complex data processing tool and as a result, the General Data Protection Regulation (GDPR) already offers suitable solutions for dealing with AI.

Aurélie Delaunay from Merck KGaA gave an overview on how to deal with a trial master file, in which documents are stored and archived in various systems. There are major challenges in terms of archiving across the entire regulated timeline. Here, the specifications for filing and archiving must be defined and documented from the beginning of the clinical trial. A new concept for clinical trials is required to being able to master the challenges of the future.

In keeping with this, Neil Konopka from Oracle spoke about difficulties in the archiving of computer systems. A phased end to operations was recommended, which, however, means additional costs and resources. There are also significant practical challenges in reactivating the systems, if necessary. Exporting data or metadata into suitable and different archiving formats represents a practical and realistic alternative. The conclusion was that archiving methods need to be improved across the industry. A simplified access and review for inspectors is an absolute requirement.

In conclusion, this year's EUCROF conference was very interesting with very good presentations, and it was worth taking part.