The first day of the CDDF workshop on Clinical Research in Central and Eastern Europe brought together a diverse group of stakeholders to facilitate dialogue and collaboration.

Here are the key takeaways from Day 1’s program:

SESSION 1: CURRENT STATUS OF CLINICAL TRIALS IN CEE

[Key Takeaways]

🔶 Global Perspective of clinical trials: how the worldwide recruitment related to efforts to make trials more representative, particularly in Central and Eastern Europe
🔶 Russian Invasion in Ukraine led to major disruption of the well developed cancer care research ecosystem. Poland Stepped up massively to address the challenges.
🔶 Patients in Poland do not have sufficient access to adequate information about clinical trials that they may be able to participate in
🔶 Patients treated in research active hospitals have better outcomes than those who are not – cancer research is a necessity, not a luxury.

[Next Steps]

🔶 Use more online tools to make trials more accessible to patients
🔶 Reflect and discuss early site selection and patient recruitment with regulatory agencies.
🔶 Identify opportunities to be innovative in the development of novel drugs and the delivery of cancer clinical trials in the region

SESSION 2: IMPROVING CLINICAL TRIALS IN CEE

🔶 Trials need to be simplified to make them more feasible for site staff and investigators. There needs to be more dialogue between sponsors and site investigators and administrative tasks should be reduced. Also the regulatory requirements from the Agencies (worldwide) need to be kept limited to those that are essential for the approval of the drug – not more and more added on. We need more communication tools with all stakeholders to provide cooperation, facilitate documentation and better manage the tasks in clinical trials.
🔶 Patients and physicians need to be able to find information on clinical trials in up-to-date databases. This is currently very difficult for patients in CEE countries as the databases are difficult to search and many physicians are not aware of the options that clinical trials can offer their patients. More education on clinical trials is needed and patient organizations should be involved in these efforts to create a trusted clinical research ecosystem.
🔶 The Polish Medicines Agency is leading the way by setting up public private partnerships with academic sites and industry to foster clinical trials. Also the creation of a network of clinical research sites will be very helpful to share experience and encourage collaboration and best practices between investigators, the Agency and trial sponsors.
🔶 The Estonian Agency have embraced the new Clinical Trial Regulation and have adapted their processes and provided extensive training to enable the legislation to work for assessors and the new Ethics Committee. They are also going to integrate Medical Device assessment into the process – this is an important aspect. From March 2024 the Agency is also offering scientific advice to sponsors for several therapeutic areas. ACT-EU offers an opportunity to facilitate clinical trials in Europe and MedEthicsEU will help to harmonize the part 2 requirements for the Ethics Committees and ensure a smoother overall approval of trials in Europe.

SESSION 3: CLINICAL TRIALS IN CEE – INDUSTRY PERSPECTIVE

🔶 Strong educational infrastructure and motivated talents foster the development of clinical trials and pharmaceutical industry in the CEE region.
🔶 To establish leadership and career development of investigators, the establishment of early stage clinical development is necessary.
🔶 Efficient start-up procedures and national support programs for clinical sites are very helpful to include also smaller countries from the region in clinical trials.
🔶 Research and Development hubs from the pharmaceutical industry in the region have been proven to accelerate the contribution to clinical trials and the development of specialised structures at the sites.

Stay tuned for Day 2’s lectures and interactive discussions!