Clinical Trials Symposium, 4th edition organized in Romania by AVANTYO Institute of Clinical Research, under the patronage of European CRO Federation (EUCROF) and Romanian Association of Companies Performing Clinical Research (ACCSCR) took place on November, in a hybrid format, both in the Hanul cu Tei conference room in Bucharest and online.
“After 2 and half years of unmet challenges in the field of clinical trials, operating under pandemic environment, we have been confronted early this year with a grim reality of a military conflict in Europe. On the one hand, COVID-19 has forced us to modernize the clinical trial ecosystem, implement new technologies and on the other hand, in the context of the military conflict, many international clinical trials have suffered a major impact and new strategies for patient enrollment had to be found. This year's main topic is the reshaping of the clinical research landscape, as a consequence of the most recent geopolitical changes," said Dr. Cristina Florescu Moraid - President of Clinical Trials Symposium and CEO of AVANTYO Institute of Clinical Research - at the welcome speech of the event.
The opening speech also came from Dr. Martine Dehlinger Kremer, President of European CRO Federation (EUCROF), who spoke about the new EU Clinical Trial Regulation (No. 536/2014), which will be applied starting from 31.01.2023. Thus, the European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have jointly established the action plan and priorities for the period 2022-2026, which will lead to the improvement of the clinical research environment and support patients in the safe use of innovative medicines at EU level.
In the first panel, the topic Implementation of the new EU legislation for clinical trials (No 536/2014) in Romania was debated. More precisely, any clinical trial that will be carried out in medical enrollment centers in Europe will have to be registered in a single computer system, CTIS (clinical trial information system), in the same way for all study centers in all EU member countries. The moderator of the debate was Dr. George Regio Tănăseanu - President of the Romanian Association of CROs (ACCSCR) Romania and CEO PSI Pharma Romania, and the guests were: Dr. Farm. Răzvan Mihai Prisada - President of the National Agency of Medicines and Medical Devices of Romania (NAMMDR), Pharm. Speranta Prada - Member of the Bioethics Commission (CNBMDM), Prof. Dr. Michael Schenker - President of the Oncology Commission of the Ministry of Health and the founder and manager of the Oncological Center "Saint Nectarie", Dr. Cătălina Sârbu - Former ACCSCR President, Prof. Dr. Viorel Jinga - Rector at the "Carol Davila" Medicine and Pharmacy University Bucharest and Farm. Mihaela David - Quality Director PSI Pharma Romania. At the end of this panel it was concluded that the development of clinical trials in our country represents an extremely important desideratum and objective. Efforts will be made in the academic environment to start with own projects, both through collaboration with the pharmaceutical industry, but also with the help of other funding resources, namely the collaborations with the European Commission and research agencies at European level.
The next topic discussed was the impact of the war in Ukraine on clinical trials. Dr. Sergii Rasputniak - State Expertise Center of the Ministry of Health and Head of Laboratory and Clinical Practices (GCP, GCL) and Dr. Evgeny Levenko - Country Manager ARSENIA Exploratory Medicine in Ukraine, took part in the online discussion. The message conveyed by the two was that the rights, safety and well-being of trial subjects are the most important issues that should prevail over the interests of science and society.
The second panel discussed the opportunities and challenges for Romania and its neighbors to boost contribution to international clinical trials in context of local geopolitics. The moderator of the debate was Dr. Cătălina Sârbu - Former ACCSCR President, and the following took part in the discussion: Dr. Adriana Vasilache - IQVIA Clinical Operations Director, Vlad Croitoru - Senior Manager, Clinical Operations PAREXEL Country Head Romania&Moldova, Dr. Yuri Titov - Country Director of PSI CRO Hungary and Dr. Lucia Turcan - Professor at the "Nicolae Testemitanu" University of Medicine and Pharmacy in Chisinau and Vice President of the Ethics Commission of the Republic of Moldova. In the next period the focus will be on replacing administrative work with technology, the enrollment of new patients, and there are high hopes for working with electronic medical records in the coming year.
The symposium continued with the following theme regarding innovative trial designs in early phases of clinical development, presentation by Dr. Med. Eugenia Prohin, Manager of International Clinical Operation, ARENSIA Exploratory Medicine in Germany.
The conference carried on with decentralized and hybrid clinical trials in EU: the regulatory environment and readiness among healthcare professionals and sponsors to implement these, with Muirinn Cullenn - Chief Operating Officer at ICON Ireland and Stacey Fergusson, PhD - Director of Corporate Development at Illingworth Research Group UK.
An extremely important topic was the digitalization of clinical research, presented by Florin Petruțiu, CIO/CISOCIO/CISO, CNS Healthcare, USA, an American clinical trial company that supports up to 200 new clinical trials every year. The complexity of clinical trials is increasingly fueled in part by technology such as wearables, patient apps, smart devices and more.
Another topic discussed was learning and take aways after 2 years of clinical research in the pandemic environment: patient enrollment and retention, performance in study centers and monitoring activities, where Jennifer Teti - Senior Director, Clinical Research at IMV Inc, Canada - discusse areas of improvement.The final debate was about the importance of the patient’s voice in clinical research. The moderator was Rozalina Lapadatu - President of Autoimmune Disease Patients Association, and the debate was attended by Alina Comanescu - Founder of Community Health Association, Radu Ganescu - President of the Coalition of Organizations of Patients with Chronic Diseases (COPAC) Marinela Debu - President of Hepatic Disease Patient Association, Cezar Irimia - President of the Association of Patients with Chronic Diseases, n(FABC) and Prof. Dr. Cristina Ștefan - Director of The Institute of Global Health Equity Research in Romania and the first woman elected as President of the African Organization for research in cancer. The panel's conclusions were that people need to be given a step-by-step explanation of what clinical trials are, the process and their importance in saving lives. At the same time, the patient is at the center of the research, so he decides the agenda. Another important aspect is the inclusion in clinical trials of subjects not only from the urban environment, but also from the rural environment. Last, but not least, there is a need for more information provided in Romanian language about clinical trials, and digitization leaders must support the patient's voice.
