On the 20th of November, for one day during 8 sessions, 42 international and local professionals have discussed virtually in front of 123 attendees interested in the clinical research arena about their experience in facing the effects of the COVID-19 pandemic on the development of clinical trials.
The lessons about the impact of the pandemic, have been presented by representatives of the competent authorities in Romania and other European countries, high-level representatives of the international biopharmaceutical industry, specialists in regulatory affairs, KOLs / medical investigators, representatives of CROs, associations of patients.
The guests have come from Bulgaria, Belgium, France, Germany, Hungary, Lebanon, Poland, Romania, Serbia, Slovakia, Ukraine, United Kingdom.
The Clinical Trials Symposium is the only national event of the Romanian community of clinical research specialists that has international participation, and this year, it aims to create a framework in which the audience can learn from distinguished guests about the latest models to avoid obstacles during confronting with COVID-19 pandemic and not only, now and in the future.
As a consequence of the times we live, the theme of this edition has been of major interest “2020: A YEAR OF UNPRECEDENTED CHALLENGES IN CLINICAL RESEARCH. WHAT DID WE LEARN AND HOW WE CAN TURN THE LEARNING FROM COVID-19 PANDEMIC IN A WIN FOR FUTURE ?”
See the agenda here - https://www.clinicaltrialsymposium.com/agenda.
Each session has revealed interesting findings.
RE-ORGANIZING THE ROMANIAN DRUG AGENCY
The symposium began with a hot topic: the reorganization of the National Agency for Medicines and Medical Devices in Romania based on Law 134/Aug2019, but not implemented after more than one year after the publication. The debate brought together representatives of regulators, academia, the pharmaceutical industry (ARPIM) and clinical trial companies (ACCSCR).
The discussions started with conclusive data from the IQVIA Romania report that was conducted at the ARPIM and ACCSCR request and published in September 2020.
Although requested, clear information about how to shorten the approval period of clinical trials in Romania (far exceeding the 60 days established in the EU regulation) was not delivered, neither a point-of-view about the appropriate strategy from the agency management. The conclusion is that patients, investigators, CROs, sponsors need more transparency and communication from the agency representatives.
It is worth mentioning that to resolve this status, other parties involved in clinical trials - academics, the Bioethics Commission, sponsors through ARPIM and CROs through ACCSCR showed their willingness to contribute to solving the situation, within the limits of the law.
Conducting clinical trials in Romania, beyond the ethical effect of contributing to improving the health of humanity, means that patients participating in studies receive treatment and care superior to those provided by the state health insurance, doctors work in international research projects with state-of-the-art discoveries, the National Insurance House is relieved of expenses of hundreds of thousands of euros annually and important amounts that could reach millions of euros are collected from the state budget.
THE PANDEMIC IMPACT
Prof. Dr Adrian Streinu-Cercel, Director of the National Institute of Infectious Diseases “1Prof. Dr Matei Balș” from Bucharest, has presented recent information and statistics on the epidemiologic impact of COVID-19 in Romania and Europe. As the second wave of the pandemic is here, Prof Streinu shared conclusions on what should be done to avoid another lock-down. With two mutations of the virus per month, we have to be prepared to test more and to find solutions on how to come back to the normal life, until the treatment is available.
During the panel discussion about the impact of the COVID-19 pandemic on the clinical research community, representatives of academia and sites (centres of investigation - medical centres and hospitals) have discussed the effects on their work from March until nowadays.
We have learned that they faced many challenges because many trials were closed or postponed. In oncology studies, the patients had limited access to sites - where they receive the medication and are monitored - even for negative or asymptomatic COVID patients.
There were a lot of delays in terms of delivering the sampling to the patients and the site.
We found out that the "Direct-to-Patient" services or "Home Care" services have been used successfully in other European Countries. The community expects that these solutions will also be used in Romania, as they are very well adapted to this period when avoiding the exposure of patients in hospitals is of great interest.
The vendor selection discussion revealed the worldwide real and legitimate fear about the patients’ visit to sites (hospitals), the concerns about delays in the patient first visit and the challenges to be faced for safe monitoring on-site and off-site.
IMPLEMENTING THE EUROPEAN CLINICAL TRIALS REGULATION
During the discussion about the European Clinical Trials Regulation No. 536/2014 that will enter into force in 2021, the speakers presented the status of implementation in the European countries present at this panel - Romania, Ukraine, Slovakia, Moldova, Poland, and also to all Europe level. We have learned that without proper implementation of CTIS (the Clinical Trial Informatics System developed by the European Medicine Agency - EMA) the European regulation cannot be applied.
INCREASING ACCESS TO CLINICAL STUDIES AND TRANSPARENCY
The result of the project "PARADIGM - the multi-stakeholder governance framework for patient involvement in Europe", presented by Dr Ingrid Klingman, emphasizes that to increase patients' access to clinical research means finding the right patient for the right study using the guidelines developed by Paradigm and the tools provided by this project. Also, both patients and the public have the right to know in a much more transparent manner, what are the results of a clinical study, how to approach a clinical trial, what is the pathology etc.
The representatives of patient associations also had the chance to discuss the enrollment of patients in clinical trials during the COVID-19 pandemic. Even if, for example, the good-news about Slovakia is that recruitment returns to normal, there are other countries such as Romania and Poland where the situation is still different, despite the efforts made to create guidelines for continuing the studies and despite the lobby for enrollment of patients. The solution is to implement these guidelines and allowing patients to be recruited and to have a chance at innovative medicines.
CONCLUSIONS
Analyzing the shared information during the event, we can conclude that we have to use the latest ways to conduct clinical trials more safely, for both patients and teams, as the new technologies offer this possibility now.
The existing guidelines and protocols must be implemented and the law respected. The pace of adaptation to the new European Regulation for Clinical Trials no. 536/2014, which enters into force in 2021, must be accelerated, including in Romania.
If Romania would align with the performance of the most efficient countries, her potential would be 10-20 times higher than now, exceeding 800 million EUR as value for the clinical trials market. The future of clinical trials depends on how the National Agency for Medicines and Medical Devices will transform its activity according to law 134/Aug2019.
An improved agency activity that will reduce the clinical trials approval period means that patients receive treatment and care superior to the state health insurance, the doctors work on international research projects with cutting-edge discoveries. Also, the Public Health System would be relieved of hundreds of thousands of euros annually, and for the state budget, to collect significant amounts of millions of euros.
ABOUT THE ANNUAL CLINICAL TRIALS SYMPOSIUM
The Clinical Trials Symposium is the only national event of the Romanian community of clinical research specialists with international participation, and this year, it aims to create a framework in which the audience can learn from distinguished guests about the latest models to avoid obstacles during confronting with COVID-19 pandemic and not only, now and in the future.
This is the second edition organized by AVANTYO Institute of Clinical Research under the auspices of EUCROF - European Federation of Clinical Trial Companies and ACCSCR - Association of Romanian Clinical Trial Companies.
AVANTYO Institute of Clinical Research is the only integrated learning platform in Romania that is dedicated to professionals in the clinical trials industry. The ultimate goal of the company's activities is to facilitate patients' access to innovative medication - www.avantyo.com
THE CONTEXT OF CLINICAL TRIALS IN ROMANIA
The representatives of the Romanian clinical trials industry are concerned to bring Romania back on the international map of interest for clinical trials with real development benefits for doctors, chances for innovative treatments for patients and significant amounts to the budget.
Although considered a country with potential, Romania's performance in attracting clinical trials is downward, and the number of studies is drastically declining since 2008.
With 98 clinical trials conducted in 2019, Romania lags behind smaller countries such as Bulgaria (108) and Hungary ( 207).
Romania registers a small number of ongoing clinical trials relative to the population, with 163 studies approved in 2019 and only ten studies per million inhabitants, occupying the penultimate place in the European hierarchy.
The actual market for clinical trials in Romania is of only EUR 72 million. Aligning its number of clinical trials per million people at country level with the best-performing countries in the region, Romania could potentially reach EUR 802 million, and even EUR 1.4 billion compared to the best performing EU countries.
Source of data: Clinical Trials – Foreign Investments in Romania, July 2020, Final Report - IQVIA Romania
See here the press release for the event in Romanian.
