What lessons does the COVID-19 pandemic bring to the clinical trial sindustry and patients?

Summary of the conclusions of the Annual Symposium of Clinical Studies 2020, organized by AVANTIO-Institute of Clinical Research

The annual Clinical Trials Symposium held online on November 20, 2020 brought together international and local professionals who shared their experience in developing new therapies and vaccines, facing the effects of the COVID-19 pandemic on the development of clinical trials, an important stage in the development of a new molecule. which is the basis of a drug, but also the one that offers multiple benefits to patients, doctors and the state budget.
The theme of the 2020 edition of the symposium was “2020 - A YEAR OF UNPRECEDENTED CHALLENGES IN CLINICAL RESEARCH. What have we learned and how can we turn what we learned during the COVID-19 pandemic into an advantage for the future? ”
“The Clinical Studies Symposium is the only national event with international participation of the community of clinical research specialists in Romania, and this year it aims to create a framework in which the audience can learn from distinguished guests about the latest models that to follow them and obstacles to avoid in the face of the COVID-19 pandemic and not only, now and in the future "said Dr. Cristina Florescu Moraid, president of the Annual Symposium of Clinical Studies 2020 and CEO AVANTYO Institute of Clinical Research organizer of the symposium . "This edition is the second 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."
The impact of the COVID-19 pandemic on the planning and management of clinical trials, together with the lessons to be considered for the future were discussed for one day in 6 interdisciplinary debating sessions and 2 presentations, supported by 42 guests as representatives of regulators in Romania and other European countries, high-level representatives of the international biopharmaceutical industry, specialists in regulatory issues, KOL / medical investigators, representatives of CROs, patient associations. The guests come from Bulgaria, Belgium, France, Germany, Lebanon, Poland, Great Britain, Romania, Serbia, Slovakia, Ukraine, Hungary. They presented their point of view to an audience of 123 professionals interested in the arena of clinical research.
The symposium began with the hot topic of the reorganization of the National Agency for Medicines and Medical Devices in Romania provided by Law 134 / Aug2019, but which is not implemented more than a year after its publication. The debate brought together representatives of regulators, academia, the pharmaceutical industry (ARPIM) and leading clinical trials companies (ACCSCR). The discussions started from conclusive data from the report on the situation of clinical trials conducted by IQVIA Romania at the request of ARPIM and ACCSCR and presented to the public in September 2020. In the absence of clear and quantifiable answers related to the steps that NAMMD, as regulator, will make them to shorten the approval period of clinical trials far exceeding the 60 days provided by law and in the absence of a point of view on the appropriate strategy by the new management of the agency, the conclusion was that more is needed. transparency and communication from the representatives of this towards the patients, investigating doctors, companies leading clinical trials (CRO), the representatives of the sponsors (pharmaceutical industry). It is worth mentioning that in order to resolve the status quo in the agency, all other representatives of the parties involved in clinical trials - academics, the Bioethics Commission, sponsors through ARPIM and CROs through ACCSCR, showed their willingness to contribute, within the limits of the law, when the situation is defused.
Recent information and statistics on the epidemiological impact of COVID-19 in Romania and Europe were provided by Prof. Dr. Adrian Streinu-Cercel, Director of the Institute of Infectious Diseases “Prof. Dr. Matei Balș ”from Bucharest, with conclusions about what needs to be done in order not to be forced to lock-down again even if we are already in the second wave of the pandemic. At the level of two mutations of the virus per month, we must be prepared to test more and find solutions to return to our normal lives until treatment is available.
From the debates on the impact of the COVID-19 pandemic on the clinical research community, where representatives of academia and websites (research centers - medical centers and hospitals) told us about the effect on their activity from March to the present, we found that they faced many challenges because many studies were closed or postponed. In oncology studies, even asymptomatic negative or COVID patients have had limited access to the site where they receive study medication.

“Analyzing what was said in several sessions of the symposium, we can conclude that we must use the latest ways to conduct studies more safely, both for patients and teams, and new technologies offer us this opportunity. 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 our country ”concludes Dr Cristina Florescu Moraid. “Strictly referring to Romania, where there is a community of very well trained professionals, if our country would align with the performance of the most efficient countries, the potential would be 10-20 times higher than now and we would end up with our study market clinical costs to exceed EUR 800 million. We can say that the future of clinical trials depends on the way in which NAMMD will transform its activity according to law 134 / Aug2019. Improving the activity of the agency with the effect of reducing the approval period of clinical trials, means that our patients receive treatment and care superior to those provided by state health insurance, doctors to work on international research projects with cutting-edge discoveries, National House to be relieved of expenses of hundreds of thousands of euros annually and to collect significant amounts from the state budget that could reach millions of euros. "
The approach to bring together the clinical trials industry in Romania around hot topics through the Annual Clinical Trials Symposium 2020, was achieved by the support offered by the corporate partners of the event IQVIA Romania, Janssen Pharmaceutical Companies of Johnson & Johnson, Arensia Exploratory Medicine and PSI Pharma Support Romania. An important contribution for the dissemination of information was provided by professional partners European Forum of GCP-EFGCP, InoMed, The Clinical Pediatrics Hospital of Sibiu, ROHEALTH - The Health and Bioeconomy Cluster, Camina Medical, ClinGroup and ClinAcademy. The event was promoted by the media partners: Medicalmanager, CASPA - Community of Patients Associations, Medical Week, Medical Market, Medical Life, 360medical.ro, Medichub, RoMedic, Patient 2.0 and Jurmed-Jurnal de santé.
Detailed information about the event on the website www.clinicaltrialsymposium.com. 
The context of clinical studies 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, with the number of studies drastically declining since 2008. Romania (98 clinical trials) lags behind smaller countries such as Bulgaria (108) and Hungary ( 207), as well as the number of clinical trials conducted in 2019. If the number of clinical trials per million people were aligned at country level with the best performing countries in the region, the market for clinical trials in Romania, of only EUR 72 million, it could have the potential to reach EUR 802 million and even EUR 1.4 billion compared to the best performing EU countries.
Romania registers a small number of ongoing clinical trials compared to the population, with 163 studies approved in 2019 and only 10 studies per million inhabitants, occupying the penultimate place in the European hierarchy. Number of clinical trials conducted in 2019, places Romania (98 clinical trials) behind the smaller neighboring countries, Bulgaria (108) and Hungary (207).
Source: Clinical Trials - Foreign Investments in Romania, July 2020, Final Report - https://www.accscr.ro/images/upload/images/Clinical Trials Study Romania_20200827_RAPORT FINAL_RO.pdf 

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AVANTYO Institute of Clinical Research is the only integrated learning platform in Romania that is dedicated to professionals in the medical clinical research industry. The ultimate goal of the company's activities is to facilitate patients' access to innovative medication - www.avantyo.co