November 19, 2021, marked the date of the latest edition of the Annual Clinical Trials Symposium held by Avantyo. This edition, like the ones before, was organized under the European CRO Federation (EUCROF), National Association of CROs in Romania (ACCSCR) and the Romanian Association of Drug Manufacturers and Importers – (ARPIM). For the duration of an entire day, a multitude of hot topics, were brought to the table in an online format.
Regulatory environment of developing clinical trials in Romania
In the first panel, Dr. Cristina Florescu Moraid (CEO of Avantyo Institute of Clinical Research) moderated the discussion on the status of the legal framework for the development of clinical trials in Romania, the reorganization of the National Medicines Agency ANMDMR as well as the situation of national clinical trials. Prof. Dr. Robert Ancuceanu (former President of ANMDMR) together with Prof. Dr. Adrian Streinu Cercel (Chairman of the Health Commission of the Romanian Senate) informed us about the legislative initiative in Parliament on the tacit approval of clinical trials within 30 and 60 days, respectively, of submitting the request for conducting the clinical trial to the authorities.
View on global COVID-19 vaccination status; status quo Romania
The topic of the Covid vaccination campaign brought together several representatives from various countries to exchange views on the management of a vaccination campaign. Mr. David Saranga (Israel’s ambassador in Romania) explained one by one the measures taken in Israel for the anti-Covid vaccination campaign, where all the informing factors of the Israeli society participated in educating the population on the benefits of vaccination against Covid, information adapted to each ethnic group, tailored towards each level of understanding. Additionally, the UK representative dr.Lucio Fumi presented the British approach for the vaccination of a large percentage of general population.
This topic remains actual, especially in the new epidemiological context represented by the appearance of the Omicron strain. Together with the Romanian speakers, i.e. dr.col.Valeriu Gheorghita, dr.Simin Aysel Florescu, dr.Radu Tincu, the conclusion over the current low percentage of vaccination rates in =Romania below the European average is the result of the level of education and of the mandated authorities in generating a not so coherent message in the campaign. Therefore, there is still a lot to do in this regard, but the main idea to learn from the UK and Israel panelists is that we must listen and respect the advice of first line specialists who face this crisis.
Harmonization of Clinical Trials in the EU. Latest Updates Related Implementation of CTR 536/2014; Status Quo Romania and CEE countries.
In the second part of the day debates on the implementation of the new European Regulation 536/2014, brought together guests from countries such as Austria, Denmark, Slovakia, Germany, Luxembourg, etc. These countries have already completed the draft document on the functioning of the CTIS (Clinical Trials Information System) transposed into national legislation. More so, Austria has already developed its own computer system which will be connected to EMA’s CTIS system.
The development of Deep dive into decentralized clinical trials (DCT) and Patients Access to Clinical Trials
The last two discussion panels referred to a debated topic at the international level, especially in the context of the pandemic, which considers at-home studies. These DCT working methods are already widely used in Western countries, where the legal framework is well established. Conversely legislation is lacking in Central and Eastern European countries. It is an area where more information and education at the level of the medical staff, patients and authorities is needed. The patient associations’ representatives also explained the important role of involving the patient into the study design from the very beginning of the study when protocol is created. Patients are willing to use home care services when they are enrolling into a clinical study but they need to be properly informed from the initial discussion they have with their doctor regarding the study.
Conclusions
Last but not least, at the end of the day, the audience enjoyed the launch of AvantYOU Journal, the latest project of the Avantyo Institute of Clinical Research. AvantYOU is a premium journal dedicated to health & technology, with a unique format, dealing with medical topics, technology, innovation and much more, spotlighting interviews with outstanding personalities, leaders, and experts.
