On January 8th, two lecturers from NOVA Medical School - Universidade Nova de Lisboa, were appointed by the Portuguese Minister of Health, as President and Vice-President of the National Ethics Committee for Clinical Research (CEIC), respectively Professor Maria Alexandra Ribeiro, a specialist in Bioethics, and Dr. António Lourenço, a specialist in General Practice Medicine and Clinical Pharmacology.
Together with INFARMED, CEIC carries out rigorous regulatory and ethical evaluation that are mandatory before the start of inclusion of participants in clinical trials, to ensure the validity of the design of these studies and the safety and protection of participants.CEIC is responsible for the prior evaluation and monitoring of all clinical trials and studies with the intervention of medical devices for human use in Portugal.
Structurally, CEIC consists of a group of professionals with recognized experience in the areas of bioethics, genetics, medicine, pharmaceutical sciences, clinical pharmacology, nursing, biostatistics, as well as in the legal and theological and other areas, that guarantee cultural values of the community.
Approval of new therapeutics, including medicines, vaccines or medical devices, requires a favourable benefit-risk profile to be demonstrated in clinical trials. European Medicine's Agency's (EMA) scientific committees conduct a comprehensive scientific evaluation of all data, in particularly clinical trials results to provide an independent recommendations for that medicine can be marketed across the EU.
In 2019, CEIC evaluated 193 new processes for clinical trials with medicines and 19 new intervention studies with medical devices. More recently, the current pandemic has emphasized the importance of:
• European and even globally worldwide networking, to design, implement and conduct clinical trials with quality in a timely manner, with thousands of patients, studying medicines that could be (i) already used for other purposes, (ii) new drugs and (iii) obviously vaccines;
• Obtain rigorous and quick regulatory and ethical evaluation and authorization of clinical trials that are mandatory before the start of inclusion of participants in clinical trials, to ensure both the validity of the study design and the safety and protection of participants.
Like in most of the European countries, regulatory and ethical authorities have put in place accelerated procedures for the evaluation and authorization of clinical trials related to the management of the pandemic COVID-19.
One of the largest European clinical trials with medicines to treat SARS-CoV2 infection is DisCoVeRy, which started in France and has been extended to several countries in Europe through a project called EU-RESPONSE, funded by the European Commission for 5 years with 15 ,7M €. The fast approval of the DisCoVeRy trial by the national authorities in September 2020 allowed Portugal to be among the first 3 countries to recruit patients in this expansion phase. At the moment, it has recruited 32 patients and has had an exemplary performance. Portugal's participation was only possible thanks to the combination of wishes of many institutions (Centro Hospitalar Universitário de S. João, INFARMED, CEIC and AICIB (Agency for Clinical Research and Biomedical Innovation), and the fact that Portugal is a founding member of Infrastructure European Clinical Research Institute (ECRIN) which is responsible for the management of the clinical trial in Europe, through its scientific partners.
The monitoring of DisCoVeRy in Portugal is provide by the clinical trial unit of PtCRIN / ECRIN NOVACRU, a service provision unit at Universidade NOVA de Lisboa. DisCoVeRy is an adaptive clinical trial that allows you to study the safety and efficacy of various drugs that are being identified as potentially useful for COVID-19. At this time, Remdesivir is the only drug being studied and to obtain new data in order to understand the utility of remdesivir i which type of patients, but at any moment other medicine such as monoclonal antibodies, may be added to the study.
Moreover, Portugal also integrates the newly created European network VACCELERATE, which brings together, in a structured way, clinical centers and laboratories trained to conduct phase II / III trials with vaccines. Portugal will play a particularly active role in testing with children and assessing immunity.
In short, Portugal was prepared and knew how to take advantage of opportunities to network in Europe to produce scientific evidence for the benefit of society.