On the 24^th of July , the second session of the Online Discussion Forum "Clinical Research: Principles and Procedures" is held under the theme " Practical aspects related to the implementation of the experimental medicines circuit in Clinical Trial hospitals” with the intervention of Mrs. Helena Farinha, National Director of the Portuguese Pharmaceutical Society.

This presentation focused on the practical aspects of the implementation of the experimental medicine circuit at the hospital.

The initial framework addresses the types of studies, the phases of clinical trials (EC) and the different designs according to the objectives and methodologies defined and the documents with the greatest impact were pointed out on the  EC (Nuremberg Code; Declaration of Helsinki; Belmont Report), specifically in the development of legislation on the regulation of clinical research (Law No. 21/2014, of April 16 - Portugal). The bodies involved for the purpose of the necessary preliminary approvals as well as all the actors in the EC (researcher, promoter, monitor and participant) are also addressed, highlighting that the EC must respect the dignity and rights of its participants above the scientific and social interests and that the participant must understand the objectives, risks, disadvantages and conditions of the clinical study, having to obtain informed consent.

The experimental medicine circuit is also  detailed (identification of the test centre, feasibility, pre-study visit; submission of the study to the competent authorities, initial visit conduct of the trial and closing visit)  and the role of hospital pharmacists in the execution of EC is evidenced ("... responsible for the receipt, storage, preparation, dispensation, collection and return or destruction of the medicinal product, having the duty to draw up a descriptive document of the experimental medicinal product circuit containing elements relating to the receipt, storage, dispensation and administration of the investigational medicinal product"). Also within the scope of this circuit, the conduct of the EC in the Pharmaceutical Services presents several stages, which  are  detailed, namely: 1) appointment of the pharmacist responsible; 2) confirmation of the conditions of realization; 3) receipt of the protocol and verification of documentation; 4) beginning of study meeting; 5) preparation of the test documentation; 6) reception and verification of the experimental medicinal product (and comparators/adjuvants, where applicable), 7) storage (temperature and humidity control); 8) medical prescription; 9) validation of the medical prescription; 10) preparation and dispensation of experimental medicine; 11) return of the experimental drug; and 12) closure of the EC.

The EC are very important because they enable the development of new medicines and therapies, representing opportunities for patients to access innovative treatments. Therefore, strict compliance with the protocols and the guarantee of the appropriate conditions for their implementation are necessary. The creation of process and performance indicators thus becomes a need and quality assurance.

The management and monitoring of the experimental medicinal product circuit is essential for the safety and quality of the execution of the test. This responsibility rests with the pharmacist, being unequivocally explained and recognized in national legislation.

On the 28th of June, the interview given by Professor Maria do Céu Patrão Neves, coordinator of the BERC-Luso project, to the journalist Luís Lucena of RDP África takes place. One year after the Symposium "International best practices in clinical research in: A Partnership with Portuguese-Speaking African Countries.” that took place on 6th June, 2019, the events held are reminded, namely the training action Biomedical Research and Clinical Trials: "Building ethics and regulatory capacity" in Cape Verde, Praia City, which exceeded all expectations; the activities carried out in pandemic time and the goals that BERC-Luso proposes to achieve next year.

Interview at RDP Africa

On June 26, the first session of the Online Discussion Forum "Clinical Research: Principles and Procedures" is held under the theme "Ethical implications associated with the inclusion/exclusion criteria of clinical trials" with the intervention of Professor Joana Araújo (Institute of Bioethics of the Portuguese Catholic University).

Conducting clinical trials is a factor in scientific and technological development, aiming to find ways to respond to new diseases, existing pathologies still without treatment or possibility of cure, and also promote direct benefits for populations. There are several factors – social, economic and even political – that can influence investment in one or another clinical trial. At the same time, it is important to consider the typical characteristics of the participants in the clinical trials: healthy men, in the order of 40 years; exclusion of children and persons unable to consent; women who undertake not to become pregnant during the trial. These aspects indicate the need for scientific approaches and ethics, becoming a stimulus to reflection and search for solutions that enhance both scientific and moral progress.

On June 5, the  fourth  session of  the  Online  Debate  Forum  dedicated to the theme "Clinical Research and Innovation" takes place, with the intervention of Professor Ana Paula Martins, President of the Portuguese Pharmaceutical Society  and Professor Helder Mota Filipe, President of the National Council for Cooperation.

The session is dedicated to the importance of research, including clinical trials, in therapeutic innovation. Clinical trials are the key pillar in generating information on  the  efficacy and safety of new medicines. The regulatory and ethical requirements that have been demanded and implemented, ensuring maximum protection of volunteers and the quality of the data generated, make it recognised today the added value of its realization for patients, for the scientific community, but also for the economy of institutions and countries where clinical trials are developed.

Africa is one of the continents with the lowest number of clinical trials conducted and with poor representation in multinational clinical trials, although we know that more trials are conducted than those formally reported in international databases. It is necessary to increase the visibility of the test centres of African countries, strengthen the infrastructure that supports them and harmonise legislation and regulation with the latest internationally recognised principles.

In addition, there is often little genetic diversity in clinical trials, an added value being the high genetic diversity that the African continent can contribute to these studies.

A public health crisis associated with the COVID-19 pandemic has created a set of opportunities that should not also be relegated to clinical trial centres in Africa, and particulary in Portuguese-Speaking African Countries. In this context, WHO encourages research centres in all countries and companies to collaborate to ensure accessibility and availability of treatment options, if effective. For this, it provides a dedicated technical technician to implement the tests in the centers that propose to join.

The BERC-Luso project has the potential to become a platform for collaboration between all the countries involved, providing the strengthening and regulatory and ethical harmonization, but may also constitute a mutual support network increasing responsiveness, research quality and international visibility.

We should not waste this opportunity to put the testing centres of our countries' institutions in the international network of clinical trials. We will therefore contribute to improving the care of our patients and to the scientific and economic development of our countries.

On May 29, the third session of the Debate Forum dedicated to the theme "Clinical investigation: pandemic-time procedures" is held, with the intervention of Dr. Joel Passarinho, director of the clinical trials unit of Infarmed and Prof. Maria Alexandra Ribeiro, Interim President of CEIC.

This session is initiated by the project coordinator, Professor Maria do Céu Patrão Neves, who welcomes all participants and introduces the theme. Mr. Joel Passarinho begins by describing the procedures required by Infarmed with regard to conducting clinical trials in pandemic conditions. These guidelines aim to ensure that health professionals can be focused on their clinical activities and consequently simplify some procedures in the conduct of clinical trials, while ensuring the protection of participants. According to infarmed's instructions, it was left to the prosecutor's consideration in conjunction with the researchers to adopt procedures appropriate to each situation. These guidelines include, for example, the possibility of immediate suspension of clinical trials, adjustment of scheduled patient visits, remote monitoring, or even the dispensing of home study medications, among others. In the context of the Provisions of Infarmed, immediate notification is provided for in situations of interruption of the treatment of participants; in the remaining cases, a final report is requested with impact assessment to be submitted after the end of the pandemic. Then, Professor Maria Alexandra Ribeiro refers that CEIC has similar procedures, differing essentially in the need for timely notification of all changes to the conduct of the study resulting from the pandemic that would allow a regular monitoring and evaluation of the measures implemented.

On May 22, the second session of the Discussion Forum takes place, this time dedicated to the theme "Informed consent in pandemic time: clinical assistance and biomedical research", with the intervention of Professor M. Patrão Neves, coordinator of the BERC-Luso Project, and Professor Maria Alexandra Ribeiro, interim President of CEIC.

The session begins to recall the realm of Informed Consent as an ethical process, which cannot be reduced to a legal act. In this context, the essence of informed consent is based on a match between professionals and patients and on the commitment of the former to listen to and meet the needs, expectations and desires of the latter. In emergency situations, such as the current pandemic, the requirements of informed consent are maintained, both in the care plan and in clinical research, in the transmission of relevant information, in listening patients/volunteers and in signing a written document. However, recognizing that it is not always possible to fully comply with all the requirements, it is emphasized that: in the care plan, alternative formats of assent should be opted for and, when not possible, the principle of beneficence prevails; in the practice of clinical research, obtaining informed consent for studies for COVID-19, given its exceptional nature of the disease, it may be acceptable to obtain informed consent by simplified means such as obtaining an oral consent, thus replacing the classic and written form usually required in the context of research. On the other hand, the ethics committee must adopt operational procedures that respond quickly, making processes more flexible, but without reducing the ethical requirements prior to the approval of the project.

The pandemic situation that the world is going through has led to profound changes in all categories of individual and social activity, forcing a constant effort to adapt to new realities and respond to current needs. The BERC-Luso also follows this dynamic. In this context, BERC-Luso, faithful to its design of ethical and regulatory training in the field of biomedicine and wanting to contribute to the better response of partners to the extraordinary demands of pandemic times, organizes a thematic Debates Forum, under the common name “ Best practices in pandemic times ”.

The webinar will contain a brief thematic introduction by the person in charge of the session in question, followed by debate between all participants.

Program:

May 15(12 pm- 13pm /Lisbon)

–Community masks: manufacture, access and use -
Mr. Jorge Batista and Professor Patrão Neves

May 22 (12 pm-13 pm /Lisbon)

– Informed consent in pandemic time: clinical assistance and biomedical research -
Professor Patrão Neves and  Professor Alexandra Ribeiro

May 29 (12 pm-13pm/Lisboa)

– Clinical research: pandemic-time procedures -
Mr. Rui Ivo and Professor Alexandra Ribeiro

June 5 (12pm-13pm/Lisbon)

– Clinical research and innovation -
Professor Ana Paula Martins and Professor Helder Mota Filipe

On May 15, the first webinar "Best International Practices in Pandemic Time" takes place, with the theme "Community masks: manufacture, access and use". The session takes place with the participation of 15 trainees of the BERC-Luso Project, and consists of a short intervention by Professor Maria do Ceu Patrão Neves, coordinator of BERC-Luso and Mr. Jorge Batista, Executive Manager of the Project BERC-Luso Project, on the use of masks in the context of the COVID-19 pandemic, followed by a debate that will count with all the participants present at the event. The intervention focuses on the differences between the numerous types of protective masks, medical devices, personal protective equipment and textile articles, their usage and indications. Subsequently, information on community masks or social masks is then presented, including their correct use, certification and widespread use in the population, including resources available in Portuguese from the Directorate-General for Health of Portugal and INFARMED.

Participants from each country can share their national experiences, regarding the national certification of these articles, the policies implemented in each country, as well as access to these products.

Finally, and responding to a previous request from the participants, a set of resources on the role of pharmacists played in the COVID-19 pandemic is shared, disseminating the Resources in Portuguese of the International Pharmaceutical Federation (FIP), consisting of health promotion material, intervention protocols and evidence material on SARS-CoV-2 infection.

The BERC-Luso coordination meets on the 7th of May 2020 with the trainees of the Republic of Angola, via electronic platform, with the presence of Ms. Jocelyne Vasconcelos, Ms. Isabel Malungue and Mr. Adelino Quiteque.

The goal of the meeting is to listen to the necessities of the partner countries in this phase of combat to the new coronavírus, maintaining a link between partner countries and the BERC-Luso project.

The goal of the meeting is to assess the needs of the partner countries in this phase of fighting against the new coronavirus, maintaining a link between partner countries and the BERC-Luso project, and to promote webinars aiming at discussing relevant topics.

The BERC-Luso coordination meets on the 6th of May 2020 with the trainees of the Republic of Cape Verde, via electronic platform, with the presence of Ms. Maria de Lourdes Monteiro, Ms.  Lenira Centeio, Ms. Ester Oliveira, Ms. Sheila Monteiro and Ms. Maria do Céu Teixeira.

The goal of the meeting is to assess the needs of the partner countries in this phase of fighting against the new coronavirus, as well as the promotion of webinars aiming at discussing relevant topics to all partner countries.