Research and Advanced Education
Inês Zimbarra Cabrita - Research at the service of Cardiology
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The CETERA space is special. Hidden in a corridor in the enormous building occupied by Santa Maria Hospital, it has a discreet and subtle appearance of rigour and good taste.
A place nearly entirely white, with soft strokes of harmony that invite you to work. And this appearance is understandable as it mirrors the role of its Coordinator, Inês Zimbarra Cabrita. She is discreet and reserved, and she knows this is often confused with antipathy. Careful and demanding, she has realised that some criticism is inherent to being successful, but despite not engaging in conflict lightly, she shows when something does not please her. She believes that image is a form of communication. And she also believes that motivation and will are reason enough to justify success.
Inês Zimbarra Cabrita came to Santa Maria in 2012 to create GAIC (Office for the Support of Cardiovascular Research), a project designed by Professor Fausto Pinto. Later CETERA (Academic Consulting Research Organisation) would be born, focusing on the promotion and monitoring of research in other hospitals nationwide. Both are departments of the AIDFM (Association for Research and Development of the Faculty of Medicine), established in 1995.
Cardiology was growing and Fausto Pinto knew that creating a Research Office was a logical step within the Hospital's Cardiology Service, so the GAIC was justifying itself, more and more. It was at that point that Inês Cabrita's choice made perfect sense.
They met when Inês decided to do a Masters in Ultrasonography and sought Fausto Pinto to hand him a letter of recommendation. A cardiopneumology graduate, she wanted to apply to the Imperial College London, where she would do a specialisation at the National Heart and Lung Institute. "I scheduled a meeting with the Professor without knowing him and explained what I wanted, and he was very helpful and gave me all of his support".
It was a grant from FCT that allowed her to study in London. Fausto Pinto would thus be one of the mentors for her Master thesis, together with other two mentors from the Imperial College. After finishing the Masters, she stayed in England independently for another year. It was there that the door to taking a PhD opened, in a large project with one of her mentors, Prof. Simon Gibbs. Looking back, she knows that staying was the right decision but she hesitated for a while, because she always wanted to return to Portugal. "At the time I came for an interview with Hospital da Luz, which helped me take my decision, and so I ended up staying there".
As she wanted to maintain her relationship with her country and needed to have a new Portuguese co-mentor on the FCT's PhD grant, she strengthened ties with Fausto Pinto.
It was London that provided her the model that she would bring to Portugal, despite being aware of the differences between the countries: "London had larger and already more advanced centres. For example, they had beds dedicated to patients that participated in trials, nurses and office staff exclusively working for the research, which means the research career was done full-time and exclusively for this purpose".
Returning to her country was now inevitable, because Inês Cabrita was pregnant and wanted to develop a more national path. It was in Portugal that she wrote her thesis. "It was after this that the Professor (Fausto Pinto) invited me to create GAIC, because he understood that there are necessary functions in research that aren't performed by doctors who don't have enough time nor, in many cases, the necessary knowledge to tackle some more bureaucratic and regulatory issues".
This Research Office placed the management and coordination of the whole organisation of clinical cardiovascular research in the hands of Inês Cabrita, and it was the perfect match for someone whose area of education was also linked to the heart. "There are many bureaucracies and particular issues that lie behind a clinical study or research project, the regulatory part, the link to the Ethics Committees, a world that lives apart from daily clinical practice".
Pioneering in Portugal, the GAIC began to show the importance of having a professional coordination of studies, but also the importance of having a now vast database that brought together all of the scientific activity, including the dozens of scientific articles and publications from the service.
The early days weren't easy, starting a project alone was itself a big challenge, but implementing it in such a large house and with a three-way relationship between Santa Maria Hospital, the Faculty and the Research was even greater. The first steps ensued through the collection of sufficient and necessary information that would allow the establishment of strict mechanisms to start walking with dexterity.
The team started to be constructed, to support the work initially developed. The GAIC started growing after the first period of time through which Inês was alone, and in 2013 she was joined by Francisca Patuleia Figueiras as GAIC Scientific Manager, whom Inês knew from her time in London and from when they were finishing their PhD.
In 2014, Fausto Pinto was invited to implement a clinical trial that involved several hospitals nationwide, at which point CETERA, was born, with a name deriving from the word "etcetera", intended to provide a sense of continuity to the project. From one clinical trial, one more department was expanded, precisely to work outside the Hospital and the Faculty, reaching other hospitals throughout the country. Inês and Francisca embraced this innovative academic project which allowed them to grow in the area of clinical research.
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How can we distinguish GAIC from CETERA?
GAIC supports clinical studies that take place here at the Hospital, and so it is a service for research teams as a support office. Currently it has four full-time Study Coordinators and one part-time Study Coordinator. It is an internal activity at the hospital.
CETERA, on the other hand, will implement, manage and conduct a study/clinical trial in any hospital in the country, with dedicated monitors that will verify if the trial is being well directed, always acting on behalf of the Promoter or Sponsor, and always from the "outside". Its activities are external to the hospital. Both GAIC and CETERA are departments within AIDFM with the common purpose of promoting and encouraging Cardiovascular Research. There are ten members in total, including a few who work for both GAIC and CETERA, a medical Cardiology consultant, and also external people like technical translators for example.
How do we work at CETERA? We are hired by a promoter, who could be a scientist from a Pharmaceutical Laboratory or an Academic Institution, who wants to implement a clinical trial in Portugal, and who subcontracts an external team to represent them in their trials/projects and we are paid for it. We are therefore intermediaries, assuming the initial contacts and then giving continuity to the project, but always as consultants. It may also be the case that when they ask us for this service, one of the centres involved in the clinical trial may be the Santa Maria Hospital, where CETERA continues its role as an external entity (from the promoter's side) and does not collide with the GAIC team, which participates with the research team at the centre (hospital side), as both are separate teams with separate functions.
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In fact, you exported a successful formula from London and applied it in Portugal?
This is precisely the concept used at the Imperial College, which has a research centre with multidisciplinary teams, including monitors that work externally and study coordinators that accompany and support the studies that take place there. The model is perfect and very professional.
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With the initial challenges behind you, how do you currently portray the teams?
When GAIC was created, we were participating in two clinical trials. We currently have more than 100 clinical studies taking place, thirty of which are clinical drug trials. There was a large growth because the promoters, who propose the studies and are external to the centre, saw that there was an Office that could assist them and ensure an effective internal coordination, and that made a difference. Regarding CETERA, the team currently works with fourteen different hospitals in the country. We serve as a network, we are the ones who respond and execute all the bureaucratic and regulatory parts, which is obligatory. The processes are long and the responses are slow, and if we, who are already in the process, take time to respond, you can imagine those who do not know the procedures of every hospital, especially the international promoters who are not aware of the local and specific processes of each centre.
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How much time can a clinical trial take?
From the day we are contacted up until the close out we may be talking about three, four, five years. So you can see how it is a very demanding work, with lots of simultaneous challenges. And the various phases of the trials have very distinct strands as they advance. Months of preparation are required before the centre is active and able to recruit patients, the so-called setup phase. It takes months to get all the necessary approvals and documentation for the research. Then we have all the management of the "researcher dossier" that needs to be complete, updated and provided in real time since the trial starts. Of course there are shorter studies, but note that a short study never lasts less than a year.
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Another parallel area that is developed and that is also very interesting are the courses provided to doctors, senior technicians, nurses and researchers. What purpose does this training have?
Both at GAIC and CETERA, we feel the need to give very specific information to someone who wants to develop a research study. And it does not only concern the bureaucratic and regulatory part with which they must comply, it also intends to make them aware that they are entirely responsible for the research. We are facilitators and we streamline processes, but if anything goes wrong, it is important that they realise if they are responsible for something, especially the Principal Researcher. Issues such as legislation, regulations, good clinical practice, reporting of patient adverse events, these all have timings and consequences, as set out in the law of clinical research, but are not always well known. Although many researchers become autonomous in this knowledge over time, we feel that little is known about these dynamics in Portugal. Training started last year for people who were already part of research and trial teams with a two-day intensive course that included an initial part on the various types of studies, regulatory information and procedures for conducting clinical trials. Then there's a very practical part where the trainee accesses the (anonymised) dossiers and documentation with practical cases, so that they see the real application of the cases. If everyone is well informed, work flows better and the patient will benefit from the team's excellence.
On March 19th and 20th, we organized the 3rd edition of the course "Clinical Research: What is it all about?”, with the presence of 12 participants. And on June 4th and 5th we will have a course entirely in English for professionals who are not Portuguese.
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Research takes time, funding, and a better knowledge of good clinical practice. Inês regrets that the country does not yet provide all the necessary conditions to better motivate researchers, but she knows that steps are taken slowly and currently considers that the Research carried out at the Department of Heart and Vessels includes excellent teams, at all levels.
The five years she lived in England gave her a sense of the world that she sees as fundamental for those who want to create change, and it was this openness to the outside world that she tried to implement, surrounding herself with the team she has as a result. To this day, 90% of the applicants are women. And that is why her current team is comprised of women only, both in GAIC and in CETERA, but also at all hospitals. She chose all of them for being organised, conciliators, care providers, for maintaining close contact with the patient and for always being willing to understand the particularities of others. They come from different areas within science and usually join without experience, but they all have a passion for the world of clinical trials.
For the future, GAIC and CETERA are designing a course for study coordinators and coordination functions within hospital teams.
As for CETERA, the client portfolio has continued to grow with foreign partners within the pharmaceutical industry, medical device manufacturers and universities calling on Portuguese Centres to participate in prestigious clinical studies. Another important component is the support throughout the implementation of an original research project for students of a PhD program who seek professionals to support them in regulatory approvals, study, data insertion, among others, through scholarships or industry aids.
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Although motivation may sometimes fail, she holds on to the results obtained by the Department and the teams she coordinates who provide their best for the benefit of quality research, and she knows that she can count on Fausto Pinto, the person who chose her. She hopes that GAIC and CETERA will continue to work as facilitating departments for research, and ultimately serve as creators of change, so that Cardiology will continue its progress.
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Joana Sousa
Editorial Team
Credits of some photo: Studio Catarina Zimbarra