Physician, specialised in internal medicine, infectious diseases and epidemiology/public health. EU-PEARL’s scientific co-coordinator, giving support to Dr Joan Genescà. He is part of the VHIR team.
How and why did you become involved in EU-PEARL?
I have been passionately engaged in research ever since the early stages of my career combining my work as a clinician with translational research from experimental models to clinical trials. As an epidemiologist, I focus on social determinants of health and health systems. When I had the chance to join the VHIR team in Barcelona and contribute to EU-PEARL, I did not hesitate since I immediately understood the ambition and potential of the project to comprehensively change an important share of the research landscape.
What is your role in the project?
My main focus in EU-PEARL is to help construct the clinical network that will serve as the basis to set up future platform trials within an integrated research platform (IRP). I also participate in other areas that relate to the project’s aim and sustainability such as methodological aspects and legal and regulatory perspectives.
You have lived the COVID-19 crisis in the first line working as an infectious diseases specialist. Can you describe your experience?
Similar to many of my fellow health professionals, merging the clinical and epidemiological perspectives has been challenging for me. As a clinician you focus on providing the best treatment option to patients admitted to the hospital. But as an epidemiologist, you need to think collectively and in potential future scenarios. One perspective projects you towards the future, to anticipate and prevent, whereas the other attaches you to the immediate present, and comes with other type of concerns such as the availability of respirators or efficacious drugs. These are hard-to-merge perspectives.
And at a more personal level, how have you confronted this crisis?
I honestly do not have a heroic vision of the health professionals’ role during the crisis. It is our duty, and we do it gladly. It is true that being in constant contact with COVID-19 entails a risk, also for your house partners and relatives. My wife and I are physicians. We rented an apartment and left our home more than seven weeks ago to avoid infecting our family. We have seen them seldom since then.
On the other hand, I have witnessed enthusiasm, adaptiveness capabilities, solidarity and kindness among colleagues, patients and families that I had not felt during recent years. When this emergency ends, we should, as a society, make a thorough and honest analysis of the lessons that the COVID-19 pandemic is giving. We need systemic approaches. I sincerely believe that the framework EU-PEARL is building can help us to better understand what is happening in the realm of clinical research during this pandemic.
It appears that this experience has, somehow, affected your vision of EU-PEARL.
Indeed. It has made me even more conscious of the relevance of our EU-PEARL mission. Generating scientific evidence and bringing necessary tools to patients and society should not be done through uncoordinated, overlapping efforts. The scientific production since the SARS-CoV-2 outbreak in Wuhan is probably without precedent and has provided key insights in a variety of aspects of COVID-19 and launched hundreds of trials, with initiatives such as the WHO SOLIDARITY trial to be complemented. However, low-quality reports, repeated studies often addressing low-relevance aspects of the pandemic and lack of joint funding and shared databases have also been a common pattern. EU-PEARL represents a coordinated effort encompassing a large number of entities from both the academic and private sectors to provide integrated solutions. I am positive this framework can be used to address urgent and emergent health issues.
What other shortcomings has COVID-19 highlighted?
To the best of my knowledge the patient-centricity aspect has been neglected during the past few months to focus on efficiency and rapid responses in COVID-19 clinical studies. This emphasizes the need for clinical and data networks that provide fast-track solutions without leaving behind relevant aspects concerning patients.
Any other learnings from the response to COVID-19 that EU-PEARL may contribute to address?
A crucial one: even those COVID-19 trials launched with a platform-based methodology, lack key aspects that EU-PEARL will provide. This shows that an IRP should go beyond the methodologically oriented definitions of platform trials to provide much more than a master protocol. Aspects such as shared and federated databases, integrated analysis, patient engagement, a clear and pre-settled legal framework and regulatory principles are fundamental to carry out “rapid clinical research”. Especially during public health emergences, we need clinical trials to be more efficient and ethically and methodologically sound, therefore largely increasing the societal impact.
In the long run, what do you expect EU-PEARL’s overall impact to be?
EU-PEARL has the potential to revolutionize how clinical research, particularly in the clinical trials domain, is performed in Europe and hopefully elsewhere. However, as in other fields, changes are generally gradual and cumulative. We expect that once EU-PEARL concludes, large research institutions in Europe will have started leaving behind dichotomies such as academic versus industry trials, investigator-driven versus cohort studies, and local versus national versus European funding of trials. In addition, by this time, we expect institutions will have initiated a transition to an era in which regulatory frameworks, shared scientific merits, funding entities, and intellectual property regulations favour a more integrated approach.
One last thought that you would like to share.
I would like to witness how, encouraged by EU-PEARL achievements, regulatory agencies and funding bodies get aligned in order to put individual researchers’ scientific ambition and companies search for profit—which is legitimate and necessary– in the background to prioritize joint, rapid and effective ways of bringing solutions to patients and to the society in general. EU-PEARL is designed to help enable this through the design and build up of the necessary frameworks, networks and practices so that we are better prepared to rapidly implement research and obtain useful evidence in the context of pandemics and other emerging health issues.