For the last twenty years, you have combined clinical research, both within the industry and at an independent level, with teaching at UPF. Now you leave clinical research in the pharmaceutical industry to devote yourself to the creation of a Research Support Unit of Bellvitge University Hospital (HUB) and the coordination of IDIBELL’s Clinical Research. What is the reason behind this career move?
Actually, I feel this project is not new; it was born ten years ago. In 2007, when HUB’s pharmacology department was created, there was talk of creating a shared IDIBELL-HUB unit to promote translational research and clinical trials. It was a project in which I was involved, but unfortunately the financial crisis put a stop to a proposal on which we had already worked very hard. Now, with the development of a Clinical Research Support Unit, something very similar is proposed, so when they offered to lead the initiative, I said yes. It is a lovely project.
What are the main challenges of this new unit, then?
We aim to be a cross-support unit that makes clinical research (clinical trials and observational studies) easy for the researcher.
Nowadays, doing clinical research implies complying with a series of requirements that can take up to 80% of the researcher’s time. These requirements are necessary to ensure the quality of the research, but if we can free the researchers of this time investment, they can dedicate themselves to seeing patients, which is their primary task, and to be up to date, as experts, of the diseases they treat (studying, writing articles ...).
In addition to logistics, we would like to offer scientific and regulatory advice. Doctors always have good ideas or questions. In fact, good questions arise from daily contact with the patients, but doctors do not always have enough methodological / regulatory knowledge to carry out the studies that should answer their questions.
How does a clinical trial work?
Every clinical trial must have a promoter, which can be public or private. The promoter of a clinical study is responsible for supervising and guaranteeing the correct development of the study according to its protocol. This is a task that monitors develop on a practical level.
Generally speaking, in order to carry out this task private promoters hire “Contract Research Organizations” (CRO). As for independent studies, there is the SCReN platform (Spanish Clinical Research Network) of Carlos III Institute, which has created the well-known UICECs (Clinical Trial Clinical Research Units) to facilitate monitoring, pharmacovigilance, database creation, etc. of all the clinical trials of this platform.
The investigator of a clinical trial is responsible for including and monitoring those patients included in the study within the hospital. Likewise, he or she must guarantee that the study is carried out correctly within the hospital and in accordance with the protocol. Within the Clinical Research Support Unit, we will help the researcher to manage daily tasks in private clinical studies (in which the promoter is the pharmaceutical industry or specific groups like a scientific society, or a patient association) as well as independent clinical studies (promoted by the researcher / Hospital itself thanks to competitive funding, for instance).
So how will all this be carried out?
The Clinical Research Support Unit is a physical space located in the HUB where patients included in clinical trials can be checked (there will be 4 consultation offices) and the treatments under study can be administrated (in 2 additional rooms and a nursing station). In addition to that, there will be a space to store the study files, a meeting area for promoters with videoconferencing technology, and a space for the study coordinators, that is, the people who will act as the researcher's “right hand” at all times.
Study coordinators work for the researcher (not for the promoter) managing daily tasks related to the patients included in a clinical trial: they schedule appointments and tests, collect samples and process them for shipment to the corresponding laboratories, and enter data in the right data collection journal.
Furthermore, the Unit will also offer scientific, technical and regulatory advice to the researcher. We will help during protocol development (including statistical advice), the preparation of the financial report, the assessment of the requirements if the researcher and promoter are the same person, the preparation of the final report, publications, etc.
It is clear that the Support Unit can contribute a lot to clinical trials in terms of quality. What are the expectations in terms of quantity?
We know that units of this type currently in operation have reduced the number of errors, increasing the quality of studies de facto, and they have also increased the number of studies that arrive at the center. In some therapeutic areas, the number of trials is doubled in 2 or 3 years.
Most clinical trials have the industry as a promoter, and the industry values two things: the doctor and the center. A good research environment, such as the one generated by a Clinical Research Support Unit, can help a good researcher become a key opinion leader, a very sought-after profile. On the other hand, a well-organized center, with personnel exclusively dedicated to clinical research, will speed up the development of trial, making collaboration with the industry more efficient and generating interest from other promoters. If we know how to do it well, we will create a virtuous circle.
We are talking about clinical research, but ... what role does basic research play in all this?
Let's not forget that we have very good basic research at IDIBELL, and we believe that the Unit can become a magnificent meeting point between basic and clinical researchers for the development of translational projects. For example, a clinical trial, in which patient information is collected in a systematic way, can also be the "source" of a sample collection that can become very useful for the development of substudies at the basic level. If we are able to connect the different (basic and clinical) research groups and manage the relationship with all the actors involved, we can carry out many joint initiatives and obtain multiple benefits from a specific project.