Ernest Vinyoles: "AGICAP offers speed, formality, and quality to clinical trial sponsors, which is why they choose us"

The coordinator of the Agency for the Management of Clinical Research in Primary Care (AGICAP), the IDIAPJGol network that manages clinical trials conducted in Primary Care in Catalonia, talks about this organization and the current situation of clinical studies

 

The Agency for the Management of Clinical Research in Primary Care (AGICAP) of IDIAPJGol is the network dedicated to the management and promotion of drug clinical trials in the primary care setting in Catalonia, and recently, in the Balearic Islands. With an agile operational model and a solid track record, AGICAP connects sponsors, researchers, and accredited centers to promote clinical studies that contribute to the development of new treatments. Currently, the network has almost 400 accredited researchers with experience conducting clinical trials.

Primary care physician and IDIAPJGol researcher Ernest Vinyoles has been coordinating the network since its inception in the early 2000s. We spoke with him to learn more about AGICAP and the state of clinical research in primary care.

 

What is AGICAP’s role in the context of clinical trials? What is its operational model?

We operate as a network and manage clinical trials that enable the development of new therapeutic solutions. The sponsor, which can be a pharmaceutical company, a scientific society, or even IDIAPJGol itself, contacts us to request researchers and accredited centers to carry out a clinical trial.

Is it mainly the pharmaceutical industry that makes these requests?

Yes, more than 90% of the requests come from companies in the pharmaceutical sector, which are the ones developing new drugs.

What are the next steps after receiving a proposal?

I receive the study protocol, assess whether it is feasible to carry it out in primary care, anonymize it, and summarize it into one or two pages, which I then share with the network members to see if anyone is interested in conducting it. I then send the list of candidates to the sponsor, who contacts them directly.

Subsequently, once the study is underway, AGICAP manages the contract and payments, so the researcher only needs to focus on recruiting participants and conducting the trial. We must do all this quickly. We have a very agile process and have managed to speed up contracts more than in other European countries.

This organization allows us to be a reference across Spain for conducting clinical trials, and we are highly regarded by sponsors worldwide.

What are the particularities of conducting clinical trials in primary care?

We mainly conduct phase III clinical trials, which verify the safety and efficacy of the drug, and some phase II trials, which analyze the product’s functioning. In the past, we conducted many phase IV studies to examine the long-term effects of drugs, but we no longer do as many.

Approximately 40% of the trials we conduct focus on cardiovascular pathology—diabetes, hypertension, lipids, antiplatelet agents, anticoagulation, and cardiovascular risk in general. There are also many studies on respiratory diseases, mainly asthma and COPD, pediatric vaccines, contraception, and gynecological pathology, which are conducted through the ASSIR (Sexual and Reproductive Health Care Centers). Finally, there’s a variety of clinical trials evaluating ointments, drops, or even nutritional products like yogurt. In general, we conduct studies that require little technology, where patients don’t need to spend many hours in the center.

How is product administration controlled in these trials?

Each study has its protocol, but periodic visits to the primary care center are usually conducted, lasting about half an hour to an hour.

What is the volume of activity at AGICAP?

We are currently compiling data for 2024. By December 2023, we had conducted nearly 500 drug trials. We usually have around 20 active trials and start 10 to 12 new studies each year, but this can vary significantly. For example, during the pandemic in 2020, and especially in 2021, this number doubled because everyone wanted to test things in Primary Care. Conversely, during the financial crisis from 2008 to 2013, activity significantly decreased.

Has there been an increase in the number of clinical trials in primary care after the pandemic?

Yes, we are still riding the momentum of the boom we experienced during those years. After the pandemic, sponsors may have realized the potential of primary care for conducting clinical trials, particularly in prevalent chronic diseases managed in primary care.

It seems that the industry is increasingly aware of primary care's capacity for conducting clinical trials.

Yes, the pharmaceutical industry demands speed, formality, and quality, and we provide all of this at AGICAP. If they continue to choose us, it’s because we do good work.

What aspects of clinical trial management could be improved?

We can reduce biases in selecting participants for a study. Typically, patients selected are those known to be compliant, who attend follow-up visits, take their medication, complete tests, and have a good relationship with their doctor. However, these patients aren’t representative of the overall patient population.

Currently, in primary care, we are beginning to conduct what are called pragmatic clinical trials, which aim to replicate clinical reality as closely as possible while maintaining safety criteria. This includes elderly patients or those with multiple pathologies who traditionally have not been included in studies but could benefit from research in this area.

Are professionals adequately trained to conduct clinical research?

In general, no. All AGICAP members are accredited to conduct clinical trials and have received the necessary training. It’s advisable for anyone interested in conducting trials to take AGICAP’s course, which accredits them as clinical trial investigators. This training goes beyond understanding clinical practice guidelines and includes aspects such as the role of the sponsor, the ethics committee, the monitor, and the investigators themselves. We also explain how to organize a primary care center to conduct clinical trials, which is important to know.

What challenges do primary care professionals face when conducting clinical trials?

The main challenge is the overwhelming workload. High motivation is also required because coordinating a clinical trial involves a lot of work—it’s like swimming against the current.

What future projects does AGICAP have?

The first is the constant renewal and rejuvenation of the network. Members who haven’t collaborated for a while are moved to a passive database, and new ones are added. The second project is the inclusion of new clinical trials to increase our visibility. One challenge is the high turnover in the industry’s departments—when we’ve established a contact, they often get replaced, and we have to start over.

What impact will the inclusion of researchers from the Balearic Islands have on the network?

We’ve had contact with researchers from the Balearic Islands for many years, have provided training, and maintained a relationship with them. Now we’re formalizing a collaboration agreement with the Health Research Institute of the Balearic Islands, allowing us to share information with primary care researchers interested in conducting clinical trials. The more members we have in AGICAP, the better.

That said, sponsors don’t always conduct studies where we’d like them to. Seventy percent of the network’s researchers are in the metropolitan area of Barcelona. However, in places like Reus and Tarragona, we have very strong research groups, as well as in other areas of Catalonia, and it’s challenging to convince sponsors to bring studies there.

AGICAP will participate in organizing the III Clinical Research in Primary Care Conference, scheduled for November 2025 in Barcelona. Do you have more information? What new developments will be presented?

We are still finalizing the program. This conference, organized with Farmaindustria, aims to promote clinical trials in primary care and brings together all the stakeholders involved: sponsors, the pharmaceutical industry, large companies, researchers, research institutes... It’s a meeting point for the sector.