Ana García: "the biggest challenge I am in is coordinating European clinical trials"

• The IDIAPJGol has the Drug Studies Unit as a management service for multicenter clinical trials that directly supports the conduct of these studies. What does this job consist of?

Clinical trials and other types of research, prospective observational for example, that involve the active inclusion of patients are studies that tend to be multicenter, especially in the field of primary care. As it is carried out simulantly in several health centers, the complexity of the care management increases. One of the services offered by the Drug Studies Unit is support for researchers in carrying out this type of research.

 

 

Our work ensures compliance with legal requirements and good clinical practice throughout the development of the study. We also organize and manage its performance, that is, planning, search for centers and researchers (together with AGICAP), presentation and follow-up of the study to all participating centers so that all participating researchers in case of any problem, statistical analysis and writing final report,… It is very difficult to try to summarize the tasks we carry out in this regard, but the idea would be that we take care of the daily management of the trial and the research team takes care of what it likes the most, research.

In addition, the IDIAPJGol Drug Studies Unit is part, from the beginning, of the different independent clinical research platforms funded by the Carlos III Health Institute. First CAIBER, currently SCReN, and recently we were informed that we had also entered the new independent research platform, which will now begin in 2021. These platforms promote independent clinical trials throughout the Spanish state, and the institutes that we are part of share procedures and collaborate in the different trials that they do in various communities.

• Why is conducting clinical trials in primary care important?

Carrying out clinical trials in primary care is very complex due to its dispersion and the fact that you normally need a high number of patients and many centers involved in the study. Even so, it is essential to conduct research in this area, since primary care is where most of the most common diseases are treated. Any small improvement in the treatment of any of these pathologies has a direct impact on the population.

• Who would you say are the most important points to guarantee a high participation of centers and professionals who frequently recruit patients?

Take the best point of view, the most important thing is that the objective of the assaig doni responds to a who is filled with professional pels in the seva daily assistance practice. It is also necessary that the logistics of the study be adapted to the reality of the primary care, and that the patient follow-up procedures follow as soon as possible. The key is to find the balance between the volume of data that is to be collected and the simplicity of design. It is to say, demand allò that it really is essential and more. As you increase the complexity, you decrease the success in the rate of recruitment and in the correct follow-up of the patients.

• What would you say are the key points to guarantee a high participation of centers and professionals who want to recruit patients?

From my point of view, the most important thing is that the objective of the essay is to answer a question relevant to professionals in their daily healthcare practice. It is also necessary that the logistics of the study be adapted to the reality of primary care, and that the patient follow-up procedures be as simple as possible. The key is to find the balance between the volume of data to be collected and the simplicity of the design. In other words, ask for everything that is really essential and nothing more. As you increase the complexity, you decrease the success in the recruitment rhythm and in the correct follow-up of the patients.

• What would you say are the key points to ensure high patient participation?

The key point is that participating investigators believe in the aim of the trial and convey this importance to their patients. Patients generally want to collaborate in research, although we return to the importance of a simple study design. The more follow-up visits, more tests, and more questionnaires the patient has to take, the more reluctance they will have to participate in the trial. In this sense, in recent years we have been pursuing the active involvement of patients in the design of the study so that it also answers their concerns. The qualitative team at IDIAP has given us a lot of support in this regard.

• Apart from the experience in patient recruitment, it is also very important to comply with the different legal or ethical requirements. What steps do you have to follow to start a trial?

Clinical trials with medicines and health products are regulated by specific legislation at the European level and at the state level. It must be borne in mind that the medication used in the trials, even if it is commercialized, has to follow the circuit and the medication requirements of a clinical trial.

 

Before starting a clinical trial with medicines or health products, you must have the authorization of the Spanish Agency for Medicine and Health Products (AEMPS) and the favorable opinion of the Ethical Committee for Research with Medicines (CEIM). In addition, a clinical trial contact and insurance policy for the trial must be signed.

 

To obtain these authorizations, you must follow the procedure established by the AEMPS, which includes completing the European clinical trial form, preparing all the documentation related to the drug, drafting the protocol following the recommended points for the ICH E6 Good Clinical Practice guide ... Also, the way to present these studies for authorization is different, using the telematics platform enabled by the AEMPS.

Once the authorization is obtained, both the AEMPS and the CEIm will have to continue to be periodically informed of the evolution of the test, as well as of certain specific events.

• What challenges have you encountered during these years?

The truth is that many, and I hope to find even more. Each new trial, whatever it may be, is a challenge, whether we are the coordinators, where or we have to raise everything, or we are collaborators of trials promoted by other institutions, where we have to adapt the study to our reality. In recent years I would highlight the participation in European clinical trials, where the degree of adaptation of the study is higher, since the design comes directly from the reality of another country. And the biggest challenge I am currently in, which is the coordination of the management of these European clinical trials.