Our country is one of the most attractive when it comes to attracting investments in clinical research, something that, according to Farmaindustria, an employer of the innovative pharmaceutical sector, recalls, benefits in several ways: clinical trials attract investment, generate reputation and allow early access to unauthorized techniques and medications.
None of this would happen without patients. End and beginning of the investigation, your participation in the trials is, however, at a time of change. The importance of this collaboration is summarized by Natacha Bolaños, regional coordinator in Europe for the Lymphoma Coalition , a global non-profit organization of groups of people with this type of cancer. ” Without the patient voluntarily entering a trial, clinical research would simply not be possible, ” says Bolaños. It is an act of generosity with many implications: vulnerability, uncertainty, extra burden of diagnostic tests …
Generally speaking, a trial is presented in the absence of treatment or if there is a suspicion of a therapy with a better outcome. Participating in one is not simple. Many factors have turned the recruitment of patients into a career with many obstacles. As a preliminary step to the approval of a drug, the regulation requires that the sample of patients in a trial (the N of the study) be representative of real life and have significant statistical value.
So far this scheme has worked, but it does not fit with the hyperspecialization of current research, which, since genomic sequencing exists , aims to treat any condition as if it were a rare disease. “For example, if you previously had x subtypes of lymphomas, now within a subtype you have multiple descriptions based on biomarkers, and this greatly complicates the research, because if you need to mark all these labels, you are reducing the number of patients to which it could reach ”, explains Bolaños.
Here comes the first problem. “Clinical trials have made little progress and have not taken into account the evolution in the treatment of the pathologies they address”, underlines Roberto Saldaña, from the European Academy of Patients (EUPATI), a training project aimed at increasing the capacity of patients to contribute to drug development.
Bureaucratic obstacles
But there are others. For example, the increasing bureaucratization of studies and the fact that not all schools participate in trials. ” It is rare that a patient who is being treated in a hospital where there are no trials is offered one, because it means moving him from hospital, city, province and even autonomous community ,” says Bolaños. In that case, there is nothing to do, unless the patient actively requests it or his doctor is very aware of the research. Issues like these, says Saldaña, sometimes mean that trials are not attractive to patients.
How to participate in a trial?
According to the European Academy of Patients, the first thing anyone interested in taking part in one should do is consult the Spanish Registry of Clinical Studies (REec) . Once the one that interests us the most is located, the ideal would be to contact the hospital or hospitals and patient associations to resolve possible doubts.
By: Carlos B. Rodríguez
