Clinical trials are essential for the incorporation of new medicines into the health system, but they also grant other benefits that, if less obvious, could be overlooked. These types of studies mean that many patients have access to innovative therapies early and, for hospital centers, hosting them means significant cost savings.
In 2018, 800 clinical trials were authorized in our country, of which more than 600 were commercial clinical trials. In addition, according to Farmaindustria, 8 out of 10 of them are promoted by the pharmaceutical industry, which currently invests 662 million euros a year -only in Spain- in clinical research, which accounts for more than half of the total allocated to R&D in the Spanish biomedical industry.
It should be noted that 52% of clinical trials promoted by the pharmaceutical industry correspond to the early stages of the research, that is, those stages in which the safety, dose and side effects of the treatment are tested. These phases are the most complex and the most relevant for the evaluation of medications.
If the total number of clinical trials has suffered a slight increase in recent years, those that are in the early stages of the investigation have increased by 41% since 2004. From Farmaindustria, an association that hosts the majority of pharmaceutical laboratories established in Spain , point out as one of the causes of this increase the entry into force of the Royal Decree of Clinical Trials in 2016, a measure that improved the conditions of the investigations and that has allowed, for example, to reduce by two months the time it takes for the trials to take in getting going.
The general increase in the number of trials and the greater facilities to implement them is the result of at least a decade of effort on the part of the country’s industry, which confirms a positive trend “that explains how Spain has managed to position itself in the last years as one of the most attractive European countries when it comes to attracting investments in clinical research, ”explains Amelia Martín Uranga, head of the Innovative Pharmaceutical Industry Platform.
Patients are the first beneficiaries of conducting clinical trials, as they are considered as an opportunity to access prematurely to treatments that would otherwise take years to reach the health system. Even in some extreme cases, such as in rare diseases (which lack treatment or alternative medication), these studies may be essential for survival.
It will be the doctors and specialists who inform their patients of the existence of a clinical trial from which they could benefit, taking into account each pathology and factors such as age, sex or previous illnesses, but it will always be the patients who voluntarily access the study, which may leave at any time if they wish. Even so, it should be remembered that the trials are closely monitored by a medical team, are carried out in hospitals or specialized centers and, most importantly, before doing the first tests with real patients, the treatments have passed strict evaluations according to the current legislation.
In this way, clinical trials have a direct impact on public health, since they are a mandatory condition for the approval of new treatments by the health authorities and for the investigations carried out to have a real application in future patients.
The economic one is another of the factors to highlight among the benefits that the realization of clinical trials can bring: they generate savings and attract investments to the health centers. Hospitals provide the necessary facilities and infrastructures, but patients undergoing treatment in a clinical trial have zero cost to the center that hosts it, since the company in charge of the study will bear the expenses such as personnel or materials.
In the last ten years eight economic studies have been carried out in several hospitals of the Spanish geography to verify the economic impact of these studies in each center. Although without making a global calculation in Spanish health, they demonstrate with specific cases that there is a great saving.
In Distefar we totally agree that thanks to clinical trials, costs are saved for the system and they are also innovative therapies for clients.