Four out of every ten clinical trials carried out in Spain are in the field of oncology; in 2025 alone, a total of 378 cancer trials were authorised in our country, which holds a leading position in clinical research, albeit one that is not without its challenges

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Research into medical oncology in our country is “one of the great strengths of our healthcare system”, according to Dr Javier de Castro, president of the Spanish Society of Medical Oncology (SEOM), speaking to ConSalud.es. In 2024, according to data from the Spanish Agency for Medicines and Health Products (AEMPS), 930 clinical trials were authorised, of which 39 per cent were in the field of medical oncology. In 2025, the figure rose to 962, of which 378 (40 per cent) were dedicated to cancer.

As these figures show, Spain ranked as the leader in the European Union, reflecting its “exceptionally significant” position. As Dr De Castro points out, this is all due to the quality of the professionals and hospitals, the highly competitive clinical research units, patient participation, the efficiency of administrative procedures by regulatory bodies, and the work carried out over decades by Spanish cooperative cancer research groups.

Patient participation is one of the essential pillars for the development of clinical trials. Although it is associated with the idea of finding treatments for patients with no other therapeutic options, it is not the only option available. “There are increasingly more trials in the earlier stages of the disease, including treatments before or after surgery, maintenance strategies or even prevention.”

“The idea that taking part in a cancer trial involves the risk of ‘not receiving treatment’ is, broadly speaking, mistaken”

This offers the opportunity to access innovative treatment strategies “before they become part of standard clinical practice”. However, the expert stresses the importance of bearing in mind that taking part in a trial does not guarantee that the new treatment will be better. “An experimental treatment may prove to be more effective, equally effective or less effective than the standard treatment, and may have side effects and toxicities that we do not yet fully understand. It is precisely to answer these questions that the trial is being conducted.” This is a process that various patients have gone through throughout history, enabling us to have what we now consider to be standard treatments. It is a stage in the research process that may cause some concern for patients and their families.

TAKING PART IN A CLINICAL TRIAL
One of the fears patients have before joining a cancer clinical trial is that they will be treated like ‘guinea pigs’ or will not receive any treatment during the trial. However, these processes are closely monitored and controlled, with the patient at the centre, and involve preliminary checks and assessments to ensure their safety and wellbeing, as well as personalised care. “Informed consent is not simply a matter of signing a document, but a process during which the patient must have all the necessary information to make a decision and is able to raise any concerns they may have. Furthermore, they can withdraw their consent at a later date without losing their right to receive the best available care,” explains Dr De Castro.

There are different types of clinical trials: double-blind, placebo-controlled or treatment-controlled. Sometimes, due to a lack of knowledge, the fear amongst the family and friends of a cancer patient is that, if they join a clinical trial, they might be assigned to the placebo group. “The idea that joining a cancer trial involves running the risk of ‘not receiving treatment’ is, generally speaking, mistaken,” reassures the oncologist. At present, placebos play a very limited role in oncology. “From an ethical point of view, a patient should not be deprived of an effective treatment needed to control their cancer simply to be given a placebo,” points out the president of the SEOM, who adds that it is generally “more appropriate” to use a standard of care as a comparator.

Thus, the placebo is only used in certain clinical trial designs, such as when a new drug is added to a standard treatment received by all patients: “One group receives standard treatment plus the new drug, and another receives standard treatment plus a placebo.” “It can also be used in certain maintenance or adjuvant settings, provided that this does not involve depriving the patient of a necessary therapy,” emphasises Dr De Castro. Added to all this is the advent of artificial intelligence, which will enable “the introduction of highly useful tools such as large-scale and more in-depth data analysis, simulation models and so-called ‘digital twins’ that can estimate the control groups for trials without the need to include patients in them”.

“Our aim must be to ensure that a patient can access a suitable clinical trial even if it is not being conducted at their hospital”

When faced with terms such as ‘randomised’, ‘experimental’ or ‘placebo’, patients often feel concerned; hence the importance of the healthcare team providing information and maintaining good communication with the patient. “The patient must understand why the trial is being offered to them, what alternatives are available outside the trial, what is known about the experimental treatment, what uncertainties exist, what adverse effects may occur, and what participation entails in terms of visits and tests.” And it is precisely because of this communication and information that many patients feel confident enough to take the step of participating in clinical trials, making Spain a leader in research. A leadership role which, however, is not sufficient to bring innovation into clinical practice.

CHALLENGES IN CLINICAL TRIALS
As Dr Javier De Castro points out, access to clinical trials is uneven: “They tend to be concentrated in hospitals with large research units.” “Our aim must be to ensure that a patient can gain access to a suitable trial even if it is not being conducted at their own hospital.” To achieve this, the expert points out, it is necessary to improve the information available on active trials, make it easier to identify potential candidates, and establish streamlined referral pathways between centres. “We must also promote academic and independent research,” he adds, “we need sufficient resources so that our collaborative groups can also address scientific questions that are not always a priority for research funded by the pharmaceutical industry, but which may have clinical relevance in terms of gaining a better understanding of the disease or attempting to answer outstanding questions, for example in patient populations that are under-represented in clinical trials”.

“Research is one of the ways we can improve care for our patients today and, at the same time, change the reality for the patients we will diagnose tomorrow”

Another challenge is that, although Spain plays a significant role in the clinical development of a medicine and helps to generate the evidence leading to its subsequent approval by medicines regulatory agencies, treatments take a long time to become available in Spain. According to the latest Patients W.A.I.T. (Waiting to Access Innovative Therapies) report, between 2021 and 2024 patients waited 627 days for anti-cancer drugs to become available. During this period, 73 per cent of the drugs approved in Europe were available in Spain. “Innovation only makes sense when it reaches the patient as soon as possible,” points out Dr De Castro.

As both professionals and patients have been calling for over the years, Spain needs streamlined and predictable assessment and funding procedures. “At SEOM, we believe we must minimise the time between the demonstration of a relevant clinical benefit, regulatory authorisation and patients’ effective access, whilst ensuring a rigorous assessment of efficacy, safety, value and sustainability,” emphasises the society’s president. “We must also uphold equity. Once an innovation is funded and incorporated into the National Health System, access to it should be provided uniformly,” he adds.

Access to innovation, the participation of under-represented populations in clinical trials, research outside major hospitals and academic research are the major challenges currently facing our country in the field of research at a time when precision medicine, immunotherapy, antibody-drug conjugates, cell therapies, new targeted drugs and the identification of resistance mechanisms “are changing the way we research and treat cancer”. “Research is one of the ways we have to improve care for our patients today and, at the same time, change the reality for the patients we will diagnose tomorrow,” concludes Dr De Castro.