Clinical trials that bring the drugs of the future closer to today's patient

For many patients, clinical trials are a lifeline, the way they can benefit from future treatments or drugs that will take years to be available in hospitals.

In addition, Spain is a benchmark in this field, both at European and global level.

, followed by trials for Covid-19.

"In terms of clinical trials in hematoncology, Spain is the second country in the world, behind the US, for its ability to attract studies and participation in them," explains Aleix Prat, head of the Oncology Service at Hospital Clínic de Barcelona and president of the Solti Group.

Although

, the same does not occur with funding and academic interest.

"In an analysis carried out by the Spanish Association for Cancer Research, this weakness in our research system was revealed. Probably the determining factor is the limited availability of public funding", underlines Luis Paz-Ares, head of the Cancer Service. Medical Oncology of the Hospital Universitario 12 de Octubre, Madrid.

Another problem is that, in addition to being scarce, this financing is used for major pathologies, leaving aside minority ones.

More options for the current patient

The incorporation of new drugs and the way to access these innovative treatments, years before they become a healthcare reality approved by the authorities, is through clinical studies

that, moreover, not only provide innovation in the therapeutic field, but also in areas such as diagnosis and

.

Since the essential objective is to demonstrate what is going to be the best treatment for tomorrow, the fundamental beneficiary will be the future patient, but it represents an additional opportunity for the current patient.

"In the main hospitals it is part of our day to day.

", underlines Prat. He also points out that whenever they have the possibility, they try to establish a study, because thanks to clinical research, in the field of oncology, many advances have been made. In addition, every time a new This new treatment does not mean that it is a substitute for the existing strategy, but rather that it is added to the range of options with which to treat a patient, "like one more bullet in the chamber", adds Paz-Ares.

shorten times

The duration or the time that passed from the beginning of a clinical trial until the treatment was part of the portfolio of services, has been shortening

.

For example, several of the trials in which Ricard Mesía, president of the Spanish Group for the Treatment of Head and Neck Tumors (TTCC), has participated, in a matter of seven years, the drugs with which he was investigating have become part of standard treatments.

"Before, it took a measurement of ten years. At the moment, many researchers work in the head and neck area, something that also has an influence. When I started, 25 years ago, we did not reach 25 researchers worldwide; now we are thousands ", Mesia highlights.

In addition, efforts were previously devoted to the most prevalent cancers, while now clinical trials are also being carried out to search for new lines of treatment for lesser-known tumors.

Survival thanks to immunotherapy and genomics

Cancer continues to be one of the leading causes of death, both in men and women; still remains to be done in terms of prognosis.

; something that will only be possible thanks to diagnostic and therapeutic innovation. In cancers such as breast, lung, prostate, skin or neurological, much progress has been made thanks to the irruption of immunotherapy. "Although in the case of the most prevalent such as the colon, pancreas or gastric, there is a long way to go. There are advances, but they are small," says Prat.

"When I started, approximately 30 years ago, the five-year survival rate did not reach 35% and today we are almost at 60% in men and, above, in the case of women. This implies that it has There has been a lot of progress in most tumors, particularly in the breast and colon," says Paz-Ares.

Although

.

And also to the change of concept that the field of oncology is experiencing.

Cancer is beginning to be approached by its biology and specific alterations, instead of by the organ where it originates.

A line of research that many studies follow, explains Prat, with drugs directed at a specific mutation.

The aim is to discover the molecular mechanism by which the tumor progresses and to inhibit it.

Another line of research is immunotherapy, the development of new drugs that allow our own defenses to attack the tumor.

"Probably in the future we will combine these lines of action, discover the molecular mechanism of the tumor and at the same time better develop new drugs", details the president of the TTCC.

Chronicize metastatic cancer

A large number of clinical studies are focused on early cancer,

a type located in the area of ​​origin of the tumor.

"In these cases, the therapeutic strategy is to cure the patients, increasing their survival and preventing them from reappearing and metastasizing", the doctor points out.

Importance is also given to toxicity, trying to develop more targeted drugs with fewer side effects, to avoid overtreating the tumor.

In advanced cancer, the lines of research are not focused on curing, but on making the disease chronic

to allow the patient to live for many years living with the disease.

The ideal would be to eradicate the patient's disease, a complicated scenario in the case of advanced cancers.

"For this reason, we try to prolong survival as much as possible and that the patient is as good as possible during that time," insists Paz-Ares.

In little more than a decade, in cases of metastatic melanomas, the average survival rate has risen.

Patients who did not live beyond two years, today exceed five years.

Paz-Ares participated in a study that was carried out in one of the lung cancer groups with the worst prognosis, patients with metastatic squamous cell lung cancer, a population with high morbidity. Adding an immunotherapy strategy with pembrolizumab, together with classical chemotherapy treatment, proved to have a high impact on the evolution of patients. They live longer and live better, with a tolerable cost of side effects.

Not all hospitals have clinical trials, something that limits the number of patients who can access them

.

Although they move, the treatments, analyzes and tests require a periodicity that is not always affordable.

For example, Prat explains how the study itself could finance travel, as a solution.

What is working is the creation of a network of hospitals, with large and small centers, well connected to each other.

It is key that oncologists from smaller hospitals have all the information on clinical trials available in other centers, in order to be able to propose them to their patients.

"Although these patients are coming more and more informed to the consultation. It is a cultural change; in areas such as breast cancer, patients are usually very proactive, something that is promoted by the powerful associations that exist," says the head of the Oncology Service of the Hospital Clinic.

Public-private collaboration

Most clinical studies are promoted by the pharmaceutical industry, about 80%.

"Thanks to this investment, we are managing to change the course of many diseases in a favorable way

. For example, from academic groups such as Solti, we design our own studies that end up being financed in this way. The objective of the study, as defined by the group , seeks answers to relevant clinical questions that do not have to be of great interest to the pharmaceutical industry, but to oncologists", Prat points out.

However, there is something that both he and various specialists are missing:

There are calls, but few and very limited. There is a lack of long-term vision, since the studies can take from three to ten years," says Prat.

"Sometimes, these three agents may have a common goal, with the pharmaceutical industry providing the funding; the public sector, the resources, and even academic groups could define the study", adds the researcher.

The ideal would be a public-private partnership.

In Spain, according to Paz-Ares, the cooperative research groups are a little different from those of other countries.

"These are usually based on a public initiative and, therefore, have some tutelage and supervision by public bodies, but above all, they have public funding. In Spain, these groups have many difficulties in accessing this type of sponsorship" , highlights Paz-Ares.

"Depending on the private sector, it will not always be possible to answer questions without commercial interest in clinical trials," she says.

THE PHARMACEUTICAL INDUSTRY DEVELOPS MORE THAN 1,300 TREATMENTS AGAINST CANCER

According to the annual reports offered by the European (EMA) and US (FDA) regulatory agencies, approximately a third of the approvals of new drugs in 2020 were for treatments against some type of tumor.

In addition, and despite the pandemic, the number of clinical trials in oncology started last year was 60% higher than those started six years ago, as reported by Farmaindustria.

Today, the pharmaceutical industry has more than 1,360 cancer treatments in development.

Of these, 145 are for various types of leukemia;

141 for lung cancer, one of the tumors with the highest mortality rates;

129 for lymphoma, including non-Hodgkin's lymphoma, which represents almost 5% of all new diagnoses;

108 for breast cancer, the most frequent tumor in women;

85 for prostate cancer;

72 for multiple myeloma, or the 67 for brain tumors, including gliomas, which represent about 33% of those in their class.

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