Clinical trials are studies conducted with a group of both healthy individuals and cancer patients that allow gathering information about how the body reacts to certain treatments or to the development of the disease itself based on different parameters.
They are designed by expert researchers and scientists in the diagnosis and treatment of cancer patients and undergo strict evaluation and approval protocols and requirements by regulatory agencies at national, European, and global levels, as well as research ethics committees, before they can be carried out.
The safety/toxicity (side effects) of participants in trials is the criterion that always prevails, as well as their freedom to participate in the trial and withdraw whenever they wish, without this affecting their subsequent medical care.
Clinical Trials: Phases
A new treatment goes through several phases, and each of these phases has a different purpose:
- Phase I Trials: study whether a new treatment is safe and seek the best way to administer the treatment. Physicians also look for signs that the cancer responds to the new treatment.
- Phase II Trials: study whether a type of cancer responds to the new treatment.
- Phase III Trials: study whether a new treatment is better than a standard treatment.
- Phase IV Trials: find more information about long-term benefits and side effects.
Participation and Benefits of Clinical Trials
Typically, all individuals who meet a series of inclusion and exclusion criteria according to the medical conditions determined by the physician investigators participate in clinical trials.
There are several benefits for patients who participate in clinical trials, such as having the opportunity to help society and other people with the same condition, contributing to medical research and a deeper understanding of the disease. Additionally, they allow access to experimental treatments or medications for patients who lack other treatment alternatives or receive personalized medical follow-up throughout the development of the clinical trial in which they participate.
Clinical trials are of vital importance for science to advance. They allow us to implement, develop, test, and validate different work protocols to improve the selection of individual patients who are candidates for targeted therapies in phase I clinical trials.
They also aim to improve the panel of genes, biomarkers, indicators, etc., that allow us to better diagnose, classify, and select patients for certain therapies, anticipate who will respond or who may experience relapses and when, etc., thus creating a vast knowledge library.
FERO and Its Commitment to Clinical Trials
The entry point for clinical trials is diagnostic units such as those we fund at FERO Foundation. At FERO, we believe in the importance of the best possible identification of mutations in order to refer patients to the correct clinical trials that can save their lives. These are units where samples from patients, in many cases candidates for entering these clinical trials, are analyzed with the purpose of identifying mutations, alterations, or other indicators that allow us a better diagnosis and support the decision of knowing what the best treatment is for their cancer. This treatment may be an already approved drug (from the multiple targeted therapies already on the market) or open the door to being included in a specific clinical trial for the identified alteration.
These precision medicine units that FERO Foundation funds are located at INCLIVA (Hospital Clínico de Valencia), Hospital Vall d’Hebron, and Hospital Clínic de Barcelona.
Paloma Díez de Madrid, an Example of the Usefulness of Clinical Trials
Today we would like to share a good example. A lung cancer patient who is receiving an experimental treatment within a clinical trial at Hospital 12 de Octubre de Madrid.
Thanks to this clinical trial, she has had a chance for a cure and therefore hope. And this is only because research advances.
Paloma Díez de Madrid was diagnosed with stage IV lung adenocarcinoma at age 58. She tells us that when they informed her, it was difficult to accept. She felt uncertainty, fear, and helplessness.
Regarding her illness, she confesses that she has trusted the specialized medical staff from the first moment of diagnosis, with the greatest fortitude possible, counting, of course, on the support of her family and friends.
After a year and a half of treatment within this clinical trial,
what has helped her most is having confidence in the oncology team and feeling, from all the information provided by them, that she was receiving the best possible treatment for her situation.
Furthermore, seeing that she was responding well to treatment gave her the necessary confidence and peace of mind to get through each day.
She is currently participating in a phase II clinical trial. This is, for now, the only treatment she has received, since she was told it was the most appropriate therapeutic option for her disease.
Paloma expresses her enormous desire for this clinical trial to reach a successful conclusion so that other patients with the same diagnosis can benefit from it, just as she is benefiting today.
When we asked her whether she believes there is a need for greater awareness about cancer or whether society is already sufficiently aware of the disease, she tells us that she does believe there is awareness in society of the relevance of the disease, but at the same time lack of knowledge about how much treatments have advanced and research on it and what it means for the quality of life and life expectancy of patients who receive it.
Paloma emphatically insists that research is extremely important and must have all possible funding.
She states that she does not understand how at this point, with more and more cancer diagnoses, this is not absolutely clear.
She declares that from her point of view “we must promote and facilitate with professional and financial incentives for researchers to obtain more and better results. Our lives depend on it.”
Clinical trials expand the range of therapeutic options available to end cancer, being the only way to see that new drugs are truly effective in humans,
after having tested them in animal and cellular models. Having Phase I clinical trials, where a drug is tested for the first time in humans, provides new opportunities to patients who, like Paloma, without this option would have no possibility of cure, since there is no drug available today for their tumor.
At FERO Foundation, we want to thank Paloma for sharing her experience with us, and all patients who participate in clinical trials for their generosity.
We believe that a future without cancer is possible, and for this, the only answer is: research.
If you want to be part of the change and help us offer the best therapies and diagnostics to patients, join FERO! https://ferocancer.org/dona/