In a new installment of the informative series Beyond the Tumor: Answering Questions About Ovarian and Breast Cancer, professionals from IVOQA and AMOH Asociación address essential topics for patients and their families.
On this occasion, Mercedes Ortíz, PhD, specialist in Coordination and Management of Clinical Research Projects, clearly and accessibly explains what a clinical trial is and why it is essential for the development of new cancer treatments.
These studies represent a key pathway for innovation in oncology, allowing access to emerging therapies within a safe and controlled environment.
What is a clinical trial?
A clinical trial is a medical research study designed to evaluate the safety and efficacy of new treatments, drugs, devices, or therapeutic strategies. These studies follow strict protocols and are regulated by national and international organizations to ensure participant protection.
In the field of oncology, clinical trials are essential to validate advances in immunotherapy, targeted therapies, biomarkers, and personalized treatments.
Why are clinical trials important in oncology?
Clinical trials make it possible to:
• Gain access to innovative treatments before they become widely available.
• Scientifically validate new therapies that can improve patients’ survival and quality of life.
• Contribute to medical knowledge and the improvement of treatment standards.
They also represent an opportunity for patients to take an active role in cancer research, helping future generations access more effective and less toxic therapies.
How is a clinical trial developed?
Mercedes Ortíz describes the phases of a clinical trial as follows:
- Phase I: Evaluates safety and appropriate dosage.
- Phase II: Analyzes preliminary efficacy and side effects.
- Phase III: Compares the new treatment with the current standard of care.
- Phase IV: Monitors long-term effects after approval.
Each phase has specific objectives and is carried out under strict ethical and scientific control, ensuring participant protection and reliable data.
Ortíz also highlights the active role of patients in these studies, as well as the importance of informed consent. The decision to participate should be made with guidance from the medical team, considering both potential benefits and associated risks.
Informed and Safe Participation
Participation in a clinical trial is always voluntary and backed by ethical committees and safety protocols.
Patients receive detailed information about the study’s goals, possible benefits and risks, and can withdraw at any time. This process guarantees respect for the patient’s autonomy, in line with the principles of medical bioethics.