The Role of Clinical Trials
Clinical Trials are one of the mandatory steps in medical and pharmaceutical development. They are studies involving people who receive new therapies. These studies are responsible for evaluating the safety, efficacy and utility of new technologies. They provide the database needed to formulate evidence-based therapeutic recommendations.
Eligibility Criteria
The rigorous definition of inclusion and exclusion criteria for a clinical condition and patient profile to be submitted to a clinical research protocol is vital for scientific validity and participant safety, ensuring research integrity and appropriate application of results.
Each clinical trial has specific inclusion and exclusion criteria, which may involve disease type, stage, age and prior treatments. Having a diagnosis does not guarantee eligibility for all clinical trials. The patient will be assessed by the clinical research team to verify whether their situation fits the study protocol.
What I need to know to participate in a clinical trial
Is my participation voluntary? Who protects my rights?
Participation in a clinical trial is always voluntary: you only enter the study if you wish and after receiving clear, understandable information. Even after signing the consent, you can change your mind and leave the trial at any time, without needing to justify the decision and without losing the right to the best available medical care. Before starting, each clinical trial is analysed and approved by an independent ethics committee and the competent regulatory authority.
Are there benefits to participating?
Participating in clinical trials may offer access to new treatments, without guarantee of individual benefit. The main benefit may be contributing to the advancement of new therapies, helping others in the future.
Will I have costs or receive payments?
Information about any costs, travel reimbursements or compensation must be explained before the patient decides to participate in the trial and must be stated in writing in the informed consent. Any financial support should only compensate study-related expenses, without making you feel pressured to participate for economic reasons.
What should I discuss with my doctor to help my decision?
Before deciding, it is important to talk with your attending physician about the benefits and risks of participating in a clinical trial, the treatment alternatives available outside the study and the practical impact of this choice on your daily life. You can bring a list of questions, such as: what are my other options, what happens if I don't participate, what tests will I need to undergo, how long does the study last and what will follow-up be like after the trial ends.
What happens if I decide to participate?
If you are considered potentially eligible for a clinical trial, the healthcare team will explain in detail the study's objective, procedures, duration, planned interventions and the treatments or comparators to be used. After clarifying all questions and choosing to participate, you will receive the Informed Consent Form, which must be read carefully and your signature will formalise your decision to participate in the study.
Phases of a Clinical Trial
Phase 1
Tests safety and dosage in a small group of people (20–80).
Phase 2
Expands the study to a larger group (100–300) to evaluate efficacy and safety.
Phase 3
Large-scale study (1,000–3,000) to confirm efficacy, monitor side effects and compare with standard treatments.
Phase 4
Post-approval studies to collect additional information about risks, benefits and optimal use.
Participating in a clinical trial is an important decision and should be made after receiving all information clearly and completely, with the support of your healthcare team and family members, always with full respect for your autonomy, your needs and your personal values.