Clinical trials are research studies conducted in people. They are used to see how a new treatment for a disease works in a safe and controlled environment. Trials help determine the efficacy of the treatment, define which dose provides the maximum benefit to the patient and determine if there are any adverse effects.
Clinical trials are an essential part of our health system. They make it possible to find safer and/or more effective treatments than those already approved.
If we think about all the medicines we have now, they can be prescribed because they were approved in clinical trials with patients in the past.
The final decision to enroll in a clinical trial is up to the patient, but it is important that you let the medical team treating you guide you.
Some of the benefits of enrolling in a clinical trial are:
Investigators test a new medicine or treatment in a small group of people (20-80) for the first time. Phase 1 trials assess the safety, determine a safe dose range and identify any side effects of the new treatment.
In Phase 2 studies, the study treatment is given to a larger group of people (100-300). Their objective is to find the most effective dose and keep evaluating its safety.
In Phase 3 studies, the study drug or treatment is given to large groups of people (1000-3000). Phase 2 studies work to confirm a treatment´s efficacy, monitor its side effects, compare it to commonly used treatments and gather information that would allow the treatment to be used safely.
In Phase 4, the study analyzes real-world experience over a long period of time and generates additional information about the risks, benefits and optimal use of the medicine.
Cancer clinical trials can be classified into different types according to their purpose:
Treatment Trials. Treatment trials are designed to find new treatments that are better than existing treatments.
Screening Trials. Screening trials are used to evaluate new diagnostic processes for detecting diseases.
Prevention Trials. Prevention trials are used in people who do not yet have cancer, but who are at high risk of cancer, to try to prevent the onset of the disease.
Quality of Life Trials. Quality of Life trials are aimed at improving the ability to enjoy normal life activities of patients who are receiving a certain treatment. The purpose of these studies is to reduce the side effects of treatments.
The decision to enroll in a clinical trial is always voluntary and is up to the patient. It is important that you understand that this is true at any time during the trial. If, for any reason, you decide that you no longer want to participate in the trial, you can always leave it. However, it is very important that you follow the advice of the doctors who are experts in the treatment.
All information regarding the clinical trial in which you are going to enroll will be shared with you transparently by the study doctor. The study doctor is available to answer any questions you may have.
To enroll in a clinical trial, you must meet a number of specific inclusion and exclusion criteria. Inclusion criteria are all those characteristics that make a patient eligible for the study. Exclusion criteria are those characteristics that would prevent a patient from enrolling in the study. These include characteristics such as sex, age range, having a certain type of disease, etc.
Screening consists of a series of tests performed before starting the study to ensure that the patient meets all the established criteria.
Informed Consent is the process of guaranteeing that the clinical trial participant is aware of his/her rights and understands his/her commitment to the study.
Once the screening phase has been completed, the patient meets with a member of the research team in charge of providing all the information he/she needs, answering his/her questions, etc.
At this meeting, the patient is given the Informed Consent Form. The Informed Consent Form describes the purpose, duration, tests, benefits and risks of the clinical trial, as well as information on study funding, sponsors and other relevant information.
By signing the Informed Consent Form, the patient confirms that he/she understands the trial and wishes to enroll. However, the patient still has the right to withdraw from the trial at any time.