Participate

The purpose of a clinical trial is to determine whether the treatment, active ingredient, therapeutic protocol, technology, diagnostic method, or preventive action being investigated is safe and effective.

A clinical trial can also be designed to treat a pathology, find a method of early diagnosis, or identify preventive behaviors and models to avoid a certain health problem, even in healthy people.

Clinical trials are sometimes designed to alleviate side effects or improve a patient's quality of life in case there is no chance of a complete cure.

Clinical trials are reviewed, approved, and supervised by an independent committee formed by specialists who are not involved in the study. This group of professionals, also called an institutional review board or IRB, ensures that the study is conducted ethically and that the rights and well-being of participants are protected.

The protocol is a research plan that details the methodology with which the clinical trial will be conducted. This plan includes information about the profile of the members in the sample and the requirements that participants must meet. It also includes the schedules of tests and procedures, drugs to be used, dose and duration of the study, as well as the parameters to be measured. Each person participating in the study must agree with the indications established in the protocol.

Proving that a new drug or treatment is safe and effective, as well as identifying its potential risks and side effects, is a long process that can take several years to be approved by health authorities.

The treatments that are being tested must go through three phases before being approved, and a fourth phase, which is basically a follow-up of variable duration once the therapy is integrated into clinical practice in order to identify and monitor its effects on patients.

Phase I. The first phase in clinical trials is conducted with a small sample of between 20 and 80 participants. It is intended to test the safety, side effects, and therapeutic dosage of a certain drug or treatment. In this phase, the best administration route is also elucidated, as well as the dose considered safe.

Phase II. These are larger studies (between 100 to 300 participants) that still test the safety of the treatments, adding research into their efficacy. Generally, these studies are done by comparing the treatment being investigated with a placebo product or procedure (without therapeutic activity) to verify its actual effect.

Likewise, the 'double-blind' method is used to avoid biases and conditioned criteria. This way, neither the researchers nor the patients know whether they are taking the active ingredient under study or the placebo.

Phase III. These are studies with larger samples (hundreds or thousands of people) and longer duration. They are the step prior to their authorization by the health authorities and are carried out when a certain treatment has yielded promising results in Phase II, something that unfortunately does not always happen. These are usually 'double-blind' trials controlled with placebo in which participants agree to be randomly selected, i.e., they are randomly assigned to either the treatment group or the control group.

Phase IV. These types of clinical trials are carried out with drugs, treatments or medical devices that have already been approved by health authorities and have been used in clinical practice for some time. The purpose of this research is to determine its effectiveness and safety in large population groups with more diverse characteristics than those found in previous phases of a clinical trial.

Each clinical trial is designed with specific criteria about the health, pathologies, age, sex, evolution of the disease, medical histories and other medical conditions of the participants. They must fit the requirements of each particular trial in order to be voluntary candidates for the sample.

All those who have been selected to participate in a clinical trial should gather as much information as possible about the purpose and methodology of the trial. It is important that they share any doubts, fears or concerns they have with the healthcare professionals and ensure that they have a clear understanding of the procedures and medical care they will undergo throughout the trial, including both the benefits and advantages, and the potential risks arising from their participation.

No. Volunteers do not pay money to participate in a clinical trial. In fact, they are usually compensated for the time and travel expenses associated with the investigation.

This compensation is different in each clinical trial and is detailed in the informed consent that is provided before a volunteer formalizes the participation in the trial.

Advantages

To receive regular, careful medical care from a research team formed by doctors, nurses, and other health care professionals.

To help others who need treatment in the future by using the findings and conclusions observed during the research.

To contribute to the progress of science by encouraging scientists and physicians to learn more about the condition or disease for which the treatment is being tested.

Potential risks

Research is to solve doubts, ask questions and seek answers that are not known. In this way, it is possible that the treatment, active ingredient or technology under study turns out to be no better than what is already available in clinical practice. In addition, side effects or consequences that are not expected may also arise.

Participants will need to monitor certain parameters of their health, follow certain guidelines, meet certain requirements, and make more visits to the doctor than if they were not part of a trial sample.