Patients

The purpose of clinical trials is to find ways to more effectively and safely prevent, diagnose, or treat disease.

Many different types of people take part in clinical trials.

Some studies include healthy volunteers, while other studies include patient volunteers. Some studies include both healthy and patient volunteers.

Each study must include only people who meet the requirements for that study. These are the study's eligibility criteria, which determine who can participate in a clinical trial.

Any patient that voluntarily wishes to contribute to the clinical trial and that meet the eligibility criteria can participate in a clinical trial.

Eligibility criteria are different for each trial. They include whether you are a healthy or patient volunteer. They also include factors such as your age and sex, the type and stage of disease, and whether you have had certain treatments or have other health problems.

The criteria ensure that new approaches are tested on similar groups of people. This makes it clear to whom a clinical trial's results apply.

Eligibility criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe, and to help ensure that researchers can find the new information they need.

Clinical trials offer hope for many people, while giving researchers a chance to find treatments that could benefit patients in the future.

Healthy volunteers say they take part to help others and contribute in the advancement of science. People with an illness or disease may take part to help others, but also to have a chance to receive the newest treatment and get added care and attention from the clinical trial staff.

Clinical trials may involve risk, as can routine medical care and the activities of daily living. When weighing the risks of clinical trials, consider the possible harms that could result from taking part in the trial, the level of harm, and the chance of any harm occurring.

It is important to acquire as much knowledge about the clinical trial as possible before being part of it. You should make sure to have all your doubts answered by the members of the team that will be doing the trial. Also, you should mention the trial to your main health provider to confirm that the trial is a viable option for you considering your current treatment.

• COFEPRIS – Comisión Federal para la Protección Contra Riesgos Sanitarios
  https://www.gob.mx/cofepris
• CONBIOETICA -- Comisión Nacional de Bioética
  https://www.gob.mx/salud/conbioetica
• NHLBI – National Heart Lung and Blood Institute - U.S. Department of Health and Human Services
  https://www.nhlbi.nih.gov/health-topics/clinical-trials
• FDA – Food and Drug Administration–
  https://www.fda.gov
• NIH - National Institutes of Health
  https://www.nih.gov

All clinical trials must be registered and are strictly regulated by a legal framework composed of laws, guides and regulations. In México they must be compliant with the General Health Law and Official Mexican Standards; as well as compliance with international guidelines (FDA guidelines, Declaration of Helsinki, Good Clinical Practices, etc.).

For more information on regulatory compliance of clinical trials click here.

The purpose of these strict regulations is to protect whoever participates in clinical trials and to ensure that the information obtained from the studies is reliable and can be used to benefit the community.

Even though there are many efforts made to avoid any potential risks to the participants during the investigation, there are some that can occur which can’t be avoided since clinical trials involve ongoing investigation of the treatments from which we are still learning and trying to perfect.

This is why volunteer patients should only be part of a clinical trial once they have full knowledge of what the trial entails, it’s advantages and possible disadvantages. Once the volunteer patient has complete knowledge of the trial, they should be asked to sign an informed consent.

• Advantages of a clinical trial:
  1. Possibility to receive a new treatment for a disease before it is widely available.
  2. You take part in helping others to have a better treatment for their diseases in the future by aiding the development of a new drug.
  3. Part of your treatment may include more regular health check-ups.
• Possible disadvantages of a clinical trial:
  1. The new treatment you receive may have cause side effects.
  2. The new treatment received may not be more efficient than the existing treatment or may not work or you.
  3. There’s the possibility that you are NOT part of the group that receives the new treatment, you could be placed in the control group, meaning you would receive what already exists as treatment or a placebo.

To be part of any clinical study you must meet all the requirements of the eligibility criteria. If you want to find out if you are eligible for on-going clinical studies within our network of institutional allies, please fill out enquiry form in the contact section, so you can receive further information.

Click on the links below to learn more about the on-going clinical trials in your area.

Please fill out an enquiry form in the contact section so you can receive further information of the clinical trials EtCurae is performing within its site network.