What are clinical trials?

A clinical trial is a type of research that allows scientists to determine whether a new drug or medical device can help prevent, detect, or treat a disease. Clinical trials also help determine how safe these new treatments are and whether they are in some way better than current therapies. They can also evaluate whether a drug that was previously used for one disease can be used to treat another.

Clinical trials are conducted with the participation of people, either healthy volunteers or patients with the condition being studied. Currently, all approved drugs on the market have undergone numerous clinical studies, and some continue to be researched.

Who Can Participate in a Clinical Trial?

Each clinical trial has specific requirements for who can and cannot participate. To join a clinical study, participants must meet the so-called “eligibility criteria”, which usually relate to:

• Age

• Gender

• Type and stage of the disease

• Medications previously or currently taken

• Other medical conditions

• Participation in other clinical studies

Some trials seek participants who have the disease under study, while others recruit healthy volunteers. Eligibility criteria are also designed to ensure participant safety.

Is There a Cost for Patients?

No. Even in Phase I studies conducted in Mexico (which are performed on healthy volunteers to assess drug absorption and distribution in the body), participants may receive compensation for their participation. In some Phase II studies and beyond, patients may receive support for transportation to the study site. All medications, treatments, laboratory tests, and imaging studies required for the trial are provided free of charge.

What Are the Benefits for Participants?

Benefits of participating in a clinical trial may include:

• Access to free laboratory and imaging tests

• Opportunity to receive treatments before they are widely available

• Opportunity to play a more active role in managing their condition

• Opportunity to contribute to scientific knowledge about a disease

• Potential compensation for time or travel expenses

• Better adherence to treatment, which may improve disease control

• Care from a research team that includes doctors and other health professionals familiar with the most advanced treatments available

Safety, Safety, Safety

When a person decides to participate in a clinical trial, they can be confident that their safety is a priority. This is ensured through multiple mechanisms. Every clinical trial must follow a protocol, a document detailing how the study will be conducted. All protocols must comply with international and national ethical guidelines.

Protocols are reviewed by Research Committees and Ethics Committees before a trial can begin. These committees may provide recommendations or even deny approval for the study. Each year, committees reevaluate ongoing studies, and if safety concerns arise, a trial may be suspended. Conversely, if patients receiving the study drug show substantial improvement, the trial may be modified so that all participants receive the treatment.

In Mexico, clinical trials must also be authorized by the Federal Commission for Protection against Sanitary Risks (COFEPRIS).