Clinical Trials.

Subject.

Welcome to the Subject Information section of Your Choice Research. We believe that informed patients are essential to the success of any clinical trial and we are committed to providing you with the information you need to make an informed decision about whether or not to participate in a trial.

¿What is a clinical trial?

Clinical trials are research studies designed to evaluate the safety and effectiveness of new drugs, medical devices, or treatments. These studies are conducted in phases, and each phase is designed to answer a specific question about the safety and effectiveness of the treatment being studied. Clinical trials are usually conducted in a controlled setting, with careful monitoring to ensure the safety of study participants.

¿Why participate in a clinical trial?

There are many reasons why you might choose to participate in a clinical trial. These include:

Access to potentially life-saving treatments: Clinical trials are often the only way to access experimental treatments that are not yet available on the market.

Contributing to medical research: By participating in a clinical trial, you are helping to advance medical knowledge and improve patient care for future generations.

Close monitoring by medical professionals: When you participate in a clinical trial, you will be closely monitored by medical professionals, who will ensure that you receive the best care possible.

¿What tests are available?

At Your Choice Research, we are currently recruiting patients for a variety of clinical trials. Our trials focus on a variety of medical conditions, including metabolic syndrome, cardiovascular disease, and infectious diseases. Each trial has specific inclusion and exclusion criteria, which are designed to ensure that trial participants are eligible for the study. To learn more about our available trials, please visit our Current Trials page.

¿What are the inclusion and exclusion criteria?

Inclusion and exclusion criteria are used to determine whether a patient is eligible to participate in a clinical trial. Inclusion criteria are the factors that must be present for a patient to be eligible for the trial, while exclusion criteria are the factors that would prevent a patient from participating. Inclusion and exclusion criteria may include factors such as age, sex, medical history, and current medications. For more information on the inclusion and exclusion criteria for our current trials, please visit our Current Trials page.

¿How do I participate in a clinical trial?

If you are interested in participating in a clinical trial, the first step is to contact Your Choice Research to learn more about the available trials and to determine if you meet the inclusion criteria. If you are eligible, you will be asked to provide informed consent, which means that you fully understand the risks and benefits of participating in the trial. Once you have provided your consent, you will be enrolled in the trial and will receive close monitoring and care from our team of medical professionals.

We hope that this information has been helpful in understanding what clinical trials are, why you might choose to participate in a trial, and what you can expect when participating in a trial. If you have any questions or would like more information about our available trials, please contact Your Choice Research.

The Four Phases of a Clinical Trial

Each clinical trial phase seeks to answer different questions about the treatment being tested and builds upon previous research and results. Usually when you join a clinical trial, you’ll be in just one phase of the trial, however some clinical trials give the option to participate in more than one phase. Clinical trials are reviewed by regulatory agencies for safety and effectiveness, and by ethical review boards. The sections below provide more information about each phase.

1.      Safety &Dosage

 

Phase 1 trials study a potential treatment in a small group of participants who are either healthy or have a specific condition. They evaluate the treatment’s safety, determine a safe dosage, and identify serious side effects. This is the first time the treatment is tested in people.

Smaller, with approximately 20 to 100 participants

Few weeks - several months

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2. Effectiveness &Side Effects

Phase 2 trials expand to a larger group of participants and evaluate the treatment’s effectiveness at treating a specific condition and study its side effects, while continuing to monitor for safety. For this reason, only participants with the specific condition may enroll.

Middle sized, with up to several hundred participants

Several months - 2 years

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3. Effectiveness &Adverse Reactions

Phase 3 trials continue to evaluate a treatment’s safety, effectiveness, and side effects by studying it among different populations with the condition and at different dosages. The potential treatment is also compared to existing treatments, or in combination with other treatments to demonstrate whether it offers a benefit to the trial participants. Once completed, the treatment may be approved by regulatory agencies.

300 to 3,000participants

Usually 1 - 4 years, but can be longer

 

4. Safety &Effectiveness

After a treatment has been approved by regulatory agencies, it continues to be monitored for safety, effectiveness, risks, benefits, and optimal use when used by participants in the general public with the condition as part of their everyday life.

Several thousand participants

Usually 1 or more years*

*Varies depending on what is being studied

References taken from the official page of https://www.gileadclinicaltrials.com/