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A clinical trial is a research study in which volunteer patients, also referred to as participants, receive investigational treatments under the supervision of a physician and other research professionals.

These treatments are developed by pharmaceutical and biotechnology companies who select qualified physicians, also known as investigators, to conduct clinical trials to determine the benefits of investigational drugs.

Clinical trials are used to learn if treatments are safe and effective to treat or prevent medical conditions and understand if new therapies can improve quality of life. The data from clinical trials is needed to support the approval of new treatments by the US Food and Drug Administration (FDA) and other similar agencies worldwide.

Clinical trials are led by a doctor, nurse, or other medical professional trained to conduct clinical trials safely and properly.

Clinical trials run in a controlled manner and follow protocols with set guidelines for each trial. The protocol defines how the trial will run, including treatments used, trial duration, participant evaluations and diagnostic tests collected from the volunteers.

All medical professionals and patients participating in a clinical trial follow the same protocol, so that all patients are treated consistently and equally. This allows for even the smallest of differences between treatments to be seen.

If you choose to volunteer for a clinical trial, you will be provided a full explanation of the study including required tests and procedures, visits that you have to attend, as well as potential risks and benefits of the study.

The clinical trial protocol defines clinical trial participation requirements, and every patient must meet the requirements before enrollment. After you provide your consent to join a trial, you’ll undergo a series of diagnostic tests to see if you qualify.

If you qualify, you may be given a treatment to use during the trial. The protocol may require the treatment to be masked or blinded to prevent the false perception that one treatment is better than the other. If treatment is blinded, you may not know what treatment you receive.

You’ll participate in a series of medical and physical examinations to measure the effects of the treatment over the trial duration. Trial duration, clinic visits and testing schedules vary from protocol to protocol. Some protocol procedures may be done at the Clinical Trials site, and some may be completed by you at home.

At the end of the trial, data from your visits and testing will be collected, pooled with patients from other sites and analyzed to see if the treatment has a real medical benefit. The data you contribute during participation is very important to understanding treatment effects, so you’re encouraged to complete the trial to the end. Your data will be used to advance science and improve medical care for patients like you.

All clinical trials have guidelines about who can participate. Volunteers must meet certain criteria based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Some research studies seek participants with specific illnesses or conditions to be studied in a clinical trial, while others require healthy participants. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants, promote participants’ safety, and ensure that researchers learn the information they need.

Risks vary based on the study. It is very important that you discuss them with your doctor. Side effects may be unpleasant, serious, or even life threatening. Some may be unexpected or appear after treatment ends. The treatment may not work, or you may be in a placebo group that gets no active treatment. There may also be extra demands on your time, including trips to the clinical trial site, more treatments, hospital stays, or complex dosage requirements.

Volunteers may withdraw from a study at any time for any reason.

Your rights, well-being, and safety are important to the clinical researchers throughout the study. All clinical research studies must follow strict federal guidelines on how participants are treated. Independent review boards approve and monitor all trials to make sure the risks are as low as possible, ethical, and that the participants’ rights are protected.

Before you decide to participate in a particular clinical trial, you will learn the key facts about the trial through a process called informed consent. The process consists of an informed consent form and a discussion between the clinical trial participant and the appropriate medical professional(s). Throughout the study you will be provided any additional information needed.

Before you join a trial, you’ll meet with the Principal Investigator to discuss known risks and benefits of the treatment, the schedule of visits and tests required by the protocol and treatment options available in the protocol. The Principal Investigator will explain the protocol procedures to you in detail so you understand the schedule and know when to meet with the Principal Investigator or staff to provide new evaluations.

If you decide to join the study and provide written informed consent to participate, you’ll have diagnostic tests performed to see if you meet the criteria to be enrolled. Not everyone will meet the entry criteria, so not everyone can be enrolled.

In some studies, participants receive a physical examination and their medical histories are reviewed by either the study physician or a research staff member once they are enrolled in the study. The volunteers’ health will continue to be monitored during and after the trial. A detailed description of what’s expected of volunteers will be outlined in consent forms along with specific clinical trial information.

After a study phase is complete, the data is collected to determine the drug’s effectiveness, if it is safe and if there are any side effects. Depending on the results, researchers then determine whether to stop testing or move to the next phase of study. After the study is complete, researchers decide if the results are medically important and may submit them to journals for peer review.

Data may then be submitted to the Food and Drug Administration (FDA) for approval. If a drug is approved, pharmaceutical companies may continue to conduct studies that compare the new drug (in terms of its safety, effectiveness, and cost) to other drugs already on the market or assess a drug’s long-term effectiveness and its impact on the quality of a person’s life.

Lucida Clinical Trials has staff fluent in English and in Portuguese.