A clinical trial is a carefully designed study that is done with volunteers who receive investigational medical treatments. The volunteers are under close watch from doctors and research professionals. The treatments are developed by pharmaceutical and biotechnology companies who selected physicians to conduct the trials. It is through these trials that the benefits of investigational drugs may be shown.
Once you have enrolled in a clinical trial (also known as a study), you may receive a physical examination
; your study physician or a research staff member will review your medical history as well. A detailed description of your specific clinical trial and what’s to be expected of you, will be outlined in your consent form. Your safety and privacy are always a priority, so with each trial we take steps to ensure them both.
Informed consent means that clinical trial volunteers understand the details of their clinical study before agreeing to participate. Participants must be provided with all the facts about a study, including treatment details and possible risks and benefits. They must sign an informed consent form before they begin a study. In addition, participants must be kept informed throughout the clinical trial.
Phase 1 studies typically last between one and two weeks. Phase 2, Phase 3, and Phase 4 studies can last several months to several years. In most studies, periodic visits to our center are required (typically with the longer study timelines).
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help answer different questions:
In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.
At Albuquerque Clinical Trials, we value our sponsors and we want to get you the best results possible. You, as the Sponsor, are the reason for new advancements in the medical field. Our team is dedicated to professionalism and accuracy, from recruiting volunteers to participate in your trials, to getting you results. Our experienced research center staff has the training and knowledge to give you a successful trial.
After a study is complete, all of the information is collected and analyzed. This information determines whether a study drug is working, safe, and if it has any side effects. FDA medical
advisers and specialists closely review this data before approving any new drug.