What is a clinical trial?

Clinical research or clinical trials involves research using human volunteers. The volunteers receive investigational products under the direct supervision of a physician. Clinical trials are designed to give medical knowledge to help treat, diagnose and possibly prevent a disease or a condition. Clinical trials help to evaluate medication or devices to treat a disease, syndrome or condition. Clinical trials may compare a new medical treatment to one that has already been approved or to a placebo treatment.

How do they work?

Clinical trials are conducted in 4 phases. Phase I is usually conducted with healthy volunteers. Phase I emphasizes safety. The goal is to find the drug's most frequent and serious adverse events, how often they happen, how the dose of medication is metabolized and secreted within the body. Phase II is to collect the data on the effectiveness of the medication (to see if the drug works in people with specific diseases/condition) Patients receiving the drug are compared to patients receiving a different treatment or a placebo (an inactive substance).

Safety is still being evaluated in this phase. Phase III the study is gathering more information about the safety and effectiveness by studying different types of populations, different diseases and using different drug combinations. Phase VI is after the FDA has approved the drug for market. The FDA requires additional studies on the drug for safety, efficacies and optimal use.

If you would like any additional information regarding clinical research or any of our clinical trials, please feel free to contact any of our study coordinators.
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Frequently Asked Questions

Who conducts clinical trials?
All clinical trials have a Primary Investigator, which is the main doctor in charge of the study and the research staff. Sub- Investigators are the other doctors on staff that will help the Primary Investigator in treating the patients. There are other staff members that may be involved in helping with the research such as study coordinators or nurses.
Who can participate in a clinical trial?
Every clinical trial has a unique protocol that outlines who can participate in a study. A patient must meet certain inclusion and exclusion criteria in order to participate in a study. Some of the inclusion/exclusion that is used to identify participates include things such as age, type of disease, other medical conditions. The inclusion and exclusion lists are important to help identify the correct patients with a specific disease or condition and to promote patient safety while participating on the trial.
How does a clinical trial work?
Patients that participate in clinical trials are usually randomized (assigned) into a specific treatment group. Patients in one group may receive the investigational medication or device, and the other group may receive the placebo (an inactive product) or a treatment that is already available. The patient, physician and the research staff may not know if they are given the placebo or the investigational medication, so that all of the patients can be observed the same way. Regardless of which treatment group the patient falls under, all patients will receives the same level of medical attention and care.
What are the benefits and risks of joining a trial?
When a patient agrees to participate in a clinical trial they are helping to develop medical treatments and cures for medical conditions and diseases. Patients also are playing an active role in their health care. Participating in research gives the patient access to medical treatments before they are available. Just as there are benefits to participating in a clinical trial, there are also risks involved. Some risks to participating in a clinical trial are that the experimental treatment may not be effective and may not help the medical condition. There maybe unpleasant, serious, or even life- threatening side effects from the experimental treatment.
What questions should I ask before choosing to participate in a clinical trial?
Patients considering participating in a clinical trial should talk about it with their healthcare provider. Some questions to ask:
  • How long will the trial last?
  • Where is the trial being conducted?
  • What treatments will be used and how?
  • What is the main purpose of the trial?
  • How will patient safety be monitored?
  • Are there any risks involved?
  • What are the possible benefits?
  • What are the alternative treatments besides the one being tested?
  • Who is sponsoring the trial?
  • Do I have to pay for any part of the trial What happens if I am harmed by the trial?
  • Can I opt to remain on this treatment, even after the termination of the trial?
What happens after the trial?
After the clinical trial is complete, the information collected throughout the study is collected and analyzed to see determine the drug's effectiveness, if it is safe and if there are any side effects. The pharmaceutical company will then make the decision to either move to the next phase of the study or stop testing the study drug. At the phase III part of the study, the pharmaceutical company decides if the data collect and the results are medically important and can submit them to journals for peer review. The data can also be sent to the Food and Drug Administration (FDA) for approval.