Alpha Stem Cell Clinic

Clinical Trial

Clinical Trials

You may be eligible to take part in one of the many clinical trials underway at the UCI branch of the UCLA-UCI Alpha Clinic. By participating in a clinical trial, patients have access to leading-edge treatments and therapies long before they are available to the general public.

The more you know about clinical trials, the better informed you will be when deciding whether to participate in a specific trial. Learn more about clinical trials below.

For more information about clinical trials, fill out this form.

What is a clinical trial?

A clinical trial is a medical research study in which patient volunteers test a new medical approach to determine whether it is safe and effective. Some clinical trials study a stem cell/drug, a medical device or a new way of doing surgery. Others test new ways to prevent disease, diagnose disease, improve quality of life, or help people with manage difficult psychological and social issues.

During a clinical trial, more information is gathered about a new treatment, its risks and how well it may work. Patients who take part in clinical trials also have an opportunity to help scientists learn - how the disease grows, how it acts and what influences its growth and spread. Many of the approaches that doctors use to treat disease today are available only because of clinical trials.

Phases of clinical trials

Phase 0 clinical trials

These trials represent the earliest step in testing new treatments in humans. In a phase 0 trial, a very small dose of a chemical or biologic agent is given to a small number of people (approximately 10-15) to gather preliminary information about how the agent is processed by the body (pharmacokinetics) and how the agent affects the body (pharmacodynamics). Because the agents are given in such small amounts, no information is obtained about their safety or effectiveness. Phase 0 trials are also called micro-dosing studies, exploratory Investigational New Drug (IND) trials, or early phase I trials. The people who take part in these trials usually have advanced disease, and no known, effective treatment options are available to them.

Phase I clinical trials

These trials are conducted mainly to evaluate the safety of chemical or biologic agents or other types of interventions (e.g., a new stem cell dosage). They help determine the maximum dose that can be given safely (also known as the maximum tolerated dose) and whether an intervention causes harmful side effects. Phase I trials enroll small numbers of people (20 or more) who have advanced disease that cannot be treated effectively with standard (usual) treatments or for which no standard treatment exists. Although evaluating the effectiveness of interventions is not a primary goal of these trials, doctors do look for evidence that the interventions might be useful as treatments.

Phase II clinical trials

These trials test the effectiveness of interventions in people who have a specific type of disease. They also continue to look at the safety of interventions. Phase II trials usually enroll fewer than 100 people but may include as many as 300. The people who participate in phase II trials may or may not have been treated previously with standard therapy for their disease. If a person has been treated previously, their eligibility to participate in a specific trial may depend on the type and amount of prior treatment they received. Although phase II trials can give some indication of whether or not an intervention works, they are almost never designed to show whether an intervention is better than standard therapy.

Phase III clinical trials

These trials compare the effectiveness of a new intervention, or new use of an existing intervention, with the current standard of care (usual treatment) for a particular disease. Phase III trials also examine how the side effects of the new intervention compare with those of the usual treatment. If the new intervention is more effective than the usual treatment and/or is easier to tolerate, it may become the new standard of care.

Phase III trials usually involve large groups of people (100 to several thousand), who are randomly assigned to one of two treatment groups, or "trial arms": 1) a control group, in which everyone in the group receives usual treatment for their disease, or 2) an investigational or experimental group, in which everyone in the group receives the new intervention or new use of an existing intervention. The trial participants are assigned to their individual groups by random assignment, or randomization. Randomization helps ensure that the groups have similar characteristics. This balance is necessary so the researchers can have confidence that any differences they observe in how the two groups respond to the treatments they receive are due to the treatments and not to other differences between the groups.

Randomization is usually done by a computer program to ensure that human choices do not influence the assignment to groups. The trial participants cannot request to be in a particular group, and the researchers cannot influence how people are assigned to the groups. Usually, neither the participants nor their doctors know what treatment the participants are receiving.

People who participate in phase III trials may or may not have been treated previously. If they have been treated previously, their eligibility to participate in a specific trial may depend on the type and the amount of prior treatment they received.

In most cases, an intervention will move into phase III testing only after it has shown promise in phase I and phase II trials.

Phase IV clinical trials

These trials study a treatment after the FDA has approved it. Phase IV trials evaluate the side effects, risks, and benefits of a drug or other therapy over a long period of time and in a larger number of people than in phase III trials. Thousands of people are involved in a phase IV trial, and randomization is generally not used.