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Phases of Clinical Trials

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How Clinical Trials Are Conducted

Search Clinical TrialsClinical trials are usually conducted in a series of steps, called phases. This allows researchers to collect reliable information while best protecting patients.

Treatment clinical trials are always assigned a phase. However, screening, prevention, diagnostic and supportive care studies do not always have a phase. Genetics, behavioral and population-based clinical trials generally do not have a phase.

Phase-III: Comparing Cancer Treatment Options

Phase III trials compare a new drug or treatment or new use of a standard treatment with a current standard therapy. Volunteer participants are randomly assigned to the standard group or the new group, usually by computer. This method, called randomization, helps to avoid bias and ensures that human choices or other factors do not affect the study's results.

Patients will not receive only a placebo, or inactive treatment, if there is a standard treatment for their type and stage of cancer. However, some studies use a placebo in combination with a standard treatment.

In most cases, studies move into phase III testing only after they have shown promise in phases I and II. Phase III trials may include hundreds of people at multiple locations across the country or around the world.

Phase-II: Studying Effectiveness

Phase II trials continue to study the safety of a new drug or treatment, evaluate how well it works and examine how it affects the human body. Phase II studies usually focus on a particular type of cancer and include fewer than 100 patients at several collaborating research centers.

Phase-I: Focusing on Safety

Phase I trials are the first step in testing a new treatment approach in humans. Researchers evaluate what dose is safe, how a new drug should be given (by mouth, injected into a vein or injected into the muscle), and how often. Researchers watch closely for any side effects. Phase I trials usually enroll a small number of patients and take place at only a few locations. The patients are divided into smaller groups, called cohorts. In general, each cohort is treated with an increased dose of the new therapy. Using this method, the highest dose with an acceptable level of side effects is determined to be appropriate for further testing. Meet the Phase I team.

Phase-0: First-in-Human Trials

Phase 0 is a recent designation for exploratory, first-in-human trials conducted in accordance with the U.S. Food and Drug Administration’s (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies. Phase 0 trials are also known as human microdosing studies and are designed to speed up the development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was anticipated from preclinical studies. Distinctive features of Phase 0 trials include the administration of single subtherapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug works in the body).

 

For more information about clinical trials at Fox Chase Cancer Center or to find a study, call 1-888-FOX CHASE (1-888-369-2427).