About Clinical Trials

What are clinical trials?

Clinical trials are studies, managed by government agencies, educational institutions, private not-for-profit organizations, or commercial businesses, to develop, produce, and evaluate the effectiveness of new treatments and therapies for diseases.

What are the phases of a clinical trial?

Most clinical research progresses in an orderly series of steps or phases.

1. Phase I trials are the first studies to evaluate how a new therapy should be administered - how often, and in what dosage. The focus is to determine safety (drug dose, device safety, or other therapy's safety) for the next phase of testing.
2. Phase II trials provide preliminary information about how well the new therapy works, and generates more information about its safety and benefits. A Phase II study usually focuses on a particular type of cancer.
3. Phase III trials compare a promising new therapy, combination of treatments, or procedure with a current standard of treatment.
4. Phase IV trials include the continuing evaluation that takes place after FDA (Food and Drug Administration) approval, when the therapy is already available for general use.

What is a clinical trial protocol?

Clinical trial protocols are the action plans or guidelines that must be followed during the course of any study. Guidelines may cover:

• the design of the study - what will be studied and how
• who may participate - criteria for patients who enter the study
• what treatments and medical tests will be used to follow the participants
• specific research questions

Several research centers may be involved in the study, and each uses the same protocols to ensure that information from all centers can be combined and compared.

Where are trials conducted?

Large cancer centers, university hospitals, local medical centers, or physician offices, all may be included in managing clinical trials. Informed consent is a process designed to protect potential participants through detailed description of important facts about a specific clinical trial. There may be only one or two locations involved in a particular study, or hundreds around the country.

Who can participate in a trial?

Each protocol in a trial defines specific characteristics, called eligibility criteria, that participants should have in order to participate in the study. Characteristics may include type of disease and its stage, as well as the participant's age and general health.

Eligibility criteria help assure that the study results answer the research question and identify who will benefit in the future from the approach being studied.

How are trial participants protected?

There are several procedures in place, as part of the protocols, to protect the safety of the participants. Informed consent is a process designed to protect potential participants through detailed description of important facts about a specific clinical trial.

Two groups that oversee the safety procedures are the:

• organization that sponsors the study, for example, the National Cancer Institute
• Institutional Review Board (IRB) that oversees clinical research in the healthcare institution. The IRB includes physicians, other healthcare providers, consumers, and sometimes members of the clergy, who do not have any personal interest in the results of the study. As neutral reviewers, they ensure that the study is conducted fairly and that there is not a high probability of harm to the participants.
• Phase III trials also have a special group called a Data Safety and Monitoring Committee that looks at the test results, monitors the safety of the participants, and decides whether the study should go forward as originally planned.

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