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Tests Used in Clinical Trials

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This is the fifth in a series of articles that describe how different types of laboratory tests are developed, validated, and made available for use by patients and their healthcare providers. This section deals with the use of tests in clinical trials. Standard regulations do not apply to these tests, but oversight is provided by Institutional Review Boards (IRBs).

Part I: Putting New Tests into Practice
Part II: Commercial Tests and FDA Approval
Part III: Laboratory-developed Tests (LDTs)
Part IV: Exceptions: Humanitarian Use
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In certain cases, new or experimental laboratory tests may be made available to patients without FDA approval or regulation by CLIA. The use of such tests is considered exceptional; nevertheless, they are closely regulated by governmental, scientific, and professional entities.

Participation in Clinical Trials
New and experimental tests may sometimes be made available to patients through participation in clinical trials. Clinical trials are research studies performed on consenting human subjects that follow a carefully controlled scientific procedure in order to gather information and data on the safety and effectiveness of a particular test. Researchers who are interested in developing new tests are required to evaluate them by conducting clinical trials with patients who consent to participate.

Patients who choose to participate in clinical trials often have the benefits of gaining access to tests that otherwise would not be available and often receive access to care at leading medical institutions. In addition, they can take an active role in decisions about their healthcare and with regard to their condition. They also contribute to medical research for the benefit of others. However, a clinical trial may also have inconveniences, such as increased demands on the patient's time and risks such as side effects with varying degrees of severity. Sometimes the test being evaluated may not have the intended result or be effective for certain patients.

Benefits and risks to patients that are part of a clinical trial must be addressed prior to the start of any study and are closely monitored as the clinical trial proceeds. As with tests that are exempted as Humanitarian Use Devices, tests used during clinical trials are carefully regulated. It is required by federal law that every clinical trial conducted in the U.S. be approved by an Institutional Review Board (IRB). An IRB is a committee comprised of doctors, scientists, healthcare advocates, and others that initially approves the research protocol and periodically reviews the study. It is the responsibility of an IRB to ensure that possible benefits from the trial have true value and outweigh any possible risks to patients. The IRB also must ensure that the risks to patients remain at a minimum as much as possible. IRBs continually oversee clinical studies to ensure that ethical standards are adhered to and that the rights of patients are protected.

For more information about clinical trials or to find out about prospective or on-going studies for a particular condition, visit the federal government-sponsored site: