A good definition of a clinical trial comes from the National Library of Medicine, which is part of the National Institutes of Health. A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest ways to find treatments that work in people and ways to improve health.
The National Library of Medicine explains that clinical trials fall into two general categories. Interventional trials determine whether experimental treatments or new ways of using approved therapies are safe and effective under controlled conditions. For example, doctors may give an experimental drug to breast cancer patients to see whether their health improves. Observational trials study health issues in large groups of people in natural settings. For example, an observational trial might follow a group of older adults to learn about the effect of different lifestyles on heart disease.
To search for a clinical trial at UCLA CTSI institutions (UCLA-Westwood, Cedars-Sinai Medical Center, Los Angeles Biomedical Institute at Harbor-UCLA Medical Center, Charles R. Drew University of Medicine and Science) go to www.clinicaltrials.gov.
The technologies and measurements tested in clinical trials fall into five main categories.
The Food and Drug Administration (FDA) typically requires that experimental drugs be tested in three phases in stepwise fashion to determine if the experimental drugs are safe and effective.
The FDA may also require Phase IV studies. A phase IV study monitors the long-term safety and effectiveness of a drug after it is on the market.
Every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth the potential benefits of the experimental therapy. The IRB is charged wit\ h ensuring a study is ethical and that the participants are not likely to be harmed.
The IRB-a committed of physicians, statisticians, patient advocates and others-can stop a study if the experimental treatment causes unexpected harm. The IRB can also stop a study if there is clear evidence that the experimental treatment is effe\ ctive.
Follow this link for information about IRBs at UCLA.
The National Institutes of Health provides the following summary of the benefits and risks of clinical trial participation.
Remember, it is always good to ask questions so you can understand the benefits and risks of entering a specific clinical trial.
The National Cancer Institute, which is part of NIH, recommends asking your doctor these questions before entering a clinical trial.
About the trial:
Risks and benefits:
NIH Senior Health has clinical trial information, a catalog of short videos, FAQs and other useful information.
Medline, a service of the National Library of Medicine, has interactive tutorials, and links to information about specific health conditions. An English-language tutorial can be found here; a Spa\ nish-language tutorial can be found here.
The National Cancer Institute provides information on participating and paying for care in clinical trials.
Just like any field of work, medical science comes with a host of words and phrases that can be difficult to understand in the context of a clinical trial. Sifting through the information and explanations can be time consuming and occasionally difficult. ClinicalTrials.gov has created a glossary of frequently used research terms. For volunteers interested in participating in a cancer clinical trial, UCLA's Jonsson Comprehensive Cancer Center has created a more specific glossary of terms often use\ d with cancer research.