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.
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. To find 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) or other locations, go to www.clinicaltrials.gov.
UC-wide Clinical Trials gives you information about the trials going on at the UC medical campuses (UC Davis, UC Irvine, UC Los Angeles, UC San Diego, and UC San Francisco). This site includes data from our university, ClinicalTrials.gov (details), and other sources., go to http://clinicaltrials.ucbraid.org.
The National Library of Medicine explains that there are clinical trials and observational studies.
In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases. Clinical trials used in drug development are sometimes described by phase. These phases are defined by the Food and Drug Administration (FDA).
In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions (which can include medical products such as drugs or devices) or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial). For example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health.
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 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 function of the IRBs is to ensure adherence to all federal, state, local, and institutional regulations concerning the protection of human subjects in research. UCLA IRB review is required for both funded and non-funded human subjects research.
Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of doctors, researchers, and members of the community. Its role is to make sure that the study is ethical and that the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other responsibilities. The IRB also reviews the informed consent document. In addition to being monitored by an IRB, some clinical studies are also monitored by data monitoring committees (also called data safety and monitoring boards). Various Federal agencies, including the Office of Human Subjects Research Protection and FDA, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants.
Click here for details on the IRB process at CTSI sites.
If you are thinking about taking part in a clinical trial, you should feel free to ask any questions or bring up any issues concerning the trial at any time. The National Institutes of Health offers suggestions that may give you some ideas as you think about your own questions. Below is a sampling of those suggestions:
Risks and possible benefits:
NIH National Institute on Aging has clinical trial information, 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. English-language health videos show the anatomy of body parts and organ systems and how diseases and conditions affect them; Spanish-language health videos can be found here.
The National Cancer Institute provides information on participating and paying for care in clinical trials.
ClinicalTrials.gov has FAQs about 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 used with cancer research.