Frequently asked questions
What is a clinical research trial?
A Clinical Trial is a form of clinical research to determine the safety and effectiveness of newly developed pharmaceutical medications. An investigator and study coordinator monitor and collect data from the subject to help determine the outcomes of the trial. Each Clinical Trial is developed to provide specific outcomes. Each study has a specific protocol (a set of guidelines to follow). An IRB Internal Review Board oversees that these guidelines are followed correctly. A Clinical Trial can provide information through controlled subjects to help the FDA (Food and Drug Administration) approve the pharmaceutical medication.
Who can participate in a clinical trial?
Each clinical trial is designed to find specific end results. The trial can either be for pediatric, adults, or both. There are specific exclusion and inclusion criteria to be met in order to be a candidate in each trial. Compensation is provided to candidates for travel.
Who conducts clinical studies?
Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals. Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to Federal agencies such as the National Institutes of Health, the U.S. Department of Defense, and the U.S. Department of Veterans Affairs. Physicians, health care providers, and other individuals can also sponsor clinical research.
How long do clinical studies last?
The length of a clinical study varies depending on what is being studied. Participants are told how long the study will last before enrolling.
How are participants protected?
Informed consent is a process in which researchers provide potential and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll or continue to participate in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. In addition to the informed consent document, the process may involve recruitment materials, verbal instructions, question-and-answer sessions, and activities to measure participant understanding. In general, a person must sign an informed consent document before joining a study to show that he or she was given information on risks, potential benefits, and alternatives and understands it. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over. See the Questions to Ask section on this page for questions to ask a health care provider or researcher about participating in a clinical study.
Institutional Review Boards. Institutional review boards. Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by the FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of physicians, 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 things. 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 the FDA, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants.
Relationship to Usual Health Care.
Typically participants continue to see their usual health care providers while enrolled in a clinical study. While most clinical studies provide participants with medical products or interventions related to the illness or condition being studied, they do not provide extended or complete health care. By having his or her usual health care provider work with the research team, the participant can make sure that the study protocol will not conflict with other medications or treatments being received.