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All clinical trials are based on a set of rules and action plan called a protocol. The study's principal investigator follows a protocol for the study. A protocol describes what types of patients may be eligible for the trial, the schedule of tests, procedures, medications and dosages, and the length of the study. While in a clinical trial, participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
The government has strict guidelines and safeguards in place to protect people who volunteer to participate in a clinical trial. In the United States, each clinical trial must be approved and monitored by a local Institutional Review Board (IRB) to ensure the risks to the study participants are as low as possible. An IRB is an independent committee of physicians, statisticians, and community advocates, among others, that ensure a clinical trial is ethical and the rights of research volunteers are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
Clinical trials may be sponsored by a government agency, a pharmaceutical company, an individual physician, a healthcare organization, a university, an organization that creates medical devices, or a physician's office. In some instances, additional testing or physician visits may be required. The cost of these extra tests may be covered by the study, although you or your insurance company may ultimately be responsible for the additional costs incurred. Information regarding this topic will be outlined in the research volunteer's Informed Consent.
Clinical trials are used to study many aspects of medical care, including:
A placebo is designed to resemble the treatment under investigation through a clinical trial. The exception is that the placebo is inactive. An example of a placebo is a pill containing sugar instead of the drug being studied. By giving one group of participants a placebo and the other group the active treatment, the researchers can compare how the two groups respond and get a truer picture of the active treatment's effects.
A control group is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug, while the control group is given either a standard treatment.
Side effects are any undesired actions or effects as a result of taking a drug or undergoing a treatment. Negative or adverse side effects may include headache, nausea, hair loss, skin irritation or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.
It is important for research volunteers to understand the general principles that apply to anyone taking part in the study: