All clinical trials have criteria--or guidelines--about who can participate in the study. Guidelines are based on such factors as age, type of disease, medical history, and current medical condition. Before joining a clinical trial, a person must qualify for the...
Who Sponsors Clinical Trials?
Clinical trials are sponsored by: government agencies such as the National Institutes of Health (NIH); pharmaceutical companies; individual physician-researchers; health care institutions such as health maintenance organizations (HMOs); and companies that develop...
What Is A Clinical Trial?
A clinical trial is a research study designed to answer specific questions about new therapies, diagnostic tests, screenings, and disease prevention by testing new procedures in people. Clinical trials (also called medical research and research studies) are used to...
What Protections Are There For People Who Participate In Clinical Trials?
Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is a committee of physicians, statisticians, patient advocates, and others...
What Is Informed Consent?
Informed consent is the process of learning the key facts about a clinical trial before an individual decides whether or not to participate. When an individual is considering joining a clinical trial, the research staff will provide informed consent documents that...
What Are Clinical Trial Phases?
Clinical trials of experimental drugs proceed through four phases: In Phase I clinical trials, researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. In...
What Is A Protocol?
All clinical trials are based on a set of rules called a protocol. A protocol describes the criteria for participation; the schedule of tests, procedures, medications, and dosages; and the length of the study.
Can A Participant Leave A Clinical Trial After It Has Begun?
Yes. Participants can leave a clinical trial at any time.
What Are The Benefits And Risks Associated With Clinical Trials?
There are both benefits and risks associated with clinical trials. By participating in a clinical trial, a person may benefit by: Helping others by contributing to medical research. Gaining access to new treatments that are not available to the public. Obtaining...