Patients & Caregivers / What is a Clinical Trial?
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An Introduction to Clinical Trials

Over the past 15 years scientists have made tremendous progress understanding exactly how Alzheimer’s disease affects the brain. Researchers continue to work diligently to find better diagnostic methods, treatments, preventions and even cures. Testing in human volunteers is essential to learning what is successful. Following successful laboratory work or animal studies, new treatments must undergo clinical trials (testing in human volunteers). Findings cannot become a reality without human testing.

What is a clinical trial?

A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.

Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe.

What happens during a clinical trial?

The clinical trial process depends on the kind of trial being conducted. The clinical trial team may include doctors and nurses, as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed. For all types of trials, the participant works with a research team.

The clinical trial process depends on the kind of trial being conducted. The clinical trial team may include doctors and nurses, as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed. For all types of trials, the participant works with a research team.

Clinical trials that are well-designed and well-executed are the best approach for eligible participants to: play an active role in their own health care; gain access to new research treatments before they are widely available; obtain expert medical care at leading health care facilities during the trial; and help others by contributing to medical research.

There are risks to clinical trials. There may be unpleasant, serious or even life-threatening side effects to experimental treatment; the experimental treatment may not be effective for the participant; the protocol may require more of their time and attention than would a non-protocol treatment.

What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, health professionals involved in the trial explain the details of the study. Then the research team provides an informed consent document that includes details about the study. The participant then decides whether or not to sign the document.

How is the safety of the participant protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants.

Does a participant continue to work with a primary health care provider while in a trial?

Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.

Can a participant leave a clinical trial after it has begun?

Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

Who sponsors clinical trials?

Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.

(Excerpted from ClinicalTrials.gov)


Clinical Trials/Research Studies