You may be eligible to take part in a clinical trial to receive new treatment for your illness, while you help others with theirs. By participating in a clinical trial, you can play a more active role in your own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
What is a clinical trial?
Clinical trials are biomedical or health-related research studies in human beings that follow a pre-defined protocol. In interventional studies, research subjects receive treatment and their outcomes are measured. In observational studies, individuals are observed and their outcomes are measured by the investigators.
All clinical trials have guidelines about who can participate. To produce reliable results, criteria may include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants.
The clinical trial team includes 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 in frequent contact with a research team.
To help someone decide whether or not to participate, the doctors and nurses 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, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained before the participant decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
Benefits
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.
- Help others by contributing to medical research.
Risks
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, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
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 How is the safety of the participant protected?
Most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it. The following questions might be helpful for the participant to discuss with the health care team.
- What is the purpose of the study?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow up care is part of this 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.
How can I find out about participating?
To find clinical trials you might qualify to participate in, visit ClinicalTrials.gov, a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details.
Source:
National Institutes of Health, developed by the U.S. National Library of Medicine More
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