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Participation in a clinical trial is an important and personal decision. Those interested in participating in a clinical trial are encouraged to discuss this opportunity with their physician, family members or friends before joining a trial. Try to find out as much information as possible about the clinical trial, the health impacts, the care that will be expected while in a trial, and the cost/compensation involved. Once trial options have been identified, the study research staff should be contacted for more details about the specific trial in which you are interested.
What is a clinical trial?
A clinical trial is a research study to help treat or prevent diseases in people. Therapies being tested in a clinical trial can be in the form of a vaccine, new medications, new devices, new lifestyle or behavioral change, or new ways of using known therapies. A clinical trial is used to determine whether new therapies are both safe and effective.
After researchers test new therapies or procedures in animal studies, only the most promising laboratory results are moved into clinical trials with human participants. This way, valuable information is gained about a new treatment, its risks, and how well they may or may not work.
Clinical trials can be sponsored or funded by a variety of organizations such as the National Institutes of Health (NIH), private foundations, and pharmaceutical companies. Trials can take place in a variety of locations, usually at hospitals, universities, doctors’ offices, or community clinics.
There are different types of clinical trials:
- Treatment trials test new treatments, including new drugs or devices, new combinations of previously approved drugs, or new approaches to therapies such as surgery or radiation therapy.
- Prevention trials look for ways to prevent disease occurrence in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle/behavioral changes.
The detailed process for each clinical trial may differ depending on the kind of trial being conducted. The clinical trial staff (including doctors, nurses, and other health care professionals) will always check the health of the participant at the beginning of the trial, provide specific instructions for participating in the trial, monitor the participant carefully during the course of the trial, and stay in touch after the trial is completed.
Who can participate in a clinical trial?
All clinical trials have specific guidelines about who can participate. The use of inclusion and exclusion criteria helps to make sure that only persons who could possibly benefit from the therapy being tested are allowed to participate, which also helps to produce more reliable results. In order for someone to participate in a clinical trial, they have to qualify under the “inclusion criteria.” If there are factors that fall under “exclusion criteria”, an individual may not be allowed to participate in a study. 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 an individual is allowed to join a clinical trial, he/she must qualify for the study. Some studies seek individuals with illnesses or conditions to be studied, while others look for healthy participants. The inclusion/exclusion criteria are used to help identify appropriate participants and keep them safe. This will also help to ensure that the researchers will be able to gain accurate information and valid test results for each study.
What are the benefits and risks?
Benefits. Clinical trials that are well-designed and carefully executed are the best treatment approaches for eligible participants to play an active role in their own health care. It allows participants to gain access to new research treatments before they are widely available. Participants are also able to obtain expert medical care at leading health care facilities during the trial. Through their participation in studies, oftentimes, the subjects are helping others by contributing to medical research.
Risks. There are risks to clinical trials, such as side effects and adverse reactions, or the possibility that the treatment may not be effective for the participant. Some of side effects to the studies may be unpleasant, or even serious. Negative adverse reactions may include problems like nausea, insomnia, or other similar problems, depending upon the medication that is being tested. Experimental treatments must be evaluated and monitored for both immediate and long-term side effects. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to assure that the risks are as low as possible and are worth any potential benefits. The study may require considerable time and attention for multiple trips to the study site, extensive memory testing, or even complex dosage requirements.
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