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Frequently asked questions
Where do the ideas for clinical trials come from?
Typically, a drug or medical device is developed and studied by researchers in the laboratory. A drug or device is first evaluated in “pre-clinical” (before human) testing. The drugs and devices that show the most promise are moved to the first phase of clinical (human) testing.
Who sponsors (pays for) a clinical trial?
A clinical trial is usually sponsored by the person or group who has an interest in finding out more about the safety and effectiveness of the drug or medical device. A sponsor can be an individual doctor, a medical institution, a research foundation, a federal agency or a pharmaceutical company.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. The factors that allow someone to participate are called inclusion criteria. Those factors that exclude someone from a study are called exclusion criteria. These criteria are based on things like age, type and severity of disease, previous treatment and other significant medical history. Inclusion/exclusion criteria are used to identify appropriate study participants and keep them safe. The criteria ensure that all people in the study are similar and can therefore be studied as a group. For your safety, the study team will not enroll you in a trial if you do not meet the criteria. If this happens, we will help you identify other options.
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. To help someone decide whether or not to participate, the research team will review and discuss the 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 in the informed consent document. After we discuss the informed consent, you will be given an opportunity to ask any questions you may have. You can then decide whether or not to sign the document. Informed consent is not a contract and you may withdraw from the trial at any time.
What can I expect to happen during a clinical trial?
The clinical trial process depends on the type of trial being conducted. 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. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team.
What are some research terms I should know?
- Placebo: A fake pill containing no active medication. Sometimes called a sugar pill.
- Open Label Study: All participants receive the study medication. Both you and the study team know you are receiving it.
- Double-Blind Study: Neither you nor the study team knows if you are receiving the study drug or the placebo. This information is available in the event of an emergency.
- Randomization: This means that you are randomly assigned (by chance, like the flip of a coin) to a study group. For example, in some studies, you may be randomized to either the study medication or the placebo. This is done by computer at another site and the study staff have no control over randomization.
- Adverse Event or A.E: Any unwanted event that occurs during the clinical trial (side effect). You will be asked to report adverse events, even if you think it is unrelated to the study or study medication.
- Voluntary Participation: Your participation in any clinical trial is always voluntary. You can stop at any time, even after you have started.
What protections are in place for clinical trial participants?
Many steps are taken to ensure that research meets strict scientific guidelines and follows rules that protect you. Several groups who are not part of the research team examine both the scientific plan and procedures to protect the interests of participants before the research may begin. Each new study, including its provisions for the protection of study participants and its informed consent document, must be approved by an Institutional Review Board (IRB). IRB members are not a part of the research team and consist of medical and non-medical professionals. The IRB must follow strict federal guidelines when reviewing research to determine if it can be conducted.
What will the study team expect of me?
As researchers, the study team is interested in knowing everything good or bad about your participation in the clinical trial. We want to know your opinion about whether or not you are feeling better, worse or about the same. Your job in the study is to report as accurately as you can how you are feeling.
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