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What is a clinical trial?
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A clinical trial is a research programme carefully designed to evaluate the effects of a medication, medical treatment or device on a group of volunteers. Clinical trials are an important step in the research and development process to make new medications available. These trials measure the drug's ability to treat a condition, its safety, and/or its possible side effects.
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What is an observational study?
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An observational study is a research programme that contains an element of prospective data collection. This includes registry studies and patient/healthcare provider surveys. Observational studies are conducted by a general physician in normal daily clinical practice and as such observational studies are an important step in collecting e.g. information on adverse events.
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What is the difference between a clinical trial and an observational study?
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The difference between a clinical trial and an observational study is the assignment of volunteers to a treatment. In a clinical trial the assignment to the intervention under study is done according to the protocol specifications, whereas for an observational study the assignment is done by the investigator.
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Who can participate in a clinical trial?
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Each trial has specific requirements of the volunteers such as age, sex or medical condition. Each physician who is conducting the research reviews each volunteer’s medical history to determine whether he/she is eligible to participate based on specific criteria.
Before a volunteer can participate in a clinical trial, he/she must read and sign an informed consent form.
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What is an Institutional Review Board/Institutional Ethics Committee (IRB/IEC)?
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An Institutional Review Board/Institutional Ethics Committee (IRB/IEC) is a group of people that includes healthcare professionals, scientists and lay people from the local community. This group carefully reviews the trial to ensure the safety and rights of each participant. Some IRB/IECs have patient advocates to answer questions.
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How can I be enrolled as a trial participant?
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If you are interested in investigating your opportunity to be a trial participant in a given trial listed in our trials registry, please submit the information requested in the contact form. For trials in the US, please call our toll-free phone number. You can find the access to the contact form or the toll-free phone number under the individual trial registration.
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