What is a clinical trial?
A clinical trial is a research study designed to answer specific questions about new therapies or new ways of using known treatments and to determine if they are both safe and effective for people to use. Clinical trials follow a detailed treatment plan, or protocol that tells what will be done, rules about who can and cannot be in the study (such as age, sex, medical history) and how the results will be evaluated.
Why participate in a clinical trial?
People participate in clinical trials for various reasons. It allows for an active role in ones own health care, accessibility to new investigational treatments before they are available to the public, and helps to impact future healthcare.
Who can participate in a clinical trial?
Before joining a clinical trial, a participant must qualify for the study. A protocol defines the guidelines for inclusion/exclusion criteria based on the scope of the study, patient safety and study outcomes. Factors such as age, gender, and medical condition may determine who is allowed to participate or meets the “inclusion criteria” and those that are not allowed, called “exclusion criteria”.
What is informed consent?
This is a process in which a person learns the details about a research study, including potential risks and benefits, before deciding whether or not to participate. If a patient decides to participate in such a clinical trial, a written informed consent form is then signed. Sometimes when informed consent interferes with immediate emergency care, it can be deferred for a short time until the patient is stabilized.
Are the patient’s rights protected?
Choosing to participate in a clinical trial is an important personal decision. Every person asked to be in a research study has the following rights to:
- Know how the study is being carried out, for how long and where.
- Be told of all known risks and benefits of the treatment/s involved in the study.
- Be told of any alternatives to participating in the study.
- Be allowed to ask questions at any time.
- Be told what will be done if complications arise.
- Know of any costs involved.
- Refuse to participate or to change ones mind after the study is started.
- Receive a copy of the signed and dated consent form.
- Not feel pressured to participate.
For More Information on Clinical Trials: www.clinicaltrials.gov, http://www.ciscrp.org/
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