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Clinical Trial Acronyms - a list of acronyms and their definitions.
Clinical trials are an important part of learning about a disease and providing adequate and sometimes ground-breaking ways in which to treat the condition. It is important to understand exactly what a clinical trial is and how you might consider taking part.
What is a clinical trial? A clinical trial is considered a biomedical or health-related research study. There are two designations for these studies; interventional and observational.
Interventional studies are those in which the participants (research subjects) are assigned to a specific treatment or intervention by an investigator/doctor. Participants are carefully monitored and the outcomes are measured.
Observational studies are just that. Participants are observed and their outcomes are measured by an investigator.
Why take part in the process? Being part of a clinical trial is just one way of taking a more active role in your own health and CML journey. Through a trial, not only can you gain access to therapies that might not be widely available or currently on the market. Additionally, you are contributing to medical research and allowing the investigators to gain greater insight into the treatment of your disease.
How do I get involved or participate? Each trial has certain guidelines that must be followed. Certain criteria is used to ensure that the research done will provide reliable results, thus participants must meet certain inclusion or exclusion criteria. These criteria may include factors such as age, gender, disease stage, previous treatment history, or other medical conditions. It is important to realize that these criteria are not used to include or exclude you PERSONALLY, they are used to identify appropriate candidates and to ensure the safety of those participating.
How does a trial work/what happens? First off, you will be assigned a trial team, which may include your present doctor. Others involved are nurses, social workers, and other healthcare professionals. The team will evaluate your current state of health and give specific instructions on participation. Additionally, they will monitor you closely during the trial and stay in touch with you after the trial is completed.
Some trials involve more tests and doctor visits than you might normally experience when seeking treatment for CML. It is important that you understand that strict adherence to the trial protocol is not only important for the research team and study, it is important for your health and safety.
What is Informed Consent? Prior to your agreeing to take part in a clinical trial, you will be informed of all details so that you can make the decision that is right for you. The information will give you key facts about the trial, including details of the study, its purpose and duration, required procedures, and key contacts. You will also be asked to sign an Informed Consent Document that outlines the potential risks and benefits of the study. Although you must sign this document to take part in the trial, the document is NOT a contract and you may withdraw from the study at any time.
What are some risks and benefits of participating? As with anything in life, there are risks and benefits. Carefully considering these items are important to insure that you are fully informed about what will take place in the trial.
Benefits - clinical trials that are well-designed and executed are the best approach for participants to:
- take an active role in their own health care.
- gain access to new treatments before they are widely available to the general public.
- obtain expert medica care at leading health care facilities
- help others by contributing to medical research
Risks - although every precaution is taken, there are risks associated with participating in a clinical trial.
- possible serious or even life-threatening side-effects to experimental treatment
- unpleasant procedures
- the treatment may not be effective for you
- the protocol may require more time and attention that non-protocol treatment, including more treatments, trips to a study site, hospital stays, or complex dosage requirements.
Things to consider before participating in a trial. You should know as much as possible about any trial you are considering. Ask members of your care team questions about the trial, what type of care can you expect during the trial, and the costs involved. Here are some questions you might ask:
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective and 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?
- Will hospitalization be required?
- 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?
- How will I know that the experimental treatment is working? Will results of the trial be provided to me?
- Who will be in charge of my care?