What is a Clinical Trial?
Medical research studies involving people are called clinical trials, or sometimes clinical studies. A clinical trial explores whether a medical strategy, drug, treatment, or device is safe and effective for patients. Studies can also look at other aspects of care, such as improving quality of life for patients.
Two Types of Clinical Trials
Interventional
Studies in which a treatment or other intervention is being given, and their outcomes are measured by the investigators.
Observational
Studies in which patients are observed and their outcomes are measured by the investigators.
Trials are divided into different stages, called phases. Each trial phase has a specific purpose and is designed to answer certain questions.
1
Determines a safe dose of the treatment under study (study drug), and monitors how the new treatment affects the human body.
2
Determines if the new treatment is seemingly effective, and monitors any side effects.
3
Confirms the treatment’s effectiveness, monitors side effects, and compares the new treatment with the current standard treatment or a control arm in a randomized controlled study.
4
Gathers more information on a drug or treatment after it has been marketed to see its effect in various populations and any side effects associated with long-term use.
Most studies are interventional studies. These will require administration of the study drug or treatment and a sequence of monitoring visits. Monitoring usually takes place under clinical conditions (in a clinic), and on rare occasions may require overnight stays.
Blood Tests
Urine Tests
Scans
Other Tests
Outlines what’s involved for the specific trial, however we encourage you to contact the trial coordinator, or the MAP nurse, who will be happy to talk through all the details, and answer any further questions you may have
Why Participate?
Participating in a clinical trial is an invaluable way to get excellent medical care and play a part in advancing research for better treatments and a cure for amyloidosis.
Amyloidosis is a rare disease, and trials can take years to accrue which can dramatically slow down the process of evaluating a drug’s effect. The good news is more and more patients like you are becoming empowered to take part.
So MAP is designed to make it easy for you to find available trials, and – where trials do not yet exist – inspire researchers to focus on new areas of study.
Myth vs Facts
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