Guest Blog Post: Understanding Clinical Trials
Today's blog post was researched and written by CancerCare intern, Alessandra Newton. Alessandra is a Prep for Prep student. She is currently a senior at Syracuse University and is a Biology major. She is a premed student and is interested in obstetrics and gynecology.
Clinical trials are research studies in which people may volunteer to evaluate a new treatment. They help further cancer research every day. Trials are open to many people at different stages in their cancer experience.
How do they work?
Clinical trials are used to study a new drug, treatment, technique, or to study different aspects of a disease. They are typically conducted using phases. Each phase is used to asses a different component of the research and development process. Knowing the phase of a clinical trial can give you an idea of where researchers are in the development process.
It’s important to note that no patient receives a placebo (a look-alike containing no active ingredient) when there is a standard treatment available. Most clinical trials are designed to compare a new treatment to a standard treatment to find out whether the new treatment has any added benefit.
Eligibility
Not everyone will qualify for a clinical trial. But for those that do, every clinical trial has a different set of guidelines for who can and cannot take part in the trial. These guidelines are called eligibility criteria. Eligibility criteria are used for safety precautions and to reduce differences in participants that can affect trial data.
What are your rights?
Being a part of clinical trials is voluntary and there are many steps before and during the trial to help ensure safety. Risks are a factor in any study, but efforts are made to reduce participant risk. Participants are primarily protected by informed consent. This is the process that ensures participant understanding of potential risks, benefits, and other aspects of the trial.
Your rights as a clinical trial participant include:
You will be asked to sign a consent form indicating your understanding of the clinical trial and showing your willingness to participate.
You will have the opportunity to review the study protocol, which describes the study in detail.
You have the right to leave a clinical trial at any time during treatment. If you decide to leave a trial after you’ve decided to take part in one, talk with your doctor and the primary researcher of the trial.
Consulting your oncologist and other members of your healthcare team will help you weigh the risks and benefits of a clinical trial, but only you can make the decision to join a trial. If you are considering participating in a clinical trial, these resources may be helpful to you:
American Cancer Society:Clinical Trials: What You Need to Know
American Cancer Society:Clinical Trial Patient Worksheet
CancerCare:Clinical Trials Fact Sheet
National Cancer Institute:NCI's Clinical Trials Programs and Initiatives
National Institutes of Health:ClinicalTrials.gov