Clinical Trials Facts You Should Know
contributed by Nicole Fawcett; first appeared on the Michigan Medicine Health Blog
Why you should consider participating in a clinical trial and what to expect from the experience.
For people with cancer or other serious health conditions, volunteering for a clinical trial is a way to make an important contribution to the future of medicine.
A clinical trial is a research study that helps doctors and researchers learn about new ways to prevent, find and treat a disease or condition. The knowledge gained from clinical trials can help improve the quality of health care over time.
Today, thanks to patients who volunteered for studies, we have a range of treatments that can cure or delay the progression of cancer for many years. We have also learned better ways to manage cancer symptoms through clinical trials.
“You might want to join a trial either to get access to a study treatment, or to contribute to knowledge that could improve the health of other patients with a similar condition to yours,” says Anne Schott, M.D., associate director for clinical research at the University of Michigan Rogel Cancer Center.
Here are six things you need to know about participating in a clinical trial:
1. Safety is the top priority
To protect your safety, researchers must go through many steps to prove the treatment or intervention being studied is as safe as possible and might be better than standard treatments. This starts with many years of research in the lab, looking at how the treatment works in cells and animals.
For all clinical trials, the study team develops a detailed plan called a protocol, which explains how the study will work and the possible risks and benefits. The team also must get approval from an Institutional Review Board, or IRB. This group is tasked with protecting people who join studies. They review the plans and monitor the study to ensure safety.
If at any point the research team or IRB suspects that the risks of the study intervention outweigh the benefits, they will stop the study immediately and you will be informed.
2. Everyone in a clinical trial gets quality health care
There’s no guarantee that a study treatment or intervention will benefit the participant. The study intervention may not cure an individual’s cancer or extend their life. But researchers will offer only a study treatment if they believe the outcome will be at least as good as the standard treatment.
There are three phases of clinical trials:
- Phase 1 trials are intended to determine the best dose and schedule of a study treatment. The focus of these trials is on understanding the side effects, although many patients have also directly benefitted from the study treatments in Phase 1 trials.
- Phase 2 trials are designed to look at how effective the study intervention is and what side effects people experience. The goal is to get an idea of whether the study treatment may be more promising than the standard alternatives.
- Phase 3 trials are designed to directly compare a study treatment with the usual treatment of the disease or condition. In these trials, people are often randomly assigned to receive the study treatment or the usual treatment.
Sometimes, a placebo — a harmless pill or injection that looks the same as the actual treatment but has no effect — may be used.
In cancer care, these are rarely used, but could be part of a study if there are no known treatments that work (in other words, if standard treatment means no treatment.) Placebos may also be used if the new treatment is being added to a standard treatment. One group would receive the new treatment and the other would not, but both groups would be receiving the standard treatment.
The research team must tell you if a study uses a placebo.
3. Clinical trials help future patients
When you join a clinical trial, you help add to the knowledge base of the best way to prevent, find and treat disease.
Many people join clinical trials because they hope the study treatment will help them more than the usual treatment. There is a chance this could happen, but it’s not guaranteed.
Every clinical trial helps us make progress. Even though researchers expect the treatment they are testing will be better, clinical trials are necessary to prove that.
4. Being in a clinical trial is your choice
Only you can decide if you want to participate in a clinical trial. Your doctor and research team can help you understand your options and answer questions about the study. You should also discuss your options with family or friends. But in the end, consider your own goals and values to decide if a clinical trial is right for you.
If you join a clinical trial, you will be asked to sign an informed consent, stating that you agree to participate and understand the possible risks, benefits and costs. You can and should ask as many questions as you want and take the time you need to decide.
If you later decide you do not want to participate, you have the legal right to withdraw from a clinical trial at any time for any reason. If you decide to withdraw, your provider will continue to treat you using the best standard therapies available.
If you choose not to participate in a clinical trial, you will still receive the best possible care for using standard treatments. You will not disappoint your doctor, even if they encouraged you to join.
5. Clinical trials should not cost you more
Clinical trials may be sponsored by federal agencies like the National Institutes of Health or by private pharmaceutical or biotechnology firms. Some trials are sponsored by the Rogel Cancer Center or other academic cancer centers.
For any procedure or study medication that is only being done for research, the sponsor will cover the costs. Most treatment trials also include standard tests or other procedures. Insurance plans usually cover the cost of tests and procedures that are part of standard medical care.
Before deciding to participate in a clinical trial, it is important to know exactly what will be covered by the trial's sponsor. Check with your insurance company to be sure they will cover the costs of standard health care procedures before you agree to volunteer.
Most cancer clinical trials do not provide payment for study volunteers. Some trials do offer a small stipend or reimbursement for certain travel expenses, child care, lodging or lost wages. The study team will include this information in the informed consent document.
6. Diversity makes clinical trials better
All types of people are needed to enroll in clinical trials: young, old, all races and ethnicities. This is the only way we can make progress for all patients.
Anyone can develop cancer. Having a diverse group of participants helps us learn whether something works for all patients or just some. This is how we improve care for everyone.
Every trial has eligibility criteria, which are rules about who can and cannot join a trial. They are designed to keep people safe and help researchers understand the results more clearly.
Certain things can stop people from being eligible for a specific trial, such as having another disease or receiving a previous treatment.
Many cancer patients think they cannot participate in a clinical trial unless standard treatments stop working. This is not true. Many experimental drugs and treatments work best in the early stages of cancer. Whether you are newly diagnosed or poised to begin a new treatment, ask your doctor if a clinical trial is available for you.
How to find a clinical trial
ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world.
For cancer trials, visit the Find a Clinical Trial webpage on the Rogel Cancer Center site; or other National Cancer Institute-designated cancer centers. Call the Cancer AnswerLine™ to speak to an oncology nurse about clinical trial options: 800-865-1125.
UMHealthResearch.org lists trials open across Michigan Medicine, including studies for specific conditions as well as those looking for healthy volunteers.