When researchers develop scientific new treatments, they must first be proven safe and effective. Only then can new treatments earn U.S. Food and Drug Administration (FDA) approval.
Scientists earn FDA approval by conducting more research. They use clinical trials — human-based research studies — to show safety and effectiveness.
That’s where volunteers come in. Clinical trials rely on volunteers to take new treatments under medical supervision. Physician-researchers closely track each patient’s condition and monitor their safety.
When the trial ends, researchers analyze the data and then share their results with the scientific community.
Cancer clinical trials need volunteers who have a specific form of the disease. Other types of clinical trials may need healthy volunteers, too.
Think a clinical trial might be for you? Here’s what you need to know.
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Why Should You Consider Participating in a Clinical Trial?
Knowledge gained from clinical trials may lead to new treatments for a certain disease or condition.
Many people who take part in clinical trials end up benefiting from the experience. For example, their cancer might respond well to the study treatment. They also might appreciate knowing they’re contributing to science.
The National Institutes of Health suggests considering a clinical trial if you want to:
- Have the chance to get a new treatment before it is available to everyone
- Play a more active role in your own medical journey
- Receive top-notch medical care throughout the clinical trial
- Help others get better treatment options for this disease in the future
You may have other reasons to consider a clinical trial — especially if your doctor identifies a specific genetic mutation in your cancer. A clinical trial may be underway to test a targeted therapy or immunotherapy drug to treat that mutation. Many doctors believe drugs targeting specific mutations offer cancer patients the best hope.
Another reason might be that you’ve exhausted all approved treatment options for your cancer. Or your current treatment may have a low chance of success. And, if you are not tolerating the side effects of your current treatment well, you might want to try a new option.
Questions You Should Ask Your Doctor
If you are considering participation in a clinical trial, you should have a candid and in-depth discussion with your doctor. You’ll need a lot of information to decide whether to join a clinical trial. Here are some questions to ask:
- What will happen during the clinical trial? What procedures or tests will I receive? What medicines will I take? How long will the clinical trial last?
- Do I need to stop my current treatment? If the research is observational, meaning that it studies existing treatments, you’ll continue your current treatment. If the study tests a new treatment or treatment combinations, you may need to change medicines or therapies.
- Will I definitely get the experimental treatment — or could I instead receive the standard treatment or a placebo? The answers depend on what type of clinical trial it is. Some studies are called “open-label,” which means both doctors and patients know what treatment is given.
- What are the possible benefits of participating in a particular clinical trial? The treatment the trial is testing may shrink your cancer, or put you into remission. It may cause fewer side effects than your regular treatment. You may also have the good feeling of knowing the information gained from your trial will help others.
- What are the possible risks of participating in a particular clinical trial? Participating in a clinical research study does come with some risks. The new treatment might not work for you, or the side effects may be worse than those with your current treatment. Some risks are specific to each trial or your medical situation, so it’s important to talk with your doctor.
- Do I have to go to a different doctor or hospital/clinic as part of a study? If your doctor participates in the trial, you may be able to continue to go for care as usual. If not, you may need to get your trial-related care through another doctor, or at another location. You will return to your own doctor after the clinical trial ends.
- Is financial help available for childcare or transportation? Some clinical trials help with transportation or childcare so more people can take part in the study.
Choosing to take part in medical research is a big decision. Discuss your options with your doctor and your family. Their opinions can help guide you. But taking part in research is your decision. That’s why you need to understand both the risks and benefits of taking part in a cancer clinical trial.
U.S. Food and Drug Administration. Development & Approval Process | Drugs. Link
National Institute on Aging. Clinical Trials: Benefits, Risks, and Safety. National Institutes of Health. Link
Beth Fan Incollingo. 8 Questions to Answer Before Going On a Clinical Trial. Cure. Link
UPMC Healthbeat. The Value of Taking Part in a Clinical Trial. Link
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