Clinical trials are research studies that explore whether a medical strategy, treatment or device is safe and effective for people. These studies also may show which medical approaches work best for certain illnesses or groups of people.
Clinical trials follow strict scientific standards, called protocols. These protocols protect patients and help produce reliable study results.
The process often begins in a laboratory (lab), where scientists first develop and test new ideas. If a new approach shows promise, doctors then test the treatment in people, usually in 3-4 phases.
- In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range and identify side effects.
- In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
- In Phase III studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug or treatment to be used safely.
- In Phase IV studies are done after the drug or treatment has been marketed. These studies continue testing the study drug or treatment to collect information about their effect in various populations and any side effects associated with long-term use.
You may be able to take part in clinical trials that include investigational drugs, diagnostic tests, or preventative measures. This helps in the development of new medicines and treatments that may offer better care for life-threatening and chronic diseases. Whatever your reason for participating, you will continue to receive quality cancer care from OHC.
Before you enroll in a study, talk to your doctor or nurse navigator. They can tell you about studies that match your situation, as well as any risks and benefits. You should also receive information about any financial obligations. Some questions you might want to ask about the research include:
- Why is this research being done?
- Who is sponsoring the study?
- Who has reviewed and approved this study?
- Why does the research team think the treatment, drug, or medical device will work?
- If I do not qualify for this clinical trial, are there others?
- Where is the study location?
- What kinds of therapies, procedures, and/or tests will I have during the trial?
- Will they hurt? If so, for how long?
- How will the tests in the study compare to tests I would have outside the study?
- How long will the study last?
- How often will I have to go to the study site?
- Who will provide my medical care after the study ends?
- Will I be able to take my regular medications during the trial?
- What medications, procedures or treatments must I avoid while in the study?
- Will I have to be in the hospital during the study?
- Will the study researchers work with my doctor while I am in the study?
- Can anyone find out that I am participating in a study?
- How do the possible risks and benefits of the study compare with approved treatments for me?
- What are the possible immediate and long-term side effects?
- What other treatment options do I have?
- Will I have to pay anything to participate in the study?
- Will my insurance most likely cover those expenses?
All of this information will be provided in writing in what’s called an Informed Consent Form.
You may receive a physical exam and your medical history will be reviewed. Once you’re enrolled in the study, feel free to discuss your medical care with your doctor or research staff at any time during the trial.
It’s important that you take all your medication as prescribed and keep all scheduled visits. It’s also important for you to answer questions honestly about how you feel or whether you’ve been taking your medication as scheduled. OHC study doctors need to record any symptoms, no matter how minor they may seem. If you miss a dose or do not take it on schedule, you should tell your doctor or the research staff.
Your Informed Consent Form will list the side effects of the medication used in your study. Because some medications are new, some side effects may still be unknown and could have implications.
After the Study
After the study is complete, your care may be followed every few months for many years to see how you’re doing. If you change to another health care provider, our research staff may contact you by phone.
Collected information is analyzed to help determine drug safety, effectiveness, and side effects. Food and Drug Administration (FDA) medical advisers and specialists closely review this data before considering any new drug for approval. After a drug has been approved by the FDA, studies continue to compare the new drug with other drugs already on the market. Other studies may research whether it can be safely administered to children or special populations, as well as its long-term effectiveness and impact on quality of life.