Clinical Trials
Reid Cancer Center’s Phase 2, 3, or 4 clinical trials through the Dayton Clinical Oncology Program might provide you with a better option of care than standard therapies.
Clinical trials: Connecting you to new options for care
Clinical trials help oncologists offer new options for care to people with cancer. Some trials test the safety and effectiveness of new medications, medical devices, and other therapies before they become widely available to the public. Other types study existing cancer treatments to see how they can be improved or used to benefit a specific group of people.
Clinical trials at Reid Cancer Center
At Reid Cancer Center, we participate in Phase 2, 3, and 4 oncology clinical trials through the National Cancer Institute-funded Dayton Clinical Oncology Program. You don’t have to travel to Dayton to participate. You can receive all your care right here in Richmond, Indiana.
Enrolling in clinical trials
If you’re interested in participating in a trial, your oncology team can let you know if you’re eligible based on the trial’s inclusion criteria. Eligibility criteria could include your health status, age, sex, cancer type and stage, and previous treatments. Trials can address diagnosis and treatment, which means you can enroll in a trial at any point of your care — whether you have early or advanced-stage cancer — based on the trial’s goal.
Clinical trial phases
Trials are generally broken into these phases:
- Phase 0 trials: These trials are the first stage. They often look at whether and how a new treatment works. These trials involve a small number of people for a short time.
- Phase 1 trials: In phase 1, trials focus on safety. Participants receive varying doses of or exposures to a treatment to give researchers a good understanding of side effects and how the treatment affects the body. This phase has the highest risk of a treatment affecting participants negatively.
- Phase 2 trials: This phase of trials continues to test the safety of the treatment and begins to evaluate its effectiveness. These trials usually focus on a particular type of cancer and involve groups of 25 to 100 people.
- Phase 3 trials: Phase 3 trials compare a new medication, combination of medications, or procedure with the current standard of care. Participants are randomly assigned to the standard-of-care group or the new therapy group. These trials often enroll large numbers of people. In phase 3 trials, some participants receive a placebo (medications with no effect on your cancer), but they usually receive the new treatment at a later date.
- Phase 4 trials: These trials test new medications approved by the U.S. Food & Drug Administration (FDA) and focus on long-term safety, side effects, and effectiveness. The trials involve several hundred to several thousand people, giving researchers better insight into how new treatments affect people of different ages, sex, races, and ethnic backgrounds. Researchers can also learn more about whether a treatment is helpful when used with other therapies.
Types of clinical trials
Many clinical trials focus on treatment. However, others focus on:
- Preventing cancer with, for example, vaccines or lifestyle changes
- Preventing cancer from recurring in people who’ve already had cancer
- Screening and other forms of cancer detection
- Improving cancer diagnosis with new tests or procedures
- Improving quality of life during or after a cancer diagnosis
Depending on the type of trial, you or your family members might be eligible to volunteer even without a cancer diagnosis.
Are clinical trials safe?
The FDA works to protect all participants in clinical research studies from unreasonable risks. The agency sets safety and ethical guidelines researchers must follow to allow the studies to take place. For many clinical trials, an institutional review board monitors the research to protect participants’ health, safety, and rights.
You’ll never be forced to participate in a clinical trial. All trials require what’s known as informed consent — you must be made aware, in writing, of the study’s purpose, any possible side effects and outcomes, and the timeframe before you can sign up. You must sign a document stating you received and understand this information before agreeing to participate. You can also withdraw from a trial at any time.
Risks and benefits of participating in clinical trials
Clinical trials offer participants access to new medications that might offer hope when standard care hasn’t been effective. By participating, you can receive treatments that aren’t widely available, and you help improve future care for other people with cancer.
In addition, participating in trials gives you a more active role in your care, and trial sponsors might cover costs associated with treatment and follow-up care, depending on the type of clinical trial.
Nevertheless, as with any new medical treatment, risks might be involved. The treatment in the trial might not work for you, or you could develop unpleasant and possibly serious side effects. Clinical trials can also require more frequent visits and complex treatment regimens.
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