Cancer Clinical Trials 101
May 9, 2018
If you’re like most people, a clinical trial sounds like one of those mysterious things best left to doctors and scientists. But when you’re faced with a cancer diagnosis, participating in a clinical trial can mean having access to the most innovative research, medication, and care. We asked Matthew Carlson, M.D., Assistant Professor in the Division of Gynecologic Oncology at UT Southwestern, to answer some of the most common questions about this treatment option. Read on to learn more and find out whether you might be a candidate.
Timeline of a clinical trial
Cancer clinical trials involve a series of phases. If a new treatment is successful in one phase, it moves on to the next. But before a patient can participate in a clinical trial, he or she must be screened to ensure it would be safe to enroll. The time from diagnosis to screening to enrollment to actual treatment can vary based on the trial, according to Matthew Carlson, M.D., Assistant Professor in the Division of Gynecologic Oncology at UT Southwestern. “We can usually screen patients at the time of diagnosis,” he says. “There is generally some testing required prior to enrollment and treatment, and this usually takes a few days to a few weeks.” During the first two phases, researchers find out if a new treatment is safe, what side effects it has and whether the treatment has any benefit to the patient. “Many of our trials now use information gained from tissue,” Dr. Carlson says. “The time from diagnosis to surgery or biopsy is usually a few weeks, and this may add to the wait time for treatment.” Phases three and four compare the new treatment with current treatments and study the long-term effects of treatments already approved by the Food and Drug Administration. “Most cancer clinical trials involve imaging every few months to assess response to the drugs,” Dr. Carlson says. “As long as there is some response and the patient tolerates the drugs, the patient will generally continue the treatment. This can be for months or years, depending on the trial.”
Q. What are the potential benefits of joining a clinical trial?
Dr. Carlson: Cancer clinical trials test new ways to treat cancer, find and diagnose cancer, prevent cancer, and manage symptoms or side effects from cancer treatments. Clinical trials offer the benefit of patients being able to receive a drug that is not commercially available. There is also an advantage to future patients who will receive improved treatments created from the knowledge gained in the clinical trial.
Q. What are the potential side effects and risks?
Dr. Carlson: Both depend on the drug or treatment used in the trial. All known side effects and risks are outlined in the consent form you will receive upon joining. Some particular risks to keep in mind: The new treatment may not be better than, or even as good as, the standard treatment that patients receive. And new treatments may have side effects that doctors don’t expect or that are worse than those of standard treatment.
Q. How could the trial affect my daily life?
Dr. Carlson: Just as the agents vary, the dosing schedule will vary from trial to trial. Also, you may be required to make more visits to the doctor than if you were receiving standard treatment, which could lead to extra expenses such as travel and child care costs.
Q. Is there someone I can talk to who has been in the trial?
Dr. Carlson: While there isn’t a formal program in place, if both patients agree, we are more than happy to connect them with each other.
Q. What happens if I decide to leave the trial?
Dr. Carlson: We hope that our consent process will give patients a good understanding of what they can expect from the clinical trial, but if after beginning the trial you decide not to continue, you can leave the trial at any time.
Q. How will I be told about the trial’s results?
Dr. Carlson: Clinical trials take years to accrue and for results to mature. The outcomes being measured are usually time to cancer progression and overall survival, which are measured in months or years. There is not generally a set way to notify patients of the results of a clinical trial, but more effort is being put into this at the federal level. Presently, clinicaltrials.gov requires reporting results to their website within two years of the primary endpoint being achieved. Therefore, while many of our studies don’t outline a process to inform individual participants, the government is making efforts to ensure the results of clinical trials become more transparent.
Q. How can I join a clinical trial at UT Southwestern Medical Center?
Dr. Carlson: Any physician at UT Southwestern should be aware of clinical trials available to his or her patients — just ask! Patients can also register through MyChart for the “Count Me In” initiative, search our Cancer Center and StudyFinder sites, or call the Cancer Answer Line.