Doctor’s Advice: What You Need to Know About Clinical Trials
If you have been diagnosed with cancer you probably have thought about joining a clinical trial. But if you’re like most patients, you have questions.
If you have been diagnosed with cancer you probably have thought about joining a clinical trial. But if you’re like most patients, you have questions. We talked with oncologist Jame Abraham, MD, about common inquiries doctors of all specialties find themselves addressing about clinical trials:
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A: In clinical trials, no patient will be given a sugar pill when there is a proven effective treatment. When there is no effective standard treatment for patients in very advanced stages, trials may be designed with placebo only. But, in general, placebo-controlled trials will include a standard treatment option. If there is a placebo, that will be discussed with you up front, and you should ask your doctor about the pros and cons of that approach.
A: That’s an important question. The sponsor of the trial will pay for most trial-related expenses. You should ask the research team that question upfront; they can clarify. Typically, the insurance company covers the standard-care aspect of the clinical trial; however, this can vary among insurance plans and states. We encourage you to inquire, as participating in clinical trials should not cause a patient extra financial burden.
A: Phase I trials focus on side effects. Those trials are “first-time-in-human” trials. However, for any new drug, we have a very good idea of potential side effects before we introduce it to patients. In addition, the clinical trial team — especially the research nurses — will be watching you like a hawk to make sure you’re not experiencing any serious side effects. Once the side effects are noted, various mechanisms are in place to make sure they’re promptly addressed and, if needed, that the dose is modified. Clinical trial teams take side effects very seriously to ensure patients are protected.
A: Yes. There are many mechanisms for informing patients; it varies with different trials. If a trial is closed early due to a major benefit from the new treatment, the patients on the control arm may be informed or allowed to cross over to the new treatment. After a trial is completed, sometimes the study team will write individual letters to patients with the results of the study. Your research team can always update you on the progress of the trial. When there’s an exciting result or breakthrough new medicine, and you hear that in the evening news, you can feel proud to have been part of history!
A: The first step is to talk to your doctor and find out if there are trials available at the center where you’re being treated. If not, ask about the most exciting development with that particular diagnosis (in patients with BRCA mutation, look for a PARP inhibitor trial; in patients with melanoma, look for an immunotherapy trial). Once you find out the promising treatments for that diagnosis, you can go to clinicaltrials.gov to find existing trials in the United States. At that site, you can choose phase I, II or III trials; your doctor can determine that. It’s OK to get a second opinion from a large center and from an expert in that field.
A: There is an element of uncertainty in most of the trials. If we know the answers completely, there’s no need to do the trials. The level of uncertainty could vary, depending upon the phase of the trial. Your study team, doctor and research nurse can help you understand the level of uncertainty of the trial.
A: In oncology, specifically, there are clinical trials for stage I through stage IV cancers. Since cancer treatment is far from perfect, we’re always looking for opportunities to improve treatment options for every stage of a cancer diagnosis, not just late stage. Many stage I or II cancers can become metastatic stage if we don’t treat or prevent it early on, which is why clinical trials are important for early-stage cancer patients, too. Clinical trials are never a last resort; they’re the gold standard treatment for any stage of cancer.