The Importance of Clinical Trials in Cancer Care

By Dr. Leslie Bradford, Director of Research, GYN Oncology

Millions of Americans depend on medications. Over 4000 experimental drug therapies are active today, and that number will only increase in the future. Clinical trials are crucial to understanding a medication’s efficacy, side effects, as well as safety. As a clinician, I rely on data from clinical trials to help me make the best evidence-based recommendations for my patients.

My patients often ask if participating in a clinical trial will make them feel like a guinea pig, the subject of an “experiment”. Participation in a trial is completely voluntary and safety is our first priority when conducting a clinical trial. All trials are reviewed by our Institutional Review Board (IRB) and many undergo additional reviews through centralized IRBs if the study is being conducted at multiple sites. Trials are continuously monitored to make sure that data is being recorded accurately and that potential side effects are being reported and monitored appropriately.

Often times it is more about finding the right clinical trial for you. This may mean a clinical trial investigating a new chemotherapy agent, a clinical trial investigating a new tool for reporting symptoms related to chemotherapy, or it could be a study where you participate in an interview about your care so that we, as clinicians, can better understand the patient perspective and thus provide better care to YOU. Clinical trials allow us to provide cutting edge care while ensuring that there is a rigorous process in place to ensure your safety, and by participating in a clinical trial, patients help to advance the science and help the next person facing the same cancer diagnosis.

There are different types of clinical trials:

• Phase 1 clinical trials focus on safety and finding the right dose.

• Phase 2 clinical trials involve a larger number of participants and focuses on efficacy.

• Phase 3 clinical trials compare an investigational therapy to the standard of care.

My patients often ask, “What are the benefits of participating in a clinical trial?” and “What will the impact be?”

One of the greatest benefits is helping to advance the science and our knowledge about a specific disease or a specific medication. As an example, several patients in our clinic were among the 209 patients who participated in the GARNET trial sponsored by GlaxoSmithKline LLC. This clinical trial evaluated the safety and efficacy of Dostarlimab, a type of immunotherapy, in patients with certain types of advanced cancers. Their participation led to the FDA approval of this immunotherapy in women with a specific subtype of recurrent endometrial cancer, adding yet another option to our toolbox when treating recurrent cancer.

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Not everyone enrolled on a trial, however, will directly benefit from a study drug, but the knowledge generated will definitely help the next patient facing the same problem. For instance, patients in our clinic participated in an international trial of Atezolizumab (an immunotherapy), Bevacizumab (a monoclonal antibody, or type of targeted therapy) and standard chemotherapy in the treated of advancestage ovarian cancer. Over 1300 women participated this trial, sponsored by Genentech and the Gynecologic Oncology Group (GOG) Foundation. This study showed that immunotherapy did not improve overall survival compared to standard of care chemotherapy alone. While we often refer to trials like this as a “negative trial”, knowing that a medication does not benefit our patients is just as important as making new drug discoveries.

Whether or not a hospital system offers clinical trials can also be a reflection of the overall quality of care provided at that institution. Hospital systems actively involved in research and clinical trials are more likely to provide care that is in accordance with national guidelines. Clinical trials can also provide access to critical chemotherapies that are effective, but not yet widely available.

Facing cancer is a terrifying experience. I am so grateful to the women who have helped us to advance the science, to provide answers and options, and hopefully provide comfort and assurance to other women and their families who are just starting on their cancer journey. If you are interested in learning more about clinical trials in general, I highly recommend the resources available through the Foundation for Women’s Cancer and Society of Gynecologic Oncology. At MaineHealth we strive to open trials that we think will best benefit our patients. If you are interested in participating in a clinical trial closer to home, please talk with your provider, or access the following link: https://redcap.mmcri.cloud/surveys/?s=XYFHECT94C

As you consider treatment options for yourself or your loved one, you may consider participation in a clinical trial. Click here to access more information and see a list of open clinical trials locally: For Patients - MHIR (mmcri.org). For a complete list of trials open in the U.S. and abroad, visit www.clinicaltrials.gov.