January 19, 2021 by Carol Higgins
Cancer Clinical Trials: The Impact of COVID-19
Clinical research trials can be lifesaving for many cancer patients. They provide vital information necessary to continue the search for a cure, as well as for new medications, devices and therapies. But the COVID-19 pandemic has some cancer patients wondering if they are still eligible to participate in current clinical trials or, if they are already participating in one, whether they should continue.
The simple answer is yes ― under the right circumstances, said Scott Lipkin, DPM, chief research officer at Miami Cancer Institute.
“Oncology integrates cutting-edge research into everyday clinical care more than any other subspecialty,” he said. “Often, experimental drugs represent the latest and best hope when there are no other options left for a patient. It’s important to mindfully continue therapeutic clinical research during these times.”
The Institute offers trials for all types of cancer, including brain, breast, lung, ovarian, pancreatic and prostate cancer, in addition to multiple myeloma, leukemia and others. There are also studies available for pediatric patients. “We have about 150 open therapeutic studies at Miami Cancer Institute at the moment,” Dr. Lipkin said. The comprehensive program includes Phase 1/first-in-human trials and studies in which the Institute is the national lead facility.
The COVID-19 pandemic has put a focus on special precautions. While clinical trials already must meet strict federal regulations, the FDA has issued COVID-19 recommendations that principal investigators and treating physicians consider for each, individual patient participating in a trial.
Among key precautions at Miami Cancer Institute:
■ Each clinical trial patient visit is reviewed to determine if it is clinically necessary. “There’s a difference between a patient coming in for a scheduled questionnaire or exam, and a patient who is scheduled for an infusion,” Dr. Lipkin said. “We may be able to complete the questionnaire and exam via telemedicine ― either through a phone call or virtual visit. If an infusion is critical for care, then a patient should come in.”
■ If you are ill or have symptoms including fever, cough or shortness of breath, call your physician immediately. “Many cancer patients are immunocompromised and it is not in their best interest to receive an infusion that will lower their immunity even more,” he said. Again, communication between patient and staff is crucial.
■ If you have qualified for a study, but haven’t yet begun, have a conversation with your care team. Enrollment into some clinical trials is limited to patients who do not have alternative treatment options. It may be that you can begin the trial at a later date, Dr. Lipkin said. In general, everyone should do what they can to reduce their risk for coronavirus exposure and that means staying home unless you have emergent needs.
■ Those who monitor clinical trials for safety and compliance are developing ways to track study patients and statistics from afar.
New trials will continue to be opened if there is a compelling reason, such as emergency use and/or expanded access, allowing more patients to receive an investigational new drug outside of a clinical trial. Trials in the pipeline are moving through the preparation process so that they will be ready for launch when the pandemic is over.
Some pharmaceutical companies that sponsor clinical trials are reporting a slowdown or switch in operations to devote time to researching COVID-19 medications or vaccines. At this point, Miami Cancer Institute’s research program hasn’t been affected, but if that occurs, physicians will communicate with patients about their options.
Employees are well trained in safety precautions, as well as the clinical skills necessary for the job. Clinical trial participants, as well as other Miami Cancer Institute patients, go through a robust COVID-19 screening prior to office visits and upon arrival for their appointment.
“We have a great, dedicated and compassionate team of employees,” Dr. Lipkin said. “Our clinical staff, which includes research and infusion nurses and research coordinators and assistants, are not only working together to provide the best care for our clinical trial patients but are also assisting in employee health screenings and patient entry screenings. We are here for those who need us.”
Editor’s Note: Because every individual’s circumstance is different, please connect with your oncologist or medical provider for answers to specific questions related to your cancer care. If you are receiving care elsewhere, check with that facility’s medical staff for any specific instructions they may have.
For the latest updates on Baptist Health South Florida and Miami Cancer Institute COVID-19 news, click here.