For cancer patients who have complex cancers with limited options or who have exhausted all other treatment options, clinical trials can be a beacon of hope. Such studies offer often-desperate patients access to new, potentially lifesaving therapies that are years away from being available to anyone else. They also give pharmaceutical companies the opportunity to test the efficacy of new drugs before they can be approved by the U.S. Food and Drug Administration (FDA). Even so, recruiting participants for clinical trials can be a challenge, experts say, particularly in a pandemic.
Resource editors spoke with medical oncologist Manmeet Ahluwalia, M.D., MBA, an internationally recognized clinical investigator with Miami Cancer Institute who specializes in the treatment of brain tumors and brain metastases. As the renowned cancer center’s deputy director, chief scientific officer and chief of solid tumor medical oncology, Dr. Ahluwalia aims to bring greater diversity and innovation to clinical trials, and improved outcomes for cancer patients everywhere.
Resource: How has COVID-19 impacted clinical trials at Miami Cancer Institute?
Dr. Ahluwalia: Perhaps the biggest change has to do with how we recruit, monitor and communicate with patients in our trials. As a clinical investigator, you want to be able to keep a close eye on your patients to make sure they’re not experiencing any adverse effects. But with COVID-19, we also want to eliminate any unnecessary face-to-face appointments.
If there is a silver lining to the pandemic, it’s that it has helped focus awareness on the role telemedicine can play – not just in clinical trials but in the delivery of healthcare overall. Physicians and patients both are growing much more comfortable with telemedicine, and COVID-19 has only hastened its adoption several folds.
When we talk about pandemic-driven change, in the healthcare field we’ve probably seen a decade’s worth of change in just one year. It’s been amazing. A question I’m often asked is, “Will telemedicine put an end to doctor’s office visits?” I say, definitely not – patients enrolled in clinical trials still need to come in for lab work and infusions, of course. But at the same time, there is much that can be accomplished remotely via one’s smartphone or computer. This is especially helpful for patients who live far away, and it will make clinical trials more appealing and accessible for a larger, more diverse population.
Resource: What are some of the challenges you face when conducting clinical trials?
Dr. Ahluwalia: Pandemic aside, our biggest challenge can be recruiting qualified participants for clinical trials. One big challenge is diversity – minorities and elderly patients are often under-represented on clinical trials. As a result, the patients in these trials don’t always reflect the demographics of the general population, and their experiences and outcomes may not extrapolate to the population at large.
Resource: Why is recruiting people for clinical trials so problematic?
Dr. Ahluwalia: There are several reasons for this. The clinical trials tend to be highly selective about the patient population, or who qualifies for enrollment in trials. For example, most patients selected for trials are, on average, a decade younger than patients in the general population with the same disease. Might we see greater drug toxicities in an older population? Of course, but you wouldn’t know for sure unless the trials had been more age-inclusive or we have real world evidence post approval.
Resource: What are some other barriers to recruitment?
Dr. Ahluwalia: Currently, patients enrolled in clinical trials here in the United States are more than ninety percent…