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 Caucasian, which means minority populations – African-Americans and Hispanics, in particular – are grossly under-represented. Racial and ethnic disparities have long been an issue in our country’s healthcare system, and it’s no different with clinical trials. There are several reasons for this, including access, economic factors and, for some, trust.
Resource: What other concerns do you typically hear from people who may want to apply for enrollment in a clinical trial?
Dr. Ahluwalia: Not everyone can afford to take the time off from work that participation in clinical trials requires, and not everyone has easy access to transportation to and from Miami Cancer Institute. Also, many of our patients come to their appointments with their caregivers, who themselves may have problems taking time off from work.
Resource: Is there a ‘technology gap’ when it comes to health care?
Dr. Ahluwalia: The exponential growth in telemedicine this past year has revealed a significant technology gap. We need to address the technological disparities in cancer care today, as some of our patients don’t have smartphones, computers or data plans, or they live in remote areas without internet service. We have to figure out how we can leverage our technology so that everyone who needs it has access to telemedicine.
Resource: What do you plan to do at Miami Cancer Institute to make clinical trials more inclusive?
Dr. Ahluwalia: Technology is already laying the foundation for the disruptive transformation of healthcare, and it will play an increasingly important role in clinical trials.
Our primary focus here at Miami Cancer Institute is on research innovation. And we couldn’t be more excited, because with Miami’s incredible diversity comes phenomenal opportunity to further our knowledge and develop new cures.
First and foremost, we want to leverage our unique patient population here to boost minority participation in our clinical trials and contribute nationally to such trial participation. We also working on developing virtual consent forms so that some of the administrative aspects can be handled by the patient at home. We need to cut down on red tape and bureaucracy, and make it easier for patients to access trials even if they can’t come in.
At the same time, we’re going to leverage existing technology such as wearable devices so that patients can be monitored from the comfort of their own homes without having to spend hours being observed following a treatment.
Resource: It sounds like you have your work cut out for you, Dr. Ahluwalia. What else is on your radar?
Dr. Ahluwalia: I’m working with my colleagues here at Miami Cancer Institute and at Lynn Cancer Institute in Boca Raton (also part of Baptist Health) to develop strategies that will help improve the healthcare disparities that exist in South Florida’s minority populations. It’s a process, and one that will take time and focus, but as our demographics continue to change we must find ways to reduce the health disparities that exist here and elsewhere. Providing easier access to health care is something we all need to be focused on.