Educated Patient® Metastatic Breast Cancer Summit Clinical Trials Presentation: June 11, 2022

There is an urgent need to completely overhaul how clinical trials are conducted to ensure a diverse patient population is well represented in studies of new and emerging cancer therapies, according to an expert.

In fact, as Dr. Kevin Kalinsky expressed, clinical trials must be simplified and have standardized protocol requirements.

“Sometimes the entry criteria for patients are just so narrow that (the studies) don't actually have any real world implications,” Kalinsky, who is the director of breast medical oncology and the Glenn Family Breast Center at Winship Cancer Institute of Emory University in Atlanta, said during CURE®’s recent Educated Patient® Metastatic Breast Cancer Summit.

The goal, he said, is not only to expand patient access to clinical trials but also usher in a new standard where the medical field recruits, retains and supports a well-trained clinical trial workforce that is representative of the patient population it treats.

Lessons Learned From COVID-19

Kalinsky emphasized that some of the lessons the medical field had to learn during COVID-19 should continue into the future.

For instance, when appropriate, telemedicine should be utilized more often during clinical trials to expand access to a variety of patients with metastatic breast cancer. Additionally, he said, clinical trials should not be limited to tertiary cancer centers — meaning treatment facilities that are highly specialized in treating certain conditions.

Instead, Kalinsky pressed for clinical trials to allow for treatment in local facilities with centralized oversight and administration provided by a main research hub. 

READ MORE: Bringing Clinical Trials in Cancer Closer to Home

He explained it as a hybrid model. If executed properly, research partnerships with large cancer centers could be established. A local, or more commonly known as community, cancer center may have limited trial accessibility and research infrastructure. However, a partnership could establish a program where the non-academic centers can more easily participate in clinical trials, according to Kalinsky.

Resources to Find Clinical Trials

Kalinsky urged patients with metastatic breast cancer to view the website ClinicalTrials.gov when interested in searching for clinical trials that they could potentially enroll in. However, he cautioned those in attendance about a problem he sees with the resource.

“As an academic (doctor), I know how to navigate this system,” he said. “But I’m not so convinced that it’s easy for our patients. What I have seen from my own anecdotal experience is that patients will go on to the website, and sometimes it's tricky to even say, ‘OK, but what would be appropriate for me?’”

He continued and noted that patients should feel comfortable working with their providers to at least mention studies that they may have found on their own to see if their care team may think they’re a fit to enroll.

Long-term Improvements

In some clinical trials, blood draws and scans must be done at the cancer center the patient is receiving their treatment. Kalinsky asked if this process is necessary and wondered if a change could bring about better recruitment to trials. Moreover, he argued that patients shouldn’t need to be physically present at the institution to be prescribed medications.

“Why can’t we just ship (the medications) to the patient,” he said.

There was also a note about patient-reported outcomes while enrolled on a trial. He questioned if this practice could be increasingly done using electronic reporting rather than having the patient return to the cancer center to report their side effects. The problem with this, he said, is many IT departments at cancer centers are cautious of doing things electronically.

“That can just delay opening a study,” he said. “From the patient perspective, and for the reliability to see, ‘OK, well, how is the patient actually doing?’ For us to catch up with the times, is critically important.”

Addressing Inequities

Clinical trial enrollment for different races and ethnicities has decreased over the decade, according to Kalinsky. There was a report he highlighted that identified that Black participation in clinical trials studying novel cancer drugs reached 10% for only two of the 31 trials.

Kalinsky continued and discussed a few things he has seen in the space that are deeply disturbing to him.

“There were data that came out nationally (that) non-Hispanic Black patients are more likely to die from breast cancer compared to lung cancer,” he said. “And they're the only race for whom that is the case.”

Additionally, he explained other data that showed that a patient’s outcome from breast cancer is dependent on the zip code they live in within Georgia.

“That's happening in our own backyard,” he said. “And that is not specific, I don't think, to the state of Georgia.”

Complexities of Cancer Treatment Clinical Trials

Kalinsky concluded by expressing the need to focus on efforts to limit the complexities of cancer treatment clinical trials.

The focus should be on how to promote patient accrual and access while collecting data in a modern way to increase institutional participation.

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