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

According to experts, there is an urgent need to completely review how clinical trials are conducted to ensure that diverse patient populations are well represented in emerging cancer treatment studies. is.

In fact, as Dr. Kevin Karinsky said, clinical trials need to be simplified and have standardized protocol requirements.

Karinsky, director of the Breast Cancer Oncology and Glen Family Breast Cancer Center at the Emory University Winship Cancer Institute, said, “If the patient’s admission criteria are so narrow that (the study) has no real impact. There is. ” Mentioned at CURE®’s recent Educated Patient® Metastatic Breast Cancer Summit in Atlanta.

The goal is not only to increase access to clinical trials for patients, but also to signal the arrival of new standards to recruit, maintain and support a well-trained clinical trial workforce that represents the patient population treated by the healthcare sector. That is.

Lessons learned from COVID-19

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

For example, where appropriate, telemedicine should be used more frequently during clinical trials to increase access to different patients with metastatic breast cancer. In addition, he said clinical trials should not be limited to tertiary cancer centers, that is, treatment facilities that are highly specialized in the treatment of specific conditions.

Instead, Karinsky sought clinical trials to enable treatment at a local facility with intensive monitoring and control provided by a major research hub.

read more: Bringing cancer clinical trials closer to home

He described it as a hybrid model. If done properly, it can establish research partnerships with large cancer centers. Cancer centers, known locally or more commonly as communities, may have limited access to trials and research infrastructure. However, according to Karinsky, the partnership will make it easier for non-academic centers to participate in clinical trials.

Resources for finding clinical trials

Kalinsky encouraged patients with metastatic breast cancer to visit the website ClinicalTrials.gov if they are interested in searching for clinical trials that may be enrolled. However, he warned attendees about the problems he saw with the resources.

“As a scholar (doctor), I know how to navigate this system,” he said. “But I’m not so convinced that it’s easy for our patients. From my own case experience, what I’ve seen is that patients visit a website,” OK. But what’s right for me? “Can be difficult to say.

He goes on to say with their providers to at least mention the studies they may have found on their own to see if their care team might think they deserve to be enrolled. He said that working together should feel comfortable.

Long-term improvement

Some clinical trials require blood sampling and scanning at the cancer center where the patient is being treated. Karinsky asked if this process was necessary and wondered if the changes could lead to better adoption in the exam. In addition, he argued that the patient did not need to be physically present at the facility to be prescribed the drug.

“Why can’t we ship (medicines) to patients,” he said.

There was also a note about the results reported by the patient while enrolling in the study. He wondered if this practice could be done more and more using electronic reporting rather than returning to the cancer center to report side effects to the patient. The problem with this is that many IT departments in cancer centers are cautious about doing things electronically.

“It may only delay the opening of the study,” he said. “From the patient’s point of view, and to confirm reliability,” OK, well, how are patients actually doing? “It’s very important for us to keep up with the times. “

Dealing with inequality

According to Kalinsky, enrollment in clinical trials of various races and ethnicities has declined in 10 years. Blacks’ participation in clinical trials investigating new anticancer drugs reached 10% in only two of the 31 trials, he emphasized.

Karinsky went on to discuss some of the things he saw in space that bothered him deeply.

“Data have been published nationwide that non-Hispanic black patients are more likely to die of breast cancer than lung cancer,” he said. “And that’s only true for them.”

In addition, he explained other data showing that the outcome of patients with breast cancer depends on the zip code that lives in Georgia.

“It’s happening in our own backyard,” he said. “And I don’t think it’s unique to Georgia.”

Complexity of clinical trials for cancer treatment

Kalinsky concludes by expressing the need to focus on efforts to limit the complexity of clinical trials for cancer treatment.

We need to focus on how to promote patient outbreak and access while collecting data in the most up-to-date ways to increase organizational participation.

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