Evolution of Clinical Trials

AVBCC Highlights

Bruce Feinberg, DO, CEO and Vice President of Clinical Affairs, Cardinal Health Specialty Solutions, opened the conversation by sharing his thoughts on the evolution of clinical trials. “When we think about the modern era of clinical trials, we’re really only talking about the past 50-60 years,” he said. “And it was only about a decade ago that we started to recognize there were problems with the methodology…patients in trials are not diverse, they’re not representative. They’re younger, they are healthier, and the list goes on and on.”

He adds that this is particularly true in today’s era of precision medicine, where the trial deeds are for smaller and smaller populations.

When looking at changing the paradigm, cost is another item that must be taken into consideration. Trials are being completed in half the time, but no less cost. How do we address this? And finally, how can we make research a strategic priority among community practitioners?

The latter question drew a passionate response from panelist Maurie Markman, MD, a Medical Oncologist with City of Hope, who shared that the information overload—caused by increasing knowledge around rare genetic mutations and other advances—is making it “absolutely impossible for medical oncologists today to care for patients.”

“We will not move forward until we figure out how to deal with this incredible increase in knowledge, [let alone] how patients process it in a 10-minute consult,” he said.

Community Oncologists Are Central to the Solution

The panel agreed that bringing trials to community oncologists who are caring for patients, allowing them to identify patients quickly and easily for trials, helping them manage and sort through the overwhelming amount of information available, as well as reducing administrative burden is a good place to start to improve access and participation in clinical trials.

“It’s great that we have so much information coming in and the evolution of science is wonderful, but there has been a big gap in where that information sits and how it gets into patient care and clinical research,” said Sibel Blau, MD, Medical Oncologist and CEO and President of Quality Cancer Care Alliance (QCCA) Network. “At QCCA we’re looking at ways to centralize the data, make sense of it, and communicate it back to the community oncology practices.”

“I’m married to a community oncologist and over the last 20 years, I’ve seen how the complexity of routine patient care has evolved as much as the complexity of clinical trials,” said Mark Lee, MD, PhD, Medical Oncologist and CEO and Founder of NPower Medicine. “We have to think of things strategically and holistically. It’s a great opportunity to think about this concept of clinical research as a care option and we have to create the time for physicians by providing infrastructure, staff, and resources to even make this possible.”

Dosing Optimization and Other Opportunities for Advancement

Elizabeth Garrett-Mayer, PhD, Biostatistician and Vice President of the Center for Research and Analytics at the American Society of Clinical Oncology, raised the idea of dosing optimization and the opportunity that exists in this area for clinical trials.

“Drugs are given to patients at doses that are too high, and with targeted agents and immune oncology agents, there’s really no reason to think that the maximum tolerated dose is the optimal dose,” she said. “For a long time, biostatisticians have been saying that 3+3 designs are wrong. So, as cancer becomes a more chronic disease—and patients need to stay on treatment longer—we need to start thinking about the doses and schedules that patients can tolerate, instead of how quickly can we get a dose to take to the next trial phase.”

The group also discussed ideas such as concurrent management of patients with standard of care, offering protocols of FDA-approved drugs for off-label use to patients across different cancer types through community sites, using AI and machine language to expedite the processing of information and patient identification, and the simplification of required data and data collection.

The panel agreed that cost is one of the leading factors that hinders clinical trials and oncology care in general. Dr. Feinberg raised the Inflation Reduction Act as the first piece of legislation to really address not only the costs of clinical trials but also the lack of diversity. Other members of the panel felt that the solutions discussed could ultimately reduce costs and would be beneficial, whether or not cost was reduced.

The legality of some of the solutions was brought into question by Dr. Markman, who stressed that current HIPAA laws and regulations make ideas like clinical trials as standard therapeutic care and the sharing of patient data are illegal. He suggests that some of the rules and regulations need to be modified, whereas others suggested appropriate patient consent could cover at least some of these areas.

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