Why is clinical research so messed up and how can it be fixed?

From left: Dr. Michael Kolodziej of Flatiron Health, Dr. Gregg Shepard of Tennessee Oncology, Dr. James Hamrick of Flatiron Health, Dr. Cary Presant of City of Hope Medical Center, Melissa Pool of the Center for Cancer and Blood Disorders

Dr. Michael Kolodziej was set to moderate a talk on developing a new infrastructure for conducting clinical trials with cancer patients. Instead, the former lead of Aetna’s oncology program and currently national medical director for New York-based health IT company Flatiron Health took his seat, looked at the panel, and then announced to the crowd he was renaming the talk.

“Why is clinical research so messed up?” he asked. “And how can we fix it?”

Kolodziej’s made his presentation, which included four other oncology experts, during the Association of Community Cancer Center’s 43rd annual meeting in Washington D.C. this week. But the reason for changing the name of this talk to the two questions Kolodziej asked quickly became apparent to the audience. After all, there’s no point in talking about a new infrastructure for clinical trials without first tackling their current troubles.

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Narrow eligibility criteria, financial feasibility, and the impediment of sheer geography are three problems that repeatedly reared their heads during the 45-minute discussion.

For Melissa Pool, a registered nurse and clinical research director at the Center for Cancer and Blood Disorders near Dallas, the geography angle was an early sticking point, especially in a state that’s as large as Texas.

“The difficulties we have are getting clinical trials out to rural communities,” she said.

Dr. Cary Presant of the City of Hope Medical Center near Los Angeles, Calif., added that part of the current challenge of conducting clinical trials is just finding appropriate trials workable at particular community sites. Presant’s group currently has about four sites with two staff at each prepared to do clinical trials. But financial feasibility remains a question in a way it isn’t for a hospital or large medical center that has the full-time staff and the resources to conduct trials.

“We find that the amount of discretionary funds to be able to do clinical trials is rapidly diminishing,” Presant said. “Unless you have a large practice, clinical trials might be a loss leader.”

There’s also something to be said about finding the perceived “perfect patient” to participate oncological trials.

“At the point of care of enrolling patients, the number one barrier is the availability of a trial to fit that patient and narrow eligibility criteria,” said Dr. Gregg Shepard of Tennessee Oncology, a large oncology group with about 100 physicians.

Of course, the whole point of conducting clinical trials is to test the efficacy of new drugs or treatments, which might be a boon to cancer patients willing to take risks in the course of their treatment programs.

But it’s often more difficult to enroll most cancer patients in clinical trials. Present said many drug companies want patients without comorbidities or without prior cancer. Most cancer patients do have comorbidities that they are treating in tandem with their cancer.

The overarching problem, it seems, is that clinical trials in their current state aren’t exactly representative of the population of people in the U.S. who have cancer.

Where there does appear to be some hope for the future of clinical trials is in the continuing digitization of health, something that Dr. James Hamrick, a practicing physician with Kaiser Permanente Georgia and senior medical director for Flatiron Health touched on. The data that doctors enter at the point of care, the routine that goes into all cancer patient encounters, can be harnessed to guide clinical trials. This can be done in a retrospective way — by gathering patient data in the aggregate, and then analyzing it to get a real-time, big-picture sense of cancer care in the U.S. It can also be done in a prospective way, by using the data to inform whether eligibility criteria of future trials should be loosened.

“It’s one of the promises of the digitization of healthcare,” Hamrick said. “It’s also part of the implicit bargain we make with patients when we click away on computers in the exam room with patients. There’s an assumption that the data we’re putting into the computer is going somewhere and being used to help other cancer patients.”

Using medical data will never replace the randomized clinical trial, Hamrick said. But with data, doctors in the future can stay one step ahead of trials by understanding who among their patients would be eligible for them. In a talk filled with important examinations of problems, the angle on healthcare data provided a spot of hope for reforming how clinical trials are done in the future.

Photo: From left: Dr. Michael Kolodziej of Flatiron Health, Dr. Gregg Shepard of Tennessee Oncology, Dr. James Hamrick of Kaiser Permanente, Dr. Cary Presant of City of Hope Medical Center, Melissa Pool of the Center for Cancer and Blood Disorders

Photo: Andrew Zaleski