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NIH pilot for several cancer trials increased costs, but didn’t work




NIH pilot for several cancer trials increased costs, but didn't work

GGovernment researchers hoped to attract a more diverse group of patients to clinical research by paying the travel expenses of cancer patients who wanted to volunteer for trials. It did not work.

Patients do not pay for the care they receive as part of National Institutes of Health clinical trials. But patients, and often their caregivers, face other costs, such as travel, food and accommodation costs, childcare and absenteeism.

The government often also pays for travel and accommodation costs. The National Cancer Institute, the largest institution among the National Institutes of Health, has long even reimbursed the travel expenses of health care providers who accompany patients in clinical trials.

But patients and caregivers must pay the initial travel costs to Bethesda, Maryland, to see if they qualify for NCI examinations. Researchers at NCI thought these so-called first-visit fees could discourage low-income patients from volunteering for trials, excluding the people of color who are often most affected by the diseases treated with drugs.

The NCI’s Center for Cancer Research has launched a program to pay for travel expenses for screening potential research volunteers and, if necessary, their caregivers, according to an internal NCI email obtained by STAT. NCI stopped the pilot after a year, an NCI spokesperson said.

It is not clear what the goals or results of the NCI pilot were or how long the pilot would last. However, the NCI spokesperson said the pilot was stopped because it was expensive and not working.

“An analysis of the data showed that the program did not result in an increase in enrollment diversity,” the spokesperson said. “Additionally, NCI CCR experienced a 45% increase in travel costs during that period, which was not sustainable.”

The additional expenditure coincided with cutbacks. Congress cut NCI funding for fiscal year 2024 by $96 million from a budget of $7.22 billion. The NCI email states that the pilot was terminated “in light of fiscal realities.”

Medicines need to be tested on a representative group of people to make sure they work for everyone. Both NIH and industry researchers have struggled to enroll enough people of color in trials. A study shows that NIH-funded trials often enroll fewer Black patients and other underrepresented racial groups than they plan to.

Congress passed a law in 2022 requiring companies to tell the Food & Drug Administration their plans for diversifying clinical trials. The agency is four months late in issuing guidelines that companies must meet that requirement. However, the FDA had already given companies guidance on diversifying trials before Congress passed that law. That guidance said companies can help patients with travel expenses, but did not specifically recommend paying for travel for healthcare providers. The guidelines do not mention screening visits to clinical trials.