Age Disparities Spell Trouble for Industry-Funded Trials

Age disparities between oncology trial participants are common and increasing over time, despite concerns raised over the issue. This trend is especially evident in industry-sponsored trials, according to the results of a recent JAMA study.

“We’ve been concerned as a research community going back 20 to 30 years now about the age disparity issue in the clinical trials,” said Gary H. Lyman, MD, MPH, Senior Lead, Healthcare Quality and Policy at Fred Hutchinson Cancer Research Center, Seattle, Washington and a professor at the University of Washington School of Medicine, in an interview with Cancer Network. “That is, patients who are eligible for and accrued to a clinical trial tend to be younger than the corresponding typical cancer patient in the population.”

In total, 302 phase III oncology randomized-clinical trials (n=262,354) were included in the analysis, with 82.5% of trials being industry funded. The average difference between participant median age and the population-based disease-site-specific median age (DMA) was 6.49 years (95% CI, −7.17­­­–5.81 years; P < .001). Mean DMA was higher in industry-funded trials (-6.84 years) vs. non-industry funded trials (-4.72 years).

Although enrollment criteria restrictions based on performance status or age cutoffs were linked to age disparities, industry was not more likely than non-industry to employ these restrictions in the trials assessed. The authors suggest that a contributing factor could be that industry-funded trials are more available at centers caring for a greater number of younger patients.

Dr. Lyman finds the results somewhat discouraging. 

“I am a bit disturbed with what they’ve shown,” he said. “This age gap may be getting larger in recent years. I don’t know why that would be with all the attention around it. It means that we really have our work cut out for us.”

Lyman said using younger patients in trials means there will only be safety and efficacy data for its effects on this particular population and not represent older patients who make up the majority of cancer diagnoses.

The results of the current study are particularly relevant for oncology practices that skew older.

“We need to try to level the playing field so that the gap between the median age of patients on the clinical trials of the new drug is closer to the median age of the population that I’m going to treat in clinical practice,” he said.

Geriatrician Carmelo Blanquicett, MD, PhD, assistant professor at Emory University School of Medicine, Atlanta, said only recently, changes have been made to improve trial age disparities.

 “Whether intervening on geriatric syndromes and deficits identified through geriatric assessments and assessment tools results in better outcomes and if the use of such assessments-as opposed to performance status measures commonly used in oncology practice or as opposed to chronological age-results in more patients being considered eligible to undergo treatment or participate in a clinical trial, still remains to be determined by future research studies,” he said.