A recent study published in JAMA Oncology reveals that there is a growing age disparity between oncology trial participants, who tend to be younger, and the corresponding typical cancer patient in the general population. This concern has been around for decades, and with the recent study, some tangible numbers can be associated with the challenge.

The Study

Conduced by a group of prominent academic medical centers, including MD Anderson, the study was recently covered by CancerNetwork’s Naveed Saleh, MD, MS. The researchers analyzed 302 phase III oncology randomized-clinical trials  (n=262,354) of which 82.5% were industry funded. The researchers found that on average oncology research participants (subjects) were 6.49 years younger than actual patients in clinical settings. Called difference of median age (DMA) they uncovered that DMA was higher in industry-funded trials (6.84 years) vs. non-industry funded trials (4.72 years).

Industry was not more likely than non-industry to employ study participation restrictions such as performance status or age cutoffs. Rather, the study authors suspect that industry-sponsored research sites tend to draw younger participants.

Troubling Trend

Naveed Saleh interviewed Dr. Gary H. Lyman, MD, MPH, Senior Lead, Healthcare Quality and Policy at Fred Hutchinson Cancer Research Center (Seattle) and a professor at the University of Washington School of Medicine, who found the results discouraging and noted that this age disparity between clinical trial participant and patient in the clinic has been a concern for decades—“patients who are eligible for and accrued to a clinical trial tend to be younger than the corresponding typical cancer patient in the population.” Lyman frets that the gap appears to be growing and this is a troubling trend.

Because as younger patients are increasingly the subjects for advanced therapies in oncology trials, the safety and efficacy data will be derived from a overall a younger population and not representative of the dynamics of the actual population in health systems, hospitals, and oncology centers. The net takeaway: the playing field must be leveled “so that 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” noted Dr. Lyman.

The Conclusions: Worsening Situation

The study authors concluded that age disparities between clinical trial participants and the actual cancer population being treated in health centers are “pervasive” across clinical trials and appear to be increasing over time. Dr. Ethan Ludmir, resident physician in the department of radiation and oncology with MD Anderson and the study lead, quoted, “We found that the age disparities in the enrollment of elderly patients, which are pervasive in clinical trials in cancer, seem to be worsening.”

The authors confirmed what those in the industry already know—that oncology-focused clinical trials recruit younger participants than those trials sponsored by academic medical centers. The authors strongly recommend that industry start addressing age disparity to ensure generalization of trial results as well as equity in trial access.

How to Move Forward: Remove the Bias

Clinical trials planners must understand why the cancer patient population for the trial is different than in the real-world setting. It is known that clinical trial patients should originate form the same general population for those that will be treated in the clinic setting. Industry perhaps needs to more thoroughly think through protocol design to ensure that rigorous criteria for patient selection better improves the participation metrics required.

Industry in some cases may be designing age cutoffs, which precludes older participants. Perhaps industry-sponsored trial designers seek those participants that are a bit younger and more fit for testing these new therapies?

Clinical research as a care option probably fits into the answer somehow. Where care is actually happening—blending the trial with the actual need in the health center.

Lead Research/Investigator

Dr. Ethan Ludmir, resident physician in the department of radiation and oncology with MD Anderson

Source: JAMA Network

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