How Do You Improve Geriatric Participation in Cancer Trials?

Ageing is long known to be a risk factor for cancer. The US population, overall, is surviving longer; 13% of the population was over 65 years of age in 2010 and this number is expected to reach 20% by 2030. Evidence shows that older adults are highly susceptible to cancer—they are the majority among the diagnosed, survivors, and the deceased. However, this population of society has insufficient representation in clinical trials, nor are there specific trials designed for the geriatric population. One particular study found that only 33% of patients in registration trials for 24 drugs approved between 2007 and 2010 were 65 years or older, considering that nearly double (59%) the population is older than 65 years.

This has prompted the American Society of Clinical Oncology (ASCO) to issue a statement asking for an improved evidence base for treating older adults with cancer.

Published in the Journal of Clinical Oncology, ASCO has made 5 recommendations that could support the process:

a. This recommendation invites regulatory agencies, funders of cancer research, and researchers themselves to evaluate evidence that would limit clinical trial eligibility based on age, performance status, and comorbid conditions.

b. NCI, FDA, and others should prompt measurements from geriatric assessment domains

c. Reporting on patient age distribution for tumor samples collected as part of a clinical trial should be mandated and correlated with the age distribution of the enrolled population and the overall disease population.

a. Funders of comparative effectiveness research should force researchers to include a study plan that mirrors the age distribution of patients with the disease.

b. Those who develop databases should ensure their system collects geriatric assessment data.

a. Congress should provide FDA the authority to require drug manufacturers and developers to collect safety, efficacy, and dosing data in older adults.

b. FDA should be allowed to provide incentives for companies that do so.

a. Improve provider education to encourage recruitment of this population in trials.

b. A common procedural terminology code should be established to reimburse those physicians who enroll, manage, and follow-up geriatric patients in clinical trials.

a. Reporting on age distribution of clinical trial participants should be mandated by journals.

b. Reviewing experts should be instructed to consider inclusion of a fair age distribution by authors, generalizability of the results to the disease population, and data analysis that might yield specific age-related evidence.

1. Use clinical trials to improve the evidence base for treating older adults with cancer2. Leverage research designs and infrastructure for generating evidence on older adults with cancer3. Increase FDA authority to incentivize and require research involving older adults with cancer4. Increase clinicians' recruitment of older adults with cancer to clinical trials5. Use journal policies to improve researchers' reporting on the age distribution and health risk profiles of research participants.

The authors write that while some of these recommendations might need longer-term commitments and involvement of multiple stakeholders, the rapidly aging population makes it essential to initiate the process now.