Exclusion of Older Patients From Ongoing Clinical Trials for Hematological Malignancies: An Evaluation of the National Institutes of Health Clinical Trial Registry

Abstract

Introduction. Cancer societies, research cooperatives, and countless publications have urged the development of clinical trials that facilitate the inclusion of older patients and those with comorbidities. We set out to determine the characteristics of currently recruiting clinical trials with hematological patients to assess their inclusion and exclusion of elderly patients. Methods. The NIH clinical trial registry was searched on July 1, 2013, for currently recruiting phase I, II or III clinical trials with hematological malignancies. Trial characteristics and study objectives were extracted from the registry website. Results. Although 5% of 1,207 included trials focused exclusively on elderly or unfit patients, 69% explicitly or implicitly excluded older patients. Exclusion based on age was seen in 27% of trials, exclusion based on performance status was seen in 16%, and exclusion based on stringent organ function

The 5Ts: Preliminary Development of a Framework to Support Inclusion of Older Adults in Research

“…For example, more than 50% of those with chronic kidney disease (CKD) are 70 years and older; however, this age group comprises less than 5% of the clinical trial populations on which many CKD Clinical Practice Guideline recommendations were based . Older adults have been disproportionately excluded from studies of heart disease, cancer, and diabetes as well …”

“…8,9 Older adults have been disproportionately excluded from studies of heart disease, cancer, and diabetes as well. [10][11][12] Underrepresentation of older adults in clinical research results in evidence that may not be generalizable to those who experience the greatest burden of disease. 13,14 To address this problem, the National Institutes of Health (NIH) "Inclusion Across the Lifespan" policy will require all grants on or after January 25, 2019, to submit a plan for including individuals of all ages.…”

Older-Patient-Specific Cancer Trials: A Pooled Analysis of 2,277 Patients (A151715)

“…Importantly, we relied on individual patient data, thus making this study particularly robust. To recapitulate findings, 26% of patients enrolled in older‐patient‐specific trials were 75 years of age or older in contrast to less than 10% in the cohort of age‐unspecified trials and in cancer registration trials in general . By testing gentler cancer treatment, older‐patient‐specific trials appear to render care to patients with ostensibly little compromise in outcomes.…”

“…Less than 3% of older patients with cancer are enrolled in cancer clinical trials, and, for drug registration trials, less than 10% of patients are 75 years of age or older . Moreover, trends in recruitment of older patients to large national cancer trials show, at best, only modest improvements .…”

Comorbidity, Physical Function, and Quality of Life in Older Adults with Acute Myeloid Leukemia

“…Older adults with AML are commonly underrepresented in clinical trials, often due to poor performance status, abnormal organ function, or active infection (73, 74). Poor representation in clinical trials leads to inadequate evidence and knowledge about responses of older patients to medications (2, 75).…”