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

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 hemat...

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Bibliographic Details
Published in:The oncologist (Dayton, Ohio) Ohio), 2014-10, Vol.19 (10), p.1069-1075
Main Authors: Hamaker, Marije E., Stauder, Reinhard, Munster, Barbara C.
Format: Article
Language:English
Subjects:
Aged
Aged, 80 and over
Ageism - ethics
Ageism - statistics & numerical data
Clinical trial design
Clinical Trials as Topic
Clinical Trials, Phase I as Topic - ethics
Clinical Trials, Phase I as Topic - methods
Clinical Trials, Phase II as Topic - ethics
Clinical Trials, Phase II as Topic - methods
Clinical Trials, Phase III as Topic - ethics
Clinical Trials, Phase III as Topic - methods
Elderly
Exclusion criteria
Geriatric Oncology
Hematologic Neoplasms - therapy
Hematological malignancies
Humans
Karnofsky Performance Status - standards
Organ Dysfunction Scores
Patient Selection
Registries
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Summary: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 restrictions was noted in 51%. One‐third of the studies that excluded older patients based on age allowed inclusion of younger patients with poor performance status; 8% did not place any restrictions on organ function. Over time, there was a shift from exclusion based on age (p value for trend
ISSN:1083-7159
1549-490X
DOI:10.1634/theoncologist.2014-0093