Older adults in hematologic malignancy trials: Representation, barriers to participation and strategies for addressing underrepresentation

Bindu Kanapuru; Harpreet Singh; Virginia Kwitkowski; Gideon Blumenthal; Ann T Farrell; Richard Pazdur

doi:10.1016/j.blre.2020.100670

Older adults in hematologic malignancy trials: Representation, barriers to participation and strategies for addressing underrepresentation

Blood Rev. 2020 Sep:43:100670. doi: 10.1016/j.blre.2020.100670. Epub 2020 Feb 7.

Authors

Bindu Kanapuru¹, Harpreet Singh², Virginia Kwitkowski³, Gideon Blumenthal⁴, Ann T Farrell⁵, Richard Pazdur⁶

Affiliations

¹ Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. Electronic address: [email protected].
² Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. Electronic address: [email protected].
³ Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. Electronic address: [email protected].
⁴ Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. Electronic address: [email protected].
⁵ Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. Electronic address: [email protected].
⁶ Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. Electronic address: [email protected].

PMID: 32241586
DOI: 10.1016/j.blre.2020.100670

Abstract

Despite a high incidence of hematologic malignancies in older adults, available data indicate that there is disproportionately low representation of adults ≥65 years with hematologic malignancies (greater in patients ≥75 years) in clinical trials. Biological and clinical differences between older and younger adults and diversity within older patients necessitate adequate representation of the older subpopulation in hematologic malignancy trials. This would allow trial results to be generalizable and inform treatment decisions in the older patient population. Restrictive eligibility criteria may be barriers to adequate representation, as older adults do not typically meet these criteria. Efforts to broaden eligibility criteria in clinical trials have been proposed and may promote enrollment of a representative older population with hematologic malignancies. Collaboration among a diverse group of stakeholders will be needed to implement current proposals and evaluate their impact on increasing representation of older adults in trials evaluating therapies for hematologic malignancies.

Keywords: Clinical trials; Enrollment barriers; Hematological malignancies; Older adults; Underrepresentation.

Publication types

Review

MeSH terms

Age Factors
Aged
Clinical Trials as Topic*
Disease Management
Hematologic Neoplasms* / epidemiology
Hematologic Neoplasms* / therapy
Humans
Patient Selection*