Improving the Evidence Base for Treatment Decision Making for Older Adults with Cancer Proceedings of a Workshop—in Brief (2021) / Chapter Skim
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Improving the Evidence Base for Treatment Decision Making for Older Adults with Cancer: Proceedings of a Workshop - in Brief
Improving the Evidence Base for Treatment Decision Making for Older Adults with Cancer: Proceedings of a Workshop - in Brief
Pages 1-10
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Workshop speakers examined the persistent underrepresentation of older adults in cancer clinical trials across the drug development continuum and identified potential solutions to strengthen the evidence base to inform treatment decision making for older adults with cancer, discussed throughout this Proceedings of a Workshop -- in Brief and highlighted in Box 1. Participants examined the importance of adequate representation of older adults in cancer drug development and discussed why some traditional approaches to clinical trial design and recruitment hinder enrollment of older adults in cancer clinical trials.
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Improving Clinical Trial Participation • Broaden eligibility criteria and require scientific justification for exclusion criteria to make clinical trials more representative. (Bertagnolli, Dotan, Extermann, Harvey, Kanapuru, Klepin, Lee, Levit, Lichtman, Muss, Pentz, Peschin, Petruzzelli, Rubin, Schilsky, Singh, Sridhara, Smith, Whitehead)
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The first strategy is to increase enrollment of older adults in cancer clinical trials through approaches such as working with FDA to devise plans to enroll representative numbers of older adults in clinical trials, broadening eligibility criteria, opening more community-based clinical trial sites, and adhering to the policy on Inclusion Across the Lifespan from the National Institutes of Health (NIH, 2017)
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Participating in a clinical trial can be disruptive to patients' lives, and traveling to distant trial sites can be particularly challenging. Several speakers, including Mihaela Popa-McKiver from Bristol Myers Squibb, Mary Lou Smith from the Research Advocacy Network, and Extermann suggested that clinical trial protocols should condense study appointments and associated tests as much as possible and enable individuals enrolled in a trial to participate from a community oncology practice and use local lab or imaging facilities.
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Whitehead and Muss suggested engaging patients and patient advocates in the trial design process to help inform more patient-friendly protocols. Smith suggested investigators take a more patient-centered approach to the informed consent process, consider patient financial burdens associated with clinical trial participation, and improve communication to help participants feel more invested and empowered when participating in clinical trials.
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Ishwaria Subbiah from the University of Texas MD Anderson Cancer Center said that Congress should act to expand FDA's authority to improve inclusion of older adults across the cancer drug development continuum by requiring that clinical trial participants adequately reflect the patient population of a given disease. Sue Peschin from the Alliance for Aging Research agreed and added that pharmaceutical companies are unlikely to change their practices unless they are required to do so.
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Several speakers suggested that regulators should require clinical trial protocols to include safety, efficacy, and dosing recommendations for older adults; engage community oncologists; make trial enrollment easier; broaden eligibility criteria; encourage the use of adaptive trial designs and geriatric assessment tools; and include geriatric experts on advisory boards. Richard Schilsky from ASCO and Randall Oyer from Penn Medicine Lancaster General also suggested that FDA update its drug labeling practices to incentivize inclusion of older adults in trials and post-marketing research.
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2017. Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research joint research statement.
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intervention to reduce treatment toxicity in older patients with advanced cancer: A University of Rochester Cancer Center NCI community oncology research program cluster randomized clinical trial (CRCT)
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Rubin, Merck Research Laboratories; and Ishwaria Subbiah, University of Texas MD Anderson Cancer Center. REVIEWERS: To ensure that it meets institutional standards for quality and objectivity, this Proceedings of a Workshop -- in Brief was reviewed by Mary Lou Smith, Research Advocacy Network, and Martine Extermann, Moffitt Cancer Center.
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