TY - JOUR
T1 - Older adult participation in cancer clinical trials
T2 - A systematic review of barriers and interventions
AU - the Cancer and Aging Research Group (CARG)
AU - Sedrak, Mina S.
AU - Freedman, Rachel A.
AU - Cohen, Harvey J.
AU - Muss, Hyman B.
AU - Jatoi, Aminah
AU - Klepin, Heidi D.
AU - Wildes, Tanya M.
AU - Le-Rademacher, Jennifer G.
AU - Kimmick, Gretchen G.
AU - Tew, William P.
AU - George, Kevin
AU - Padam, Simran
AU - Liu, Jennifer
AU - Wong, Andrew R.
AU - Lynch, Andrea
AU - Djulbegovic, Benjamin
AU - Mohile, Supriya G.
AU - Dale, William
N1 - Funding Information:
There are several ways to modify trial designs to accommodate the needs of older adults. The CARG, in collaboration with the National Institute on Aging (NIA) and the NCI, held a series of conferences funded by a U13 grant to identify and address gaps in knowledge about the care of older adults with cancer. The group has published several white papers, including one focused on how to modify clinical trials for older adults with cancer. Here, we highlight several of these recommendations and how they have been incorporated into current trials. 47
Funding Information:
To facilitate the development and implementation of these trials, collaboration between patient advocates, geriatricians, and oncologists should take place to ensure that these studies are amenable to the participation of older and/or frail patients and that the endpoints measured meet their needs. Furthermore, efforts should be made to ensure that these pragmatic trials are open in community settings, where the vast majority of older patients are treated. As our findings highlight, older adults may face more challenges than younger patients with travel, caregiver support, and other logistics associated with trial participation. Infrastructures, such as the NCI Community Oncology Research Program (NCORP), a national network designed to open participation of NCI‐approved studies at community‐based practices, should be leveraged to support a larger and more diverse patient population, accelerate accrual, and increase generalizability of trial findings. One successful example of this is the Improving Communication in Older Cancer Patients and Their Caregivers (COACH) study (ClinicalTrials.gov identifier NCT02054741), a cluster‐randomized clinical trial of community oncology practices within the University of Rochester NCORP that examined whether a GA summary with recommendations to oncologists can reduce toxicities and improve communication in patients aged ≥70 years with advanced cancer. Future efforts are needed to increase the design and conduct of geriatric‐specific pragmatic trials through partnership with NCORP, the NCI National Clinical Trials Network (NCTN), and the national infrastructure for geriatric oncology research through CARG, supported by the National Institute on Aging. Our hope is that increased conduct of pragmatic trials designed for older adults in diverse health care settings will represent the seeds of a more inclusive clinical trial system to improve the evidence base for treating cancer in older adults, especially those who are frail or have comorbidities. 44,90,113 114 115,116 117 118‐123
Publisher Copyright:
© 2020 American Cancer Society
PY - 2021/1/1
Y1 - 2021/1/1
N2 - Cancer is a disease of aging and, as the world's population ages, the number of older persons with cancer is increasing and will make up a growing share of the oncology population in virtually every country. Despite this, older patients remain vastly underrepresented in research that sets the standards for cancer treatments. Consequently, most of what we know about cancer therapeutics is based on clinical trials conducted in younger, healthier patients, and effective strategies to improve clinical trial participation of older adults with cancer remain sparse. For this systematic review, the authors evaluated published studies regarding barriers to participation and interventions to improve participation of older adults in cancer trials. The quality of the available evidence was low and, despite a literature describing multifaceted barriers, only one intervention study aimed to increase enrollment of older adults in trials. The findings starkly amplify the paucity of evidence-based, effective strategies to improve participation of this underrepresented population in cancer trials. Within these limitations, the authors provide their opinion on how the current cancer research infrastructure must be modified to accommodate the needs of older patients. Several underused solutions are offered to expand clinical trials to include older adults with cancer. However, as currently constructed, these recommendations alone will not solve the evidence gap in geriatric oncology, and efforts are needed to meet older and frail adults where they are by expanding clinical trials designed specifically for this population and leveraging real-world data.
AB - Cancer is a disease of aging and, as the world's population ages, the number of older persons with cancer is increasing and will make up a growing share of the oncology population in virtually every country. Despite this, older patients remain vastly underrepresented in research that sets the standards for cancer treatments. Consequently, most of what we know about cancer therapeutics is based on clinical trials conducted in younger, healthier patients, and effective strategies to improve clinical trial participation of older adults with cancer remain sparse. For this systematic review, the authors evaluated published studies regarding barriers to participation and interventions to improve participation of older adults in cancer trials. The quality of the available evidence was low and, despite a literature describing multifaceted barriers, only one intervention study aimed to increase enrollment of older adults in trials. The findings starkly amplify the paucity of evidence-based, effective strategies to improve participation of this underrepresented population in cancer trials. Within these limitations, the authors provide their opinion on how the current cancer research infrastructure must be modified to accommodate the needs of older patients. Several underused solutions are offered to expand clinical trials to include older adults with cancer. However, as currently constructed, these recommendations alone will not solve the evidence gap in geriatric oncology, and efforts are needed to meet older and frail adults where they are by expanding clinical trials designed specifically for this population and leveraging real-world data.
KW - clinical trials
KW - older adults
KW - oncology
KW - patient participation
KW - patient selection
KW - practice patterns
UR - http://www.scopus.com/inward/record.url?scp=85091755965&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85091755965&partnerID=8YFLogxK
U2 - 10.3322/caac.21638
DO - 10.3322/caac.21638
M3 - Review article
C2 - 33002206
AN - SCOPUS:85091755965
SN - 0007-9235
VL - 71
SP - 78
EP - 92
JO - CA Cancer Journal for Clinicians
JF - CA Cancer Journal for Clinicians
IS - 1
ER -