Systematic Review of Barriers to the Recruitment of Older Patients With Cancer Onto Clinical Trials

2005 ◽  
Vol 23 (13) ◽  
pp. 3112-3124 ◽  
Author(s):  
Carol A. Townsley ◽  
Rita Selby ◽  
Lillian L. Siu
Keyword(s):  
Clinical Trials ◽  
Functional Status ◽  
Older Patients ◽  
Tumor Biology ◽  
Physician Education ◽  
Cancer Clinical Trials ◽  
Comorbid Conditions ◽  
Eligibility Criteria ◽  
Patients With Cancer ◽  
Significant Barrier

Purpose Older patients are significantly underrepresented in cancer clinical trials. A literature review was undertaken to identify the barriers that impede the accrual of this vulnerable population onto clinical trials and to determine what specific strategies are needed to improve the representation of older patients in research studies. Methods A systematic literature search was undertaken using several different strategies to identify relevant articles. Results Nine of 31 relevant papers from 159 citations were included. Age is a significant barrier to recruitment; only a quarter to one third of potentially eligible older patients are enrolled onto trials. Physicians' perceptions, protocol eligibility criteria with restrictions on comorbid conditions, and functional status to optimize treatment tolerability are the most important reasons resulting in the exclusion of older patients. Other barriers include the lack of social support and the need for extra time and resources to enroll these patients. Conversely, older patients do not view their age as an important reason for refusing trials. Conclusion Specific clinical trials confined to older patients should be conducted to evaluate tumor biology, treatment tolerability, and the effect of comorbid conditions. Protocol designs need to stratify for age and be less restrictive with respect to exclusions on functional status, comorbidity, and previous cancers, such that results are generalizable to older patients. Physician education to dispel unfounded perceptions, improved access to available clinical trials, and provision of personnel and resources to accommodate the unique requirements of an older population are possible solutions to remove the barriers of ageism.

Geriatric Oncology and Clinical Trials

2015 ◽  
pp. e127-e131 ◽  
Author(s):  
Stuart M. Lichtman
Keyword(s):  
Clinical Trials ◽  
Older Patients ◽  
Geriatric Oncology ◽  
Life Changes ◽  
Eligibility Criteria ◽  
Patients With Cancer ◽  
Eligibility Assessment ◽  
Dose Limiting Toxicity ◽  
Meaningful Data

The overall aging of the population has resulted in a marked increase in the number of older patients with cancer. These patients have specific needs that are different from those of the younger population. Cancer clinical trials have included an inadequate number of older patients, resulting in lack of meaningful data to make evidence-based decisions for this population. As a result, clinicians have to extrapolate data from younger and healthier patients. There are a number of reasons for this under-representation, including a design and implementation structure for clinical trials that does not meet the needs of this vulnerable population. Issues that need to be addressed include alterations in eligibility criteria to make them less restrictive by accounting for multiple comorbidities and prior malignancy and endpoints specific for older patients, such as quality of life, changes in function, and maintenance of independence. Other issues specific to the older population include alterations in dose-limiting toxicity, measures of treatment-related toxicity, and polypharmacy. Phase I trials can be appropriate for older patients but need to be tailored to their needs. Some form of geriatric assessment needs to be included to help with eligibility, assessment, and stratification. For future clinical trials to be truly meaningful they need to appropriately assess and incorporate the needs of the majority of the cancer population.

COMMON AND DISTINCT CHARACTERISTICS ASSOCIATED WITH SELF-REPORTED FUNCTIONAL STATUS IN OLDER PATIENTS WITH CANCER RECEIVING CHEMOTHERAPY

2021 ◽  
pp. 102033
Author(s):  
Ann Helen Torstveit ◽  
Christine Miaskowski ◽  
Borghild Løyland ◽  
Ellen Karine Grov ◽  
Marianne Grønlie Guren ◽  
...  
Keyword(s):  
Functional Status ◽  
Older Patients ◽  
Patients With Cancer

scholarly journals Strategies to Improve Participation of Older Adults in Cancer Research

2020 ◽  
Vol 9 (5) ◽  
pp. 1571 ◽  
Author(s):  
Jennifer Liu ◽  
Eutiquio Gutierrez ◽  
Abhay Tiwari ◽  
Simran Padam ◽  
Daneng Li ◽  
...  
Keyword(s):  
Older Adults ◽  
Behavioral Interventions ◽  
Older Patients ◽  
Trial Participation ◽  
Eligibility Criteria ◽  
Targeted Interventions ◽  
Patients With Cancer ◽  
Healthcare Settings ◽  
Substantial Investment ◽  
Evidence Based Care

Cancer is a disease associated with aging. As the US population ages, the number of older adults with cancer is projected to dramatically increase. Despite this, older adults remain vastly underrepresented in research that sets the standards for cancer treatments and, consequently, clinicians struggle with how to interpret data from clinical trials and apply them to older adults in practice. A combination of system, clinician, and patient barriers bar opportunities for trial participation for many older patients, and strategies are needed to address these barriers at multiple fronts, five of which are offered here. This review highlights the need to (1) broaden eligibility criteria, (2) measure relevant end points, (3) expand standard trial designs, (4) increase resources (e.g., institutional support, interdisciplinary care, and telehealth), and (5) develop targeted interventions (e.g., behavioral interventions to promote patient enrollment). Implementing these solutions requires a substantial investment in engaging and collaborating with community-based practices, where the majority of older patients with cancer receive their care. Multifaceted strategies are needed to ensure that older patients with cancer, across diverse healthcare settings, receive the highest-quality, evidence-based care.

Reducing patient eligibility criteria in cancer clinical trials.

1996 ◽  
Vol 14 (4) ◽  
pp. 1364-1370 ◽  
Author(s):  
S L George
Keyword(s):  
Clinical Trials ◽  
Sample Size ◽  
Acute Lymphocytic Leukemia ◽  
Lymphocytic Leukemia ◽  
Phase Iii ◽  
Eligibility Criterion ◽  
Cancer Clinical Trials ◽  
Recent Trial ◽  
Eligibility Criteria ◽  
Eligibility Requirements

PURPOSE To discuss patient eligibility criteria in phase III cancer clinical trials in the larger setting of the complexity of these trials, to review the various reasons for imposing restrictive eligibility requirements, to discuss the problems caused by these requirements, to argue that these requirements should be greatly relaxed in most cancer clinical trials, to provide some guiding principles and practical suggestions to facilitate such a relaxation, and to give an example of how eligibility requirements were reduced in a recent clinical trial in acute lymphocytic leukemia. METHODS Implicit and explicit reasons for including eligibility criteria in clinical trials are reviewed. Safety concerns and sample size issues receive special attention. The types of problems restrictive eligibility criteria cause with respect to scientific interpretation, medical applicability, complexity, costs, and patient accrual are described. RESULTS A list of three items that each eligibility criterion should meet in order to be included is proposed and applied to a recent trial in acute lymphocytic leukemia. CONCLUSION Phase III clinical trials in cancer should have much broader eligibility criteria than the traditionally restrictive criteria commonly used. Adoption of less restrictive eligibility criteria for most studies would allow broader generalizations, better mimic medical practice, reduce complexity and costs, and permit more rapid accrual without compromising patient safety or requiring major increases in sample size.

Managing Choices for Older Patients with Colon Cancer: Adjuvant Therapy

2013 ◽  
pp. e190-e193
Author(s):  
Christina Wu ◽  
Richard M. Goldberg
Keyword(s):  
Colon Cancer ◽  
Clinical Trials ◽  
Adjuvant Therapy ◽  
Older Patients ◽  
Tumor Biology ◽  
The United States ◽  
Individual Risk ◽  
Definitive Evidence ◽  
Medical Oncologists ◽  
Population Treatment

Colon cancer is among the most common cancers in the United States, and the median age of patients at diagnosis is 70. Medical oncologists are commonly asked to comprehensively evaluate elderly patients to estimate individual risk/benefit ratios for adjuvant treatment. Although 40% of patients with colon cancer are elderly, clinical trials enroll mainly younger patients. Consequently, we are forced to depend on subgroup analyses, observational studies, and personal experience to guide recommendations. Decision-making in adjuvant therapy for colon cancer is increasingly complex, as we subdivide patients with stage II to III colon cancer by molecular as well as anatomic staging to predict which are likely to benefit from chemotherapy and then whether the addition of oxaliplatin to 5-fluorouracil (5-FU) is worth the toxicity. It is likely that the tumor biology of younger and older patients differs, and more research is needed to dissect out the biologic heterogeneity of both the tumors and their elderly hosts to help guide treatment. We recognize that our evaluations should not solely be based on temporal age and factor physiology, pharmacology, psychology, functional status, and social support into these considerations. Older patients who are treated must be monitored closely for toxicities when undergoing treatment. Although there is a clear need for clinical trials in this population, treatment decisions confront us today in the absence of definitive evidence. How can we help our patients navigate through these important choices?

Functional status in older patients with cancer

2021 ◽  
Author(s):  
Anne-Laure Couderc ◽  
Pierre Suchon ◽  
Bérengère Saliba-Serre ◽  
Dominique Rey ◽  
Emilie Nouguerede ◽  
...  
Keyword(s):  
Functional Status ◽  
Older Patients ◽  
Patients With Cancer

scholarly journals Promoting Accrual of Older Patients with Cancer to Clinical Trials: An Alliance for Clinical Trials in Oncology Member Survey (A171602)

2018 ◽  
Vol 23 (9) ◽  
pp. 1016-1023 ◽  
Author(s):  
Rachel A. Freedman ◽  
Travis J. Dockter ◽  
Jacqueline M. Lafky ◽  
Arti Hurria ◽  
Hyman J. Muss ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Older Patients ◽  
Patients With Cancer

Strategies to Maximize Patient Participation in Clinical Trials

2017 ◽  
pp. 216-221
Author(s):  
Eric H. Rubin ◽  
Mary J. Scroggins ◽  
Kirsten B. Goldberg ◽  
Julia A. Beaver
Keyword(s):  
Clinical Trials ◽  
Patient Participation ◽  
Patient Perspective ◽  
Heterogeneous Population ◽  
Patient Access ◽  
Eligibility Criteria ◽  
Enrollment Rate ◽  
Patients With Cancer ◽  
Multiple Obstacles ◽  
Oncology Drug Development

Despite considerable interest and success in oncology drug development, the minority of patients with cancer diagnoses enroll in clinical trials. Multiple obstacles account for this low enrollment rate. An improvement in patient participation in clinical trials could increase patient access to novel and potentially promising agents, provide faster trial results, and, with implementation of rational eligibility criteria, allow for a better understanding of the drug’s safety and efficacy in a heterogeneous population. We present barriers and potential solutions to maximize patient participation, including a review of the ASCO and Friends of Cancer Research (FoCR) Modernizing Eligibility Criteria Project, U.S. Food and Drug Administration (FDA) regulatory considerations, an industry perspective, and a patient perspective.

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