The exclusion of older subjects from clinical trials

Cherubini, Antonio; Crome, Peter

doi:10.1002/9781118323434.ch1

Cited by 4 publications

(4 citation statements)

References 40 publications

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“…To date, they have shown modest benefits. 6 However, these studies and meta-analyses have been hindered by functional heterogeneity among older adults, difficulties in enrolling older participants, and challenges with study reproducibility. Moreover, functional assessment itself is challenged by heterogeneity among measures with respect to terminology, content, methods, and scoring.…”

Section: Barriers To Implementation Of Functional Metrics and Interve...mentioning

confidence: 99%

Embedding and Sustaining a Focus on Function in Specialty Research and Care

Callahan

Boustani

Ferrante

et al. 2020

J American Geriatrics Society

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See related editorial by Ling et al. in this issue.Function and the independent performance of daily activities are of critical importance to older adults. Although function was once a domain of interest primarily limited to geriatricians, transdisciplinary research has demonstrated its value across the spectrum of medical and surgical care. Nonetheless, integrating a functional perspective into medical and surgical therapeutics has yet to be implemented consistently into clinical practice. This article summarizes the presentations and discussions from a workshop, "Embedding/Sustaining a Focus on Function in Specialty Research and Care," held on January 31 to February 1, 2019. The third in a series supported by the National Institute on Aging and the John A. Hartford Foundation, the workshop aimed to identify scientific gaps and recommend research strategies to advance the implementation of function in care of older adults. Transdisciplinary leaders discussed implementation of mobility programs and functional assessments, including comprehensive geriatric assessment; integrating cognitive and sensory functional assessments; the role of culture, environment, and community in incorporating function into research; innovative methods to better identify functional limitations, techniques, and interventions to facilitate functional gains; and the role of the health system in fostering integration of function. Workshop participants emphasized the importance of aligning goals and assessments and adopting a team science approach that includes clinicians and frontline staff in the planning, development, testing, and implementation of tools and initiatives. This article summarizes those discussions.

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Section: Barriers To Implementation Of Functional Metrics and Interve...mentioning

confidence: 99%

Embedding and Sustaining a Focus on Function in Specialty Research and Care

Callahan

Boustani

Ferrante

et al. 2020

J American Geriatrics Society

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“…Considering the limits of experimental designs in geriatric research, well-conducted observational studies might represent the best way of getting insight into disease etiology, the effect of age-related changes, and might provide an important perspective on health risk factors and disabilities in an aging population [2,3]. Unlike Randomized Clinical Trials (RCT), observational studies assess outcomes of medical intervention in daily and real clinical practice, involving often unselected populations that reflects true compliance with treatment or intervention [4].…”

Section: Introductionmentioning

confidence: 99%

Methodological issues in the observational studies conducted in older population: a narrative review

Poscia

Collamati

Milovanovic

et al. 2022

ebph

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Introduction Well-conducted observational studies may represent valuable tools for getting insight to disease etiology, detecting the effect of age-related changes, and providing an important perspective on health risk factors and disabilities in an aging population. Nevertheless, this kind of research poses several challenges for researchers. The main aim of this narrative review was to address the potential methodological issues in performing the observational studies in the elderly, the factors that influence their participation, and the possible solutions for overcoming the barriers to research in this population. Methods Comprehensive search for the papers published in the period from January 1st 1980 until 31st July 2016 in English or Italian was conducted through MEDLINE, Scopus and Web of Science electronic databases. Findings from the included papers were finally summarized. Results In cohort studies, the following barriers were addressed: sample size calculation, ascertainment of the target population, frequency of data collection, exposure determination, multifactorial loss to follow-up (drop-outs), cognitive impairment, definition of confounders, and ethical aspects. Case-control studies were reported to be prone to the issues like ascertainment of cases and controls, willingness to participate, data accuracy, recall bias, issues related to patients’ multimorbidity, and cognitive impairment. Conclusions Important factors to consider in research in elderly people include: precise definition of the study population, well conducted recruitment process, engagement with family and home care staff, cognitive impairment assessment and the consequent relevant ethical and legal issues, relief of participant burden in order to minimize withdrawal, and engagement with the media.

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“…What literature there is focuses more generally on the exclusion of older adults from clinical research and indicates that upper age limits often exist without justification. 6 Clinical trials commonly have upper age limits for participation, even when the trials involve illnesses that are associated with old age, like Alzheimer’s Disease, 7 Parkinson’s Disease, 8 heart failure, 7 , 9 diabetes, 10 and colorectal cancer. 7 Upper age limits also exist for clinical trials involving medications.…”

Section: Introductionmentioning

confidence: 99%

“… 6 Clinical trials commonly have upper age limits for participation, even when the trials involve illnesses that are associated with old age, like Alzheimer’s Disease, 7 Parkinson’s Disease, 8 heart failure, 7 , 9 diabetes, 10 and colorectal cancer. 7 Upper age limits also exist for clinical trials involving medications. 11 One review of over 300 clinical intervention research protocols sent to a research ethics committee found that one-third had an upper age limit that was arbitrary and applied even when the condition under study was prevalent among older adults.…”

Section: Introductionmentioning

confidence: 99%

Age and perceived risks and benefits of preventive genomic screening

Waltz

Cadigan

Prince

et al. 2018

Genetics in Medicine

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Purpose As genome sequencing moves from research to clinical practice, sequencing technologies focused on “medically actionable” targets are being promoted for preventive screening despite the dearth of systematic evidence of risks and benefits and criteria for who should be screened. This study investigates researchers’ and research participants’ perceptions of these issues within the context of a preventive genomic screening study, GeneScreen. Methods We recorded researcher deliberations regarding age eligibility criteria and the risks and benefits of screening, and conducted interviews with 50 GeneScreen participants about their motivations for joining and perceptions of risks and benefits. Results Researchers made assumptions about who would want and benefit from screening based on age. After discussion, researchers opted not to have an upper age limit for enrollment. Participants of all ages perceived similar benefits, including prevention, treatment, and cascade testing, and similar risks such as insurance discrimination and worry. Conclusion While clinical benefits of preventive genomic screening for older adults are debatable, our respondents perceived a range of benefits of screening in both clinical and research settings. Researchers and clinicians should carefully consider decisions about excluding older adults and providing information about benefits and risks across age groups.

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The exclusion of older subjects from clinical trials

Cited by 4 publications

References 40 publications

Embedding and Sustaining a Focus on Function in Specialty Research and Care

Embedding and Sustaining a Focus on Function in Specialty Research and Care

Methodological issues in the observational studies conducted in older population: a narrative review

Age and perceived risks and benefits of preventive genomic screening

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