Exclusion of older adults from clinical trials in cancer-related pain

Abstract

Pain is one of the most common symptoms in cancer patients including older adults. The objective of this study was to evaluate the enrollment criteria that can limit the inclusion of older adults in clinical trials concerning cancer-related pain (CRP). The study included 356 trials registered with ClinicalTrials.gov. Our primary outcome measures were the proportion of trials that excluded patients based on upper age limits (80 years of age or less), strict organ-specific exclusion criteria, broad and imprecise criteria, and inadequate performance score. One hundred and twenty-six trials (35.4%) had upper age limits. Strict exclusion criteria were used in 95 (26.7%) trials. Broad and imprecise exclusion criteria were listed in 57 (16.2%) trials. Low performance score was used as an exclusion criterion in 4 trials (1.1%). Overall, in 241 trials (67.7%) there was either an upper age limit or at least one strict or broad and imprecise exclusion criterion, or a criterion involving the performance status. The odds of excluding older adults were significantly higher in certain neoplasm types, study objectives, intervention types, and center locations. In conclusion, considerable proportion of recent clinical trials concerning CRP either explicitly exclude older adults or create high risk of such exclusion which substantially limits the evidence base for the treatment of such patients in clinical practice. Sponsors and investigators should consider careful modification of the enrollment criteria to improve the inclusion of older individuals who make up the major proportion of cancer patients population.

Immunotherapy and Hypofractionated Radiotherapy in Older Patients with Locally Advanced Cutaneous Squamous-Cell Carcinoma of the Head and Neck: A Proposed Paradigm by the International Geriatric Radiotherapy Group

“…Older patients with cancer and minorities are frequently excluded from clinical trials [19][20][21]. Up to 67% of the trials listed in ClinicalTrials.gov have upper age limits and/or exclusion criteria that limit the recruitment of older patients [19]. A similar analysis of 1012 clinical trials registered on ClinicalTrials.gov also corroborates that not only are older cancer patients excluded from clinical trials, but minorities and women are also less likely to be enrolled [21].…”

“…Recently, immunotherapy with check-point inhibitors (CPIs) has emerged as a promising agent for cSCC because of its efficacy and safety profile [16][17][18]. Older patients with cancer and minorities are frequently excluded from clinical trials [19][20][21]. Up to 67% of the trials listed in ClinicalTrials.gov have upper age limits and/or exclusion criteria that limit the recruitment of older patients [19].…”

Eligibility criteria in clinical trials in breast cancer: a cohort study

“…In analysis of the upper age limits, in line with the limits of main age categories adopted by CT.gov [ https://www.clinicaltrials.gov/ct2/search/advanced ], we considered individuals aged 65 and older as older adults. The assessment of the eligibility criteria concerning comorbidities was based on the classification system developed by Lewis et al with a view to investigating the exclusion of older patients from clinical trials in oncology [ 20 ]; it was also used in other studies on the exclusion of older adults from clinical trials including a study from our group [ 16 , 21 ]. The classification includes a comprehensive set of comorbidities of different organs and systems including the liver, the kidneys, bone marrow, the cardiovascular system, and the pulmonary system.…”

El transhumanismo y la mejora de la calidad de vida de las personas mayores: ¿Cómo podría configurar el futuro del dolor y el sufrimiento en las personas mayores?

“…Para poner esto en perspectiva empírica, Krzysztof Krysa y otros, examinaron ensayos registrados en ClinicalTrials.gov sobre pacientes geriátricos reclutados en ensayos sobre el dolor relacionado con el cáncer, haciendo hincapié en los criterios de selección de los pacientes (46). Baste señalar que la cruda realidad fue que los ensayos se diseñaron de tal manera que excluían a este segmento de la población, principalmente debido a las exclusiones por criterios de alto riesgo que hacían casi imposible reclutar a estos pacientes.…”