Participant exclusion criteria in treatment research on neurological disorders: Are unrepresentative study samples problematic?

Exclusion criteria in treatment research on alcohol, tobacco and illicit drug use disorders: A review and critical analysis

“…The high rates of exclusion identified here are not unique to the SUD treatment research field. Other studies from the CREAM group which have examined exclusion rates in psychiatric research have found approximately 75–85% for depression , 80% for schizophrenia , nearly 80% for neurological conditions and up to 92% for anxiety disorders . Similarly, non‐enrolment rates in SUD treatment trials do not differ from those in trials focused on a broad array of medical conditions .…”

“…From this cross‐disease pool of literature, evidence on the individual diseases was extracted for more focused reviews. Prior CREAM reviews have focused on schizophrenia , neurological disorders , major depression and anxiety disorders . The current review focuses on alcohol, tobacco and illicit drug use disorders.…”

Factors Associated With Participation in Rheumatic Disease–Related Research Among Underrepresented Populations: A Qualitative Systematic Review

“…Homogeneity is a dominant paradigm in randomized controlled trials where strict, intentional inclusion/exclusion criteria are applied to improve internal validity and statistical power at the expense of study diversity and external validity (48,49). Exclusion criteria are intended to protect patients who may be inappropriate for or at direct risk from a novel medication, but they often disproportionately exclude underrepresented populations from research participation (50). Frequently, explicit justification for exclusion criteria are not provided (50).…”

Systematic literature review of clinical trials evaluating pharmacotherapy for overactive bladder in elderly patients: An assessment of trial quality

“…Although trials of adult patients may not explicitly limit upper age in the inclusion criteria, older subjects are not as likely to be represented due to physician‐, patient‐, and trial‐related (eg, exclusion criteria related to comorbidities or comedications) factors that limit elderly patients’ trial participation . Thus, results from trials that ostensibly include patients of all ages may not be generalizable to the full non‐trial population with its large proportion of elderly patients . The disconnect between a condition's prevalence in older ages and availability of treatment data from studies of older subjects has been recognized in cancer, cardiovascular disease, hypertension, Alzheimer's disease, and depression …”

“…7,8 Thus, results from trials that ostensibly include patients of all ages may not be generalizable to the full non-trial population with its large proportion of elderly patients. [9][10][11][12] The disconnect between a condition's prevalence in older ages and availability of treatment data from studies of older subjects has been recognized in cancer, 13 cardiovascular disease, 14 hypertension, 7 Alzheimer's disease, 7 and depression. 7 The purpose of this systematic literature review was to assess the quantity and quality of the evidence provided by randomized, controlled drug trials that have been conducted in older-aged OAB patients.…”