title: Ageism and clinical research.
abstract: Despite being the most significant consumers of health care resources and medications worldwide, recent international research has highlighted the under-representation of older participants from clinical trials. This creates problems for physicians as the patients seen in clinical practice are not representative of those on which medical treatments and interventions have been trialled, and we need to consider whether results (both negative and positive) from these trials are applicable to these patients. Our aim was to gauge whether exclusion of older people was prevalent in research proposals submitted to Dublin teaching hospitals. We audited all clinical research proposals submitted to the Research Ethics committee (REC) covering the teaching hospitals attached to Trinity College Dublin (TCD) from July 2008 to July 2011 inclusive, recording exclusion of patients based on an arbitrary upper age limit. Of the 226 relevant trials studied, 31(13.7%) excluded participants based solely on an arbitrary upper age limit. 22 (9.8%) of the relevant trials were submitted by geriatricians, none of which excluded patients based solely on age. Over 50% (12 of 22) trials submitted by neurology/psychiatry excluded patients based on an upper age limit. The mean upper age limit used over all trials as a cut-off was 69.2 years of age. As well as this, the majority of the remaining trials also contained other exclusion criteria, especially those based on cognitive function which further limited participation of older people. While we found that a significant proportion of clinical trials submitted to the TCD REC still excluded patients based arbitrarily on an upper age limit, participation rates of older people seem to be higher in this Irish centre than that seen in international trials. Significant room for improvement still remains however and there needs to be a promotion of greater awareness of the need for developing, testing and licensing medicines so that it mirrors the consumer groups in which they will be used. Increased input from geriatricians around the testing and licensing of medicines, and in licensing agencies, would greatly help in this regard. It is both unhelpful for optimal healthcare as well as fundamentally unjust to exclude participants from clinical research based solely on an arbitrary age limit.
authors.affiliation: Centre for Ageing, Neuroscience and the Humanities, Tallaght Hospital, Dublin.
authors.forename: R
authors.initials: R
authors.lastname: Briggs
authors.forename: S
authors.initials: S
authors.lastname: Robinson
authors.forename: D
authors.initials: D
authors.lastname: O'Neill
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D063506:Ageism / Q000706:statistics & numerical data*; D035843:Biomedical Research; D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data*; D005260:Female; D015577:Geriatric Assessment / Q000379:methods / Q000706:statistics & numerical data*; D005853:Geriatrics / Q000458:organization & administration; D006304:Health Status; D006801:Humans; D007494:Ireland; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D012107:Research Design