Research Professional Université Laval Québec, Canada
Background: Older adults have historically been excluded from clinical trials, limiting evidence-based data. It is unclear whether the situation is similar with newly marketed medications.
Objectives: To describe 1) recommendations specific to older adults in monographs of newly marketed medications; 2) representation of older adults in clinical trials of those medications.
Methods: This descriptive analysis focused on all medications that received a notice of compliance from Health Canada in 2006-2020, excluding those with indications irrelevant to geriatrics or community practice and locally acting medications. Based on the most recent product monographs available, we assessed the availability and clarity of recommendations regarding older adults. We selected 30 medications widely used in older adults among those previously listed and found their associated National Clinical Trial (NCT) numbers on ClinicalTrials.gov. Phase III and IV randomized controlled double-blind trials led in Canada and/or United States were included. For each NCT, we extracted information on study design (e.g., trial’s phase, inclusion criteria based on age), participants (e.g., mean age, number/proportion aged ≥ 65 and ≥75, number of concomitant medications/health issues), as well as efficacy and/or safety analysis specific to older adults. Data extraction was based on information found in ClinicalTrials.gov and scientific paper(s) indexed to the database. If no articles were linked, we searched Pubmed/Google Scholar. We used simple linear regression to analyse time trends in the representation of older adults.
Results: A total of 195 monographs were included. Of the 130 monographs (67%) reporting a geriatric dosing recommendation, 53 (41%) also reported limited/insufficient data in older adults or subgroups (e.g., ≥75 years). Of the 373 included trials, most (n=217;58%) did not integrate a maximal age as inclusion criterion. However, only 113 (30%) included a proportion of older adults representative (or over-representative) of the Canadian geriatric population. Only 2 studies (0.5%) reported information on the number of concomitant medications per participant and 3 (0.8%), the number/score of comorbidities. Most trials (n=289;78%) did not provide efficacy or safety data specific to older adults. The proportion of older adults within trials seems to be increasingly reported over time, but it does not clearly result in their greater inclusion.
Conclusions: Newly marketed medications still appear to under-represent older adults. The resulting lack of clear recommendations in monographs compromises evidence-based practice, thereby perpetuating the risk to older adults’ health.
