Evidence‐based data for newly approved medications' use in older adults: An analysis from clinical trials to monographs
Bibliographic record
Abstract
BACKGROUND: Older adults have historically been excluded from clinical trials, limiting evidence-based data. An updated picture of the situation with newly marketed medications is needed. We aimed to describe (1) the recommendations specific to older adults in monographs of newly marketed medications; (2) the representation of older adults in clinical trials of those medications. METHODS: In November 2020, we listed all medications that received a notice of compliance from Health Canada between January 2006 and September 2020, excluding those with indications irrelevant to community-dwelling older adults and locally acting medications. We assessed the availability and clarity of recommendations in monographs regarding older adults. Using Clinicaltrials.gov, we identified randomized controlled double-blind Phase III-IV trials led in Canada/United States of a sample of 30 commonly used medications among those previously listed. We extracted information on study design, participants, and efficacy/safety analysis specific to older patients. We used simple linear regression and Chi-square/Fisher's exact tests to analyze time trends in the representation of older adults over different periods. RESULTS: A total of 195 monographs were included. Of the 130 monographs reporting a dosing recommendation in older adults, 53 (41%) also reported limited/insufficient data in this population or its subgroups. Of the 373 trials included, 217 (58%) did not integrate a maximum age as an inclusion criterion. However, only 113 (30%) reported including a proportion of older adults representative (or over-representative) of the Canadian older population. Most trials (n = 289; 78%) did not provide efficacy or safety data specific to older adults. In our sample, the number/proportion of older adults in trials seemed to be increasingly reported over time, either explicitly or implicitly (e.g., inclusion criterion specifies <65 years old). 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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.105 | 0.330 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.007 | 0.011 |
| Bibliometrics | 0.018 | 0.025 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.004 | 0.004 |
| Open science | 0.002 | 0.003 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".