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. 2019 Apr;85(4):838-844.
doi: 10.1111/bcp.13876. Epub 2019 Feb 23.

Under-representation of elderly in clinical trials: An analysis of the initial approval documents in the Food and Drug Administration database

Rikje Ruiter  1   2 , Jacobus Burggraaf  1   3   4 , Robert Rissmann  1   3   4
Affiliations

Under-representation of elderly in clinical trials: An analysis of the initial approval documents in the Food and Drug Administration database

Rikje Ruiter et al. Br J Clin Pharmacol. 2019 Apr.

Abstract

Aims: To evaluate the availability of pharmacokinetic, safety and efficacy analyses specifically targeted at elderly, prior to the authorization of drugs.

Methods: A cross-sectional, structured review of publicly available initial approval documents of Food and Drug Administration-approved drugs was performed. The 10 most frequently on-label prescribed drug classes, drugs with known pharmacokinetic differences in the elderly or drugs that are relatively contraindicated in elderly (e.g. anticholinergics or benzodiazepines) were included in the analyses.

Results: In total, 1129 unique active pharmaceutical ingredients were found eligible for the analyses, of these, 506 were found in the Food and Drug Administration database (45%). The initial approval documents were available for 182 drugs. For the majority of the drugs, the initial approval documents in the database showed information on pharmacokinetics in elderly (n = 113; 62%). Furthermore, over time, the availability of information with regard to elderly increased statistically significantly from 0% in the period 1970-1979 to 76% for the period 2010-2018. Information on safety and efficacy was less frequently present, i.e. 42% and 45%, respectively and, moreover, the availability of information did not improve over time.

Conclusion: The under-representation of elderly in clinical trials thereby challenging the external validity of benefit/risk assessments of launched drugs was confirmed. Priority should be given to a study population that is representative for the target population.

Keywords: clinical trials; efficacy; elderly; pharmacokinetics; safety.

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Conflict of interest statement

There are no competing interests to declare.

Figures

Figure 1
Figure 1
Flow diagram of the availability of initial approval documents in the Food and Drug Administration (FDA) database. WHO, World Health Organization
See this image and copyright information in PMC

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MeSH terms