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Updated: Jul 29, 2025

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Temporal changes in characteristics and external validity of randomized controlled trials in older people from 2012

Estelle van Eijk1, Yanna M van der Spek1, Floor J A van Deudekom2

  • 1Section of Gerontology and Geriatrics, Department of Internal Medicine, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, the Netherlands.

BMC Geriatrics
|May 24, 2023
PubMed
Abstract

Insights

Inclusion of older adults in clinical trials increased slightly between 2012 and 2019, with improved reporting of geriatric assessments. However, dedicated trials for older populations remain infrequent, necessitating further research efforts.

Area of Science:

  • Geriatric Medicine
  • Clinical Trial Methodology
  • Evidence-Based Practice

Background:

  • Older adults are underrepresented in clinical trials, with limited reporting of geriatric characteristics in past studies.
  • This review examines changes in the characteristics and external validity of randomized controlled trials (RCTs) involving older individuals between 2012 and 2019.

Approach:

  • A systematic review of PubMed-indexed RCTs published in 2019, comparing findings to identical reviews from 2012.
  • RCTs were categorized based on specific design for older populations (mean age ≥70 or age cutoff ≥55) or inclusion of a majority of older individuals (mean age ≥60).
  • Screening for the reporting of geriatric assessments was conducted for trials including a majority of older participants.

Key Points:

  • In 2019, 8% of RCTs were specifically designed for older people, a slight increase from 7% in 2012.
  • The proportion of trials including a majority of older participants rose from 22% in 2012 to 25% in 2019.
  • Reporting of geriatric assessments in trials with older adults increased significantly, from 34% in 2012 to 52% in 2019.

Conclusions:

  • While the proportion of RCTs specifically targeting older adults remains low, there has been a notable improvement in reporting geriatric assessment characteristics.
  • Continued efforts are crucial to enhance both the quantity and validity of clinical trials involving the older population.
Keywords:
Geriatric assessmentsOlder individualsRandomized controlled trialsSystematic reviewTemporal changes

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