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Updated: Jan 14, 2026

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Inclusion of Older Adults in Early-Phase Cancer Clinical Trials: Safety, Efficacy and a Way Forward

Jessie Nguyen1, Nicolò Matteo Luca Battisti2, Danielle Ní Chróinín3,4

  • 1Department of Medical Oncology, Liverpool Hospital, Liverpool, NSW, Australia.

Drugs & Aging
|October 23, 2025
PubMed

Insights

Older adults are underrepresented in early-phase clinical trials (EPCTs) for cancer, despite increasing incidence. This review examines participation, outcomes, and strategies to improve inclusivity for this demographic.

Area of Science:

  • Oncology
  • Geriatric Medicine
  • Clinical Trial Design

Background:

  • Early-phase clinical trials (EPCTs) are crucial for novel cancer therapy evaluation.
  • Older adults (≥65 years) are disproportionately affected by cancer but are underrepresented in EPCTs.
  • This disparity creates a significant evidence gap in cancer management for the aging population.

Purpose of the Study:

  • To review the current landscape of older adults in EPCTs.
  • To identify participation rates, outcomes, and challenges contributing to underrepresentation.
  • To explore strategies for enhancing the inclusion of older adults in cancer clinical trials.

Main Methods:

  • This is a review article.
  • It synthesizes existing literature on older adult participation in EPCTs.
  • It analyzes challenges and proposes solutions for improved inclusivity.

Main Results:

  • Older adults remain underrepresented in EPCTs despite rising cancer incidence in this age group.
  • Concerns regarding safety and quality of life have historically limited participation.
  • The landscape of EPCTs is evolving, with increasing data on safety and efficacy.

Conclusions:

  • Underrepresentation of older adults in EPCTs necessitates targeted strategies for improved inclusion.
  • Addressing participation barriers is essential for evidence-based cancer care in older populations.
  • Enhancing inclusivity will lead to better cancer treatment outcomes for older adults.

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