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Clinical Trials for Special Populations: Children, Older Adults, and Rare Diseases

Robert M Jacobson1, Robert J Pignolo2, Konstantinos N Lazaridis3

  • 1Department of Pediatric and Adolescent Medicine and Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA.

Mayo Clinic Proceedings
|February 3, 2024
PubMed

Insights

Maximizing population health requires inclusive clinical trials for special populations like children, older adults, and rare disease patients. Ethical considerations and innovative trial designs are crucial for equitable health outcomes and reducing disparities.

Area of Science:

  • Clinical Research
  • Public Health
  • Health Equity

Background:

  • Population health improvement necessitates inclusive research practices.
  • Special populations (children, older adults, rare diseases) require tailored clinical trial approaches.
  • Ethical conduct in research with vulnerable groups is paramount.

Purpose of the Study:

  • To review US regulations for clinical trials involving special populations.
  • To identify unique challenges and ethical issues in pediatric, geriatric, and rare disease research.
  • To explore innovative trial designs and strategies for enhancing generalizability and reducing health disparities.

Main Methods:

  • Literature review of US research regulations.
  • Analysis of challenges and ethical considerations in clinical trials for special populations.
  • Examination of strategies for improving generalizability and community engagement.

Main Results:

  • Special populations present distinct challenges in clinical trial design and execution.
  • Adherence to ethical principles is critical when involving vulnerable participants.
  • Innovative approaches and community engagement can improve trial generalizability and reduce disparities.

Conclusions:

  • Inclusive clinical trial practices are essential for advancing population health.
  • Addressing the unique needs of children, older adults, and rare disease patients is vital.
  • Enhanced generalizability and community involvement are key to reducing health disparities.

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