Module232025

07/05/2025

Underserved populations - conclusions

• Clinical trials possible in almost all underserved populations I haven’t yet found an exception, but…..

Key aspects: Understand “that which is true”

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how patients are normally treated the different challenges every patient group presents trials will often take longer to enrol – plan for that sites may be less experienced - offer additional support prescribing physicians need to know what dose to prescribe – trials provide best evidence families often more “involved” than usual

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References

1. NIHR (2020). Improving inclusion of under-served groups in clinical research: guidance from the NIHR-INCLUDE Project; see https://www.nihr.ac.uk/improving-inclusion-under-served-groups-clinical-research-guidance-include- project 2. Pardhan et al. (2025) Barriers and facilitators for engaging underrepresented ethnic minority populations in healthcare research: an umbrella review. Int.J.Equity in Health 24:70-85 3. Eke et al (2023). Physiologic Changes During Pregnancy and Impact on Small-Molecule Drugs, Biologic (Monoclonal Antibody) Disposition, and Response. J.Clin.Pharmacol., 63(S1):S34-S50 4. Ngcobo, N.N et al (2025) Influence of Ageing on the Pharmacodynamics and Pharmacokinetics of Chronically Administered Medicines in Geriatric Patients: A Review. Clin Pharmacokinet 64: 335–367 5. Riffo, R. et al (2025). Reading Comprehension in Older Adults - Effects of Age, Educational Level, and Reading Habits. J. Intell. 13: 1-16. 6. Murman, DL (2015) The Impact of Age on Cognition. Semin Hear. 36:111–121 7. van Boxtel, W, Lawyer, L. Sentence comprehension in ageing and Alzheimer's disease. Lang Linguist Compass. 2021;e12430. 8. Vargesson, N. (2015) Thalidomide-induced teratogenesis: history and mechanisms. Birth Defects Res. C. Embryo Today 105, 140–156. 9. FDA. (2021) FDA Postmarketing Requirements in Pregnant and Lactating Women: Past, Present, and Future. Center for Drug Evaluation and Research, US Food and Drug Administration. 10. Avachat, C. et al (2023) Characterization of the US Food and Drug Administration Post-Marketing Commitments and Requirements for Pregnancy and Lactation. Clin.Pharm.Ther. 114; 1238–1242.

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