Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2025 Sep 15;17(9):e92388.
doi: 10.7759/cureus.92388. eCollection 2025 Sep.

The Essential Role of Medical Monitors in Clinical Trials

Gerald L Klein  1   2 , Elizabeth Barabash  3 , Roger E Morgan  4 , Gail Brown  5 , Mark Tulchinskiy  6 , Freddy Byrth  7 , Emilia Jones Amaowei  8 , Pavle Vukojevic  9 , Shabnam Vaezzadeh  10 , Katie-Louise Dawson  11 , Gabriel Cohn  12 , Stephen Haworth  13 , Anne Blackwood-Chirchir  14 , Johannes Wolff  15 , Angela Overton  16
Affiliations
Editorial

The Essential Role of Medical Monitors in Clinical Trials

Gerald L Klein et al. Cureus. .

Abstract

Medical monitors (MMs) play a critical and often underrecognized role in ensuring patient safety, regulatory compliance, and scientific integrity during clinical trials. Particularly in early-stage pharma, biotechnology, and medical device development, the MM serves as an independent safeguard against bias and unanticipated risks. This editorial outlines the rationale, responsibilities, and operational value of the MM role, emphasizing its function in document review, real-time safety oversight, and regulatory alignment. Through illustrative case studies and current best practices, we argue that the independence and objectivity of the MM is a strategic business necessity, not merely a regulatory checkbox.

Keywords: clinical trials in all phases (i-iv); drug and device; investigator brochure; medical monitor; protocols; safety patient; us fda.

PubMed Disclaimer

Conflict of interest statement

Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.

References

    1. U.S. Department of Health and Human Services, Food and Drug Administration. Oversight of clinical investigations — a risk-based approach to monitoring. U.S. Department of HHS and the FDA; [ Jun; 2025 ]. 2013. Food and Drug Administration. Oversight of clinical investigations - A risk-based approach to monitoring.
    1. Medical monitoring of clinical research studies. Klein GL, Johnson PC, Morgan R. https://www.researchgate.net/publication/349636278_Medical_Monitoring_of... J Clin Res Best Pract. 2021;17:1–5.
    1. Potential errors and corrections in early phase drug development. Klein GL, Morgan R. https://scispace.com/pdf/potential-errors-and-corrections-in-early-phase... Clin Trial Pract Open J. 2022;5:1–5.
    1. The role of medical monitors in safety oversight. [ Aug; 2025 ]. 2014. https://www.niaid.nih.gov/sites/default/files/medicalmonitor.pdf https://www.niaid.nih.gov/sites/default/files/medicalmonitor.pdf
    1. Clinical trial designs and endpoints. Zeissler ML, Chapman R. Handb Clin Neurol. 2024;205:123–134. - PubMed

Publication types

LinkOut - more resources