# Novel Approaches to Monitor the Safety and Effectiveness of Newly Marketed Diabetes Medications in Older Adults Considering Frailty and Multimorbidity

> **NIH NIH K08** · BRIGHAM AND WOMEN'S HOSPITAL · 2020 · $165,240

## Abstract

This application for a Mentored Clinical Scientist Research Career Development Award (K08) is submitted by
Elisabetta Patorno, MD, DrPH in response to PA-16-191. Dr. Patorno is a preventive medicine physician and
pharmacoepidemiologist in the Division of Pharmacoepidemiology at Brigham and Women's Hospital, and
Assistant Professor of Medicine at Harvard Medical School. With a rapidly increasing US population ≥ 65
years, who use the largest proportion of medications, a better understanding of the effects of medications in
older adults as used in routine care is imperative. This need is even more acute for new drugs that usually
enter the market on the basis of evidence from relatively small, short, and often placebo-controlled randomized
trials (RCTs), in which older patients are often underrepresented or excluded. As a result, clinicians often
struggle choosing the best treatment for their older patients, particularly those with frailty and multimorbidity.
Dr. Patorno is committed to a career as an independent clinical investigator, focused on advancing
research for rigorously monitoring the effects of medications in older adults as treated in routine care.
To achieve this, Dr. Patorno proposes a 4-year program of career development and mentored research
centered on the development of a valid system for timely and high-quality evidence on new diabetes
drugs in older patients specifically tailored to address the unique aspects of care in older patients
such as frailty and multimorbidity. This setting of research combines the urgent need for information on the
effects of over 10 new antidiabetic agents approved by the FDA in the last decade with the need for the
development of novel methods for prospective drug monitoring in real-world older adults. Within the highly
productive and supportive research environment of the Division of Pharmacoepidemiology, Dr. Patorno will
work with an interdisciplinary team of mentors and collaborators drawn from across institutions at Harvard
University that have deep expertise and national/international reputations in the specific substantive areas of
her proposed training: clinical geriatrics and diabetology, methods for prospective monitoring and data mining,
and health services research in older populations. The overarching objective of her mentored research is to
create and implement a novel approach for the near-real-time monitoring of the comparative safety and
effectiveness of new diabetes drugs in older patients as treated in routine care. This novel monitoring
approach will use Medicare claims data available with a relatively short lag time, linked to electronic medical
records and the Medicare Current Beneficiary Survey. The proposed work will provide timely and actionable
knowledge for clinicians treating older adults, defining the net incremental value of new antidiabetic agents in
older patients with frailty and multimorbidity. The knowledge gained from this work will impact several million
older adult...

## Key facts

- **NIH application ID:** 9817672
- **Project number:** 5K08AG055670-03
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Elisabetta Patorno
- **Activity code:** K08 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $165,240
- **Award type:** 5
- **Project period:** 2017-12-01 → 2021-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9817672

## Citation

> US National Institutes of Health, RePORTER application 9817672, Novel Approaches to Monitor the Safety and Effectiveness of Newly Marketed Diabetes Medications in Older Adults Considering Frailty and Multimorbidity (5K08AG055670-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9817672. Licensed CC0.

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