# Ethical Issues in Prescribing Drugs to Older Adults for Whom Representative Randomized Trial Data Is Lacking

> **NIH NIH R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2021 · $178,384

## Abstract

Older adults are often underrepresented in or even excluded from the randomized controlled trials
(RCTs) leading to FDA approval of new drugs, but for many drugs they then represent the majority of patients
receiving the drug in routine care after approval. Drugs demonstrated to have certain outcomes in trials of
younger populations may not have similar effectiveness in older adults, and such use may also put patients in
underrepresented older age groups at increased risk for unexpected side effects. The current R01 grant
(“Understanding effectiveness of new drugs in older adults shortly after market entry”) evaluates a framework
for developing more timely and robust insight regarding the effectiveness of new FDA-approved drugs in older
adults. This supplemental application augments the R01 grant with bioethics research examining the
issues in prescribing drugs for older patients when RCTs leading to FDA approval did not include
those patients.
 We will explore the bioethical implications of the use of drugs in populations different from those
recruited into their pivotal RCTs, including the need for enhanced disclosure as part of informed consent
procedures and regulatory changes that would make approvals conditional on evidence generated in real-
world patient populations. These goals will be pursued by conducting focus groups with older adult patients
and semi-structured interviews with prescribers. Based on the results of these research efforts, we will
formulate regulatory and clinical practice recommendations to promote patient autonomy and informed
decision making.

## Key facts

- **NIH application ID:** 10366434
- **Project number:** 3R01AG053302-04S1
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Shirley Wang
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $178,384
- **Award type:** 3
- **Project period:** 2018-08-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10366434

## Citation

> US National Institutes of Health, RePORTER application 10366434, Ethical Issues in Prescribing Drugs to Older Adults for Whom Representative Randomized Trial Data Is Lacking (3R01AG053302-04S1). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10366434. Licensed CC0.

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