# Developing and Disseminating the Approach to Defining, Classifying, and Monitoring Adverse and Serious Adverse Events in Clinical Trials involving Older, Seriously Ill Populations

> **NIH NIH U24** · WAKE FOREST UNIVERSITY HEALTH SCIENCES · 2024 · $179,414

## Abstract

PROJECT SUMMARY
Research to support older adults with serious illness is a public health priority. Defining and
monitoring serious and other adverse events [(S)AEs] in clinical trials involving older adults with
serious illness pose challenges to investigators, regulators, sponsor agency members, and
patient stakeholders. Challenges include the reporting of events that are: implausibly related to
the intervention, misaligned with patient values, and/or caused by already established, well-
known relationships. There are also challenges with data and safety monitoring board
education, oversight and communication. In 2020, the NIA sponsored an initiative to convene a
multi-disciplinary group that met four times over 12 months. Efforts of the convening resulted in
new framework anchored by six principles including: 1) Consider interventions, populations and
settings (e.g., whether the study is FDA-regulated and therefore must adhere to specific
reporting standards, or alternatively, whether there is investigator discretion as in socio-
behavioral trials); 2) Adhere to the importance of safety reporting but use aggregate and routine
over singular and expedited reporting for most (S)AEs; 3) Prioritize intervention relatedness
(i.e., whether the (S)AE is ‘unlikely,’ ‘possibly,’ or ‘probably’ related to the intervention
mechanism using existing tools to support unbiased causality identification); 4) Subsume
expectedness into relatedness determination; given difficulties in forecasting the full range of
(S)AEs in seriously ill older adults at a trial’s outset, expectedness should be ascertained when
events occur by “ruling out underlying disease states”; 5) Consider concordance with patients’
goals of care; and 6) Assess seriousness, marking the events regulatory bodies are most
concerned about (e.g., death, hospitalization, life threatening events), after relatedness and
goal-concordance to highlight (S)AEs of greatest concern, and report them in an expedited,
case-by-case manner. The current proposed project will reconvene a working group to initially
develop the details of the methodology for defining, classifying and reporting (S)AEs for clinical
trials involving older, seriously ill adults. The group will focus on better defining and tracking
interventions, populations, settings; elaborating upon the relatedness determination; further
developing how to meaningfully determine patient goal concordance with events; and develop
content to align these efforts with existing NIA and related tools and guidance. This effort will
involve the creation of publicly available tools to support the research community, and the
widespread dissemination of the framework to encourage its implementation within clinical trials.

## Key facts

- **NIH application ID:** 10912253
- **Project number:** 3U24AG059624-07S1
- **Recipient organization:** WAKE FOREST UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** Abigail Baim-Lance
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $179,414
- **Award type:** 3
- **Project period:** 2018-07-15 → 2028-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10912253

## Citation

> US National Institutes of Health, RePORTER application 10912253, Developing and Disseminating the Approach to Defining, Classifying, and Monitoring Adverse and Serious Adverse Events in Clinical Trials involving Older, Seriously Ill Populations (3U24AG059624-07S1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10912253. Licensed CC0.

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