# Research Project 1 will develop in silico models that predict PD progression and inform clinical trial design

> **NIH NIH P50** · UNIVERSITY OF ROCHESTER · 2021 · $177,303

## Abstract

SUMMARY
Disease progression modeling uses mathematical functions and data-driven algorithms to quantitatively
describe and predict the time course of progressive disease. In 2004, the United States Food and Drug
Administration (FDA) launched its Critical Path Initiative, which aims to modernize drug development. In this
initiative, disease progression modeling was promoted as a key opportunity for the advancement of novel
therapeutics. Since that time, disease progression modeling has been widely adopted by the pharmaceutical
industry and regulatory agencies. However, the application of disease progression modeling for PD is at a
nascent stage. Direct evidence demonstrating that disease progression modeling and clinical trial simulations
will improve PD research, care, and outcomes is limited. For example, the common notion that the
identification of specific types of patients (e.g., those at high-risk for specific progression rates) will lead to
clinical trials being conducted with greater efficiency cannot be assumed. This lack of evidence strongly
supports the need for more research on modeling and simulation tools in relation to PD research, care and
outcomes. The expected outcomes of the efforts, networks, and platforms developed from this research project
are modeling and simulation tools, and rapidly published studies to form the evidence base supporting the use
of such tools in PD research.

## Key facts

- **NIH application ID:** 10242056
- **Project number:** 5P50NS108676-04
- **Recipient organization:** UNIVERSITY OF ROCHESTER
- **Principal Investigator:** KARL D. KIEBURTZ
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $177,303
- **Award type:** 5
- **Project period:** 2018-09-30 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10242056

## Citation

> US National Institutes of Health, RePORTER application 10242056, Research Project 1 will develop in silico models that predict PD progression and inform clinical trial design (5P50NS108676-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10242056. Licensed CC0.

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