# Statistical Methods and Adaptive Trial Designs for Cardiovascular Outcomes with Information Sharing

> **NIH NIH K01** · UNIVERSITY OF COLORADO DENVER · 2022 · $148,420

## Abstract

Project Summary/Abstract. This application for a K01 award describes the research & mentoring plans and
coursework for Dr. Alexander Kaizer, an Assistant Professor of Biostatistics and Informatics at the University
of Colorado-Anschutz Medical Campus (CU-AMC), to achieve advancement towards independent research in
the use of adaptive designs for cardiovascular outcome clinical trials that facilitate information sharing across
different sources of data to improve the statistical efficiency of evaluating new therapies. The process to develop
effective novel treatments traditionally proceeds through a series of studies and phases. Conventionally, each
phase is treated independently from previous phases, which are traditionally only used in the design stage of a
new trial. This represents a potentially inefficient use of all available data that could be incorporated beyond the
design stage and represents an important limitation for newer trial designs that may include multiple treatments
within the context of a single protocol, but where comparisons only use concurrently collected data. The statistical
methodologies and trial designs proposed in this application address this limitation by developing new methods
to facilitate information sharing along with applications to platform trial designs. In this award, the development of
statistical methods will be coupled with formal training in the biology of the cardiovascular system to assure that
these new methods have seamless application in the design of cardiovascular outcomes research. To achieve
the training goals and research aims laid out in this K01, a research team of three mentors has been assembled.
Dr. John Kittelson, Professor of Biostatistics and Informatics at CU-AMC, is an expert in clinical trial design
and has extensive experience with cardiovascular trial implementation and analysis. Dr. Gregory Schwartz,
Professor of Medicine at CU-AMC and Chief of the Cardiology Section at the VA Medical Center, is a leader in
proposing, implementing, and disseminating cardiovascular outcome clinical trials. Dr. Robert Eckel, Professor
of Medicine at CU-AMC, past President of the American Heart Association, and President-elect of the American
Diabetes Association, is an expert in lipid and lipoprotein metabolism and diabetes.
In Aim 1, we will develop statistical methods for incorporating data from supplemental sources, such as past
trials, into the analysis of a current study based on their exchangeability (i.e., equivalence) after adjusting for
covariates (also known as information sharing). In Aim 2, we will develop adaptive platform trial designs that
consider new treatment arms compared to a shared control arm. To improve the accessibility of the new methods,
user-friendly software will be developed (Aim 3). The methods and designs from these aims will be evaluated
via rigorous simulation study to understand their small sample properties under various scenarios. Methods
will be illustrated throug...

## Key facts

- **NIH application ID:** 10378560
- **Project number:** 5K01HL151754-02
- **Recipient organization:** UNIVERSITY OF COLORADO DENVER
- **Principal Investigator:** Alexander Mark Kaizer
- **Activity code:** K01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $148,420
- **Award type:** 5
- **Project period:** 2021-04-01 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10378560

## Citation

> US National Institutes of Health, RePORTER application 10378560, Statistical Methods and Adaptive Trial Designs for Cardiovascular Outcomes with Information Sharing (5K01HL151754-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10378560. Licensed CC0.

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