Research Interests
Data Access and Transparency
Pragmatic Clinical Trials
Clinical Trial Design
Data Monitoring Committees
Safety and Pharmacovigilance
Pragmatic Clinical Trials
Clinical Trial Design
Data Monitoring Committees
Safety and Pharmacovigilance
Selected Grants
Integrated Biostatistical Training for CVD Research
Inst. Training Prgm or CMEMentor · Awarded by North Carolina State University · 2022 - 2027Infrastructure for Musculoskeletal Pediatric Acute Care Clinical Trials (IMPACCT)
ResearchStatistical Investigator · Awarded by Ann & Robert H Lurie Children's Hospital of Chicago · 2021 - 2026Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss
ResearchCo Investigator · Awarded by Patient-Centered Outcomes Research Institute · 2021 - 2026HERO Program, HERO Registry, HERO-HCQ Trial
Clinical TrialStatistical Investigator · Awarded by Patient-Centered Outcomes Research Institute · 2020 - 2025Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)
ResearchCo Investigator · Awarded by National Institutes of Health · 2016 - 2025RECOVER Infrastructure Modification 11 (Yr 3)
ResearchInvestigator · Awarded by Research Triangle Institute International · 2022 - 2025ADAPTABLE Supplement
Clinical TrialBiostatistician Investigator · Awarded by Patient-Centered Outcomes Research Institute · 2015 - 2023The ISCHEMIA Trial - SDCC
Clinical TrialStatistical Investigator · Awarded by National Institutes of Health · 2011 - 2022ACT-EARLY
Clinical TrialPrincipal Investigator · Awarded by Eidos Therapeutics · 2021 - 2022Innovative statistical methodologies to subgroup analysis in clinical trials
ConferencePrincipal Investigator · Awarded by Brigham and Women's Hospital · 2020 - 2021The ISCHEMIA Trial - SDCC- Subcontract with NYU
Clinical TrialStatistical Investigator · Awarded by New York University · 2017 - 2019Fellowships, Gifts, and Supported Research
Addressing the clinical dilemma and patient preference for unilateral versus bilateral hearing aids ·
February 2020
Co Investigator ·
Awarded by: PCORI
Innovative statistical methodologies to subgroup analysis in clinical trials ·
November 2019
CO PI ·
Awarded by: FDA
EIDOS THERAPEUTICS EIDO-01 ·
June 2019
Faculty Investigator ·
Awarded by: Eidos Therapeutics
Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations (PREPARE) ·
2018
- 2021
Investigator ·
Awarded by: Patient-Centered Outcomes Research Institute
Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations (PREPARE)
PACT-ADDF ·
2018
- 2021
Investigator ·
Awarded by: Alzheimers Drug Discovery Foundation
A Phase II Study of an ApoE mimetic peptide to reduce Postoperative Delirium and Cognitive Dysfunction after Non-Cardiac Surgery in Older Adults
The ISCHEMIA Trial - SDCC ·
2017
- 2020
Faculty Statistician ·
Awarded by: National Institutes of Health
· $1,398,828.00
The objective is to determine the best management strategy for patients with stable ischemic heart disease (SIHD) and moderate-severe ischemia.
Phase III Stroke Trial ·
2017
- 2020
Faculty Statistician ·
Awarded by: ReNeuron Group
· $13,544,374.00
This is a randomised, controlled, phase 3 study of the safety and efficacy of intracerebral stem cells (CTX0E03 DP) in patients with disability following an ischemic stroke.
REA in 1VIT15043 Study ·
2017
- 2020
Faculty Statistician ·
Awarded by: Luitpold Pharmaceuticals
· $28,687,822.00
A randomized, double-blind, placebo controlled study to investigate the efficacy and safety of injectafer (ferric carboxymaltose as therapy for patient with heart failure and iron deficiency.
BMS Clinical Trial Data Sharing Program ·
2017
PI ·
Awarded by: Bristol-Myers Squibb
Manage SOAR platform and governance process
Gemini Phase 3 ·
2016
- 2017
Awarded by: Janssen Research & Development
· $178,530.00
This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multicenter study to compare the efficacy and safety of rivaroxaban versus acetylsalicylic acid.
EUCLID Secondary Manuscripts ·
2016
- 2020
Faculty Statistician ·
Awarded by: AstraZeneca AB
· $2,426,062.00
This is a randomized, double-blind, parallel group, multicenter phase IIIb study to compare ticagrelor with clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischemic stroke.
EXSCEL Cardiovascular Outcomes Study in Diabetes ·
2016
- 2017
Awarded by: Amylin Pharmaceuticals
· $35,257,749.00
This study will compare the impact of including exenatide once weekly in addition to usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction (MI), or nonfatal stroke.
GEMINI ACS 1 ·
2016
- 2018
Awarded by: Janssen Research & Development
· $2,426,062.00
This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multicenter study to compare the safety of Rivaroxaban versus Acetylsalicylic Acid in addition to either Clopidogrel or Ticagrelor therapy in subjects with acute coronary syndrome.
ADAPTABLE ·
2016
- 2020
Faculty Statistician ·
Awarded by: Patient-Centered Outcomes Research Institute
· $16,098,559.00
In this pragmatic, patient-centered clinical trial, we will compare the effectiveness of two doses of aspirin currently in widespread use (81 mg and 325 mg) in a secondary-prevention population of patients with ASCVD. The trial will use a novel format that uses existing electronic health records (EHRs), as well as a web-based portal to collect patient reported outcomes, and available claims data to supplement/support the EHR. One of the important aims of ADAPTABLE is to engage patients, their healthcare providers, and trial investigators utilizing the infrastructure PCORnet has developed and continues to be refined.
External Relationships
- Adaptic Health
- Alkermes, Inc.
- Amgen, Inc.
- AskBio (owned by Bayer)
- AstraZeneca
- Biogen
- BridgeBio
- Bristol Myers Squibb
- California Instiitute for Regenerative medicine
- Clover BioPharmaceuticals Australia
- Dr. Evidence
- Eli Lilly & Co.
- European Medicines Agency Technical Advisory Group
- Frontier Science and Research Technology Foundation
- Gilead Sciences, Inc.
- GlaxoSmithKline
- HunterRockhold, Inc.
- Icosavax
- Intercept Pharmaceuticals
- Inventprise
- Merck Research Laboratories
- Neurocrine Biosciences, Inc. (Diurnal)
- Novartis
- Odyssey Topco (financial holding company)
- Pulmocide
- Resolve Therapeutics
- Sanofi
- Spencer Health Solutions
- UCB Pharma
This faculty member (or a member of their immediate family) has reported outside activities with the companies, institutions, or organizations listed above. This information is available to institutional leadership and, when appropriate, management plans are in place to address potential conflicts of interest.