Kaleab Z. Abebe, PhD

  • Assistant Vice Chancellor for Clinical Trials, Health Sciences
  • Associate Professor of Medicine, Biostatistics, and Clinical and Translational Science
  • Director, Center for Research on Health Care Data Center (CRHC-DC)
  • Director, Center for Clinical Trials and Data Coordination (CCDC)

Dr. Abebe's collaborative research focuses on design, conduct, coordination, and analysis of multicenter randomized controlled trials (RCTs). He is the PI of two large NIH-funded consortiums: the COPE-AKI Consortium Scientific & Data Research Center, which is developing and testing interventions to reduce morbidity and mortality in AKI survivors; and the Data Coordinating Center (DCC) for the REBIRTH Study, which will assess the effect of bromocriptine on left ventricular ejection fraction in women with peripartum cardiomyopathy. He is the Co-PI for the CaRISMA study, which is a pragmatic trial examining the effectiveness of computerized cognitive behavioral therapy (vs pain education) on pain intensity in adults with sickle cell disease (SCD). Dr. Abebe’s methodological interests revolve around the design and analysis of cluster randomized trials.

In addition to his research collaborations, Dr. Abebe is the director of the Clinical Trials Track for the MS in Clinical Research at the Institute for Clinical Research Education. He is a standing member of the Kidney, Endocrine, and Digestive Disorders (KEDD) Study Section, and he is a member of the Board of Directors and chair of the Equity, Diversity, and Inclusion committee for the Society for Clinical Trials.

Outside of work, Dr. Abebe enjoys spending time with his wife and two children. He’s also an avid soccer player, and he forces his family to watch him occasionally. 

Education & Training

  • BA (Mathematics) Goshen College, 2003
  • MA (Statistics) University of Pittsburgh, 2006
  • PhD (Statistics) University of Pittsburgh, 2009

Representative Publications

Abebe KZ, Rockhold FW. The impact of landscape changes on DSMB oversight of clinical trials. NEJM Evid. 2022;1(9).

This Clinical Trials Workshop describes how external factors (or landscape changes) can affect monitoring of an ongoing clinical trial and discusses issues to consider to avoid stopping a trial too early while maintaining equipoise for enrolled participants.

Abebe KZ, Althouse AD, Comer D, Holleran K, Koerbel G, Kojtek J, Weiss J, Spillane S. Creating an academic research organization to efficiently design, conduct, coordinate, and analyze clinical trials: The center for Clinical Trials & Data Coordination. Contemporary Clinical Trials Communications. 2019;16:100488.

We describe the organizational structure of the Center for Clinical Trials & Data Coordination, as well as the homegrown clinical trial management system integrating electronic data capture, eligibility and randomization, drug and external data tracking, safety reporting, outcome adjudication, data and safety monitoring, statistical analysis and reporting, data sharing, and regulatory compliance.

Abebe KZ, Scifres C, Simhan HMN, Day N, Catalano P, Bodnar LM, Costacou T, Matthew D, Illes A, Orris S, Duell J, Ly K, Davis EM. Comparison of two screening strategies for gestational diabetes (GDM2) trial: Design and rationale. Contemporary Clinical Trials Communications. 2017;62:43-49.

This paper describes the design and analysis plan of the Comparison of Two Screening Strategies for Gestational Diabetes (GDM2) Trial, as well as the overall challenges in assessing the impact of screening and diagnosis strategy on adverse pregnancy outcomes. We will also assess whether the additional women diagnosed with the one-step approach benefit from treatment as assessed by metabolic profiles at one year postpartum.

Schrier RW, Abebe KZ, Perrone RD, Torres VE, Braun WE, Steinman TI, Winklhofer FT, Brosnahan G, Czarncki PG, Hogan MC, Miskulin DC, Rahbari-Oskoui FF, Grantham JJ, Harris PC, Flessner MF, Bae KT, Moore CG, Chapman AB, the HALT-PKD Trial Investigators. Blood pressure in early autosomal dominant polycystic kidney disease. New England Journal of Medicine. 2014;371(24):2255-2266.

In this double-blind, placebo-controlled trial, we randomly assigned 558 hypertensive participants with autosomal dominant polycystic kidney disease to either a standard or a low blood-pressure target, and to either lisinopril plus telmisartan or lisinopril plus placebo. We assessed the impact of medication and blood pressure interventions on slowing the progression of PKD, as measured by total kidney volume.

Click here for a more complete bibliography of Dr. Abebe's works.

Research Interests

  • Data coordinating centers
  • Trial management systems
  • Cluster randomized trials
  • Kidney disease studies