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  • Durkalski, Valerie, MPH, Ph.D.
  • Director DCU
  • Professor of Biostatistics, Department of Public Health Sciences
  • College of Medicine, Medical University of South Carolina
  • Phone: 843-876-1911
  • Fax: 843.876.1923
  • Email: durkalsv@musc.edu
  • Experience: Phase I-III clinical trials; drugs and device trials
  • Research: Clinical trial methodology and implementation, design and analysis of non-inferiority studies
  • Projects: Neurological Emergencies, Diabetes, Digestive Diseases, Psychiatry
Valerie Durkalski, Ph.D., M.P.H., is a Professor of Biostatistics in the Department of Public Health Sciences at the Medical University of South Carolina (MUSC) and the Director of The Data Coordination Unit. She received her M.P.H. from Emory University (1996) and her Ph.D. in Biostatistics from MUSC (2001). As Director of the DCU, she collaborates on several large multicenter clinical trials in various therapeutic areas and has published and presented on various topics related to the design and conduct of multicenter trials. Currently, she is co-PI of the Statistical and Data Management Center (SDMC) for the NINDS sponsored Neurological Emergencies Treatment Trial Network (The NETT Network) and PI of the SDMC for the NIDDK sponsored Acute Liver Failure Study Group (ALFSG). In addition to these roles, Dr. Durkalski has research interests in non-inferiority trials as well as the implementation and analysis of adaptive trial designs.

Publications
 

Presentations
 
  • Zhao W, Durkalski V
  • Benefit of response afaptive randomization in confirmative clinical trilas could be unreal
  • Society for Clinical Trials 35th Annual Meeting, May 2014, Philadelphia, PA. Poster presentation
  • Zhao W, Durkalski V
  • The impact of response adaptive randomization and time trends on the type 1 error in clinical trials
  • Society for Clinical Trials 35th Annual Meeting, May 2014, Philadelphia, PA. Poster presentation
  • Zhao W, Durkalski V
  • Response adaptive randomization in large phase III confirmative clinical trials with binary outcomes – Benefits are unlikely
  • International Society for Clinical Biostatistics 35th Annual Meeting, Sept 2014, Vienna, Austria. Oral presentation
  • Palesch YY, Martin RL, Yeatts SD, Durkalski VL.
  • Caution! Approaching Interim Analysis.
  • Presented at the Society for Clinical Trials, Philadelphia, PA, May 2014. Oral presentation.
  • Ellerbe CN, Elm J, Ramakrishnan V, Turnbull B, Durkalski V.
  • Bias correction and optimized patient allocation for seamless adaptive dose selection design with repeated measures.
  • May 2014. Society for Clinical Trials Annual Meeting. Philadelphia, PA. Oral.
  • Ellerbe CN, Elm J, Ramakrishnan V, Turnbull B, Jauch E, DeSantis S, Durkalski V.
  • Phase II/III Seamless Adaptive Dose Selection Design for Longitudinal Patient Data.
  • September 2013. FDA. White Oak, VA. Oral. Presented also at 2013 Joint Statistical Meeting and 2013 Society for Clinical Trials
  • Ellerbe CN, Elm J, Ramakrishnan V, Turnbull B, Jauch E, DeSantis S, Durkalski V.
  • Optimal Longitudinal Data Utilization in a Seamless Adaptive (SA) Phase II/III Clinical Trial - Use of the conditional test statistic to identify the correct patient allocation ratio at each trial phase.
  • February 2013. ASA Conference on Statistical Practice. New Orleans, LA. Poster.
  • Garofolo KM, Yeatts SD, Ramakrishnan V, Jauch EJ, Johnston KC, Durkalski VL.
  • Responder Analysis Outcomes in the Analysis of Acute Stroke Clinical Trials.
  • Presented at the Society for Clinical Trials, Boston, MA, 2013. Oral presentation.
  • Durkalski VL, Wu Q.
  • Assessing the Success of the Blinded in Sham-Controlled Trials.
  • Society for Clinical Trials Annual Meeting, May 2013, Boston, MA. Oral presentation.
  • Zhao W, Kim J, Pauls K, Dillon C, Waldman B, Durkalski VL, Bonham T, Deyampert A, Palesch YY.
  • Design and Implementation of Risk-based Approach to Monitoring in Neurological Emergencies Treatment Trials Network.
  • Society for Clinical Data Management, Sept 2012, Los Angeles, LA
  • Dillon C, Zhao W, Durkalski V.
  • Case Report Form Design for Web-based Clinical Trial Data Management Systems.
  • Society for Clinical Trials Annual Meeting. May 2010. Baltimore, Maryland.
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