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Kousick Biswas, PhD

Academic Title:

Assistant Professor

Primary Appointment:

Epidemiology & Public Health

Additional Title:

Director Cooperative Studies Program (CSP) Coordinating Center at Perry Point/Baltimore, Maryland Office of Research & Development (ORD) U.S. Department of Veterans Affairs

Phone (Primary):

410-642-2411 ext. 5283

Phone (Secondary):




Education and Training

Ph.D., Engineering (with Statistics emphasis), West Virginia University, 1997

M.S., Statistics, West Virginia University, 1997

B.S., Engineering, Calcutta University, 1986


Professional Services:

  • Service to VA Committees

  • Member of Board of Directors, Baltimore Research and Educational Foundation, a non-profit organization at the VA Maryland Healthcare System

  • Representing VA Office of Research & Development (ORD) in Security of VA Research Data workgroup (2014 – current);

  • Representing VA Cooperative Studies Program (VACSP) in a VA ORD/OIT Regionalized Storage of ORD Data (RSORDD) work group (2014 – current);

  • Lead, VA CSP Public Data Access Workgroup (2013 – current);

  • Service to Professional Society

  • Member of Education Committee, Society for Clinical Trials (2013 - current);

  • Member of Program Committee, Society for Clinical Trials (2017 -)

  • Member of Editorial Board

  • Journal of Epidemiology and Drug Research  (2012 – current) ;

  • Statistical Reviewer in Research Grant Review Panels

  • Government Steering Committee, VA/DOD Consortium to Alleviate PTSD (CAP) (2015 - )

  • VA Clinical Trial Review Panel on Neuropsychiatric Disorders (VA CLIN) (2013 – current);

  • ZAR1 CNR M1 Special Emphasis Panel (NIH)  (2011);

  • Peer Review of NIAMS Clinical Studies Support Contract Proposal (2011);

  • National Center of PTSD review panel, VA Office of Mental Health Services (MHBB) (2009 – 2015);

  • VA Merit Review – Neurobiology subcommittee (2008);

  • Statistical Member of Data Monitoring Committees

  • Data Safety Monitoring Board, R01 "Implementing Chronic Care Management for Bipolar Disorder" (R01MH079994); PI: Amy Kilbourne (2011);

  • CSR&D Data Monitoring Committee for Phase I Protocols evaluation of the Merit Review submissions (2010 – 2013);

  • CSR&D Data Monitoring Committee for Medical and Surgical Protocols evaluation of the Merit Review submissions (2008 – 2010);

  • CSR&D Data Monitoring Committee for Mental Health Protocols evaluation of the Merit Review submissions (2008 – current);

  • Statistical Reviewer of Journal Publications

  • Journal of Immigrant and Minority Health

  • Journal of Rehabilitation Research and Development

  • Journal of Geriatric Psychiatry and Neurology

  • Subdomain/Workgroups/Committees

  • Process Action Committee member for the VA CSP Clinical Web Site on the Austin DMZ (2013);

  • Coordinating Center Representative, “Cross-functional Quality Improvement Committee” for the VA Cooperative Services Program (2013 – 2015);

  • Member, CSP NODES site visit team (2012);

  • Chair, EDC Advisory Committee, VA CSP (2010 – current);

  • Lead, Data Management Sub-domain, VA Cooperative Studies Program, (2008 – 2015);

  • Team Lead, “Data Capturing Systems” subgroup of the “Information Technology Standardization Workgroup” for the VA Cooperative Studies Program (2007 – 2008);

  • Coordinating Center Representative, “Data Management and Informatics Functional Domain” for the VA Cooperative Services Program (2008);

  • Miscellaneous

  • Session Chair for “Recent Advances in Methods for Handling Missing Data in Clinical Trials” at 38th Society for Clinical Trials Annual Meeting, May 2017, Liverpool, UK

  • Session Chair for “Electronic Data Capture and Data Visualization” at 37th Society for Clinical Trials Annual Meeting, May 2016, Montreal, Canada.

  • Statistical Faculty of VA CSP Clinical Trials Course (2010)

  • Member of Cross-functional ISO-9001 Team (CFIT), VA CSP (2009-2013)

  • Session Chair for ‘AP-Evaluation & Mining System Optimization Through Artificial Intelligence & Neural Network’ at APCOM (Application of Computers in Mineral Industry), February 2002, Phoenix, AZ.

Research/Clinical Keywords

- Strategic planning in key functional areas for planning and execution of Clinical Trial Management processes for VA CSP; - Administration and Management of Multisite Clinical Trials Coordinating Center; - Planning, Design and Conduct of Phase II/III, Multi-site Clinical Trials; - Statistical Analysis, Data Management and safety management for clinical studies; - Use of electronic medical records (EMR) for site selection, effect size calculation and safety reporting - Strategic planning in security and storage of research data for VA’s Office of research and development

Highlighted Publications

  1. Gabrielle H. Saunders, Kousick Biswas, Tracey Serpi, Stephanie McGovern, Alexander Libin, Shirley Groer, Kathryn M. Magruder, Michael T. Fallon, Patricia Dorn, Grant Huang, and SDPTSD study team, “A randomized trial comparing the impact of quality of life of providing service dogs and emotional support dogs to Veterans with PTSD”, accepted for publication at Controlled Clinical Trials, Volume 62, November 2017, Pages 105–113 []


  1. Song N, Ding P, Biswas K,  Mi Z. (2016) “Simultaneous Prediction Intervals for Dose-response Curve Quality Control”. Biom Biostat Int J 3(6): 00080.


  1. Panos Kougias MD, Zhibao Mi, PhD, Sherene Sharath MPH, Neal R Barshes MD MPH, and Kousick Biswas, PhD, “Impact of Postoperative Nadir Hemoglobin and Cardiac Risk Status on Outcomes after Major General and Vascular Surgery Operative Interventions” under review JAMA Surgery, 2017.


  1. Gorodetzky, Charles, Walsh, Sharon, Martin, Peter, Saxon, Andrew, Gullo, Kristen, Biswas, Kousick, “A Phase III, Randomized, Multi-Center, Double Blind, Placebo Controlled Study of Safety and Efficacy of Lofexidine for Relief of Symptoms in Subjects Undergoing Inpatient Opiate Detoxification”, Drug and Alcohol Dependence, Volume 176, 1 July 2017, Pages 79–88.


  1. Zhibao Mi, MD PhD, Kousick Biswas Ph.D, J. Kaci Fairchild, PhD,  Annie Davis-Karim, PharmD, Ciaran Phibbs, PhD,  Steve Forman, MD,Michale Thase, MD,  Gerald Georgette, RN,Tamara Beale, MA, David Pittman, Margaret Windy McNerney, PhD,  Allyson Rosen, PhD, Grant Huang, MPH, PhD,Mark George, MD, Jerome A. Yesavage, MD, “Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment-Resistant Major Depression (TRMD) Patients: Rationale and Design of a Trial Focusing on Veterans”, accepted for publication,  Trials (TRLS-D-16-00309), 2017


  1. Somaia Mohamed, Gary Johnson, M.S.; Julia Vertrees, PharmD, BCPP; Peter Guarino, Ph.D.; Kimberly Weingart, Ph.D.; Ilanit Young, Ph.D.; Jean Yoon , Ph.D.; Theresa Gleason ; Katie Kirkwood ; Amy Kilbourne, Ph.D.; Martha Gerrity , M.D.; Steve Marder, M.D.; Kousick Biswas, Ph.D.; Paul Hicks, M.D.; Lori Davis, M.D.; Peijun Chen, M.D.; Alix Kelada ; Grant Huang; David Lawrence; Mary LeGwin; Sidney Zisook , M.D. “The VA augmentation and switching treatments for improving depression outcomes (VAST-D) study: Rationale and design considerations”, Psychiatry Research , Volume 229, Issue 3, 30 October 2015, Pages 760–770


  1. Sofie Livio, M.S.,Nancy Strockbine, Ph.D.,Sandra Panchalingam, Ph.D., Sharon M. Tennant, Ph.D.,Eileen M. Barry, Ph.D.,Martin Antonio, Ph.D.,Anowar Hossain, M.D.,  Inacio Mandomando, Ph.D., John B. Ochieng, M.Sc.,Joseph O. Oundo, Ph.D.,Shahida Qureshi, M.Sc.,T. Ramamurthy, Ph.D., … Kousick Biswas, Ph.D.,Dani Cohen, Ph.D,Tamer Farag, Ph.D.,Dilruba Nasrin, M.B.B.S., Ph.D.,Karen L. Kotloff, M.D.,James P. Nataro, M.D., Ph.D.,Myron M. Levine, M.D., D.T.P.H., “Shigella Isolates from the Global Enteric Multicenter Study (GEMS) Inform Vaccine Development”, Clinical Infectious Disease, Volume 59,  Issue 7 Pp.  933-941. 2014


  1. Zenati, M.A., Gaziano, M.J., Collins, J.F., Biswas, K., Gabany, J., Quin, J., Bitondo, J., Bakeen, F., Kelly, R. Shroyer, L. A., and Bhatt, D., “Choice of Vein Harvest Technique for CABG: Rationale and Design of the REGROUP TrialClinical Cardiology, Vol. 37, Issue 6, June 2014; pp 325-330.



Additional Publication Citations

Book Chapter(s):


Section 4: Statistical Considerations

  • Part A: Basic statistical considerations (co-authored with Dr. Eileen Stock)

  • Part C: Sample size Calculation (co-authored with Dr. Eileen Stock)

  • Part D: Missing Data


“Clinical Trials Design in Invasive Operative and Non Operative Procedures” Editors: Kamal Itani, MD and Domenic Reda, PhD

Publisher: Springer Science

May 2017

Research Interests

Major Clinical Trials:


VA/CSP#2015 “Multicenter, Randomized, Double-Blind, Placebo-Controlled Comparator Effectiveness Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson’s Disease Psychosis

(CESAPP Study)”

Role: Coordinating Center PI

Project Status: Planning

Funding Agency: VA/CSR&D/CSP


VA/CSP “Opioid Tapering: A Novel Strategy

Role:Coordinating Center PI

Project Status: Pre-planning (LOI submitted)

Funding Agency: VA/CSR&D/CSP


VA/NIDA# 1033 “Lorcaserin in the Treatment of Cocaine Disorder”

Role: Coordinating Center PI

Project Status: Recruitment (2017 – 2019)

Funding Agency: NIH/National Institute on Drug Abuse 

FY 17 support - $1,252,973


VA/CSP# 599 “Transfusion Triggers After Operations for PAD (TOP)

Role: Coordinating Center PI

Project Status: Start-up phase (2017 - 2022)

Funding Agency: VA/CSR&D/CSP


VA/CSP# 2003 “Exoskeletal-Assisted Walking in Persons with SCI: Impact on Quality of Life

Role: Coordinating Center PI

Project Status: Active recruitment (2016 – 2021)

Funding Agency: VA/CSR&D/CSP

FY 17 support - $5,818,773


VA/NIDA# 1032 “Smoking Cessation Study Using AZD 8529

Role: Coordinating Center PI

Project Status: Completed (2015 – 2017)

Funding Agency: NIH/National Institute on Drug Abuse

FY 17 support - $1,230,779


VA/CSP/RR&D “Service Dogs for Veterans with PTSD

Role: Coordinating Center PI

Project Status: Recruitment (2013 – 2021)

Funding Agency: VA/ORD 

FY 17 support - $1,927,198


VA/CSP# 588 “Randomized Endo-vein Graft Prospective – REGROUP

Role: Coordinating Center PI

Project Status: Participant Accrual phase completed; Follow-up phase (2013 - 2020)

Funding Agency: VA/CSR&D/CSP

FY 17 support - $2,475,536


VA/NIDA#1031 “Safety and Efficacy of Nepicastat in the Treatment of Cocaine Dependence

Role: Coordinating Center PI

Project Status: Completed (2013- 2015)

Funding Agency: NIH/National Institute on Drug Abuse


VA/CSP# 556 “The Effectiveness of rTMS in Depressed VA Patients”

Role:Coordinating Center PI

Project Status: Active enrollment completed (2012-2016); Final analysis (2017)

Funding Agency: VA/CSR&D/CSP

FY 17 support - $1,684,979