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Kousick Biswas, PhD

Academic Title:

Associate 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

Location:

VA Medical Center, Perry Point, MD

Phone (Primary):

410-642-2411 ext. 25283

Phone (Secondary):

443-462-9980 (Mobile)

Fax:

410-642-1860

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

Biosketch

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

 Recent Publications (last 6 years)

  1. Karen L. Kotloff, M.D., Dilruba Nasrin, Ph.D, William C. Blackwelder, Ph.D., Yukun Wu, Ph.D., Tamer Farag, Ph.D., Sandra Panchalingham, Ph.D., Samba O. Sow, M.D., Dipika Sur, M.D., Anita K.M. Zaidi, M.B.B.S., Abu S. G. Faruque, M.D., Debasish Saha, M.S., Pedro L. Alonso, M.D., Ph.D., Boubou Tamboura, Pharm.D., Doh Sanogo, M.D., Uma Onwuchekwa, M.S., Byomkesh Manna, Ph.D., T. Ramamurthy, Ph.D., Suman Kanungo, M.B.B.S., Shahnawaz Ahmed, M.B.B.S., Shahida Qureshi, M.Sc., Farheen Quadri, M.B.B.S.,  Anowar Hossain, M.D., Sumon K. Das, M.B.B.S., Martin Antonio, Ph.D., M. Jahangir Hossain, M.B.B.S., Inacio Mandomando, B.S., Sozinho Acácio, Kousick Biswas, Ph.D., Sharon Tennant, Ph.D., Jaco J. Verweiij, Ph.D., Halvor Sommerfelt, Ph.D., James P. Nataro, M.D., Roy M. Robins-Browne, Ph.D., and Myron M. Levine, M.D., “Incidence, etiology, and adverse clinical consequences of diarrheal episodes according to disease severity among infants and children residing in developing countries:  the Global Enteric Multicenter Study (GEMS)”, The Lancet Global Health, Vol. 7, Issue 5, PE568-E584, May 2019
  2. Marco A. Zenati, M.D., Deepak L. Bhatt, M.D., M.P.H., Faisal G. Bakaeen, M.D., Eileen M. Stock, Ph.D., Kousick Biswas, Ph.D., J. Michael Gaziano, M.D., Rosemary F. Kelly, M.D., Elaine Tseng, M.D., Jerene Bitondo, P.A.-C., Jacquelyn A. Quin, M.D., M.P.H., G. Hossein Almassi, M.D., Miguel Haime, M.D., Brack Hattler, M.D., Michael Jessen, M.D., Ellen DeMatt, Alexandra Scrymgeour, R.Ph., for the REGROUP Trial Investigators, “Endoscopic Vein Harvest in Patients Undergoing Coronary Artery Surgery”, New England Journal of Medicine, November 11 2018 [epub ahead of print]; 2019; 380:132-141, Jan 2019.
  3. Jerome A. Yesavage, MD, J. Kaci Fairchild, PhD, Zhibao Mi, PhD, Kousick Biswas PhD, Anne Davis-Karim, PharmD, Ciaran S. Phibbs, PhD, Steven D. Forman, MD, PhD, Michael Thase, MD, Gerald Georgette, RN, Tamara Beale, MA, David Pittman, Margaret Windy McNerney, PhD, Allyson Rosen, PhD, Grant D. Huang, MPH, PhD, Art Noda, MS, Mark S. George, MD, “A Department of Veterans Affairs Cooperative Study of Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment-Resistant Major Depression, JAMA Psychiatry, 2018 Sep 1;75(9):884-893. doi: 10.1001/jamapsychiatry.2018.1483
  4. 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”, Controlled Clinical Trials, Volume 62, November 2017, Pages 105–113 [https://doi.org/10.1016/j.cct.2017.08.017]
  5. 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.
  6. 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”,  Trials (TRLS-D-16-00309),  18(1), 2017
  7. Song N, Ding P, Biswas K,  Mi Z. “Simultaneous Prediction Intervals for Dose-response Curve Quality Control, Biometrics & Biostatistics International Journal, Vol. 3(6), 2016
  8. 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
  9. 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
  10. 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.
  11. **Karen L. Kotloff, M.D., James P. Nataro, M.D., Ph.D., M.B.A., William C. Blackwelder, Ph.D., Dilruba Nasrin, M.B.B.S, Ph.D., Tamer Farag, Ph.D., Sandra Panchalingham, Ph.D., Yukun Wu, Ph.D., …, Kousick Biswas, Ph.D., Lynette Berkeley, Ph.D., Ciara E. O’Reilly, Ph.D., Eric D. Mintz, M.D., Khitam Muhsen, Ph.D., Halvor Sommerfelt, Ph.D., Roy M. Robins-Browne, M.B. B.Ch., Ph.D., and Myron M. Levine, M.D., D.T.P.H., Burden and Etiology of Diarrheal Disease in Infants and Young Children in Developing Countries: The Global Enteric Multicenter Study (GEMS),  The Lancet, Early Online Publication, 14 May 2013 [doi:10.1016/S0140-6736(13)60844-2]

 

 

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#2019 "Topical Chemoprevention of Keratinocyte Carcinoma (ToCKC) Trial”

Role: Coordinating Center PI

Project Status: Planning (2019)

Funding Agency: VA/ORD/CSP

 

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 (2018)

Funding Agency: VA/ORD/CSP

 

VA/CSP “Opioid Tapering: A Novel Strategy”

Role: Coordinating Center PI

Project Status: Planning of a demonstration project (2018 - 19)

Funding Agency: VA/ORD/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 

 

 

VA/CSP# 599 “Transfusion Triggers After Operations in High Cardiac Risk Patients (TOP)”

Role: Coordinating Center PI

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

Funding Agency: VA/ORD/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/ORD/CSP

 

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

 

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

Role: Coordinating Center PI

Project Status: Recruitment (2013 – 2021)

Funding Agency: VA/ORD 

 

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/ORD/CSP

 

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/ORD/CSP

 

VA/CSP# 573 “A Randomized Trial of Medical and Surgical Treatments for Patients with GERD Symptoms that are Refractory to Proton Pump Inhibitors”

Role: Coordinating Center PI

Project Status: Active enrollment completed (2012-2016); Final analysis (2017-18)

Funding Agency: VA/ORD/CSP