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NIH Clinical Center Senior Staff

Paul Wakim, PhD


Dr. Paul Wakim is Chief of the Biostatistics and Clinical Epidemiology Service at the National Institutes of Health Clinical Center. Prior to joining the Clinical Center in 2015, he was Senior Mathematical Statistician at the Center for the Clinical Trials Network at the National Institute on Drug Abuse, where he was involved for almost 14 years in the design, statistical analysis, and monitoring of multi-site clinical trials.

Prior to joining NIDA, he worked in litigation at PricewaterhouseCoopers, in the Statistics Department of the American Petroleum Institute, and in the Statistical Research Division of the U.S. Census Bureau. He taught evening courses in Mathematics and Statistics at the University of Maryland University College, College Park, and at Gallaudet University, Washington, DC. He conducted several workshops and lectures at the NIH and at the annual meetings of the Society for Clinical Trials. He is currently a member of the Society for Clinical Trials Board of Directors (2015-2019).

Dr. Wakim received a B.Sc. in Mathematics from the University of Illinois at Urbana-Champaign. From the University of California at Berkeley, he received an M.A. in Statistics, an M.S. in Industrial Engineering and Operations Research and a Ph.D. in Statistics.

Honors and Awards

Received the NIH Director's Award in 2007 for contributing to the launch of the Clinical and Translational Science Award Program.

Selected Publications

Hammoud D, Sinharay S, Shah S, Schreiber-Stainthorp W, Maric D, Muthusamy S, Lee D, Lee C, Basuli F, Reid W, Wakim P, Matsuda K, Hirsch V, Nath A & Di Mascio M. Neuroinflammatory Changes in Relation to Cerebrospinal Fluid Viral Load in Simian Immunodeficiency Virus Encephalitis. mBio, published online: 28 May 2019,

Shah S, Sinharay S, Matsuda K, Schreiber-Stainthorp W, Muthusamy S, Lee D, Wakim P, Hirsch V, Nath A, Di Mascio M & Hammoud DA. Potential Mechanism for HIV-Associated Depression: Upregulation of Serotonin Transporters in SIV-Infected Macaques Detected by 11C-DASB PET. Frontiers in Psychiatry, published online: 23 May 2019,

Defaye FB, Danis M, Wakim P, Berhane Y, Norheim OF & Miljeteig I. Bedside Rationing Under Resource Constraints—A National Survey of Ethiopian Physicians’ Use of Criteria for Priority Setting. AJOB Empirical Bioethics, 2019, 10(2):125-135.

Miljeteig I, Defaye FB, Wakim P, Neema Desalegn D, Berhane Y, Norheim OF & Danis M. Financial risk protection at the bedside: How Ethiopian physicians try to minimize out-of-pocket health expenditures. PLOS ONE, published online: 12 February 2019,

Sullivan HK, Bayefsky M, Wakim PG, Huddleston K, Biesecker BB, Chandros Hull S & Berkman B. Noninvasive Prenatal Whole Genome Sequencing: Pregnant Women’s Views and Preferences. Obstetrics & Gynecology, 2019, 133(3):525-532.

Hammoud DA, Sinharay S, Steinbach S, Wakim PG, Smith BR & Nath A. Global and regional brain hypometabolism on FDG-PET in treated HIV-infected individuals. Neurology, published online: 26 September 2018,

Wang L, Almeida LEF, Kamimura S, van der Meulen JH, Nagaraju K, Quezado M, Wakim P & Quezado ZMN. The role of nitrite in muscle function, susceptibility to contraction injury, and fatigability in sickle cell mice. Nitric Oxide, 2018, 80:70-81.

Mikhail AS, Pritchard WF, Negussie AH, Krishnasamy VP, Amchin DB, Thompson JG, Wakim PG, Woods D, Bakhutashvili I, Esparza-Trujillo JA, Karanian JW, Willis SL, Lewis AL, Levy EB & Wood BJ. Mapping Drug Dose Distribution on CT Images Following Transarterial Chemoembolization with Radiopaque Drug-Eluting Beads in a Rabbit Tumor Model. Radiology, 2018, 289:396-404.

Witherspoon JW, Vasavada RP, Waite MR, Shelton M, Chrismer IC, Wakim PG, Jain MS, Bönnemann CG & Meilleur KG. 6-minute walk test as a measure of disease progression and fatigability in a cohort of individuals with RYR1-related myopathies. Orphanet Journal of Rare Diseases, 2018, 13:105-111.

Montealegre Sanchez GA, Reinhardt A, Ramsey S, Wittkowski H, Hashkes PJ, Berkun Y, …, Wakim PG, Brogan PA, Macias WL & Goldbach-Mansky R. JAK1/2 inhibition with baricitinib in the treatment of autoinflammatory interferonopathies. Journal of Clinical Investigation, 2018, 128(7):3041-3052.

Cunningham SC, Aizvera J, Wakim P & Felber L. Use of a self-reported psychosocial distress screening tool as a predictor of need for psychosocial intervention in a general medical setting. Social Work in Health Care, 2018, 57(5):315-331.

Casas R, Muthusamy S, Wakim PG, Sinharay S, Lentz MR, Reid WC, Hammoud DA. MR brain volumetric measurements are predictive of neurobehavioral impairment in the HIV-1 transgenic rat. NeuroImage: Clinical, 2018, 17:659-666.

Kim H, Brooks KM, Tang CC, Wakim P, Blake M, Brooks SR, Montealegre Sanchez GA, de Jesus AA, Huang Y, Tsai WL, Gadina M, Prakash A, Janes JM, Zhang X, Macias WL, Kumar P & Goldbach-Mansky R. Pharmacokinetics, Pharmacodynamics, and Proposed Dosing of the Oral JAK1 and JAK2 Inhibitor Baricitinib in Pediatric and Young Adult CANDLE and SAVI Patients. Clinical Pharmacology & Therapeutics, 2018, 104:364-373.

Wakim PG & Shaw PA. Data and Safety Monitoring. In: Gallin JI, Ognibene FP & Johnson LL, editors. Principles and Practice of Clinical Research, 4th Edition, 2018, Chapter 10, pp. 127-140, Elsevier Inc.

Hammoud DA, Mahdi E, Panackal AA, Wakim P, Sheikh V, Sereti I, Bielakova B, Bennett JE & Williamson PR. Choroid Plexitis and Ependymitis by Magnetic Resonance Imaging are Biomarkers of Neuronal Damage and Infammation in HIV-negative Cryptococcal Meningoencephalitis. Scientific Reports, published online: 23 August 2017.

Braverman DW, Marcus BS, Wakim PG, Mercurio MR & Kopf GS. Healthcare Professionals’ Attitudes About Physician-Assisted Death: An Analysis of Their Justifications and the Roles of Terminology and Patient Competency. Journal of Pain and Symptom Management, 2017, 54:538-545.

Schmidt PJ, Martinez PE, Nieman LK, Koziol DE, Thompson KD, Schenkel L, Wakim PG & Rubinow DR. Premenstrual Dysphoric Disorder Symptoms Following Ovarian Suppression: Triggered by Change in Ovarian Steroid Levels But Not Continuous Stable Levels. American Journal of Psychiatry, 2017, 174:980-989.

Bayefsky MJ, White A, Wakim P, Chandros Hull S, Wasserman D, Chen S & Berkman BE. Views of American OB/GYNs on the Ethics of Prenatal Whole-Genome Sequencing. Prenatal Diagnosis, 2016, 36:1250-1256.

Lindblad R, Hu L, Oden N, Wakim P, Rosa C & VanVeldhuisen P. Mortality Rates Among Substance Use Disorder Participants in Clinical Trials: Pooled Analysis of Twenty-Two Clinical Trials Within the National Drug Abuse Treatment Clinical Trials Network. Journal of Substance Abuse Treatment, 2016, 70:73-80.

Guerrieri GM, Wakim PG, Keenan PA, Schenkel LA, Berlin K, Gibson CJ, Rubinow DR & Schmidt PJ. Sex differences in visuospatial abilities persist during induced hypogonadism. Neuropsychologia, 2016, 81:219-229.

Hser Y-I, Evans E, Huang D, Weiss R, Saxon A, Carroll KM, Woody G, Liu D, Wakim P, Matthews AG, Hatch-Maillette M, Jelstrom E, Wiest K, McLaughlin P & Ling W. Long-term outcomes after randomization to buprenorphine/naloxone versus methadone in a multi-site trial. Addiction, 2016, 11: 695–705. doi: 10.1111/add.13238.

Jacobs P, Ang A, Hillhouse MP, Saxon AJ, Nielsen S, Wakim PG, Mai BE, Mooney LJ, Potter JS & Blaine JD. Treatment Outcomes in Opioid Dependent Patients With Different Buprenorphine/Naloxone Induction Dosing Patterns and Trajectories, American Journal on Addictions, 2015, 24:667-675.

Conway KP, Vullo GC, Kennedy AP, Finger MS, Agrawal A, Bjork JM, Farrer LA, Hancock DB, Hussong A, Wakim P, Huggins W, Hendershot T, Nettles DS, Pratt J, Maiese D, Junkins HA, Ramos EM, Strader LC, Hamilton CM & Sher KJ. Data compatibility in the addiction sciences: An examination of measure commonality, Drug and Alcohol Dependence, 2014, 141:152-158.

Wakim PG, Rosa C, Kothari P & Michel ME. Relation of Study Design to Recruitment and Retention in CTN Trials, American Journal of Drug and Alcohol Abuse, 2011, 37:426–433.

Potter JS, Donovan DM, Weiss RD, Gardin J, Lindblad R, Wakim P & Dodd D. Site Selection in Community-Based Clinical Trials for Substance Use Disorders: Strategies for Effective Site Selection, American Journal of Drug and Alcohol Abuse, 2011, 37:400–407.

Oden NL, VanVeldhuisen PC, Wakim PG, Trivedi MH, Somoza E & Lewis D. Power of Automated Algorithms for Combining Time-Line Follow-Back and Urine Drug Screening Test Results in Stimulant-Abuse Clinical Trials, American Journal of Drug and Alcohol Abuse, 2011, 37:350–357.

Donovan DM, Bigelow GE, Brigham GS, Carroll KM, Cohen AJ, Gardin JG, Hamilton JA, Huestis MA, Hughes JR, Lindblad R, Marlatt GA, Preston KL, Selzer JA, Somoza EC, Wakim PG & Wells EA. Primary outcome indices in illicit drug dependence treatment research: systematic approach to selection and measurement of drug use end-points in clinical trials, Addiction, 2011, 107: 694–708.

Korte JE, Rosa CL, Wakim PG & Perl HI. Addiction treatment trials: how gender, race/ethnicity, and age relate to ongoing participation and retention in clinical trials, Substance Abuse and Rehabilitation, 2011, 2:205–218.

Nunes EV, Ball S, Booth R, Brigham G, Calsyn DA, Carroll K, Feaster DJ, Hien D, Hubbard RL, Ling W, Petry NM, Rotrosen J, Selzer J, Stitzer M, Tross S, Wakim P, Winhusen T & Woody G. Multisite effectiveness trials of treatments for substance abuse and co-occurring problems: Have we chosen the best designs?, Journal of Substance Abuse Treatment, 2010, 38 (Suppl 1):S97–S112.

Brigham GS, Feaster DJ, Wakim PG & Dempsey CL. Choosing a control group in effectiveness trials of behavioral drug abuse treatments, Journal of Substance Abuse Treatment, 2009, 37:388–397.

Wu L-T, Blazer DG, Patkar AA, Stitzer ML, Wakim PG & Brooner RK. Heterogeneity of Stimulant Dependence: A National Drug Abuse Treatment Clinical Trials Network Study, American Journal on Addictions, 2009, 18: 206–218.

Pan J-J, Nahm M, Wakim PG, Cushing C, Poole L, Tai B & Pieper CF. A centralized informatics infrastructure for the National Institute on Drug Abuse Clinical Trials Network, Clinical Trials, 2009, 6:67–75.

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This page last updated on 06/03/2019

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