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Center of Excellence in Regulatory Science and Innovation

Publications

Books

Featured Articles

Spiker J, Kreimeyer K, Dang O, Boxwell D, Chan V, Cheng C, et al. Information Visualization Platform for Postmarket Surveillance Decision Support. Drug Saf. 2020 May 22. [Epub before print.]

Subbaswamy A, Saria S. From Development to Deployment: Dataset Shift, Causality, and Shift-Stable Models in Health AI. Biostatistics. 2019.

Singh H, Kennedy RDLagasse LP, Czaplicki LM, Cohen JE. E-cigarettes and Weight Loss—Product Design Innovation Insights From Industry Patents. Nicotine and Tobacco Research. 2018 Jul 9;20(8):1010-1014. doi: 10.1093/ntr/ntx112.

More Publications by CERSI Faculty

  1. Benkeser D, Diaz I, Luedtke A, Segal J, Scharfstein D, Rosenblum M. Improving Precision and Power in Randomized Trials for COVID-19 Treatments Using Covariate Adjustment, for Binary, Ordinal, and Time-to-Event Outcomes. Under review.
     
  2. Spiker J, Kreimeyer K, Dang O, Boxwell D, Chan V, Cheng C, Gish P, Lardieri A, Wu E, De S, Naidoo J, Lehmann H, Rosner GL, Ball R, Botsis T. Information Visualization Platform for Postmarket Surveillance Decision Support. Drug Saf. 2020 May 22. doi: 10.1007/s40264-020-00945-0. [Epub before print.]
     
  3. Maertens A, Tran V, Maertens M, Kleensang A, Luechtefeld T, Hartung T, Paller C. Functionally enigmatic genes: Are we still looking under the lamppost for the lost keys? Molecular Systems Biology Journal. Under review.
     
  4. Moran MB, Czaplicki L, Lagasse L, Cino S, Trigger S, Zandberg I, Sawdey MD, Engstrom M, Kennedy RD. JUUL e-cigarette advertising in traditional US media between 2015 and 2017. Under review.
     
  5. Huang EJ, Fang EX, Hanley DF, Rosenblum M. Constructing a confidence interval for the fraction who benefit from treatment, using randomized trial data. Biometrics. 2019 Dec;75(4):1228-1239. doi: 10.1111/biom.13101. Epub 2019 Sep 2.
     
  6. Subbaswamy A, Saria S. From Development to Deployment: Dataset Shift, Causality, and Shift-Stable Models in Health AI. Biostatistics. 2019.
     
  7. Wang C, Rosner G. A Bayesian Non-Parametric Causal Inference Model for Synthesizing Randomized Clinical Trial and Real-World Evidence. Stat Med. 2019;38(14):2573-2588. doi: 10.1002/sim.813 Epub 2019 Mar 18.
     
  8. Weaver JL, Zadrozny LM, Gabrielson K, Semple KM, Shea KI, Howard KE (2019) BLT-immune humanized mice as a model for nivolumab induced immune-mediated adverse events: Comparison of the NOG and NOG-EXL strains. Toxicological Sciences. 2019;169(1):194-208. doi: 10.1093/toxsci/kfz04
     
  9. Ogasawara K, Alexander GC. Use of Population Pharmacokinetic Analyses Among FDA-Approved Biologics. Clin Pharmacol Drug Dev. 2019;8(7):914-921. doi: 10.1002/cpdd.658. 
     
  10. Maertens A, Tran V, Kleensang A, and Hartung T. Weighted Gene Correlation Network Analysis (WGCNA) Reveals Novel Transcription Factors Associated With Bisphenol A Dose-Response. Front. Genet. 2018;9:508
     
  11. Alexander GC, Ogasawara A, Wiegand D, Lin DH, Breder CD. Clinical Development of Biologics Approved by the U.S. Food and Drug Administration, 2003-2016. Ther Innov Regul Sci. 2018 Dec 3:216847901881205
     
  12. Moore TJ, Zhang H, Anderson G, Alexander GC. Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016. JAMA Intern Med. 2018 Nov 1;178(11):1451-1457
     
  13. Hong H, Wang C, Rosner G. Meta-analysis of rare adverse events in randomized clinical trials: Bayesian and frequentist methods. Under review.
     
  14. Baksh S, McAdams-DeMarco M, Segal J, Alexander GC. Cardiovascular safety signals with dipeptidyl peptidase-4 inhibitors: A disproportionality analysis among high risk patients. Pharmacoepidemiol Drug Saf. 2018 Apr 14. doi: 10.1002/pds.4437. [Epub ahead of print]
     
  15. Tieu C, DePaola M, Lucas E, Rosman L, Alexander GC. Efficacy and safety of biosimilar insulins compared to their reference products: A systematic review. PLoS ONE. 2018;13(4): e01950
     
  16. Janssen E, Benz H, Tsai J, Bridges J. Identifying and prioritizing concerns associated with prosthetic devices for use in a benefit-risk assessment: A mixed-methods study. Expert Rev Med Devices. 2018;15(5): 385-398.
     
  17. Mayo-Wilson E, Heyward J, Keyes A, Reynolds J, White S, Atri N, Alexander GC, Omar A, Ford DE. Clinical trial registration and reporting at academic organizations in the United States. BMC Medicine. 2018 2018;16(1):60.
     
  18. Ogasawara A, Breder CD, Lin DH, Alexander GC. Exposure and dose-response analyses in dose selection and labeling of FDA approved biologics. Clinical Therapeutics. 2018; 40:95-102.e2.
     
  19. Janssen E, Hauber A, Bridges J. Conducting a discrete-choice experiment study following recommendations for good research practices: an application to eliciting patient preferences for diabetes treatments. Value in Health. 2017; 21(1):59-68.
     
  20. Janssen E, Bridges J. Art and science of instrument development for stated-preference methods. Patient. 2017; 10:377-379.
     
  21. Dy S, Janssen E, Ferris A, Bridges J. Live, Learn, Pass it on: the lived experience of lung cancer survivors. J of Patient Experience. 2017; 4(4):162-168.
     
  22. Singh H, Kennedy RD, Lagasse LP, Czaplicki LM, Cohen JE. E-cigarettes and Weight Loss—Product Design Innovation Insights From Industry Patents. Nicotine Tob Res. 2017 May doi: 10.1093/ntr/ntx112. [Epub ahead of print]
     
  23. dosReis S, Park A, Ng X, Frosch E, Reeves G, Cunningham C, Janssen E, Bridges J. Caregiver Treatment Preferences for Children with a New Versus Existing Attention-Deficit/Hyperactivity Disorder Diagnosis. J Child Adolesc Psychopharmacol. 2017; 27(3):234-242.
     
  24. Huang EJ, Fang EX, Hanley DP, Rosenblum M. Inequality in treatment benefits: Can we determine if a new treatment benefits the many or the few? Biostatistics. 2017; 18(2):308-324
     
  25. Leibler JH, Dalton K, Pekosz A, Gray GC. and Silbergeld, E. K. Epizootics in Industrial Livestock Production: Preventable Gaps in Biosecurity and Biocontainment. Zoonoses Public Health. 2017; 64:137–145.
     
  26. Le JT, Viswanathan S, Tarver ME, Eydelman M, Li T. Assessment of the Incorporation of Patient-Centric Outcomes in Studies of Minimally Invasive Glaucoma Surgical Devices. JAMA Opthamology. 2016; 134:1054-1056.
     
  27. Danner M, Vennedey V, Hiligsmann M, Fauser S, Stock S. Focus Groups in Elderly Ophthalmologic Patients: Setting the Stage for Quantitative Preference Elicitation. Patient. 2016; 9:47-57. Acknowledged: Bridges J (Editor)
     
  28. Forsythe LP, Ellis LE, Edmundson L, Sabharwal R, Rein A, Konopka K, Frank L. Patient and Stakeholder Engagement in the PCORI Pilot Projects: Description and Lessons Learned. J Gen Intern Med. 2016; 31:13-21.
     
  29. Fain KM, Yu T, Li T, Boyd CM, Singh S, Puhan MA. Evidence Selection for a Prescription Drug's Benefit-Harm Assessment: Challenges and Recommendations. J Clin Epidemiol. 2016; 74:151-157.
     
  30. Rosenblum M, Qian T, Du Y, Qiu H, Aaron Fisher. Multiple testing procedures for adaptive enrichment designs: combining group sequential and reallocation approaches. Biostatistics. 2016; 17:650-662.
     
  31. Janssen E, Segal JB, Bridges J. A framework for instrument development of a choice experiment: an application to type 2 diabetes. Patient. 2016; 9:465-479.
     
  32. Cheung KL, Wijen BH, Hollin IL, u, Bridges J, Evers SM, Hiligsmann M. Using best-worst scaling to investigate preferences in health care. Pharmacoeconomics. 2016; 34:1195-1209.
     
  33. Kennedy RD, Awopegba A, De Leon E, Cohen JE. Global approaches to regulating electronic cigarettes. Tob Control. 2017; 26(40):440-445.
     
  34. Purnell TS, Lynch TJ, Bone L, Segal JB, Evans C, Longo DR, Bridges JF. Perceived Barriers and Potential Strategies to Improve Self-Management among Adults with Type 2 Diabetes: A Community-Engaged Research Approach. Patient. 2016; 9:349-358.
     
  35. Janssen EM, Bridges JF. Treatment preferences of patients with type 2 diabetes in the United States: an application of good research principles for discrete choice experiments. Value in Health. 2016. 19:A207 PDB60
     
  36. Oakes A, Garmo V, Segal J, Bridges J. Developing and testing a survey instrument to assess the barriers and facilitators to the self-management of type 2 diabetes. International Society for Pharmaceoeconomics and Outcomes Research. Value in Health. 2016. 19:A207 PDB63
     
  37. Zhou M, Bridges J. Heterogeneity in patients’ stated preferences for type 2 diabetes medications: a latent class analysis. Value in Health. 2016. 19:A207 PDB61
     
  38. Bridges JF, Zhou M, study team, and DAB members. “Stated-Preference Methods.” White Paper. July 2-14. Baltimore, Maryland
     
  39. Baksh S, Gellad WF, Alexander GC. Maximizing the Post-Approval Safety of Flibanserin: A Role for Regulators, Clinicians, and Patients. Drug Safety. 2016; 39:375-380.
     
  40. Fain KM, Alexander GC, Dore DD, Segal J, Zullo AR, Salgado CC. Frequency and predictors of analgesic prescribing in U.S. nursing home residents with persistent pain. JAGS. 2016; 65(2):286-293.
     
  41. Fain KM, Salgado CC, Dore DD, Segal J, Zullo AR, Alexander GC. Inappropriate fentanyl prescribing among nursing home residents in the United States. JAMDA. 2016; 18:138-144.
     
  42. Li T, Hutfless S, Scharfstein DO, Daniels MJ, Hogan JW, Little RJ, Roy JA, Law AH, Dickersin K. Standards should be applied in the prevention and handling of missing data for patient-centered outcomes research: a systematic review and expert consensus. Journal of Clinical Epidemiology. 2014;67(1):15-32.
     
  43. Nguyen JM, Holbrook JT, Wei CY, Gerald LB, Teague WG, Wise RA. Validation and psychometric properties of the Asthma Control Questionnaire among children. J Allergy and Clinical Immunology. 2014;133(1):91-97.
     
  44. Chan AW, Song F, Vickers A, Jefferson T, Dickersin K, Gøtzsche PC, Krumholz HM, Ghersi D, van der Worp HB. Increasing value and reducing waste: addressing inaccessible research. Lancet.2014;383(9913):257-66. doi: 10.1016/S0140-6736(13)62296-5. 2014; PMID: 24411650.
     
  45. Vedula SS, Li T, Dickersin K. Differences in reporting of analyses in internal company documents versus published trial reports: comparisons in industry-sponsored trials in off-label uses of gabapentin. PLoS Med. 2013 Jan;10(1):e1001378. doi: 10.1371/journal.pmed.1001378.
     
  46. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jeric K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: Defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200-7.
     
  47. Fain K, Daubresse M, Alexander GC.  The Food and Drug Administration Ammendments Act (FDAAA) and Postmarketing Commitments to the FDA.  Journal of the American Medical Association.  JAMA. 2013;310(2):202-204.
     
  48. Dickersin K, Rennie D. The evolution of trial registries and their use to assess the clinical trial enterprise.  JAMA. 2012;307:1861-4.
     
  49. Dusetzina SB, Higashi A (*co-first author), Dorsey ER, Conti R, Huskamp HA, Zhu S, Garfield CF, Alexander GC.  Impact of FDA risk communications on health care utilization and health behaviors: a systematic review. Medical Care. 2012;50:466-78
     
  50. Little RJ, D’Agostino R, Cohen ML, Dickersin K, Emerson S, Farrar JT, Frangakis C, Hogan JW, Molenberghs G, Murphy SA, Neaton JD, Rotnitsky A, Scharfstein D, Weichung JS, Siegel JP, Stern H. The prevention and treatment of missing data in clinical trials. New England Journal of Medicine. 2012;367:1355-1360.
     
  51. Holbrook JT, Wise RA, Gold BD, Blake K, Brown ED, Castro M, Dozor AJ, Lima JJ, Mastronarde JG, Sockrider MM, Teague WG for the American Lung Association’s Asthma Clinical Research Centers.  Lansoprazole for children with poorly controlled asthma: a randomized clinical trial in Children with Asthma.  JAMA 2012;307(4):1-9.
     
  52. Li T, Vedula SS, Scherer R, Dickersin K. What comparative effectiveness research is needed? A framework for using guidelines and systematic reviews to identify evidence gaps and research priorities. Annals of Internal Medicine. 2012;156(5):367-77.
     
  53. Kempen JH, Altaweel MM, Holbrook JT, Jabs DA, Louis TA, Sugar EA, Thorne JE. Randomized comparison of systemic anti-inflammatory therapy versus flucinolone actinide intraocular implant for intermediate, posterior and panuveitis: The Multicenter Uveitis Treatment Trial. Ophthalmology 2011;118(10):736-743. PMC3191365
     
  54. Li T, Puhan M, Vedula SS, Singh S, Dickersin K.  Network meta-analysis - highly attractive but more methodological research is needed. BMC Medicine. 2011;9:79.
     
  55. Chen DT, Wynia MK, Moloney RM, Alexander GC.  Physician knowledge of the FDA-approved indications of commonly prescribed drugs: results of a national survey.  Pharmacoepidemiology and Drug Safety.  2009;18:1094-100.  PMID: 19697444
     
  56. Vedula SS, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored trials of gabapentin for off-label use. New England Journal of Medicine. 2009;361:1963-71.
     
  57. Krleža-Jerić K, Chan A-W, Dickersin K, Sim I, Grimshaw J, Gluud C for the Ottawa Group.  Principles for international registration of protocol information and results from human trials of health-related interventions: Ottawa statement (part 1). BMJ 330:956-958, 2005.  Ottawa Group members list and full statement.http://BMJ.com/cgi/content/full/330/7497/956.