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Center of Excellence in Regulatory Science and Innovation



Featured Articles

Moore TJ, Zhang H, Anderson G, Alexander GCEstimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016. JAMA Internal Medicine.  2018 Sept 24. doi:10.1001/jamainternmed.2018.3931. [Epub ahead of print]

Chang HY, Singh S, Mansour O, Baksh S, Alexander GC.  Association Between Sodium-glucose Cotransporter-2 (SGLT-2) Inhibitors and Lower Extremity Amputation: A Retrospective Cohort Study.  JAMA Internal Medicine.  Published online August 13, 2018. doi:10.1001/jamainternmed.2018.3034

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. 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.
  2. Wang C, Rosner G. A Bayesian Non-Parametric Causal Inference Model for Synthesizing Randomized Clinical Trial and Real-World Evidence. Statistics in Medicine. 2019 [Accepted for publication].
  3. 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 [Accepted for publication].
  4. Chang HY, Singh S, Mansour O, Baksh S, Alexander GCAssociation Between Sodium-Glucose Cotransporter 2 Inhibitors and Lower Extremity Amputation Among Patients With Type 2 Diabetes. JAMA Intern Med. 2018 Sep 1;178(9):1190-1198. doi: 10.1001/jamainternmed.2018.3034.
  5. 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 3:2168479018812058.
  6. Ogasawara K, Alexander GC. Use of Population Pharmacokinetic Analyses Among FDA-Approved Biologics. Clin Pharmacol Drug Dev. 2019 Feb 1. doi: 10.1002/cpdd.658. [Epub ahead of print]
  7. Hong H, Wang C, Rosner G. Meta-analysis of rare adverse events in randomized clinical trials: Bayesian and frequentist methods. Under review.
  8. Moore TJ, Zhang H, Anderson G, Alexander GCEstimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016. JAMA Internal Medicine. 2018 Sep 24. doi: 10.1001/jamainternmed.2018.3931. [Epub ahead of print]
  9. Baksh S, McAdams-DeMarco M, Segal J, Alexander GC. Cardiovascular safety signals with dipeptidyl peptidase-4 inhibitors: A disproportionality analysis among high risk patients. Pharmacoepidemiology and Drug Safety. 2018 Apr 14. doi: 10.1002/pds.4437. [Epub ahead of print]
  10. Chang HY, Singh S, Mansour O, Baksh S, Alexander GCAssociation Between Sodium-glucose Cotransporter-2 (SGLT-2) Inhibitors and Lower Extremity Amputation: A Retrospective Cohort Study.  JAMA Internal Medicine.  Published online August 13, 2018. doi:10.1001/jamainternmed.2018.3034
  11. Editorial: Fralick M, Patorno E, Fischer MA. Sodium-Glucose Cotransporter 2 Inhibitors and the Risk of Amputation: Results and Challenges from the Real World. Published online August 13, 2018. doi:10.1001/jamainternmed.2018.3025
  12. 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.
  13. 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:e0195012.
  14. 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 Review of Medical Devices. 2017;15(5):385-398.
  15. 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 Jan;40(1):95-102.e2. doi: 10.1016/j.clinthera.2017.11.012. 
  16. Mayo-Wilson E, Heyward J, Keyes A, Reynolds J, White S, Atri N, Alexander C, Omar A, Ford DE. Clinical trial registration and reporting at academic organizations in the United States. BMC Medicine. 2018 May 2;16(1):60. doi: 10.1186/s12916-018-1042-6.
  17. 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 Health (In Press).
  18. Janssen E, Bridges J. Art and science of instrument development for stated-preference methods. Patient. 2017. doi:10.1007/s40271-017-0261-
  19.  Dy S, Janssen E, Ferris A, Bridges J. Live, Learn, Pass it on: the lived experience of lung cancer survivors. Journal of Patient Experience. 2017. doi: 10.1177/2374373517714451
  20. Chang LC, Mahmood R, Qureshi S, Breder CD. Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications. PLoS One. 2017 Jun 1;12(6):e0178104. doi: 10.1371/journal.pone.0178104. eCollection 2017.
  21. 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. Journal of Child Adolescent Psychopharmacology. 2017;27(3):234-242.
  22. 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. doi:10.1001/jamaophthalmol.2016.2101
  23. 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. doi: 10.1007/s40271-015-0122-3.
  24. 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. Journal of General Internal Medicine. 2016; 31:13-21.
  25. 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. Journal of Clinical Epidemiology. 2016; 74:151-157.
  26. Khadka J, McAlinden C, Craig JE, Fenwick EK, Lamoureux EL, Pesudovs K. Identifying content for the glaucoma-specific item bank to measure quality-of-life parameters. Journal of Glaucoma. 2015; 24:12-19. doi:10.1097/IJG.0b013e318287ac11.
  27. Yu T, Hsu YJ, Fain KM, Boyd CM, Holbrook JT, Puhan MA. Use of surrogate outcomes in US FDA drug approval, 2003-2012: a survey. BMJ Open. 2015; 5(11):e007960. doi: 10.1136/bmjopen-2015-007960.
  28. Frank L, Forsythe L, Ellis L, Schrandt S, Sheridan S, Gerson J, Konopka K, Daugherty S. Conceptual and practical foundations of patient engagement in research at the patient-centered outcomes research institute. Quality of Life Research. 2015; 24:1033-1041.
  29. 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.
  30. 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. 2016; 2017;18:308-324.
  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, Janssen E, Bridges J, Evers SM, Hiligsmann M. Using best-worst scaling to investigate preferences in health care. Pharmacoeconomics. 2016; 34:1195-1209.
  33. Swain RS, Holbrook JT, Teltsch DY, Segal JB, Alexander GC. Continuous subcutaneous insulin infusion and continuous glucose monitoring in children with type 1 diabetes.  Under review.
  34. Leibler JH, Dalton K, Peoksz A, Gray GC, Silbergeld EK. Epizootics in industrial livestock production: preventable gaps in biosecurity and biocontainment. Zoonoses Public Health. 2016 Sep 4. 2017;64:137–145.
  35. Kennedy RD, Awopegba A, De Leon E, Cohen JE. Global approaches to regulating electronic cigarettes. Tobacco Control. 2016; pii: tobaccocontrol-2016-053179. [epub ahead of print] doi:10.1136/tobaccocontrol-2016-053179.
  36. Klein EG, Kennedy RD, Berman M. Tobacco control policies in outdoor areas of high volume American transit systems. Journal of Community Health. 2014; 39:660-667.
  37. 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.
  38. Purnell TS, Joy S, Little E, Bridges JF, Maruther N. Patent preferences for non-insulin diabetes medication: a systematic review. Diabetes Care. 2014; 37:2055-2062.
  39. 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
  40. 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
  41. 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
  42. Bridges JF, Zhou M, study team, and DAB members. “Stated-Preference Methods.” White Paper July 2-14. Baltimore, Maryland
  43. Baksh SN, Gellad WF, Alexander GC. Maximizing the Post-Approval Safety of Flibanserin: A Role for Regulators, Clinicians, and Patients. Drug Safety. 2016. 39:375-380.
  44. Fain KM, Alexander GC, Dore DD, Segal JB, Zullo AR, Salgado CC.  Frequency and predictors of analgesic prescribing in U.S. nursing home residents with persistent pain. Journal of the American Geriatrics Society. 2016.
  45. Fain KM, Salgado CC, Dore DD, Segal JB, Zullo AR, Alexander GC.  Inappropriate fentanyl prescribing among nursing home residents in the United States.  JAMDA. 2016; 18:138-144.
  46. 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.
  47. 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.
  48. Chan AW, Song F, Vickers A, Jefferson T, Dickersin K, Gøtzsche PC, Krumholz HM, Ghersi D, van der Worp HBIncreasing value and reducing waste: addressing inaccessible research. Lancet.2014;383(9913):257-66. doi: 10.1016/S0140-6736(13)62296-5. 2014; PMID: 24411650.
  49. 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.
  50. 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.
  51. 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.
  52. Dickersin K, Rennie D. The evolution of trial registries and their use to assess the clinical trial enterprise.  JAMA. 2012;307:1861-4.
  53. 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
  54. 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.
  55. 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.
  56. 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.
  57. 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
  58. 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.
  59. 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
  60. 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.
  61. 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.