Yale University-Mayo Clinic CERSI

Center of Excellence in Regulatory Science and Innovation

CERSI-Supported Publications

Coming soon!

Other Relevant Publications

Premarket regulatory review and approval

Downing NS, Zhang AD, Ross JS. Regulatory Review of New Therapeutic Agents - FDA versus EMA, 2011-2015. NEJM. 2017;376(14):1386-1387.

Larochelle M, Downing NS, Ross JS, David FS. Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: A cohort study. BMJ Open. 2017;7(2):e014582.

Gupta R, Kesselheim AS, Downing NS, Greene J, Ross JS. Generic drug approvals since the 1984 Hatch-Waxman Act. JAMA Intern Med. 2016;176(9):1391-1393.

Downing NS, Shah ND, Neiman JH, Aminawung JA, Krumholz HM, Ross JS. Participation of the elderly, women and minorities in pivotal trials supporting 2011-2013 U.S. Food and Drug Administration approvals. Trials. 2016;17(1):199.

Ross JS, Dzara K, Downing NS. Efficacy and safety concerns are important reason why the FDA requires multiple reviews before approval. Health Aff. 2015;34(4):681-688.

Downing NS, Shah ND, Krumholz HM, Ross JS. Regulatory Watch: Characterizing the US FDA's approach to promoting transformative innovation. Nat Rev Drug Discov. 2015;14:740-741.

Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of clinical studies conducted over the total product life cycle of high-risk therapeutic medical devices receiving FDA premarket approval in 2010 and 2011. JAMA. 2015;314(6):604-612.

Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical trial evidence supporting FDA approval of novel therapeutics, 2005-2012. JAMA. 2014;311(4):368-377.

Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Regulatory review of novel therapeutics: Comparison of three regulatory agencies. NEJM. 2012;366(24):2284-2293.

Adoption/De-adoption of medical technologies

Lipska KJ, Yao X, Herrin J, McCoy RG, Ross JS, Steinman MA, Inzucchi SE, Gill TM, Krumholz HM, Shah ND. Trends in drug utilization, glycemic control, and rates of severe hypoglycemia, 2006-2013. Diabetes Care. 2017;40(4):468-475.

Parikh R, Ross JS, Sangaralingham LR, Adelman RA, Shah ND, Barkmeier AJ. Trends of anti-vascular endothelial growth factor use in ophthalmology among privately insured and Medicare Advantage patients. Opthalmology. 2017;124(3):352-358.

McCoy RG, Lipska KJ, Yao X, Ross JS, Montori VM, Shah ND. Intensive treatment and severe hypoglycemia among adults with type 2 diabetes. JAMA Intern Med. 2016;176(7):969-978.

Yao X, Sangaralingham LR, Ross JS, Shah ND, Tadawalker JA. Adoption of new agents and changes in treatment patterns for hepatitis C: 2010-2014. Am J Manag Care. 2016;22(6):e224-232.

McCoy R, VanHouten H, Ross JS, Montori VM, Shah ND. HbA1c overtesting and overtreatment among adults with controlled type 2 diabetes, 2001-2013: Observational population based study. BMJ. 2015;351:h6138.

Lipska KJ, Ross JS, Miao Y, Shah ND, Lee SJ, Steinman MA. Potential overtreatment of diabetes among older adults with tight glycemic control. JAMA Intern Med. 2015;175(3):356-362.

Psutka SP, Kim SP, Gross CP, Van Houten H, Thompson RH, Abouassaly R, Weight C, Boorjian SA, Leibovich BC, Shah ND. The impact of targeted therapy of management of metastatic renal cell carcinoma: Trends in systemic therapy and cytoreductive nephrectomy utilization. Urology. 2015;85(2):442-450.

Ross JS, Frazee SG, Garavaglia SB, Levin R, Novshadian H, Jackevicius CA, Stettin GS, Krumholz HM. Trends in use of ezetimibe after the ENHANCE trial, 2007-2010. JAMA Intern Med. 2014;174(9):1486-1493.

Lipska KJ, Ross JS, van Houten HK, Beran D, Yudkin JS, Shah ND. Use and out-of-pocket costs of insulin for type 2 diabetes mellitus from 2000 to 2010. JAMA. 2014;311(22):2331-2333.

Lu L, Krumholz HM, Tu JV, Ross JS, Ko DT, Jackevicius CA. Impact of the ENHANCE trial on the use of ezetimibe in the United States and Canada. Am Heart J. 2014;167(5):683-689.

Jackevicius CA, Tu JV, Ross JS, Ko DT, Carreon D, Krumholz HM. Use of fibrates in the United States and Canada. JAMA. 2011;305(12):1217-1224.

Jackevicius CA, Tu JV, Ross JS, Ko DT, Krumholz HM. Use of ezetimibe in the United States and Canada. NEJM. 2008;358:1819-1828.

Postmarket regulatory review and surveillance

Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun J, Krumholz HM, Ross JS. Postmarket safety events among novel therapeutics approved by the us food and drug administration between 2001 and 2010. JAMA. 2017;317:1854-1863.

Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND and Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. BMJ. 2017;357:j1680.

Motosue MS, Bellolio MF, Van Houten HK, Shah ND, Campbell RL. Increasing emergency department visits for anaphylaxis, 2005-2014. J Allergy Clin Immunol Pract. 2016;5(1):171-175.

Yao X, Abraham NS, Sangaralingham LR, Bellolio MF, McBane RD, Shah ND, Noseworthy PA. Effectiveness and safety of dabigatran, rivaroxaban, and apixaban versus warfarin in nonvalvular atrial fibrillation. J Am Heart Assoc. 2016;5(6):e003725.

Del-Carpio Munoz F, Yao X, Abraham NS, Bellolio MF, Rabinstein AA, Asirvatham SJ, McBane RD, Gersh BJ, Shah ND, Noseworthy PA. Dabigatran versus warfarin in relation to renal function in patients with atrial fibrillation. J Am Coll Cardiol. 2016;68(1):129-131.

Noseworthy PA, Yao X, Shah ND, Gersh BJ. Stroke and bleeding risks in NOAC- and warfarin-treated patients with hypertrophic cardiomyopathy and atrial fibrillation. J Am Coll Cardiol. 2016;67(25):3020-3021.

Singh S, Heien HC, Sangaralingham LR, Schilz SR, Kappelman MD, Shah ND, Loftus EV Jr. Comparative effectiveness and safety of anti-tumor necrosis factor agents in biologic-naïve patients with crohn's disease. Clin Gastroenterol Hepatol. 2016;14(8);1120-1129.

Yao X, Abraham NS, Alexander GC, Crown W, Montori VM, Sangaralingham LR, Gersh BJ, Shah ND, Noseworthy PA. Effect of adherence to oral anticoagulants on risk of stroke and major bleeding among patients with atrial fibrillation. J Am Heart Assoc. 2016;5(2):e003074.

Samuel AM, Rathi VK, Grauer JA, Ross JS. How do orthopaedic devices change after their initial FDA premarket approval?  Clin Orthop . 2016;474(4):1053-1068.

Zeitoun JD, Lefevre JH, Downing NS, Bergeron H, Ross JS. Regulatory anticipation of post-market safety problems for novel medicines approved by the EMA between 2001 and 2010: A cross-sectional study. Pharmacoepidem Dr S. 2016;25(6):687-694.

Jackevicius CA, Tu J, Austin P, Stukel T, Ross JS, Krumholz HM, Ko DT. Comparative effectiveness of generic atorvastatin and Lipitor® in patients hospitalized with an acute coronary syndrome. J Am Heart Assoc. 2016;5(4):e003350.

Abraham NS, Noseworthy PA, Yao X, Sangaralingham LR, Shah ND. Gastrointestinal safety of direct oral anticoagulants: A large population-based study. Gastroeterology. 2016;152(5):932-934.

Noseworthy PA, Yao X, Abraham NS, Sangaralingham LR, McBane RD, Shah ND. Direct comparison of dabigatran, rivaroxaban, and apixaban for effectiveness and safety in nonvalvular atrial fibrillation. Chest. 2016;150(6):1302-1312.

Noseworthy PA, Kapa S, Deshmukh AJ, Madhavan M, Houten HV, Haas LR, Mulpuru SK, McLeod CJ, Asirvatham SJ, Friedman PA, Shah ND, Packer DL. Risk of stroke after catheter ablation versus cardioversion for atrial fibrillation: A propensity matched study of 24,244 patients. Heart Rhythm. 2015;12(6):1154-1161.

Abraham NS, Singh S, Alexander GC, Heien H, Haas LR, Crown W, Shah ND. Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: Population based cohort study. BMJ. 2015;350:h1857.

Dunlay SM, Haas L, Herrin J, Schilz SR, Stulak JM, Kushwaha SS, Shah ND. Use of post-acute care services and readmissions after left ventricular assist device implantation in privately insured patients. J Card Fail. 2015;21(10):816-823.

Pachman DR, Ruddy K, Sangaralingham LR, Grothey A, Shah ND, Beutler AS, Hubbard JM, Loprinzi CL. Calcium and magnesium use for oxaliplatin-induced neuropathy: A case study to assess how quickly evidence translates into practice. J Natl Compr Canc Netw. 2015;13(9):1097-1101.

Rank MA, Liesinger JT, Branda ME, Gionfriddo MR, Schatz M, Zeiger RS, Shah ND. Comparative safety and costs of stepping down asthma medications in patients with controlled asthma. J Allergy Clin Immunol. 2015;137(5):1373-1379.

Noseworthy PA, Yao X, Deshmukh AJ, Van Houten H, Sangaralingham LR, Siontis KC, Piccini JP, Asirvatham SJ, Friedman PA, Packer DL, Gersh BJ, Shah ND. Patterns of anticoagulation and cardioembolic risk after catheter ablation for atrial fibrillation. J Am Heart Assoc. 2015;4(11):e002597.

Rathi VK, Ross JS, Samuel AM, Mehra S. Postmarket modifications of high-risk therapeutic devices in otolaryngology cleared by US Food and Drug Administration. Otolaryngol Head Neck Surg. 2015;153(3):400-408.

Zeitoun JD, Lefevre JH, Downing NS, Bergeron H, Ross JS. Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: A cross-sectional study. Br J Clin Pharmacol. 2015;80(4):716-726.

Ross JS, Bount KL, Ritchie JE, Hodshon B, Krumholz HM. Post-market clinical research conducted by medical device manufacturers: A cross-sectional survey. Med Devices. 2015;2015(8):241-249.

Zeitoun JD, Lefevre JH, Downing NS, Bergeron H, Ross JS. Inconsistencies among European Union pharmaceutical regulator safety communications: A cross-country comparison. PLoS ONE. 2014;9(10):e109100.

Downing NS, Ross JS, Jackevicius CA, Krumholz HM. Avoidance of generic competition by Abbott Laboratories' fenofibrate franchise. Arch of Intern Med. 2012;172(9):724-730.

Ross JS, Jackevicius CA, Krumholz HM, Ridgeway JL, Montori VM, Alexander GC, Zerzan JT, Fan J, Shah ND. State Medicaid programs did not make use of prior authorization to promote safer prescribing after rosiglitazone warning. Health Aff. 2012;31(1):188-198.

Korenstein D, Keyhani S, Medelson A, Ross JS. Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing. PLoS ONE. 2011;6(8):e23336.

Advanced Analytics and Methods

Agoritsas T, Merglen A, Shah ND, O'Donnell M, Guyatt GH. Adjusted analyses in studies addressing therapy and harm: Users' guides to the medical literature. JAMA. 2017;317(7):748-759.

Crown W, Chang J, Olson M, Kahler K, Swindle J, Buzinec P, Shah N, Borah B. Can statistical linkage of missing variables reduce bias in treatment effect estimates in comparative effectiveness research studies? J Comp Eff Res. 2015;4(5):455-463.

Paulus JK, Shah ND, Kent DM. All else being equal, men and women are still not the same: Using risk models to understand gender disparities in care. Circ Cardiovasc Qual Outcomes. 2015;8(3):317-320.

Shared decision-making

Hess EP, Hollander JE, Schaffer JT, Kline JA, Torres CA, Diercks DB, Jones R, Owen KP, Meisel ZF, Demers M, Leblanc A, Shah ND, Inselman J, Herrin J, Castaneda-Guarderas A, Montori VM. Shared decision making in patients with low risk chest pain: Prospective randomized pragmatic trial. BMJ. 2016;355:i6165.

Coylewright M, Dick S, Zmolek B, Askelin J, Hawkins E, Branda M, Inselman JW, Zeballos-Palacios C, Shah ND, Hess EP, LeBlanc A, Montori VM, Ting HH. Percutaneous coronary intervention choice decision aid for stable coronary artery disease: A randomized trial. Circ Cardiovasc Qual Outcomes. 2016;10(3).

Hargraves I, LeBlanc A, Shah ND, Montori VM. Shared decision making: The need for patient-clinician conversation, not just information. Health Aff. 2016;35(4):627-629.

Inselman J, Branda M, Castaneda-Guarderas A, Gionfriddo MR, Zeballos-Palacios CL, Morris MM, Shah ND, Montori VM, LeBlanc A. Uptake and documentation of the use of an encounter decision aid in usual practice: A retrospective analysis of the use of the statin/aspirin choice decision aid. Med Decis Making. 2015;36(4):557-561.

LeBlanc A, Herrin J, Williams MD, Inselman JW, Branda ME, Shah ND, Heim EM, Dick SR, Linzer M, Boehm DH, Dall-Winther KM, Matthews MR, Yost KJ, Shepel KK, Montori VM. Shared decision making for antidepressants in primary care: A cluster randomized trial. JAMA Intern Med. 2015;175(11):1761-1770.

LeBlanc A, Wang AT, Wyatt K, Branda ME, Shah ND, Van Houten H, Pencille L, Wermers R, Montori VM. Encounter decision aid vs. clinical decision support or usual care to support patient-centered treatment decisions in osteoporosis: The Osteoporosis Choice randomized trial II. PLoS One. 2015;10(5):e0128063.

Wang EH, Gross CP, Tilburt JC, Yu JB, Nguyen PL, Smaldone MC, Shah ND, Abouassally R, Sun M, Kim SP. Shared decision making and use of decision aids for localized prostate cancer: Perceptions from radiation oncologists and urologists. JAMA Intern Med. 2015;175(5):792-799.

Hess EP, Coylewright M, Frosch DL, Shah ND. Implementation of shared decision making in cardiovascular care: Past, present and future. Circ Cardiovasc Qual Outcomes. 2014;7(5):797-803.

Coylewright M, Branda M, Inselman JW, Shah ND, Hess E, Leblanc A, Montori VM, Ting HH. Impact of sociodemographic patient characteristics on the efficacy of decision aids: A patient-level meta-analysis of 7 randomized trials. Circ Cardiovasc Qual Outcomes. 2014;7(3):360-7.

Bouma AB, Tiedje K, Poplau S, Boehm DH, Shah ND, Commers MJ, Linzer M, Montori VM. Shared decision making in the safety net: Where do we go from here?  J Am Board Fam Med. 2014;27(2):292-294.

Gionfriddo MR, Leppin AL, Brito JP, Leblanc A, Shah ND, Montori VM. Shared decision making and comparative effectiveness research for patients with chronic conditions: An urgent synergy for better health. J Comparative Effectiveness Research. 2013; 2(6):595-603.