The Center for Cancer Systems Pharmacology

Research

CRS Bibliography

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Cho Y, Choi EY, Choi A, Han JY, Ye BD, Kim JH, Shin JY. Anti-Tumor Necrosis Factor Therapy and the Risk of Gestational Diabetes in Pregnant Women With Inflammatory Bowel Disease. Am J Gastroenterol. 2025 Jan 1;120(1):241–250. PMID: 39315687
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Brewster RCL, Nagy M, Wunnava S, Bourgeois FT. US FDA Approval of Pediatric Artificial Intelligence and Machine Learning-Enabled Medical Devices. JAMA Pediatr. 2024 Dec 16; PMID: 39680415
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Ellithi M, Elsallab M, Lunning MA, Holstein SA, Sharma S, Trinh JQ, Ma J, Maus MV, Frigault MJ, D’Angelo CR. Neurotoxicity and Rare Adverse Events in BCMA-Directed CAR T Cell Therapy: A Comprehensive Analysis of Real-World FAERS Data. Transplant Cell Ther. 2024 Dec 12;S2666-6367(24)00803–0. PMID: 39672542
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Elsallab M, Ouvina M, Arfe A, Bourgeois FT. Mapping the Clinical Development Trajectory of Cell and Gene Therapy Products. Clin Pharmacol Ther. 2024 Dec 10; PMID: 39655466
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Kakkilaya A, Shahzad M, Bourgeois FT. FDA Approval of Orphan Drug Indications for Pediatric Patients, 2011-2023. JAMA Pediatr. 2024 Dec 9; PMID: 39652344
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Gardner RA, White C, Elsallab M, Farnia S, Fraint E, Grilley B, Bateman-House A, Grupp SA, Kenderian S, Locke FL, Nikiforow S, Oluwole OO, Rouce RH, Spiegel J, Shah NN, Sharma A, Komanduri K, Gill S. ACT To Sustain: Adoptive Cell Therapy To Sustain Access to Non-Commercialized Genetically Modified Cell Therapies. Transplant Cell Ther. 2024 Aug;30(8):776–787. PMCID: PMC11296902
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Sinha MS, Stern AD, Rai AK. Four Decades of Orphan Drugs and Priorities for the Future. N Engl J Med. 2024 Jul 11;391(2):100–102. PMID: 38973724
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Ryu JH, Choi A, Woo J, Lee H, Kim J, Yoo J, Shin JY. Cardiovascular Safety of COVID-19 Vaccination in Patients With Cancer: A Self-Controlled Case Series Study in Korea. J Korean Med Sci. 2024 Jun 24;39(24):e190. PMCID: PMC11196855
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Tiberi S, Meili J, Cai P, Soneson C, He D, Sarkar H, Avalos-Pacheco A, Patro R, Robinson MD. DifferentialRegulation: a Bayesian hierarchical approach to identify differentially regulated genes. Biostatistics. 2024 Jun 17;kxae017. PMID: 38887902
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Choi A, Lee H, Jeong HE, Lee SY, Kwon JS, Han JY, Choe YJ, Shin JY. Association between exposure to antibiotics during pregnancy or early infancy and risk of autism spectrum disorder, intellectual disorder, language disorder, and epilepsy in children: population based cohort study. BMJ. 2024 May 22;385:e076885. PMCID: PMC11109903
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Guo X, Bourgeois FT, Cai T. Quantifying proportion of treatment effect by surrogate endpoint under heterogeneity. Stat Methods Med Res. 2024 May 8;9622802241247720. PMID: 38717356
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Masanneck L, Stern AD. Tracing Digital Therapeutics Research Across Medical Specialties: Evidence from ClinicalTrails.gov. Clin Pharmacol Ther. 2024 Apr 2; PMID: 38563641
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Elsallab M, Bourgeois F, Maus MV. National Survey of FACT-Accredited Cell Processing Facilities: Assessing Preparedness for Local Manufacturing of Immune Effector Cells. Transplant Cell Ther. 2024 Mar 16;S2666-6367(24)00289–6. PMID: 38494077
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Campbell CM, Webster C, Parisi M, Sherafat-Kazemzadeh R, Braid J, Switzer T, Alves Fávaro M, Sassano C, Coravos A. An aligned framework of actively collected and passively monitored clinical outcome assessments (COAs) for measure selection. NPJ Digit Med. 2024 Mar 16;7(1):71. PMCID: PMC10944461
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Tang M, Mishuris RG, Payvandi L, Stern AD. Differences in Care Team Response to Patient Portal Messages by Patient Race and Ethnicity. JAMA Netw Open. 2024 Mar 4;7(3):e242618. PMCID: PMC10949096
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Aboy M, Crespo C, Stern A. Beyond the 510(k): The regulation of novel moderate-risk medical devices, intellectual property considerations, and innovation incentives in the FDA’s De Novo pathway. NPJ Digit Med. 2024 Feb 8;7(1):29. PMCID: PMC10853500
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Marra C, Stern AD. Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms. Clin Pharmacol Ther. 2024 Feb 2; PMID: 38308421
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Brönneke JB, Herr A, Reif S, Stern AD. Dynamic HTA for digital health solutions: opportunities and challenges for patient-centered evaluation. Int J Technol Assess Health Care. 2023 Nov 17;39(1):e72. PMID: 37973549
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Knox RP, Wang J, Feldman WB, Kesselheim AS, Sarpatwari A. Outcomes of the 340B Drug Pricing Program: A Scoping Review. JAMA Health Forum. 2023 Nov 3;4(11):e233716. PMCID: PMC10665972
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Ong MS, Wu AC, Bourgeois FT. Enrollment of Pediatric Patients in COVID-19 Interventional Trials. JAMA Health Forum. 2023 Nov 3;4(11):e233939. PMCID: PMC10665967
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Olsen A, Beall RF, Knox RP, Tu SS, Kesselheim AS, Feldman WB. Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986-2019. PLoS Med. 2023 Nov;20(11):e1004309. PMCID: PMC10653475
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Tang M, Nakamoto CH, Stern AD, Zubizarreta JR, Marcondes FO, Uscher-Pines L, Schwamm LH, Mehrotra A. Effects of Remote Patient Monitoring Use on Care Outcomes Among Medicare Patients With Hypertension : An Observational Study. Ann Intern Med. 2023 Nov;176(11):1465–1475. PMID: 37931262
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Elsallab M, Maus MV. Expanding access to CAR T cell therapies through local manufacturing. Nat Biotechnol. 2023 Oct 26; PMID: 37884746
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van Kessel R, Srivastava D, Kyriopoulos I, Monti G, Novillo-Ortiz D, Milman R, Zhang-Czabanowski WW, Nasi G, Stern AD, Wharton G, Mossialos E. Digital Health Reimbursement Strategies of 8 European Countries and Israel: Scoping Review and Policy Mapping. JMIR Mhealth Uhealth. 2023 Sep 29;11:e49003. PMCID: PMC10576236
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Raab R, Küderle A, Zakreuskaya A, Stern AD, Klucken J, Kaissis G, Rueckert D, Boll S, Eils R, Wagener H, Eskofier BM. Federated electronic health records for the European Health Data Space. Lancet Digit Health. 2023 Sep 21;S2589-7500(23)00156–5. PMID: 37741765
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Wang X, Ayakulangara Panickan V, Cai T, Xiong X, Cho K, Cai T, Bourgeois FT. Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices. JAMA Intern Med. 2023 Aug 21;e233562. PMCID: PMC10442779
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Quazi S, Narang C, Espinoza JC, Bourgeois FT. Characteristics and Results of Pediatric Medical Device Studies: 2017-2022. Pediatrics. 2023 Aug 11;e2022059842. PMID: 37565273
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Kath J, Du W, Martini S, Elsallab M, Franke C, Hartmann L, Drosdek V, Glaser V, Stein M, Schmueck-Henneresse M, Reinke P, Volk HD, Abou-El-Enein M, Wagner DL. CAR NK-92 cell-mediated depletion of residual TCR+ cells for ultrapure allogeneic TCR-deleted CAR T-cell products. Blood Adv. 2023 Aug 8;7(15):4124–4134. PMCID: PMC10388728
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Lee LK, Narang C, Rees CA, Thiagarajan RR, Melvin P, Ward V, Bourgeois FT. Reporting and Representation of Participant Race and Ethnicity in National Institutes of Health-Funded Pediatric Clinical Trials. JAMA Netw Open. 2023 Aug 1;6(8):e2331316. PMCID: PMC10469249
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Tang M, Sharma Y, Goldsack JC, Stern AD. Building the Business Case for an Inclusive Approach to Digital Health Measurement With a Web App (Market Opportunity Calculator): Instrument Development Study. JMIR Form Res. 2023 Jul 26;7:e45713. PMCID: PMC10413230
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Hwang TJ, Reaman GH, Bourgeois FT. Clinical trials for paediatric cancers under new legislation in the USA. Lancet Child Adolesc Health. 2023 Jul;7(7):e13. PMID: 37349019
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Bourgeois FT, Espinoza JC. Advancing Equity in Medical Device Development for Children. JAMA Pediatr. 2023 Jun 1;177(6):561–562. PMID: 37093608
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Arfè A, Narang C, DuBois SG, Reaman G, Bourgeois FT. Clinical development of new drugs for adults and children with cancer, 2010-2020. J Natl Cancer Inst. 2023 May 12;djad082. PMCID: PMC10407707
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Everhart AO. Time to publication of cost-effectiveness analyses for medical devices. Am J Manag Care. 2023 May;29(5):265–268. PMCID: PMC10214008
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Toce MS, Michelson KA, Hudgins JD, Olson KL, Monuteaux MC, Bourgeois FT. Association of prescription drug monitoring programs with benzodiazepine prescription dispensation and overdose in adolescents and young adults. Clin Toxicol (Phila). 2023 Apr;61(4):234–240. PMID: 36919488
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Toce MS, Michelson KA, Hudgins JD, Hadland SE, Olson KL, Monuteaux MC, Bourgeois FT. Association of Prescription Drug Monitoring Programs With Opioid Prescribing and Overdose in Adolescents and Young Adults. Ann Emerg Med. 2023 Apr;81(4):429–437. PMCID: PMC10091852
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Masanneck L, Gieseler P, Gordon WJ, Meuth SG, Stern AD. Evidence from ClinicalTrials.gov on the growth of Digital Health Technologies in neurology trials. NPJ Digit Med. 2023 Feb 10;6(1):23. PMCID: PMC9918454
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Elsallab M, Ellithi M, Hempel S, Abdel-Azim H, Abou-El-Enein M. Long-term response to autologous anti-CD19 chimeric antigen receptor T cells in relapsed or refractory B cell acute lymphoblastic leukemia: a systematic review and meta-analysis. Cancer Gene Ther. 2023 Feb 7; PMCID: PMC10281866
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Avalos-Pacheco A, Ventz S, Arfè A, Alexander BM, Rahman R, Wen PY, Trippa L. Validation of Predictive Analyses for Interim Decisions in Clinical Trials. JCO Precis Oncol. 2023 Feb;7:e2200606. PMCID: PMC10166373
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Everhart AO, Sen S, Stern AD, Zhu Y, Karaca-Mandic P. Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance. JAMA. 2023 Jan 10;329(2):144–156. PMCID: PMC9857565
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Gressler LE, Avila-Tang E, Mao J, Avalos-Pacheco A, Shaya FT, Torosyan Y, Liebeskind A, Kinard M, Mack CD, Normand SL, Ritchey ME, Marinac-Dabic D. Data sources and applied methods for paclitaxel safety signal discernment. Front Cardiovasc Med. 2023;10:1331142. PMCID: PMC10920218
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Nader JH, Bourgeois F, Bagatell R, Moreno L, Pearson ADJ, DuBois SG. Systematic review of clinical drug development activities for neuroblastoma from 2011 to 2020. Pediatr Blood Cancer. 2022 Dec 2;e30106. PMID: 36458672
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Knox R, Curfman G. The Humira patent thicket, the Noerr-Pennington doctrine and antitrust’s patent problem. Nat Biotechnol. 2022 Dec;40(12):1761–1763. PMID: 36477501
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Tang M, Nakamoto CH, Stern AD, Mehrotra A. Trends in Remote Patient Monitoring Use in Traditional Medicare. JAMA Intern Med. 2022 Sep 1;182(9):1005–1006. PMCID: PMC9344385
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Torous J, Stern AD, Bourgeois FT. Regulatory considerations to keep pace with innovation in digital health products. NPJ Digit Med. 2022 Aug 19;5(1):121. PMCID: PMC9390099
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Wunnava S, Miller TA, Narang C, Nathan M, Bourgeois FT. US Food and Drug Administration Approval of High-risk Cardiovascular Devices for Use in Children and Adolescents, 1977-2021. JAMA. 2022 Aug 9;328(6):580–582. PMCID: PMC9364120
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Knox RP, Kesselheim AS, Sarpatwari A. Risks to the 340B Drug Pricing Program Related to Manufacturer Restrictions on Drug Availability. JAMA. 2022 May 3;327(17):1647–1648. PMID: 35426909
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Wunnava S, Miller TA, Bourgeois FT. Improving FDA postmarket adverse event reporting for medical devices. BMJ Evid Based Med. 2022 Feb 17;bmjebm-2021-111870. PMID: 35177481
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Khorrami P, Sinha MS, Bhanja A, Allen HL, Kesselheim AS, Sommers BD. Differences in Diabetic Prescription Drug Utilization and Costs Among Patients With Diabetes Enrolled in Colorado Marketplace and Medicaid Plans, 2014-2015. JAMA Netw Open. 2022 Jan 4;5(1):e2140371. PMCID: PMC8760612
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Russo M, Scarpa B. Learning in Medicine: The Importance of Statistical Thinking. Methods Mol Biol. 2022;2486:215–232. PMID: 35437725