CRS Bibliography

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

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. Frontiers in Cardiovascular Medicine [Internet]. 2024 [cited 2024 Feb 29];10. Available from: https://www.frontiersin.org/articles/10.3389/fcvm.2023.1331142

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

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. PMID: 37171887

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. PMID: 36848613

Bourgeois FT, Espinoza JC. Advancing Equity in Medical Device Development for Children. JAMA Pediatr. 2023 Jun 1;177(6):561–562. PMID: 37093608

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

Elsallab M, Maus MV. Expanding access to CAR T cell therapies through local manufacturing. Nat Biotechnol. 2023 Oct 26; PMID: 37884746

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; PMID: 36750666

Everhart AO. Time to publication of cost-effectiveness analyses for medical devices. Am J Manag Care. 2023 May;29(5):265–268. PMCID: PMC10214008

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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. PMID: 37773610

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

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. PMID: 35029667

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

Knox RP, Kesselheim AS, Sarpatwari A. Risks to the 340B Drug Pricing Program Related to Manufacturer Restrictions on Drug Availability. JAMA [Internet]. 2022 Apr 15 [cited 2022 Apr 15]; Available from: https://doi.org/10.1001/jama.2022.5959

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

Russo M, Scarpa B. Learning in Medicine: The Importance of Statistical Thinking. Methods Mol Biol. 2022;2486:215–232. PMID: 35437725

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

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

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

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

Antonini MJ, Plana D, Srinivasan S, Atta L, Achanta A, Yang H, Cramer AK, Freake J, Sinha MS, Yu SH, LeBoeuf NR, Linville-Engler B, Sorger PK. A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19 Pandemic. Front Digit Health. 2021 Mar;3:617106. PMCID: PMC8064560

Arfè A, Silverman LB, Bourgeois F. Master Protocols and Adaptive Trial Designs to Develop Tumor-Agnostic Drugs for Children: Essential Tools in the Era of the Research to Accelerate Cure and Equity Act. JAMA Oncol. 2021 Jun 10; PMID: 34110376

Barenie RE, Sinha MS, Kesselheim AS. Factors Affecting Buprenorphine Utilization and Spending in Medicaid, 2002-2018. Value Health. 2021 Feb;24(2):182–187. PMID: 33518024

Bourgeois FT, Gutiérrez-Sacristán A, Keller MS, Liu M, Hong C, Bonzel CL, Tan ALM, Aronow BJ, Boeker M, Booth J, Cruz Rojo J, Devkota B, García Barrio N, Gehlenborg N, Geva A, Hanauer DA, Hutch MR, Issitt RW, Klann JG, Luo Y, Mandl KD, Mao C, Moal B, Moshal KL, Murphy SN, Neuraz A, Ngiam KY, Omenn GS, Patel LP, Jiménez MP, Sebire NJ, Balazote PS, Serret-Larmande A, South AM, Spiridou A, Taylor DM, Tippmann P, Visweswaran S, Weber GM, Kohane IS, Cai T, Avillach P, Consortium for Clinical Characterization of COVID-19 by EHR (4CE). International Analysis of Electronic Health Records of Children and Youth Hospitalized With COVID-19 Infection in 6 Countries. JAMA Netw Open. 2021 Jun 1;4(6):e2112596. PMCID: PMC8196345

Bourgeois FT, Avillach P, Turner MA. The urgent need for research coordination to advance knowledge on COVID-19 in children. Pediatr Res. 2021 Aug;90(2):250–252. PMCID: PMC7656217

Bresler J, Sinha MS. The Other Three Waves: Re-assessing the Impact of Industry-Prescriber Relations on the Opioid Crisis. J Leg Med. 2021 Jun;41(1–2):47–81. PMID: 34296970

Carmody S, Coravos A, Fahs G, Hatch A, Medina J, Woods B, Corman J. Building resilient medical technology supply chains with a software bill of materials. NPJ Digit Med. 2021 Feb 23;4(1):34. PMCID: PMC7902663

Cherla A, Naci H, Kesselheim AS, Gyawali B, Mossialos E. Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval. JAMA Intern Med. 2021 Apr 1;181(4):490–498. PMCID: PMC7900925

Cramer AK, Plana D, Yang H, Carmack MM, Tian E, Sinha MS, Krikorian D, Turner D, Mo J, Li J, Gupta R, Manning H, Bourgeois FT, Yu SH, Sorger PK, LeBoeuf NR. Analysis of SteraMist ionized hydrogen peroxide technology in the sterilization of N95 respirators and other PPE. Sci Rep [Internet]. 2021 Jan 21 [cited 2021 Jan 25];11(1):2051. Available from: https://www.nature.com/articles/s41598-021-81365-7

Gordon WJ, Coravos AR, Stern AD. Ushering in safe, effective, secure, and ethical medicine in the digital era. NPJ Digit Med. 2021 Mar 25;4(1):56. PMCID: PMC7994831

Gyawali B, Kesselheim AS. FDA approval standards for anticancer agents - lessons from two recent approvals in breast cancer. Nat Rev Clin Oncol. 2021 Jul;18(7):397–398. PMID: 33767454

Kassamali B, Yu Z, Davis C, Carmack M, Bui ATN, Said JT, Plana D, Yang H, Sorger P, LeBoeuf NR, LaChance AH. Conversion of Existing UVB Phototherapy Units to UVC Germicidal Chambers for N95 Decontamination: Lessons Learned. Photobiomodul Photomed Laser Surg. 2021 Feb;39(2):83–85. PMCID: PMC8106246

Kothakonda A, Atta L, Plana D, Ward F, Davis C, Cramer A, Moran R, Freake J, Tian E, Mazor O, Gorelik P, Van C, Hansen C, Yang H, Li Y, Sinha MS, Li J, Yu SH, LeBoeuf NR, Sorger PK. De Novo Powered Air-Purifying Respirator Design and Fabrication for Pandemic Response. Front Bioeng Biotechnol. 2021;9:690905. PMCID: PMC8450396

McAvoy M, Bui ATN, Hansen C, Plana D, Said JT, Yu Z, Yang H, Freake J, Van C, Krikorian D, Cramer A, Smith L, Jiang L, Lee KJ, Li SJ, Beller B, Huggins K, Short MP, Yu SH, Mostaghimi A, Sorger PK, LeBoeuf NR. 3D Printed frames to enable reuse and improve the fit of N95 and KN95 respirators. BMC Biomed Eng. 2021 Jun 7;3(1):10. PMCID: PMC8182357

Mecklai K, Smith N, Stern AD, Kramer DB. Remote Patient Monitoring - Overdue or Overused? N Engl J Med. 2021 Apr 15;384(15):1384–1386. PMID: 33853209

Plana D, Tian E, Cramer AK, Yang H, Carmack MM, Sinha MS, Bourgeois FT, Yu SH, Masse P, Boyer J, Kim M, Mo J, LeBoeuf NR, Li J, Sorger PK. Assessing the filtration efficiency and regulatory status of N95s and nontraditional filtering face-piece respirators available during the COVID-19 pandemic. BMC Infectious Diseases [Internet]. 2021 Jul 29 [cited 2021 Jul 30];21(1):712. Available from: https://doi.org/10.1186/s12879-021-06008-8

Rome BN, Lee CC, Gagne JJ, Kesselheim AS. Factors Associated With Generic Drug Uptake in the United States, 2012 to 2017. Value Health. 2021 Jun;24(6):804–811. PMID: 34119078

Sahragardjoonegani B, Beall RF, Kesselheim AS, Hollis A. Repurposing existing drugs for new uses: a cohort study of the frequency of FDA-granted new indication exclusivities since 1997. Journal of Pharmaceutical Policy and Practice [Internet]. 2021 Jan 4 [cited 2021 Jan 8];14(1):3. Available from: https://doi.org/10.1186/s40545-020-00282-8

Srivastava A, Bourgeois FT. Evaluation of Publication of Pediatric Drug Trials. JAMA Netw Open. 2021 Apr 1;4(4):e215829. PMCID: PMC8047779

Stern AD, Chen JL, Ouellet M, Trusheim MR, El-Kilani Z, Jessup A, Berndt ER. Biosimilars And Follow-On Products In The United States: Adoption, Prices, And Users. Health Aff (Millwood). 2021 Jun;40(6):989–999. PMID: 34097520

Wang X, Cai T, Tian L, Bourgeois F, Parast L. Quantifying the feasibility of shortening clinical trial duration using surrogate markers. Stat Med. 2021 Sep 2; PMID: 34474500

Arfè A, Alexander B, Trippa L. Optimality of testing procedures for survival data in the nonproportional hazards setting. Biometrics. 2020 Jun 14; PMID: 32535892

Arfè A, Fell G, Alexander B, Awad MM, Rodig SJ, Trippa L, Schoenfeld JD. Meta-Analysis of PD-L1 Expression As a Predictor of Survival After Checkpoint Blockade. JCO Precis Oncol. 2020 Nov;4:1196–1206. PMID: 35050777

Avorn J, Kesselheim A. Regulatory Decision-making on COVID-19 Vaccines During a Public Health Emergency. JAMA. 2020 Oct 6;324(13):1284–1285. PMID: 32870268

Avorn J, Kesselheim AS. Up Is Down - Pharmaceutical Industry Caution vs. Federal Acceleration of Covid-19 Vaccine Approval. N Engl J Med. 2020 Oct 29;383(18):1706–1708. PMID: 32931162

Barenie RE, Avorn J, Tessema FA, Kesselheim AS. Public funding for transformative drugs: the case of sofosbuvir. Drug Discov Today. 2020 Oct 1; PMCID: PMC7528745

Barenie RE, Gagne JJ, Kesselheim AS, Pawar A, Tong A, Luo J, Bateman BT. Rates and Costs of Dispensing Naloxone to Patients at High Risk for Opioid Overdose in the United States, 2014-2018. Drug Saf. 2020;43(7):669–675. PMID: 32180134

Beletsky L, Seymour S, Kang S, Siegel Z, Sinha MS, Marino R, Dave A, Freifeld C. Fentanyl panic goes viral: The spread of misinformation about overdose risk from casual contact with fentanyl in mainstream and social media. Int J Drug Policy. 2020 Sep 16;86:102951. PMCID: PMC7492952

Bui ATN, Yu Z, Lee K, Li SJ, Tsiaras WG, Yu SH, LeBoeuf NR, Mostaghimi A. A pilot study of the impact of facial skin protectants on qualitative fit testing of N95 masks. Journal of the American Academy of Dermatology [Internet]. 2020 [cited 2021 Jan 8]; Available from: https://linkinghub.elsevier.com/retrieve/pii/S0190962220311671

Carmack M, Hwang T, Bourgeois FT. Pediatric Drug Policies Supporting Safe And Effective Use Of Therapeutics In Children: A Systematic Analysis. Health Aff (Millwood). 2020 Oct;39(10):1799–1805. PMID: 33017255

Conti RM, David FS. Public research funding and pharmaceutical prices: do Americans pay twice for drugs? F1000Res. 2020 Jul 15;9:707. PMCID: PMC7642989

Coravos A, Doerr M, Goldsack J, Manta C, Shervey M, Woods B, Wood WA. Modernizing and designing evaluation frameworks for connected sensor technologies in medicine. NPJ Digit Med. 2020;3:37. PMCID: PMC7070075

Cramer A, Plana D, Yang HL, Carmack M, Tian E, Sinha MS, Krikorian D, Turner D, Mo J, Li J, Gupta R, Manning H, Bourgeois FT, Yu SH, Sorger P, LeBoeuf NR. Analysis of SteraMist ionized hydrogen peroxide technology in the sterilization of N95 respirators and other PPE: a quality improvement study. medRxiv. 2020 Apr 23; PMCID: PMC7273248

Cramer A, Tian E, Galanek M, Lamere E, Li J, Gupta R, Short M. Assessment of the Qualitative Fit Test and Quantitative Single-Pass Filtration Efficiency of Disposable N95 Masks Following Gamma Irradiation. JAMA Netw Open [Internet]. 2020 May 26 [cited 2021 Jan 8];3(5):e209961. Available from: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2766200

D’Andrea E, Kesselheim AS, Franklin JM, Jung EH, Hey SP, Patorno E. Heterogeneity of antidiabetic treatment effect on the risk of major adverse cardiovascular events in type 2 diabetes: a systematic review and meta-analysis. Cardiovasc Diabetol. 2020 Sep 29;19(1):154. PMCID: PMC7525990

Darrow JJ, Kesselheim AS. Incentivizing Antibiotic Development: Why Isn’t the Generating Antibiotic Incentives Now (GAIN) Act Working? Open Forum Infect Dis. 2020 Jan;7(1):ofaa001. PMCID: PMC6986775

Darrow JJ, Kesselheim AS. Incentivizing Antibiotic Development: Why Isn’t the Generating Antibiotic Incentives Now (GAIN) Act Working? Open Forum Infect Dis [Internet]. 2020 Jan 28 [cited 2020 Mar 13];7(1). Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6986775/ PMCID: PMC6986775

Darrow JJ, Najafzadeh M, Stefanini K, Kesselheim AS. Regulatory approval characteristics of antimicrobial versus non-antimicrobial products, 1984-2018: an evaluation of Food and Drug Administration flexibilities. Lancet Infect Dis. 2020;20(7):e159–e164. PMID: 32502431

Darrow JJ, Chong JE, Kesselheim AS. Reconsidering the scope of US state laws allowing pharmacist substitution of generic drugs. BMJ. 2020 Jun 23;369:m2236. PMID: 32576554

Darrow JJ, Avorn J, Kesselheim AS. FDA Approval and Regulation of Pharmaceuticals, 1983-2018. JAMA. 2020 14;323(2):164–176. PMID: 31935033

Darrow JJ, Avorn J, Kesselheim AS. FDA Approval and Regulation of Pharmaceuticals, 1983-2018. JAMA. 2020 Jan 14;323(2):164–176. PMID: 31935033

Dave CV, Sinha MS, Beall RF, Kesselheim AS. Estimating The Cost Of Delayed Generic Drug Entry To Medicaid. Health Aff (Millwood). 2020 Jun;39(6):1011–1017. PMID: 32479219

Druedahl LC, Almarsdóttir AB, Kälvemark Sporrong S, De Bruin ML, Hoogland H, Minssen T, van de Weert M, Kesselheim AS, Sarpatwari A. A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways. Nat Biotechnol. 2020;38(11):1253–1256. PMID: 33144720

Feldman WB, Gagne JJ, Kesselheim AS. Trends in Medicare Part D Inhaler Spending, 2012-2018. Ann Am Thorac Soc. 2020 Nov 18; PMID: 33207126

Fralick M, Gagne JJ, Patorno E, Levin R, Kesselheim AS. Using Data From Routine Care to Estimate the Effectiveness and Potential Limitations of Outcomes-Based Contracts for Diabetes Medications. Value Health. 2020;23(4):434–440. PMID: 32327160

Gerke S, Stern AD, Minssen T. Germany’s digital health reforms in the COVID-19 era: lessons and opportunities for other countries. NPJ Digit Med. 2020 Jul 10;3:94. PMCID: PMC7351985

Godfrey A, Goldsack JC, Tenaerts P, Coravos A, Aranda C, Hussain A, Barreto ME, Young F, Vitorio R. BioMeT and Algorithm Challenges: A Proposed Digital Standardized Evaluation Framework. IEEE J Transl Eng Health Med. 2020;8:0700108. PMCID: PMC7292480

Goldsack JC, Coravos A, Bakker JP, Bent B, Dowling AV, Fitzer-Attas C, Godfrey A, Godino JG, Gujar N, Izmailova E, Manta C, Peterson B, Vandendriessche B, Wood WA, Wang KW, Dunn J. Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs). NPJ Digit Med. 2020;3:55. PMCID: PMC7156507

Gunnarsdóttir HD, Sinha MS, Gerke S, Minssen T. Applying the proportionality principle to COVID-19 antibody testing. J Law Biosci. 2020 Jun;7(1):lsaa058. PMCID: PMC7454743

Gyawali B, Hey SP, Kesselheim AS. Evaluating the evidence behind the surrogate measures included in the FDA’s table of surrogate endpoints as supporting approval of cancer drugs. EClinicalMedicine. 2020 Apr;21:100332. PMCID: PMC7201012

Gyawali B, D’Andrea E, Franklin JM, Kesselheim AS. Response Rates and Durations of Response for Biomarker-Based Cancer Drugs in Nonrandomized Versus Randomized Trials. Journal of the National Comprehensive Cancer Network [Internet]. 2020 Jan 1 [cited 2020 Dec 14];18(1):36–43. Available from: https://jnccn.org/view/journals/jnccn/18/1/article-p36.xml

Hey SP, Kesselheim AS, Patel P, Mehrotra P, Powers JH. US Food and Drug Administration Recommendations on the Use of Surrogate Measures as End Points in New Anti-infective Drug Approvals. JAMA Intern Med [Internet]. 2020 Jan 1 [cited 2020 Jan 23];180(1):131–138. Available from: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2754093

Hey SP, Gyawali B, D’Andrea E, Kanagaraj M, Franklin JM, Kesselheim AS. A Systematic Review and Meta-Analysis of Bevacizumab in First-Line Metastatic Breast Cancer: Lessons for Research and Regulatory Enterprises. J Natl Cancer Inst. 2020 Apr 1;112(4):335–342. PMCID: PMC7156929

Hey SP, Gerlach CV, Dunlap G, Prasad V, Kesselheim AS. The evidence landscape in precision medicine. Sci Transl Med. 2020 Apr 22;12(540). PMID: 32321867

Hong P, Kesselheim AS, Sarpatwari A. Transformative Models to Promote Prescription Drug Innovation and Access: A Landscape Analysis. Yale journal of health policy, law, and ethics. 2020;19(2):56-.

Hwang TJ, Ross JS, Vokinger KN, Kesselheim AS. Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study. BMJ. 2020 Oct 7;371:m3434. PMCID: PMC7537471

Hwang TJ, Randolph AG, Bourgeois FT. Inclusion of Children in Clinical Trials of Treatments for Coronavirus Disease 2019 (COVID-19). JAMA Pediatr. 2020 Sep 1;174(9):825–826. PMID: 32379296

Jung EH, Sarpatwari A, Kesselheim AS. Novelty of Active Ingredients in High-Cost Brand-Name Drugs. J Gen Intern Med. 2020 Jul;35(7):2219–2221. PMCID: PMC7352024

Kesselheim AS, Darrow JJ, Kulldorff M, Brown BL, Mitra-Majumdar M, Lee CC, Moneer O, Avorn J. An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19. Health Aff (Millwood). 2020 Nov 19;101377hlthaff202001620. PMID: 33211535

Kurzrock R, Kantarjian HM, Kesselheim AS, Sigal EV. New drug approvals in oncology. Nat Rev Clin Oncol. 2020;17(3):140–146. PMID: 32020042

Lauenroth VD, Kesselheim AS, Sarpatwari A, Stern AD. Lessons From The Impact Of Price Regulation On The Pricing Of Anticancer Drugs In Germany. Health Aff (Millwood). 2020 Jul;39(7):1185–1193. PMID: 32634355

Lee CC, Kesselheim AS, Sarpatwari A. Clinical Development Times for Biosimilars in the United States. Mayo Clin Proc. 2020;95(10):2152–2154. PMID: 33012346

Lee CC, Kesselheim AS, Avorn J. Variations in Generic Combination Opioid Use Across State Medicaid Programs. J Gen Intern Med. 2020 Nov 2; PMID: 33140274

Lee CC, Darrow JJ, Avorn J, Kesselheim AS. Origins and Ownership of Remdesivir: Implications for Pricing. J Law Med Ethics. 2020;48(3):613–618. PMID: 33021169

Lin KJ, Dvorin E, Kesselheim AS. Prescribing systemic steroids for acute respiratory tract infections in United States outpatient settings: A nationwide population-based cohort study. PLoS Med. 2020;17(3):e1003058. PMCID: PMC7108689

Lite S, Gordon WJ, Stern AD. Association of the Meaningful Use Electronic Health Record Incentive Program With Health Information Technology Venture Capital Funding. JAMA Netw Open. 2020 02;3(3):e201402. PMCID: PMC7093764

Liu M, Caputi TL, Dredze M, Kesselheim AS, Ayers JW. Internet Searches for Unproven COVID-19 Therapies in the United States. JAMA Intern Med. 2020 Aug 1;180(8):1116–1118. PMCID: PMC7191468

Liu M, MacKenna B, Feldman WB, Walker AJ, Avorn J, Kesselheim AS, Goldacre B. Projected spending for brand-name drugs in English primary care given US prices: a cross-sectional study. J R Soc Med. 2020;113(9):350–359. PMCID: PMC7488930

Luo J, Kesselheim AS, Sarpatwari A. Insulin access and affordability in the USA: anticipating the first interchangeable insulin product. Lancet Diabetes Endocrinol. 2020;8(5):360–362. PMID: 32203681

Manta C, Jain SS, Coravos A, Mendelsohn D, Izmailova ES. An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19. Clin Transl Sci. 2020;13(6):1034–1044. PMCID: PMC7719373

Angus DC, Alexander BM, Berry S, Buxton M, Lewis R, Paoloni M, Webb SAR, Arnold S, Barker A, Berry DA, Bonten MJM, Brophy M, Butler C, Cloughesy TF, Derde LPG, Esserman LJ, Ferguson R, Fiore L, Gaffey SC, Gaziano JM, Giusti K, Goossens H, Heritier S, Hyman B, Krams M, Larholt K, LaVange LM, Lavori P, Lo AW, London AJ, Manax V, McArthur C, O’Neill G, Parmigiani G, Perlmutter J, Petzold EA, Ritchie C, Rowan KM, Seymour CW, Shapiro NI, Simeone DM, Smith B, Spellberg B, Stern AD, Trippa L, Trusheim M, Viele K, Wen PY, Woodcock J, The Adaptive Platform Trials Coalition. Adaptive platform trials: definition, design, conduct and reporting considerations. Nature Reviews Drug Discovery [Internet]. 2019 Aug 28; Available from: https://doi.org/10.1038/s41573-019-0034-3

Bakker JP, Goldsack JC, Clarke M, Coravos A, Geoghegan C, Godfrey A, Heasley MG, Karlin DR, Manta C, Peterson B, Ramirez E, Sheth N, Bruno A, Bullis E, Wareham K, Zimmerman N, Forrest A, Wood WA. A systematic review of feasibility studies promoting the use of mobile technologies in clinical research. npj Digital Medicine [Internet]. 2019 [cited 2019 Oct 24];2(1). Available from: http://www.nature.com/articles/s41746-019-0125-x

Beall RF, Hwang TJ, Kesselheim AS. Major Events in the Life Course of New Drugs, 2000-2016. N Engl J Med. 2019 Mar 14;380(11):e12. PMID: 30865793

Beall RF, Kesselheim AS, Sarpatwari A. New Drug Formulations and Their Respective Generic Entry Dates. J Manag Care Spec Pharm. 2019 Feb;25(2):218–224. PMID: 30698097

Beall RF, Hwang TJ, Kesselheim AS. Pre-market development times for biologic versus small-molecule drugs. Nat Biotechnol. 2019 Jul;37(7):708–711. PMID: 31213674

Beall RF, Darrow JJ, Kesselheim AS. Approximating Future Generic Entry for New Drugs. J Law Med Ethics. 2019 Mar;47(1):177–182. PMID: 30994060

Bourgeois FT, Kesselheim AS. Promoting Pediatric Drug Research and Labeling - Outcomes of Legislation. N Engl J Med. 2019 29;381(9):875–881. PMID: 31461599

Bourgeois FT, Graham DA, Kesselheim AS, Randolph AG. Cost Implications of Escalating Intravenous Acetaminophen Use in Children. JAMA Pediatr. 2019 Mar 11; PMID: 30855654

Coravos A, Khozin S, Mandl KD. Developing and adopting safe and effective digital biomarkers to improve patient outcomes. npj Digital Medicine [Internet]. 2019 Mar 11;2(1):14. Available from: https://doi.org/10.1038/s41746-019-0090-4

Coravos A, Goldsack JC, Karlin DR, Nebeker C, Perakslis E, Zimmerman N, Erb MK. Digital Medicine: A Primer on Measurement. Digit Biomark [Internet]. 2019 May 9 [cited 2019 Oct 24];3(2):31–71. Available from: https://www.karger.com/Article/FullText/500413

D’Andrea E, Hey SP, Ramirez CL, Kesselheim AS. Assessment of the Role of Niacin in Managing Cardiovascular Disease Outcomes: A Systematic Review and Meta-analysis. JAMA Netw Open. 2019 Apr 5;2(4):e192224. PMID: 30977858

Darrow JJ, Beall RF, Kesselheim AS. The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents. Appl Health Econ Health Policy. 2019 Feb;17(1):47–54. PMID: 30141133

Dave CV, Brill G, Kesselheim AS. Changes in Price for Generic Drugs in the USA, 2008-2016. J Gen Intern Med. 2019 Sep;34(9):1677–1679. PMCID: PMC6712128

Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, Raofi S, Bohn J, Connolly JG, Fischer MA, Kesselheim AS, Gagne JJ. Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims. PLoS Med. 2019 Mar;16(3):e1002763. PMCID: PMC6415809

Feldman WB, Hey SP, Franklin JM, Kesselheim AS. Public Approval of Exception From Informed Consent in Emergency Clinical Trials. JAMA Netw Open [Internet]. 2019 Jul 24 [cited 2019 Nov 18];2(7). Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6659147/ PMCID: PMC6659147

Feldman WB, Avorn J, Kesselheim AS. Potential Medicare Savings on Inhaler Prescriptions Through the Use of Negotiated Prices and a Defined Formulary. JAMA Intern Med. 2019 Dec 2; PMCID: PMC6902106

Fischer MA, Kesselheim AS, Lu Z, Ross KM, Tessema FA, Avorn J. Physician Perceptions of Step Therapy Prescribing Requirements. J Manag Care Spec Pharm [Internet]. 2019 [cited 2019 Oct 31];25(11):1210–1224. Available from: https://www.jmcp.org/doi/10.18553/jmcp.2019.25.11.1210

Fralick M, Kesselheim AS. The U.S. Insulin Crisis - Rationing a Lifesaving Medication Discovered in the 1920s. N Engl J Med. 2019 Nov 7;381(19):1793–1795. PMID: 31693804

Fralick M, Schneeweiss S, Wallis CJD, Jung EH, Kesselheim AS. Desmopressin and the risk of hyponatremia: A population-based cohort study. PLoS Med. 2019 Oct;16(10):e1002930. PMID: 31634354

Gordon WJ, Stern AD. Challenges and opportunities in software-driven medical devices. Nat Biomed Eng [Internet]. 2019 [cited 2019 Jul 22];3(7):493–497. Available from: http://www.nature.com/articles/s41551-019-0426-z

Growdon ME, Sacks CA, Kesselheim AS, Avorn J. Potential Medicare Savings From Generic Substitution and Therapeutic Interchange of ACE Inhibitors and Angiotensin-II-Receptor Blockers. JAMA Intern Med. 2019 Aug 5; PMCID: PMC6686978

Gyawali B, Kesselheim AS. US Food and Drug Administration Approval of New Drugs Based on Noninferiority Trials in Oncology: A Dangerous Precedent? JAMA Oncol. 2019 Mar 28; PMID: 30920591

Gyawali B, Kesselheim AS. The promise of ESCAT: a new system for evaluating cancer drug-target pairs. Nat Rev Clin Oncol. 2019 Mar;16(3):147–148. PMID: 30317250

Gyawali B, Bouche G, Pantziarka P, Kesselheim AS, Sarpatwari A. Lung Cancer Survival Gains: Contributions of Academia and Industry. J Law Med Ethics. 2019 Sep;47(3):465–467. PMID: 31560624

Gyawali B, Tessema FA, Jung EH, Kesselheim AS. Assessing the Justification, Funding, Success, and Survival Outcomes of Randomized Noninferiority Trials of Cancer Drugs: A Systematic Review and Pooled Analysis. JAMA Netw Open [Internet]. 2019 Aug 2 [cited 2019 Nov 18];2(8):e199570–e199570. Available from: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2749263

Gyawali B, Hey SP, Kesselheim AS. Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval. JAMA Intern Med. 2019 Jul 1;179(7):906–913. PMCID: PMC6547118

Hey SP, D’Andrea E, Jung EH, Tessema F, Luo J, Gyawali B, Kesselheim AS. Challenges and Opportunities for Biomarker Validation. J Law Med Ethics. 2019 Sep;47(3):357–361. PMID: 31560620

Hey SP, Feldman WB, Jung EH, D’Andrea E, Kesselheim AS. Surrogate Endpoints and Drug Regulation: What Is Needed to Clarify the Evidence. J Law Med Ethics. 2019 Sep;47(3):381–387. PMID: 31560631

Hong P, Sarpatwari A, Kesselheim AS. Orphan Drug Designation and Exclusivity for “Same Drugs.” J Law Med Ethics. 2019 Jun;47(2):347–349. PMID: 31298092

Hudgins JD, Porter JJ, Monuteaux MC, Bourgeois FT. Trends in Opioid Prescribing for Adolescents and Young Adults in Ambulatory Care Settings. Pediatrics. 2019;143(6). PMID: 31138669

Hwang TJ, Bourgeois FT, Franklin JM, Kesselheim AS. Impact Of The Priority Review Voucher Program On Drug Development For Rare Pediatric Diseases. Health Aff (Millwood). 2019 Feb;38(2):313–319. PMID: 30715972

Hwang TJ, Jain N, Lauffenburger JC, Vokinger KN, Kesselheim AS. Analysis of Proposed Medicare Part B to Part D Shift With Associated Changes in Total Spending and Patient Cost-Sharing for Prescription Drugs. JAMA Intern Med. 2019 Jan 14; PMID: 30640379

Hwang TJ, Sinha MS, Dave CV, Kesselheim AS. Prescription Opioid Epidemic and Trends in the Clinical Development of New Pain Medications. Mayo Clin Proc. 2019;94(12):2437–2443. PMID: 31685265

Hwang TJ, Kesselheim AS, Vokinger KN. Lifecycle Regulation of Artificial Intelligence- and Machine Learning-Based Software Devices in Medicine. JAMA. 2019 Nov 22; PMID: 31755907

Jiao K, Gupta R, Fox E, Kesselheim A, Ross JS. Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration. JAMA Netw Open. 2019 Oct 2;2(10):e1913029. PMCID: PMC6804024

Jung EH, Sarpatwari A, Kesselheim AS, Sinha MS. FDA and EMA Biosimilar Approvals. J Gen Intern Med. 2019 Oct 21; PMID: 31637641

Kesselheim AS, Sinha MS, Rausch P, Lu Z, Tessema FA, Lappin BM, Zhou EH, Dal Pan GJ, Zwanziger L, Ramanadham A, Loughlin A, Enger C, Avorn J, Campbell EG. Patients’ Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey. J Law Med Ethics. 2019 Sep;47(3):430–441. PMID: 31560634

Kesselheim AS, Sinha MS, Campbell EG, Schneeweiss S, Rausch P, Lappin BM, Zhou EH, Avorn J, Dal Pan GJ. Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem. Drug Saf. 2019 Jul 13; PMID: 31302895

Kesselheim AS, Woloshin S, Lu Z, Tessema FA, Ross KM, Schwartz LM. Physicians’ Perspectives on FDA Approval Standards and Off-Label Drug Marketing. JAMA Intern Med. 2019 Jan 22; PMID: 30667474

Khozin S, Coravos A. Decentralized Trials in the Age of Real-World Evidence and Inclusivity in Clinical Investigations. Clin Pharmacol Ther. 2019 Apr 23; PMID: 31013350

Lee TT, Solomon DH, Kesselheim AS. Fool Me Twice? The Reemergence of Rofecoxib and the Orphan Drug Act. Ann Intern Med. 2019 Oct 1; PMID: 31569216

Li DG, Najafzadeh M, Kesselheim AS, Mostaghimi A. Spending on World Health Organization essential medicines in Medicare Part D, 2011-15: retrospective cost analysis. BMJ. 2019 17;366:l4257. PMCID: PMC6635813

Liu S, Kesselheim AS. Experiences With and Challenges Afforded by Expedited Regulatory Pathways. Clin Pharmacol Ther [Internet]. 2019 [cited 2019 Oct 24];105(4):795–797. Available from: http://ascpt.onlinelibrary.wiley.com/doi/abs/10.1002/cpt.1365

Luo J, Khan NF, Manetti T, Rose J, Kaloghlian A, Gadhe B, Jain SH, Gagne JJ, Kesselheim AS. Implementation of a Health Plan Program for Switching From Analogue to Human Insulin and Glycemic Control Among Medicare Beneficiaries With Type 2 Diabetes. JAMA. 2019 29;321(4):374–384. PMCID: PMC6439763

Luo J, Kulldorff M, Sarpatwari A, Pawar A, Kesselheim AS. Variation in Prescription Drug Prices by Retail Pharmacy Type: A National Cross-sectional Study. Ann Intern Med. 2019 Oct 1; PMID: 31569218

Monteleone PP, Banerjee S, Kothapalli P, Stern AD, Fehder D, Ginor R, Vollmar D, Fry ETA, Pirwitz MJ. The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System. J Invasive Cardiol. 2019 Oct 15; PMID: 31611426

Morten CJ, Kesselheim AS, Ross JS. The Supreme Court’s Latest Ruling on Drug Liability and its Implications for Future Failure-to-Warn Litigation. J Law Med Ethics. 2019 Dec;47(4):783–787. PMID: 31957583

Nayak RK, Avorn J, Kesselheim AS. Public sector financial support for late stage discovery of new drugs in the United States: cohort study. BMJ [Internet]. 2019 Oct 23 [cited 2019 Oct 31];l5766. Available from: http://www.bmj.com/lookup/doi/10.1136/bmj.l5766

Kaplan AV, Stern AD. The Central and Unacknowledged Role of the US Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials. JAMA Cardiol [Internet]. 2018 Jan 1 [cited 2019 May 8];3(1):5–6. Available from: https://jamanetwork-com.ezp-prod1.hul.harvard.edu/journals/jamacardiology/fullarticle/2660061

Stern AD, Alexander BM, Chandra A. Innovation Incentives and Biomarkers. Clin Pharmacol Ther. 2018 Jan;103(1):34–36. PMID: 29034452

Palmer AC, Sorger PK. Combination Cancer Therapy Can Confer Benefit via Patient-to-Patient Variability without Drug Additivity or Synergy. Cell [Internet]. 2017 Dec 14 [cited 2021 Aug 16];171(7):1678-1691.e13. Available from: https://www.sciencedirect.com/science/article/pii/S0092867417313181