All CRS Publications
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2024 Publications
Aboy, Mateo, Cristina Crespo, and Ariel Stern. “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 Digital Medicine 7, no. 1 (February 8, 2024): 29. https://doi.org/10.1038/s41746-024-01021-y.
Gressler, Laura Elisabeth, Erika Avila-Tang, Jialin Mao, Alejandra Avalos-Pacheco, Fadia T. Shaya, Yelizaveta Torosyan, Alexander Liebeskind, et al. “Data Sources and Applied Methods for Paclitaxel Safety Signal Discernment.” Frontiers in Cardiovascular Medicine 10 (2024). https://www.frontiersin.org/articles/10.3389/fcvm.2023.1331142.
Marra, Caroline, and Ariel D. Stern. “Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms.” Clinical Pharmacology and Therapeutics, February 2, 2024. https://doi.org/10.1002/cpt.3192.
2023 Publications
Arfè, Andrea, Claire Narang, Steven G. DuBois, Gregory Reaman, and Florence T. Bourgeois. “Clinical Development of New Drugs for Adults and Children with Cancer, 2010-2020.” Journal of the National Cancer Institute, May 12, 2023, djad082. https://doi.org/10.1093/jnci/djad082.
Avalos-Pacheco, Alejandra, Steffen Ventz, Andrea Arfè, Brian M. Alexander, Rifaquat Rahman, Patrick Y. Wen, and Lorenzo Trippa. “Validation of Predictive Analyses for Interim Decisions in Clinical Trials.” JCO Precision Oncology 7 (February 2023): e2200606. https://doi.org/10.1200/PO.22.00606.
Bourgeois, Florence T., and Juan C. Espinoza. “Advancing Equity in Medical Device Development for Children.” JAMA Pediatrics 177, no. 6 (June 1, 2023): 561–62. https://doi.org/10.1001/jamapediatrics.2023.0790.
Brönneke, Jan B., Annika Herr, Simon Reif, and Ariel D. Stern. “Dynamic HTA for Digital Health Solutions: Opportunities and Challenges for Patient-Centered Evaluation.” International Journal of Technology Assessment in Health Care 39, no. 1 (November 17, 2023): e72. https://doi.org/10.1017/S0266462323002726.
Elsallab, Magdi, and Marcela V. Maus. “Expanding Access to CAR T Cell Therapies through Local Manufacturing.” Nature Biotechnology, October 26, 2023. https://doi.org/10.1038/s41587-023-01981-8
Elsallab, Magdi, Moataz Ellithi, Susanne Hempel, Hisham Abdel-Azim, and Mohamed Abou-El-Enein. “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 Therapy, February 7, 2023. https://doi.org/10.1038/s41417-023-00593-3.
Everhart, Alexander O. “Time to Publication of Cost-Effectiveness Analyses for Medical Devices.” The American Journal of Managed Care 29, no. 5 (May 2023): 265–68. https://doi.org/10.37765/ajmc.2023.89359
Everhart, Alexander O., Soumya Sen, Ariel D. Stern, Yi Zhu, and Pinar Karaca-Mandic. “Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance.” JAMA 329, no. 2 (January 10, 2023): 144–56. https://doi.org/10.1001/jama.2022.22974.
Hwang, Thomas J., Gregory H. Reaman, and Florence T. Bourgeois. “Clinical Trials for Paediatric Cancers under New Legislation in the USA.” The Lancet. Child & Adolescent Health 7, no. 7 (July 2023): e13. https://doi.org/10.1016/S2352-4642(23)00125-6.
Kath, Jonas, Weijie Du, Stefania Martini, Magdi Elsallab, Clemens Franke, Laura Hartmann, Vanessa Drosdek, et al. “CAR NK-92 Cell-Mediated Depletion of Residual TCR+ Cells for Ultrapure Allogeneic TCR-Deleted CAR T-Cell Products.” Blood Advances 7, no. 15 (August 8, 2023): 4124–34. https://doi.org/10.1182/bloodadvances.2022009397.
Kessel, Robin van, Divya Srivastava, Ilias Kyriopoulos, Giovanni Monti, David Novillo-Ortiz, Ran Milman, Wojciech Wilhelm Zhang-Czabanowski, et al. “Digital Health Reimbursement Strategies of 8 European Countries and Israel: Scoping Review and Policy Mapping.” JMIR mHealth and uHealth 11 (September 29, 2023): e49003. https://doi.org/10.2196/49003.
Knox, Ryan P., Junyi Wang, William B. Feldman, Aaron S. Kesselheim, and Ameet Sarpatwari. “Outcomes of the 340B Drug Pricing Program: A Scoping Review.” JAMA Health Forum 4, no. 11 (November 3, 2023): e233716. https://doi.org/10.1001/jamahealthforum.2023.3716.
Lee, Lois K., Claire Narang, Chris A. Rees, Ravi R. Thiagarajan, Patrice Melvin, Valerie Ward, and Florence T. Bourgeois. “Reporting and Representation of Participant Race and Ethnicity in National Institutes of Health-Funded Pediatric Clinical Trials.” JAMA Network Open 6, no. 8 (August 1, 2023): e2331316. https://doi.org/10.1001/jamanetworkopen.2023.31316.
Masanneck, Lars, Pauline Gieseler, William J. Gordon, Sven G. Meuth, and Ariel D. Stern. “Evidence from ClinicalTrials.Gov on the Growth of Digital Health Technologies in Neurology Trials.” NPJ Digital Medicine 6, no. 1 (February 10, 2023): 23. https://doi.org/10.1038/s41746-023-00767-1.
Olsen, Anders, Reed F. Beall, Ryan P. Knox, Sean S. Tu, Aaron S. Kesselheim, and William B. Feldman. “Patents and Regulatory Exclusivities on FDA-Approved Insulin Products: A Longitudinal Database Study, 1986-2019.” PLoS Medicine 20, no. 11 (November 2023): e1004309. https://doi.org/10.1371/journal.pmed.1004309.
Ong, Mei-Sing, Ann Chen Wu, and Florence T. Bourgeois. “Enrollment of Pediatric Patients in COVID-19 Interventional Trials.” JAMA Health Forum 4, no. 11 (November 3, 2023): e233939. https://doi.org/10.1001/jamahealthforum.2023.3939.
Quazi, Sabrina, Claire Narang, Juan C. Espinoza, and Florence T. Bourgeois. “Characteristics and Results of Pediatric Medical Device Studies: 2017-2022.” Pediatrics, August 11, 2023, e2022059842. https://doi.org/10.1542/peds.2022-059842.
Raab, René, Arne Küderle, Anastasiya Zakreuskaya, Ariel D. Stern, Jochen Klucken, Georgios Kaissis, Daniel Rueckert, et al. “Federated Electronic Health Records for the European Health Data Space.” The Lancet. Digital Health, September 21, 2023, S2589-7500(23)00156-5. https://doi.org/10.1016/S2589-7500(23)00156-5.
Tang, Mitchell, Carter H. Nakamoto, Ariel D. Stern, Jose R. Zubizarreta, Felippe O. Marcondes, Lori Uscher-Pines, Lee H. Schwamm, and Ateev Mehrotra. “Effects of Remote Patient Monitoring Use on Care Outcomes Among Medicare Patients With Hypertension : An Observational Study.” Annals of Internal Medicine 176, no. 11 (November 2023): 1465–75. https://doi.org/10.7326/M23-1182.
Tang, Mitchell, Yashoda Sharma, Jennifer C. Goldsack, and Ariel Dora Stern. “Building the Business Case for an Inclusive Approach to Digital Health Measurement With a Web App (Market Opportunity Calculator): Instrument Development Study.” JMIR Formative Research 7 (July 26, 2023): e45713. https://doi.org/10.2196/45713.
Toce, Michael S., Kenneth A. Michelson, Joel D. Hudgins, Scott E. Hadland, Karen L. Olson, Michael C. Monuteaux, and Florence T. Bourgeois. “Association of Prescription Drug Monitoring Programs With Opioid Prescribing and Overdose in Adolescents and Young Adults.” Annals of Emergency Medicine 81, no. 4 (April 2023): 429–37. https://doi.org/10.1016/j.annemergmed.2022.11.003.
Toce, Michael S., Kenneth A. Michelson, Joel D. Hudgins, Karen L. Olson, Michael C. Monuteaux, and Florence T. Bourgeois. “Association of Prescription Drug Monitoring Programs with Benzodiazepine Prescription Dispensation and Overdose in Adolescents and Young Adults.” Clinical Toxicology (Philadelphia, Pa.) 61, no. 4 (April 2023): 234–40. https://doi.org/10.1080/15563650.2023.2181092.
Wang, Xuan, Vidul Ayakulangara Panickan, Tianrun Cai, Xin Xiong, Kelly Cho, Tianxi Cai, and Florence T. Bourgeois. “Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices.” JAMA Internal Medicine, August 21, 2023, e233562. https://doi.org/10.1001/jamainternmed.2023.3562.
2022 Publications
Khorrami, Peggah, Michael S. Sinha, Aditi Bhanja, Heidi L. Allen, Aaron S. Kesselheim, and Benjamin D. Sommers. “Differences in Diabetic Prescription Drug Utilization and Costs Among Patients With Diabetes Enrolled in Colorado Marketplace and Medicaid Plans, 2014-2015.” JAMA Network Open 5, no. 1 (January 4, 2022): e2140371. https://doi.org/10.1001/jamanetworkopen.2021.40371.
Knox, Ryan, and Gregory Curfman. “The Humira Patent Thicket, the Noerr-Pennington Doctrine and Antitrust’s Patent Problem.” Nature Biotechnology 40, no. 12 (December 2022): 1761–63. https://doi.org/10.1038/s41587-022-01583-w.
Knox, Ryan P., Aaron S. Kesselheim, and Ameet Sarpatwari. “Risks to the 340B Drug Pricing Program Related to Manufacturer Restrictions on Drug Availability.” JAMA, April 15, 2022. https://doi.org/10.1001/jama.2022.5959.
Nader, Jaclynne H., Florence Bourgeois, Rochelle Bagatell, Lucas Moreno, Andrew D. J. Pearson, and Steven G. DuBois. “Systematic Review of Clinical Drug Development Activities for Neuroblastoma from 2011 to 2020.” Pediatric Blood & Cancer, December 2, 2022, e30106. https://doi.org/10.1002/pbc.30106.
Russo, Massimiliano, and Bruno Scarpa. “Learning in Medicine: The Importance of Statistical Thinking.” Methods in Molecular Biology (Clifton, N.J.) 2486 (2022): 215–32. https://doi.org/10.1007/978-1-0716-2265-0_11.
Tang, Mitchell, Carter H. Nakamoto, Ariel D. Stern, and Ateev Mehrotra. “Trends in Remote Patient Monitoring Use in Traditional Medicare.” JAMA Internal Medicine 182, no. 9 (September 1, 2022): 1005–6. https://doi.org/10.1001/jamainternmed.2022.3043.
Torous, John, Ariel D. Stern, and Florence T. Bourgeois. “Regulatory Considerations to Keep Pace with Innovation in Digital Health Products.” NPJ Digital Medicine 5, no. 1 (August 19, 2022): 121. https://doi.org/10.1038/s41746-022-00668-9.
Wunnava, Susmitha, Timothy A. Miller, and Florence T. Bourgeois. “Improving FDA Postmarket Adverse Event Reporting for Medical Devices.” BMJ Evidence-Based Medicine, February 17, 2022, bmjebm-2021-111870. https://doi.org/10.1136/bmjebm-2021-111870.
Wunnava, Susmitha, Timothy A. Miller, Claire Narang, Meena Nathan, and Florence T. Bourgeois. “US Food and Drug Administration Approval of High-Risk Cardiovascular Devices for Use in Children and Adolescents, 1977-2021.” JAMA 328, no. 6 (August 9, 2022): 580–82. https://doi.org/10.1001/jama.2022.10041.
2021 Publications
Antonini, Marc-Joseph, Deborah Plana, Shriya Srinivasan, Lyla Atta, Aditya Achanta, Helen Yang, Avilash K. Cramer, et al. “A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19 Pandemic.” Frontiers in Digital Health 3 (March 2021): 617106. https://doi.org/10.3389/fdgth.2021.617106.
Arfè, Andrea, Lewis B. Silverman, and Florence Bourgeois. “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 Oncology, June 10, 2021. https://doi.org/10.1001/jamaoncol.2021.1508.
Barenie, Rachel E., Michael S. Sinha, and Aaron S. Kesselheim. “Factors Affecting Buprenorphine Utilization and Spending in Medicaid, 2002-2018.” Value in Health: The Journal of the International Society for Pharmacoeconomics and Outcomes Research 24, no. 2 (February 2021): 182–87. https://doi.org/10.1016/j.jval.2020.04.1840.
Bourgeois, Florence T., Paul Avillach, and Mark A. Turner. “The Urgent Need for Research Coordination to Advance Knowledge on COVID-19 in Children.” Pediatric Research 90, no. 2 (August 2021): 250–52. https://doi.org/10.1038/s41390-020-01259-8.
Bourgeois, Florence T., Alba Gutiérrez-Sacristán, Mark S. Keller, Molei Liu, Chuan Hong, Clara-Lea Bonzel, Amelia L. M. Tan, et al. “International Analysis of Electronic Health Records of Children and Youth Hospitalized With COVID-19 Infection in 6 Countries.” JAMA Network Open 4, no. 6 (June 1, 2021): e2112596. https://doi.org/10.1001/jamanetworkopen.2021.12596.
Bresler, Jessica, and Michael S. Sinha. “The Other Three Waves: Re-Assessing the Impact of Industry-Prescriber Relations on the Opioid Crisis.” The Journal of Legal Medicine 41, no. 1–2 (June 2021): 47–81. https://doi.org/10.1080/01947648.2021.1929589.
Carmody, Seth, Andrea Coravos, Ginny Fahs, Audra Hatch, Janine Medina, Beau Woods, and Joshua Corman. “Building Resilient Medical Technology Supply Chains with a Software Bill of Materials.” NPJ Digital Medicine 4, no. 1 (February 23, 2021): 34. https://doi.org/10.1038/s41746-021-00403-w.
Cherla, Avi, Huseyin Naci, Aaron S. Kesselheim, Bishal Gyawali, and Elias Mossialos. “Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval.” JAMA Internal Medicine 181, no. 4 (April 1, 2021): 490–98. https://doi.org/10.1001/jamainternmed.2020.8441.
Cramer, Avilash K., Deborah Plana, Helen Yang, Mary M. Carmack, Enze Tian, Michael S. Sinha, David Krikorian, et al. “Analysis of SteraMist Ionized Hydrogen Peroxide Technology in the Sterilization of N95 Respirators and Other PPE.” Scientific Reports 11, no. 1 (January 21, 2021): 2051. https://doi.org/10.1038/s41598-021-81365-7.
Gordon, William J., Andrea R. Coravos, and Ariel D. Stern. “Ushering in Safe, Effective, Secure, and Ethical Medicine in the Digital Era.” NPJ Digital Medicine 4, no. 1 (March 25, 2021): 56. https://doi.org/10.1038/s41746-021-00424-5.
Gyawali, Bishal, and Aaron S. Kesselheim. “FDA Approval Standards for Anticancer Agents - Lessons from Two Recent Approvals in Breast Cancer.” Nature Reviews. Clinical Oncology 18, no. 7 (July 2021): 397–98. https://doi.org/10.1038/s41571-021-00504-1.
Kassamali, Bina, Zizi Yu, Christopher Davis, Mary Carmack, Ai-Tram N. Bui, Jordan T. Said, Deborah Plana, et al. “Conversion of Existing UVB Phototherapy Units to UVC Germicidal Chambers for N95 Decontamination: Lessons Learned.” Photobiomodulation, Photomedicine, and Laser Surgery 39, no. 2 (February 2021): 83–85. https://doi.org/10.1089/photob.2020.4968.
Kothakonda, Akshay, Lyla Atta, Deborah Plana, Ferrous Ward, Chris Davis, Avilash Cramer, Robert Moran, et al. “De Novo Powered Air-Purifying Respirator Design and Fabrication for Pandemic Response.” Frontiers in Bioengineering and Biotechnology 9 (2021): 690905. https://doi.org/10.3389/fbioe.2021.690905.
McAvoy, Malia, Ai-Tram N. Bui, Christopher Hansen, Deborah Plana, Jordan T. Said, Zizi Yu, Helen Yang, et al. “3D Printed Frames to Enable Reuse and Improve the Fit of N95 and KN95 Respirators.” BMC Biomedical Engineering 3, no. 1 (June 7, 2021): 10. https://doi.org/10.1186/s42490-021-00055-7.
Mecklai, Keizra, Nicholas Smith, Ariel D. Stern, and Daniel B. Kramer. “Remote Patient Monitoring - Overdue or Overused?” The New England Journal of Medicine 384, no. 15 (April 15, 2021): 1384–86. https://doi.org/10.1056/NEJMp2033275.
Plana, Deborah, Enze Tian, Avilash K. Cramer, Helen Yang, Mary M. Carmack, Michael S. Sinha, Florence T. Bourgeois, et al. “Assessing the Filtration Efficiency and Regulatory Status of N95s and Nontraditional Filtering Face-Piece Respirators Available during the COVID-19 Pandemic.” BMC Infectious Diseases 21, no. 1 (July 29, 2021): 712. https://doi.org/10.1186/s12879-021-06008-8.
Rome, Benjamin N., ChangWon C. Lee, Joshua J. Gagne, and Aaron S. Kesselheim. “Factors Associated With Generic Drug Uptake in the United States, 2012 to 2017.” Value in Health: The Journal of the International Society for Pharmacoeconomics and Outcomes Research 24, no. 6 (June 2021): 804–11. https://doi.org/10.1016/j.jval.2020.12.020.
Sahragardjoonegani, Babak, Reed F. Beall, Aaron S. Kesselheim, and Aidan Hollis. “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 14, no. 1 (January 4, 2021): 3. https://doi.org/10.1186/s40545-020-00282-8.
Srivastava, Ananya, and Florence T. Bourgeois. “Evaluation of Publication of Pediatric Drug Trials.” JAMA Network Open 4, no. 4 (April 1, 2021): e215829. https://doi.org/10.1001/jamanetworkopen.2021.5829.
Stern, Ariel Dora, Jacqueline L. Chen, Melissa Ouellet, Mark R. Trusheim, Zeid El-Kilani, Amber Jessup, and Ernst R. Berndt. “Biosimilars And Follow-On Products In The United States: Adoption, Prices, And Users.” Health Affairs (Project Hope) 40, no. 6 (June 2021): 989–99. https://doi.org/10.1377/hlthaff.2020.02239.
Wang, Xuan, Tianxi Cai, Lu Tian, Florence Bourgeois, and Layla Parast. “Quantifying the Feasibility of Shortening Clinical Trial Duration Using Surrogate Markers.” Statistics in Medicine, September 2, 2021. https://doi.org/10.1002/sim.9185.
2020 Publications
Arfè, Andrea, Brian Alexander, and Lorenzo Trippa. “Optimality of Testing Procedures for Survival Data in the Nonproportional Hazards Setting.” Biometrics, June 14, 2020. https://doi.org/10.1111/biom.13315.
Arfè, Andrea, Geoffrey Fell, Brian Alexander, Mark M. Awad, Scott J. Rodig, Lorenzo Trippa, and Jonathan D. Schoenfeld. “Meta-Analysis of PD-L1 Expression As a Predictor of Survival After Checkpoint Blockade.” JCO Precision Oncology 4 (November 2020): 1196–1206. https://doi.org/10.1200/PO.20.00150.
Avorn, Jerry, and Aaron Kesselheim. “Regulatory Decision-Making on COVID-19 Vaccines During a Public Health Emergency.” JAMA 324, no. 13 (October 6, 2020): 1284–85. https://doi.org/10.1001/jama.2020.17101.
Avorn, Jerry, and Aaron S. Kesselheim. “Up Is Down - Pharmaceutical Industry Caution vs. Federal Acceleration of Covid-19 Vaccine Approval.” The New England Journal of Medicine 383, no. 18 (October 29, 2020): 1706–8. https://doi.org/10.1056/NEJMp2029479.
Barenie, Rachel E., Jerry Avorn, Frazer A. Tessema, and Aaron S. Kesselheim. “Public Funding for Transformative Drugs: The Case of Sofosbuvir.” Drug Discovery Today, October 1, 2020. https://doi.org/10.1016/j.drudis.2020.09.024.
Barenie, Rachel E., Joshua J. Gagne, Aaron S. Kesselheim, Ajinkya Pawar, Angela Tong, Jing Luo, and Brian T. Bateman. “Rates and Costs of Dispensing Naloxone to Patients at High Risk for Opioid Overdose in the United States, 2014-2018.” Drug Safety 43, no. 7 (2020): 669–75. https://doi.org/10.1007/s40264-020-00923-6.
Beletsky, Leo, Sarah Seymour, Sunyou Kang, Zachary Siegel, Michael S. Sinha, Ryan Marino, Aashka Dave, and Clark Freifeld. “Fentanyl Panic Goes Viral: The Spread of Misinformation about Overdose Risk from Casual Contact with Fentanyl in Mainstream and Social Media.” The International Journal on Drug Policy 86 (September 16, 2020): 102951. https://doi.org/10.1016/j.drugpo.2020.102951.
Bourgeois, Florence T., Paul Avillach, and Mark A. Turner. “The Urgent Need for Research Coordination to Advance Knowledge on COVID-19 in Children.” Pediatric Research, November 11, 2020. https://doi.org/10.1038/s41390-020-01259-8.
Bui, Ai-Tram N., Zizi Yu, Karen Lee, Sara J. Li, William G. Tsiaras, Sherry H. Yu, Nicole R. LeBoeuf, and Arash Mostaghimi. “A Pilot Study of the Impact of Facial Skin Protectants on Qualitative Fit Testing of N95 Masks.” Journal of the American Academy of Dermatology, June 2020. https://doi.org/10.1016/j.jaad.2020.06.069.
Carmack, Mary, Thomas Hwang, and Florence T. Bourgeois. “Pediatric Drug Policies Supporting Safe And Effective Use Of Therapeutics In Children: A Systematic Analysis.” Health Affairs (Project Hope) 39, no. 10 (October 2020): 1799–1805. https://doi.org/10.1377/hlthaff.2020.00198.
Conti, Rena M., and Frank S. David. “Public Research Funding and Pharmaceutical Prices: Do Americans Pay Twice for Drugs?” F1000Research 9 (July 15, 2020): 707. https://doi.org/10.12688/f1000research.24934.1.
Coravos, Andrea, Megan Doerr, Jennifer Goldsack, Christine Manta, Mark Shervey, Beau Woods, and William A. Wood. “Modernizing and Designing Evaluation Frameworks for Connected Sensor Technologies in Medicine.” NPJ Digital Medicine 3 (2020): 37. https://doi.org/10.1038/s41746-020-0237-3.
Cramer, Avilash, Deborah Plana, Helen L. Yang, Mary Carmack, Enze Tian, Michael S. Sinha, David Krikorian, et al. “Analysis of SteraMist Ionized Hydrogen Peroxide Technology in the Sterilization of N95 Respirators and Other PPE: A Quality Improvement Study.” MedRxiv: The Preprint Server for Health Sciences, April 23, 2020. https://doi.org/10.1101/2020.04.19.20069997.
Cramer, Avilash, Enze Tian, Mitchell Galanek, Edward Lamere, Ju Li, Rajiv Gupta, and Mike Short. “Assessment of the Qualitative Fit Test and Quantitative Single-Pass Filtration Efficiency of Disposable N95 Masks Following Gamma Irradiation.” JAMA Network Open 3, no. 5 (May 26, 2020): e209961. https://doi.org/10.1001/jamanetworkopen.2020.9961.
D’Andrea, Elvira, Aaron S. Kesselheim, Jessica M. Franklin, Emily H. Jung, Spencer Phillips Hey, and Elisabetta Patorno. “Heterogeneity of Antidiabetic Treatment Effect on the Risk of Major Adverse Cardiovascular Events in Type 2 Diabetes: A Systematic Review and Meta-Analysis.” Cardiovascular Diabetology 19, no. 1 (September 29, 2020): 154. https://doi.org/10.1186/s12933-020-01133-1.
Darrow, Jonathan J., Jerry Avorn, and Aaron S. Kesselheim. “FDA Approval and Regulation of Pharmaceuticals, 1983-2018.” JAMA 323, no. 2 (January 14, 2020): 164–76. https://doi.org/10.1001/jama.2019.20288.
Darrow, Jonathan J., Jessica E. Chong, and Aaron S. Kesselheim. “Reconsidering the Scope of US State Laws Allowing Pharmacist Substitution of Generic Drugs.” BMJ (Clinical Research Ed.) 369 (June 23, 2020): m2236. https://doi.org/10.1136/bmj.m2236.
Darrow, Jonathan J., and Aaron S. Kesselheim. “Incentivizing Antibiotic Development: Why Isn’t the Generating Antibiotic Incentives Now (GAIN) Act Working?” Open Forum Infectious Diseases 7, no. 1 (January 2020): ofaa001. https://doi.org/10.1093/ofid/ofaa001.
Darrow, Jonathan J., Mehdi Najafzadeh, Kristina Stefanini, and Aaron S. Kesselheim. “Regulatory Approval Characteristics of Antimicrobial versus Non-Antimicrobial Products, 1984-2018: An Evaluation of Food and Drug Administration Flexibilities.” The Lancet. Infectious Diseases 20, no. 7 (2020): e159–64. https://doi.org/10.1016/S1473-3099(20)30197-3.
Dave, Chintan V., Michael S. Sinha, Reed F. Beall, and Aaron S. Kesselheim. “Estimating The Cost Of Delayed Generic Drug Entry To Medicaid.” Health Affairs (Project Hope) 39, no. 6 (June 2020): 1011–17. https://doi.org/10.1377/hlthaff.2019.00673.
Druedahl, Louise C., Anna Birna Almarsdóttir, Sofia Kälvemark Sporrong, Marie Louise De Bruin, Hans Hoogland, Timo Minssen, Marco van de Weert, Aaron S. Kesselheim, and Ameet Sarpatwari. “A Qualitative Study of Biosimilar Manufacturer and Regulator Perceptions on Intellectual Property and Abbreviated Approval Pathways.” Nature Biotechnology 38, no. 11 (2020): 1253–56. https://doi.org/10.1038/s41587-020-0717-7.
Feldman, William B., Joshua J. Gagne, and Aaron S. Kesselheim. “Trends in Medicare Part D Inhaler Spending, 2012-2018.” Annals of the American Thoracic Society, November 18, 2020. https://doi.org/10.1513/AnnalsATS.202008-1082RL.
Fralick, Michael, Joshua J. Gagne, Elisabetta Patorno, Raisa Levin, and Aaron S. Kesselheim. “Using Data From Routine Care to Estimate the Effectiveness and Potential Limitations of Outcomes-Based Contracts for Diabetes Medications.” Value in Health: The Journal of the International Society for Pharmacoeconomics and Outcomes Research 23, no. 4 (2020): 434–40. https://doi.org/10.1016/j.jval.2019.11.004.
Gerke, Sara, Ariel D. Stern, and Timo Minssen. “Germany’s Digital Health Reforms in the COVID-19 Era: Lessons and Opportunities for Other Countries.” NPJ Digital Medicine 3 (July 10, 2020): 94. https://doi.org/10.1038/s41746-020-0306-7.
Godfrey, Alan, Jennifer C. Goldsack, Pamela Tenaerts, Andrea Coravos, Clara Aranda, Azid Hussain, Marcos E. Barreto, Fraser Young, and Rodrigo Vitorio. “BioMeT and Algorithm Challenges: A Proposed Digital Standardized Evaluation Framework.” IEEE Journal of Translational Engineering in Health and Medicine 8 (2020): 0700108. https://doi.org/10.1109/JTEHM.2020.2996761.
Goldsack, Jennifer C., Andrea Coravos, Jessie P. Bakker, Brinnae Bent, Ariel V. Dowling, Cheryl Fitzer-Attas, Alan Godfrey, et al. “Verification, Analytical Validation, and Clinical Validation (V3): The Foundation of Determining Fit-for-Purpose for Biometric Monitoring Technologies (BioMeTs).” NPJ Digital Medicine 3 (2020): 55. https://doi.org/10.1038/s41746-020-0260-4.
Gunnarsdóttir, H. D., M. S. Sinha, S. Gerke, and T. Minssen. “Applying the Proportionality Principle to COVID-19 Antibody Testing.” Journal of Law and the Biosciences 7, no. 1 (June 2020): lsaa058. https://doi.org/10.1093/jlb/lsaa058.
Gyawali, Bishal, Elvira D’Andrea, Jessica M. Franklin, and Aaron S. Kesselheim. “Response Rates and Durations of Response for Biomarker-Based Cancer Drugs in Nonrandomized Versus Randomized Trials.” Journal of the National Comprehensive Cancer Network 18, no. 1 (January 1, 2020): 36–43. https://doi.org/10.6004/jnccn.2019.7345.
Gyawali, Bishal, Spencer P. Hey, and Aaron S. Kesselheim. “Evaluating the Evidence behind the Surrogate Measures Included in the FDA’s Table of Surrogate Endpoints as Supporting Approval of Cancer Drugs.” EClinicalMedicine 21 (April 2020): 100332. https://doi.org/10.1016/j.eclinm.2020.100332.
Hey, Spencer Phillips, Cory V. Gerlach, Garrett Dunlap, Vinay Prasad, and Aaron S. Kesselheim. “The Evidence Landscape in Precision Medicine.” Science Translational Medicine 12, no. 540 (April 22, 2020). https://doi.org/10.1126/scitranslmed.aaw7745.
Hey, Spencer Phillips, Bishal Gyawali, Elvira D’Andrea, Manoj Kanagaraj, Jessica M. Franklin, and Aaron S. Kesselheim. “A Systematic Review and Meta-Analysis of Bevacizumab in First-Line Metastatic Breast Cancer: Lessons for Research and Regulatory Enterprises.” Journal of the National Cancer Institute 112, no. 4 (April 1, 2020): 335–42. https://doi.org/10.1093/jnci/djz211.
Hey, Spencer Phillips, Aaron S. Kesselheim, Pranav Patel, Preeti Mehrotra, and John H. Powers. “US Food and Drug Administration Recommendations on the Use of Surrogate Measures as End Points in New Anti-Infective Drug Approvals.” JAMA Internal Medicine 180, no. 1 (January 1, 2020): 131–38. https://doi.org/10.1001/jamainternmed.2019.5451.
Hong, Phebe, Aaron S. Kesselheim, and Ameet Sarpatwari. “Transformative Models to Promote Prescription Drug Innovation and Access: A Landscape Analysis.” Yale Journal of Health Policy, Law, and Ethics 19, no. 2 (2020): 56-.
Hwang, Thomas J., Adrienne G. Randolph, and Florence T. Bourgeois. “Inclusion of Children in Clinical Trials of Treatments for Coronavirus Disease 2019 (COVID-19).” JAMA Pediatrics 174, no. 9 (September 1, 2020): 825–26. https://doi.org/10.1001/jamapediatrics.2020.1888.
Hwang, Thomas J., Joseph S. Ross, Kerstin N. Vokinger, and Aaron S. Kesselheim. “Association between FDA and EMA Expedited Approval Programs and Therapeutic Value of New Medicines: Retrospective Cohort Study.” BMJ (Clinical Research Ed.) 371 (October 7, 2020): m3434. https://doi.org/10.1136/bmj.m3434.
Jung, Emily H., Ameet Sarpatwari, and Aaron S. Kesselheim. “Novelty of Active Ingredients in High-Cost Brand-Name Drugs.” Journal of General Internal Medicine 35, no. 7 (July 2020): 2219–21. https://doi.org/10.1007/s11606-019-05565-8.
Kesselheim, Aaron S., Jonathan J. Darrow, Martin Kulldorff, Beatrice L. Brown, Mayookha Mitra-Majumdar, ChangWon Charlie Lee, Osman Moneer, and Jerry Avorn. “An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19.” Health Affairs (Project Hope), November 19, 2020, 101377hlthaff202001620. https://doi.org/10.1377/hlthaff.2020.01620.
Kurzrock, Razelle, Hagop M. Kantarjian, Aaron S. Kesselheim, and Ellen V. Sigal. “New Drug Approvals in Oncology.” Nature Reviews. Clinical Oncology 17, no. 3 (2020): 140–46. https://doi.org/10.1038/s41571-019-0313-2.
Lauenroth, Victoria D., Aaron S. Kesselheim, Ameet Sarpatwari, and Ariel D. Stern. “Lessons From The Impact Of Price Regulation On The Pricing Of Anticancer Drugs In Germany.” Health Affairs (Project Hope) 39, no. 7 (July 2020): 1185–93. https://doi.org/10.1377/hlthaff.2019.01122.
Lee, ChangWon C., Jonathan J. Darrow, Jerry Avorn, and Aaron S. Kesselheim. “Origins and Ownership of Remdesivir: Implications for Pricing.” The Journal of Law, Medicine & Ethics: A Journal of the American Society of Law, Medicine & Ethics 48, no. 3 (2020): 613–18. https://doi.org/10.1177/1073110520958890.
Lee, ChangWon C., Aaron S. Kesselheim, and Jerry Avorn. “Variations in Generic Combination Opioid Use Across State Medicaid Programs.” Journal of General Internal Medicine, November 2, 2020. https://doi.org/10.1007/s11606-020-06315-x.
Lee, ChangWon C., Aaron S. Kesselheim, and Ameet Sarpatwari. “Clinical Development Times for Biosimilars in the United States.” Mayo Clinic Proceedings 95, no. 10 (2020): 2152–54. https://doi.org/10.1016/j.mayocp.2020.06.039.
Liu, Michael, Brian MacKenna, William B. Feldman, Alex J. Walker, Jerry Avorn, Aaron S. Kesselheim, and Ben Goldacre. “Projected Spending for Brand-Name Drugs in English Primary Care given US Prices: A Cross-Sectional Study.” Journal of the Royal Society of Medicine 113, no. 9 (2020): 350–59. https://doi.org/10.1177/0141076820918238.
Lin, Kueiyu Joshua, Evan Dvorin, and Aaron S. Kesselheim. “Prescribing Systemic Steroids for Acute Respiratory Tract Infections in United States Outpatient Settings: A Nationwide Population-Based Cohort Study.” PLoS Medicine 17, no. 3 (2020): e1003058. https://doi.org/10.1371/journal.pmed.1003058.
Lite, Samuel, William Joseph Gordon, and Ariel Dora Stern. “Association of the Meaningful Use Electronic Health Record Incentive Program With Health Information Technology Venture Capital Funding.” JAMA Network Open 3, no. 3 (02 2020): e201402. https://doi.org/10.1001/jamanetworkopen.2020.1402.
Liu, Michael, Theodore L. Caputi, Mark Dredze, Aaron S. Kesselheim, and John W. Ayers. “Internet Searches for Unproven COVID-19 Therapies in the United States.” JAMA Internal Medicine 180, no. 8 (August 1, 2020): 1116–18. https://doi.org/10.1001/jamainternmed.2020.1764.
Luo, Jing, Aaron S. Kesselheim, and Ameet Sarpatwari. “Insulin Access and Affordability in the USA: Anticipating the First Interchangeable Insulin Product.” The Lancet. Diabetes & Endocrinology 8, no. 5 (2020): 360–62. https://doi.org/10.1016/S2213-8587(20)30105-4.
Manta, Christine, Sneha S. Jain, Andrea Coravos, Dena Mendelsohn, and Elena S. Izmailova. “An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID-19.” Clinical and Translational Science 13, no. 6 (2020): 1034–44. https://doi.org/10.1111/cts.12874.
Marra, Caroline, Jacqueline L. Chen, Andrea Coravos, and Ariel D. Stern. “Quantifying the Use of Connected Digital Products in Clinical Research.” NPJ Digital Medicine 3 (2020): 50. https://doi.org/10.1038/s41746-020-0259-x.
McAvoy, Malia, Ai-Tram N. Bui, Christopher Hansen, Deborah Plana, Jordan T. Said, Zizi Yu, Helen Yang, et al. “3D Printed Frames to Enable Reuse and Improve the Fit of N95 and KN95 Respirators.” MedRxiv: The Preprint Server for Health Sciences, July 26, 2020. https://doi.org/10.1101/2020.07.20.20151019.
Molto, Consolación, Thomas J. Hwang, Maria Borrell, Marta Andres, Ignasi Gich, Agustí Barnadas, Eitan Amir, Aaron S. Kesselheim, and Ariadna Tibau. “Clinical Benefit and Cost of Breakthrough Cancer Drugs Approved by the US Food and Drug Administration.” Cancer 126, no. 19 (October 1, 2020): 4390–99. https://doi.org/10.1002/cncr.33095.
Mostaghimi, Arash, Marc-Joseph Antonini, Deborah Plana, Philip D. Anderson, Brandon Beller, Edward W. Boyer, Amber Fannin, et al. “Regulatory and Safety Considerations in Deploying a Locally Fabricated, Reusable Face Shield in a Hospital Responding to the COVID-19 Pandemic.” Med (New York, N.Y.), June 19, 2020. https://doi.org/10.1016/j.medj.2020.06.003.
Naci, Huseyin, and Aaron S. Kesselheim. “Specialty Drugs - A Distinctly American Phenomenon.” The New England Journal of Medicine 382, no. 23 (June 4, 2020): 2179–81. https://doi.org/10.1056/NEJMp1909513.
Nam, Kevin, Kay Larholt, Gigi Hirsch, Paul Beninger, David Fritsche, Diane Shoda, John Ferguson, et al. “Dynamic Dossier in the Cloud: A Sociotechnical Architecture for a Real-Time and Metrics-Based Data Tracking System with Gene and Cell Therapies as a Case Study.” Therapeutic Innovation & Regulatory Science, October 28, 2020. https://doi.org/10.1007/s43441-020-00227-y.
Palmer, Adam C., Deborah Plana, and Peter K. Sorger. “Comparing the Efficacy of Cancer Therapies between Subgroups in Basket Trials.” Cell Systems 11, no. 5 (November 18, 2020): 449-460.e2. https://doi.org/10.1016/j.cels.2020.09.003.
Parmet, Wendy E., and Michael S. Sinha. “Covid-19 - The Law and Limits of Quarantine.” The New England Journal of Medicine 382, no. 15 (April 9, 2020): e28. https://doi.org/10.1056/NEJMp2004211.
Plana, Deborah, Enze Tian, Avilash K. Cramer, Helen Yang, Mary M. Carmack, Michael S. Sinha, Florence T. Bourgeois, et al. “Assessing the Quality of Nontraditional N95 Filtering Face-Piece Respirators Available during the COVID-19 Pandemic.” MedRxiv: The Preprint Server for Health Sciences, July 27, 2020. https://doi.org/10.1101/2020.07.25.20161968.
Rome, Benjamin N., Joshua J. Gagne, Jerry Avorn, and Aaron S. Kesselheim. “Non-Warfarin Oral Anticoagulant Copayments and Adherence in Atrial Fibrillation:A Population-Based Cohort Study.” American Heart Journal, December 21, 2020. https://doi.org/10.1016/j.ahj.2020.12.010.
Rome, Benjamin N., and Aaron S. Kesselheim. “Federal Spending on Off-Patent Drugs That Lack Generic Competition.” Journal of General Internal Medicine, March 6, 2020. https://doi.org/10.1007/s11606-020-05752-y.
Rome, Benjamin N., ChangWon C. Lee, and Aaron S. Kesselheim. “Market Exclusivity Length for Drugs with New Generic or Biosimilar Competition, 2012-2018.” Clinical Pharmacology and Therapeutics, July 12, 2020. https://doi.org/10.1002/cpt.1983.
Rome, Benjamin N., Frazer A. Tessema, and Aaron S. Kesselheim. “US Spending Associated With Transition From Daily to 3-Times-Weekly Glatiramer Acetate.” JAMA Internal Medicine 180, no. 9 (September 1, 2020): 1165–72. https://doi.org/10.1001/jamainternmed.2020.2771.
Sacks, Chana A., Victor L. Van de Wiele, Lisa A. Fulchino, Lajja Patel, Aaron S. Kesselheim, and Ameet Sarpatwari. “Assessment of Variation in State Regulation of Generic Drug and Interchangeable Biologic Substitutions.” JAMA Internal Medicine, August 31, 2020. https://doi.org/10.1001/jamainternmed.2020.3588.
Sarpatwari, Ameet, Jerry Avorn, and Aaron S. Kesselheim. “Accounting for US Public Funding in Drug Development: How Can We Better Balance Access, Affordability, and Innovation?” BMJ (Clinical Research Ed.) 371 (October 8, 2020): m3841. https://doi.org/10.1136/bmj.m3841.
Sarpatwari, Ameet, Dana Brown, and Aaron S. Kesselheim. “Development of a National Public Pharmaceutical Research and Development Institute.” The Journal of Law, Medicine & Ethics: A Journal of the American Society of Law, Medicine & Ethics 48, no. 1 (2020): 225–27. https://doi.org/10.1177/1073110520917023.
Sarpatwari, Ameet, Mengdong He, Frazer A. Tessema, Joshua J. Gagne, and Aaron S. Kesselheim. “Changes in Erythropoiesis Stimulating Agent Use Under a Risk Evaluation and Mitigation Strategy (REMS) Program.” Drug Safety, November 18, 2020. https://doi.org/10.1007/s40264-020-01017-z.
Sarpatwari, Ameet, Anna Kaltenboeck, and Aaron S. Kesselheim. “Missed Opportunities on Emergency Remdesivir Use.” JAMA 324, no. 4 (July 28, 2020): 331–32. https://doi.org/10.1001/jama.2020.11932.
Sinha, Michael S., Florence T. Bourgeois, and Peter K. Sorger. “Personal Protective Equipment for COVID-19: Distributed Fabrication and Additive Manufacturing.” American Journal of Public Health 110, no. 8 (2020): 1162–64. https://doi.org/10.2105/AJPH.2020.305753.
Sinha, Michael S., John C. Messinger, and Leo Beletsky. “Neither Ethical Nor Effective: The False Promise of Involuntary Commitment to Address the Overdose Crisis.” The Journal of Law, Medicine & Ethics: A Journal of the American Society of Law, Medicine & Ethics 48, no. 4 (December 2020): 741–43. https://doi.org/10.1177/1073110520979384.
Sinha, Michael S., John H. Powers Iii, and Aaron S. Kesselheim. “The Wrong Cure: Financial Incentives for Unimpressive New Antibiotics.” The Journal of Infectious Diseases, August 22, 2020. https://doi.org/10.1093/infdis/jiaa536.
Slade, David H., and Michael S. Sinha. “Return to Work during Coronavirus Disease 2019 (COVID-19): Temperature Screening Is No Panacea.” Infection Control and Hospital Epidemiology, September 23, 2020, 1–2. https://doi.org/10.1017/ice.2020.1225.
Spring, Laura M., Geoffrey Fell, Andrea Arfe, Chandni Sharma, Rachel Adams Greenup, Kerry L. Reynolds, Barbara L. Smith, et al. “Pathological Complete Response after Neoadjuvant Chemotherapy and Impact on Breast Cancer Recurrence and Survival: A Comprehensive Meta-Analysis.” Clinical Cancer Research: An Official Journal of the American Association for Cancer Research, February 11, 2020. https://doi.org/10.1158/1078-0432.CCR-19-3492.
Tessema, Frazer A., Aaron S. Kesselheim, and Michael A. Sinha. “Generic but Expensive: Why Prices Can Remain High for off-Patent Drugs.” Hastings Law Journal 71, no. 4 (2020 2019): 1019–52.
Thomas J Bollyky, and Aaron S Kesselheim. “Reputation and Authority: The FDA and the Fight over U.S. Prescription Drug Importation.” Vanderbilt Law Review 73, no. 5 (2020): 1331–1400.
Toce, Michael S., Kenneth Michelson, Joel Hudgins, Michele M. Burns, Michael C. Monuteaux, and Florence T. Bourgeois. “Association of State-Level Opioid-Reduction Policies With Pediatric Opioid Poisoning.” JAMA Pediatrics 174, no. 10 (October 1, 2020): 961–68. https://doi.org/10.1001/jamapediatrics.2020.1980.
Tully, Jeffrey, Andrea Coravos, Megan Doerr, and Christian Dameff. “Connected Medical Technology and Cybersecurity Informed Consent: A New Paradigm.” Journal of Medical Internet Research 22, no. 3 (30 2020): e17612. https://doi.org/10.2196/17612.
Tyan, Kevin, Adriane Levin, Alejandra Avalos-Pacheco, Deborah Plana, Eleanor A. Rand, Helen Yang, Laura E. Maliszewski, et al. “Considerations for the Selection and Use of Disinfectants Against SARS-CoV-2 in a Health Care Setting.” Open Forum Infectious Diseases 7, no. 9 (September 2020): ofaa396. https://doi.org/10.1093/ofid/ofaa396.
Vokinger, Kerstin N., Thomas J. Hwang, Thomas Grischott, Sophie Reichert, Ariadna Tibau, Thomas Rosemann, and Aaron S. Kesselheim. “Prices and Clinical Benefit of Cancer Drugs in the USA and Europe: A Cost-Benefit Analysis.” The Lancet. Oncology 21, no. 5 (2020): 664–70. https://doi.org/10.1016/S1470-2045(20)30139-X.
Vreman, Rick A., Huseyin Naci, Wim G. Goettsch, Aukje K. Mantel-Teeuwisse, Sebastian G. Schneeweiss, Hubert G. M. Leufkens, and Aaron S. Kesselheim. “Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe.” Clinical Pharmacology and Therapeutics 108, no. 2 (August 2020): 350–57. https://doi.org/10.1002/cpt.1835.
Woloshin, Steven, Neeraj Patel, and Aaron S. Kesselheim. “False Negative Tests for SARS-CoV-2 Infection - Challenges and Implications.” The New England Journal of Medicine 383, no. 6 (August 6, 2020): e38. https://doi.org/10.1056/NEJMp2015897.
Zhai, Mike Z., Carolyn T. Lye, and Aaron S. Kesselheim. “Need for Transparency and Reliable Evidence in Emergency Use Authorizations for Coronavirus Disease 2019 (COVID-19) Therapies.” JAMA Internal Medicine 180, no. 9 (September 1, 2020): 1145–46. https://doi.org/10.1001/jamainternmed.2020.2402.
2018-2019 Publications
Angus, Derek C., Brian M. Alexander, Scott Berry, Meredith Buxton, Roger Lewis, Melissa Paoloni, Steven A. R. Webb, et al. “Adaptive Platform Trials: Definition, Design, Conduct and Reporting Considerations.” Nature Reviews Drug Discovery, August 28, 2019. https://doi.org/10.1038/s41573-019-0034-3.
Bakker, Jessie P., Jennifer C. Goldsack, Michael Clarke, Andrea Coravos, Cynthia Geoghegan, Alan Godfrey, Matthew G. Heasley, et al. “A Systematic Review of Feasibility Studies Promoting the Use of Mobile Technologies in Clinical Research.” Npj Digital Medicine 2, no. 1 (December 2019). https://doi.org/10.1038/s41746-019-0125-x.
Beall, Reed F., Jonathan J. Darrow, and Aaron S. Kesselheim. “Approximating Future Generic Entry for New Drugs.” The Journal of Law, Medicine & Ethics: A Journal of the American Society of Law, Medicine & Ethics 47, no. 1 (March 2019): 177–82. https://doi.org/10.1177/1073110519840499.
Beall, Reed F., Thomas J. Hwang, and Aaron S. Kesselheim. “Major Events in the Life Course of New Drugs, 2000-2016.” The New England Journal of Medicine 380, no. 11 (March 14, 2019): e12. https://doi.org/10.1056/NEJMp1806930.
Beall, Reed F., Thomas J. Hwang and Aaron S. Kesselheim. “Pre-Market Development Times for Biologic versus Small-Molecule Drugs.” Nature Biotechnology 37, no. 7 (July 2019): 708–11. https://doi.org/10.1038/s41587-019-0175-2.
Beall, Reed F., Aaron S. Kesselheim, and Ameet Sarpatwari. “New Drug Formulations and Their Respective Generic Entry Dates.” Journal of Managed Care & Specialty Pharmacy 25, no. 2 (February 2019): 218–24. https://doi.org/10.18553/jmcp.2019.25.2.218.
Bourgeois, Florence T., Dionne A. Graham, Aaron S. Kesselheim, and Adrienne G. Randolph. “Cost Implications of Escalating Intravenous Acetaminophen Use in Children.” JAMA Pediatrics, March 11, 2019. https://doi.org/10.1001/jamapediatrics.2019.0101.
Bourgeois, Florence T., and Aaron S. Kesselheim. “Promoting Pediatric Drug Research and Labeling - Outcomes of Legislation.” The New England Journal of Medicine 381, no. 9 (29 2019): 875–81. https://doi.org/10.1056/NEJMhle1901265.
Coravos, Andrea, Jennifer C. Goldsack, Daniel R. Karlin, Camille Nebeker, Eric Perakslis, Noah Zimmerman, and M. Kelley Erb. “Digital Medicine: A Primer on Measurement.” Digital Biomarkers 3, no. 2 (May 9, 2019): 31–71. https://doi.org/10.1159/000500413.
Coravos, Andrea, Sean Khozin, and Kenneth D. Mandl. “Developing and Adopting Safe and Effective Digital Biomarkers to Improve Patient Outcomes.” Npj Digital Medicine 2, no. 1 (March 11, 2019): 14. https://doi.org/10.1038/s41746-019-0090-4.
D’Andrea, Elvira, Spencer P. Hey, Cherie L. Ramirez, and Aaron S. Kesselheim. “Assessment of the Role of Niacin in Managing Cardiovascular Disease Outcomes: A Systematic Review and Meta-Analysis.” JAMA Network Open 2, no. 4 (April 5, 2019): e192224. https://doi.org/10.1001/jamanetworkopen.2019.2224.
Darrow, Jonathan J., Reed F. Beall, and Aaron S. Kesselheim. “The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents.” Applied Health Economics and Health Policy 17, no. 1 (February 2019): 47–54. https://doi.org/10.1007/s40258-018-0420-8.
Dave, Chintan V., Gregory Brill, and Aaron S. Kesselheim. “Changes in Price for Generic Drugs in the USA, 2008-2016.” Journal of General Internal Medicine 34, no. 9 (September 2019): 1677–79. https://doi.org/10.1007/s11606-019-05033-3.
Desai, Rishi J., Ameet Sarpatwari, Sara Dejene, Nazleen F. Khan, Joyce Lii, James R. Rogers, Sarah K. Dutcher, et al. “Comparative Effectiveness of Generic and Brand-Name Medication Use: A Database Study of US Health Insurance Claims.” PLoS Medicine 16, no. 3 (March 2019): e1002763. https://doi.org/10.1371/journal.pmed.1002763.
Feldman, William B., Spencer P. Hey, Jessica M. Franklin, and Aaron S. Kesselheim. “Public Approval of Exception From Informed Consent in Emergency Clinical Trials.” JAMA Network Open 2, no. 7 (July 24, 2019). https://doi.org/10.1001/jamanetworkopen.2019.7591.
Fischer, Michael A., Aaron S. Kesselheim, Zhigang Lu, Kathryn M. Ross, Frazer A. Tessema, and Jerry Avorn. “Physician Perceptions of Step Therapy Prescribing Requirements.” Journal of Managed Care & Specialty Pharmacy 25, no. 11 (November 2019): 1210–24. https://doi.org/10.18553/jmcp.2019.25.11.1210.
Fralick, Michael, Sebastian Schneeweiss, Christopher J. D. Wallis, Emily H. Jung, and Aaron S. Kesselheim. “Desmopressin and the Risk of Hyponatremia: A Population-Based Cohort Study.” PLoS Medicine 16, no. 10 (October 2019): e1002930. https://doi.org/10.1371/journal.pmed.1002930.
Gordon, William J., and Ariel D. Stern. “Challenges and Opportunities in Software-Driven Medical Devices.” Nature Biomedical Engineering 3, no. 7 (July 2019): 493–97. https://doi.org/10.1038/s41551-019-0426-z.
Growdon, Matthew E., Chana A. Sacks, Aaron S. Kesselheim, and Jerry Avorn. “Potential Medicare Savings From Generic Substitution and Therapeutic Interchange of ACE Inhibitors and Angiotensin-II-Receptor Blockers.” JAMA Internal Medicine, August 5, 2019. https://doi.org/10.1001/jamainternmed.2019.3107.
Gyawali, Bishal, Gauthier Bouche, Pan Pantziarka, Aaron S. Kesselheim, and Ameet Sarpatwari. “Lung Cancer Survival Gains: Contributions of Academia and Industry.” The Journal of Law, Medicine & Ethics: A Journal of the American Society of Law, Medicine & Ethics 47, no. 3 (September 2019): 465–67. https://doi.org/10.1177/1073110519876182.
Gyawali, Bishal, Spencer Phillips Hey, and Aaron S. Kesselheim. “Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval.” JAMA Internal Medicine 179, no. 7 (July 1, 2019): 906–13. https://doi.org/10.1001/jamainternmed.2019.0462.
Gyawali, Bishal, and Aaron S. Kesselheim. “The Promise of ESCAT: A New System for Evaluating Cancer Drug-Target Pairs.” Nature Reviews. Clinical Oncology 16, no. 3 (March 2019): 147–48. https://doi.org/10.1038/s41571-018-0110-3.
Gyawali, Bishal, and Aaron S. Kesselheim. “US Food and Drug Administration Approval of New Drugs Based on Noninferiority Trials in Oncology: A Dangerous Precedent?” JAMA Oncology, March 28, 2019. https://doi.org/10.1001/jamaoncol.2019.0093.
Gyawali, Bishal, Frazer A. Tessema, Emily H. Jung, and Aaron S. Kesselheim. “Assessing the Justification, Funding, Success, and Survival Outcomes of Randomized Noninferiority Trials of Cancer Drugs: A Systematic Review and Pooled Analysis.” JAMA Network Open 2, no. 8 (August 2, 2019): e199570–e199570. https://doi.org/10.1001/jamanetworkopen.2019.9570.
Hey, Spencer Phillips, Elvira D’Andrea, Emily H. Jung, Frazer Tessema, Jing Luo, Bishal Gyawali, and Aaron S. Kesselheim. “Challenges and Opportunities for Biomarker Validation.” The Journal of Law, Medicine & Ethics: A Journal of the American Society of Law, Medicine & Ethics 47, no. 3 (September 2019): 357–61. https://doi.org/10.1177/1073110519876162.
Hey, Spencer Phillips, William B. Feldman, Emily H. Jung, Elvira D’Andrea, and Aaron S. Kesselheim. “Surrogate Endpoints and Drug Regulation: What Is Needed to Clarify the Evidence.” The Journal of Law, Medicine & Ethics: A Journal of the American Society of Law, Medicine & Ethics 47, no. 3 (September 2019): 381–87. https://doi.org/10.1177/1073110519876167.
Hong, Phebe, Ameet Sarpatwari, and Aaron S. Kesselheim. “Orphan Drug Designation and Exclusivity for ‘Same Drugs.’” The Journal of Law, Medicine & Ethics: A Journal of the American Society of Law, Medicine & Ethics 47, no. 2 (June 2019): 347–49. https://doi.org/10.1177/1073110519857293.
Hudgins, Joel D., John J. Porter, Michael C. Monuteaux, and Florence T. Bourgeois. “Trends in Opioid Prescribing for Adolescents and Young Adults in Ambulatory Care Settings.” Pediatrics 143, no. 6 (2019). https://doi.org/10.1542/peds.2018-1578.
Hwang, Thomas J., Aaron S. Kesselheim, and Kerstin N. Vokinger. “Lifecycle Regulation of Artificial Intelligence- and Machine Learning-Based Software Devices in Medicine.” JAMA, November 22, 2019. https://doi.org/10.1001/jama.2019.16842.
Hwang, Thomas J., Michael S. Sinha, Chintan V. Dave, and Aaron S. Kesselheim. “Prescription Opioid Epidemic and Trends in the Clinical Development of New Pain Medications.” Mayo Clinic Proceedings 94, no. 12 (2019): 2437–43. https://doi.org/10.1016/j.mayocp.2019.05.015
Hwang, Thomas J., Florence T. Bourgeois, Jessica M. Franklin, and Aaron S. Kesselheim. “Impact Of The Priority Review Voucher Program On Drug Development For Rare Pediatric Diseases.” Health Affairs (Project Hope) 38, no. 2 (February 2019): 313–19. https://doi.org/10.1377/hlthaff.2018.05330.
Hwang, Thomas J., Nina Jain, Julie C. Lauffenburger, Kerstin N. Vokinger, and Aaron S. Kesselheim. “Analysis of Proposed Medicare Part B to Part D Shift With Associated Changes in Total Spending and Patient Cost-Sharing for Prescription Drugs.” JAMA Internal Medicine, January 14, 2019. https://doi.org/10.1001/jamainternmed.2018.6417.
Jiao, Kuo, Ravi Gupta, Erin Fox, Aaron Kesselheim, and Joseph S. Ross. “Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration.” JAMA Network Open 2, no. 10 (October 2, 2019): e1913029. https://doi.org/10.1001/jamanetworkopen.2019.13029.
Jung, Emily H., Ameet Sarpatwari, Aaron S. Kesselheim, and Michael S. Sinha. “FDA and EMA Biosimilar Approvals.” Journal of General Internal Medicine, October 21, 2019. https://doi.org/10.1007/s11606-019-05408-6.
Kaplan, Aaron V., and Ariel D. Stern. “The Central and Unacknowledged Role of the US Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials.” JAMA Cardiology 3, no. 1 (January 1, 2018): 5–6. https://doi.org/10.1001/jamacardio.2017.4038.
Kesselheim, Aaron S., Steven Woloshin, Zhigang Lu, Frazer A. Tessema, Kathryn M. Ross, and Lisa M. Schwartz. “Physicians’ Perspectives on FDA Approval Standards and Off-Label Drug Marketing.” JAMA Internal Medicine, January 22, 2019. https://doi.org/10.1001/jamainternmed.2018.8121.
Kesselheim, Aaron S., Michael S. Sinha, Eric G. Campbell, Sebastian Schneeweiss, Paula Rausch, Brian M. Lappin, Esther H. Zhou, Jerry Avorn, and Gerald J. Dal Pan. “Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem.” Drug Safety, July 13, 2019. https://doi.org/10.1007/s40264-019-00849-8.
Kesselheim, Aaron S., Michael S. Sinha, Paula Rausch, Zhigang Lu, Frazer A. Tessema, Brian M. Lappin, Esther H. Zhou, et al. “Patients’ Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey.” The Journal of Law, Medicine & Ethics: A Journal of the American Society of Law, Medicine & Ethics 47, no. 3 (September 2019): 430–41. https://doi.org/10.1177/1073110519876176.
Khozin, Sean, and Andrea Coravos. “Decentralized Trials in the Age of Real-World Evidence and Inclusivity in Clinical Investigations.” Clinical Pharmacology and Therapeutics, April 23, 2019. https://doi.org/10.1002/cpt.1441.
Lee, Theodore T., Daniel H. Solomon, and Aaron S. Kesselheim. “Fool Me Twice? The Reemergence of Rofecoxib and the Orphan Drug Act.” Annals of Internal Medicine, October 1, 2019. https://doi.org/10.7326/M19-1218.
Li, David G., Mehdi Najafzadeh, Aaron S. Kesselheim, and Arash Mostaghimi. “Spending on World Health Organization Essential Medicines in Medicare Part D, 2011-15: Retrospective Cost Analysis.” BMJ (Clinical Research Ed.) 366 (17 2019): l4257. https://doi.org/10.1136/bmj.l4257.
Liu, Sheng, and Aaron S. Kesselheim. “Experiences With and Challenges Afforded by Expedited Regulatory Pathways.” Clinical Pharmacology & Therapeutics 105, no. 4 (2019): 795–97. https://doi.org/10.1002/cpt.1365.
Luo, Jing, Nazleen F. Khan, Thomas Manetti, Jim Rose, Ani Kaloghlian, Balu Gadhe, Sachin H. Jain, Joshua J. Gagne, and Aaron S. Kesselheim. “Implementation of a Health Plan Program for Switching From Analogue to Human Insulin and Glycemic Control Among Medicare Beneficiaries With Type 2 Diabetes.” JAMA 321, no. 4 (29 2019): 374–84. https://doi.org/10.1001/jama.2018.21364.
Luo, Jing, Martin Kulldorff, Ameet Sarpatwari, Ajinkya Pawar, and Aaron S. Kesselheim. “Variation in Prescription Drug Prices by Retail Pharmacy Type: A National Cross-Sectional Study.” Annals of Internal Medicine, October 1, 2019. https://doi.org/10.7326/M18-1138.
Monteleone, Peter P., Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry, and Mark J. Pirwitz. “The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System.” The Journal of Invasive Cardiology, October 15, 2019.
Nayak, Rahul K, Jerry Avorn, and Aaron S Kesselheim. “Public Sector Financial Support for Late Stage Discovery of New Drugs in the United States: Cohort Study.” BMJ, October 23, 2019, l5766. https://doi.org/10.1136/bmj.l5766.
Palmer, Adam C., and Peter K. Sorger. “Combination Cancer Therapy Can Confer Benefit via Patient-to-Patient Variability without Drug Additivity or Synergy.” Cell 171, no. 7 (December 14, 2017): 1678-1691.e13. https://doi.org/10.1016/j.cell.2017.11.009.
Perakslis, Eric, and Andrea Coravos. “Is Health-Care Data the New Blood?” The Lancet Digital Health 1, no. 1 (May 1, 2019): PE8-E9. https://doi.org/10.1016/S2589-7500(19)30001-9.
Rees, Chris A., Natalie Pica, Michael C. Monuteaux, and Florence T. Bourgeois. “Noncompletion and Nonpublication of Trials Studying Rare Diseases: A Cross-Sectional Analysis.” PLoS Medicine 16, no. 11 (November 2019): e1002966. https://doi.org/10.1371/journal.pmed.1002966.
Rogers, James R., Ameet Sarpatwari, Rishi J. Desai, Justin M. Bohn, Nazleen F. Khan, Aaron S. Kesselheim, Michael A. Fischer, Joshua J. Gagne, and John G. Connolly. “Effect of Lawyer-Submitted Reports on Signals of Disproportional Reporting in the Food and Drug Administration’s Adverse Event Reporting System.” Drug Safety 42, no. 1 (January 2019): 85–93. https://doi.org/10.1007/s40264-018-0703-x.
Rome, Benjamin N., and Aaron S. Kesselheim. “Transferrable Market Exclusivity Extensions to Promote Antibiotic Development: An Economic Analysis.” Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America, October 20, 2019. https://doi.org/10.1093/cid/ciz1039.
Sanders, Samantha F, Terwiesch, Mats, Gordon, William J, and Stern, Ariel S. “How Artificial Intelligence Is Changing Health Care Delivery.” NEJM Catalyst, October 17, 2019. https://catalyst.nejm.org/health-care-ai-systems-changing-delivery/.
Sarpatwari, Ameet, Rachel Barenie, Gregory Curfman, Jonathan J. Darrow, and Aaron S. Kesselheim. “The US Biosimilar Market: Stunted Growth and Possible Reforms.” Clinical Pharmacology and Therapeutics 105, no. 1 (January 2019): 92–100. https://doi.org/10.1002/cpt.1285.
Sarpatwari, Ameet, Jonathan DiBello, Marie Zakarian, Mehdi Najafzadeh, and Aaron S. Kesselheim. “Competition and Price among Brand-Name Drugs in the Same Class: A Systematic Review of the Evidence.” PLoS Medicine 16, no. 7 (July 2019): e1002872. https://doi.org/10.1371/journal.pmed.1002872.
Sarpatwari, Ameet, Joshua J. Gagne, Zhigang Lu, Eric G. Campbell, Wendy J. Carman, Cheryl L. Enger, Sarah K. Dutcher, Wenlei Jiang, and Aaron S. Kesselheim. “A Survey of Patients’ Perceptions of Pill Appearance and Responses to Changes in Appearance for Four Chronic Disease Medications.” Journal of General Internal Medicine 34, no. 3 (March 2019): 420–28. https://doi.org/10.1007/s11606-018-4791-1.
Sarpatwari, Ameet, and Aaron S. Kesselheim. “Reforming the Orphan Drug Act for the 21st Century.” The New England Journal of Medicine 381, no. 2 (July 11, 2019): 106–8. https://doi.org/10.1056/NEJMp1902943.
Sarpatwari, Ameet, and Aaron S. Kesselheim. “Tepid Steps on Drug Pricing.” JAMA Internal Medicine, January 22, 2019. https://doi.org/10.1001/jamainternmed.2018.6593.
Stern, Ariel D., Brian M. Alexander, and Amitabh Chandra. “Innovation Incentives and Biomarkers.” Clinical Pharmacology and Therapeutics 103, no. 1 (January 2018): 34–36. https://doi.org/10.1002/cpt.876.
Stern, Ariel Dora. “Managing the Use and Dissemination of Information about Biomarkers: The Importance of Incentive Structures.” The Journal of Law, Medicine & Ethics: A Journal of the American Society of Law, Medicine & Ethics 47, no. 3 (September 2019): 396–97. https://doi.org/10.1177/1073110519876171.
Stern, Ariel Dora, William J Gordon, Adam B Landman, and Daniel B Kramer. “Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries.” BMJ Open 9, no. 6 (June 2019): e025374. https://doi.org/10.1136/bmjopen-2018-025374.
Stern, Ariel Dora, and W Nicholson Price. “Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning.” Biostatistics, November 19, 2019. https://doi.org/10.1093/biostatistics/kxz044.
Vokinger, Kerstin Noëlle, and Aaron S. Kesselheim. “Application of Orphan Drug Designation to Cancer Treatments (2008-2017): A Comprehensive and Comparative Analysis of the USA and EU.” BMJ Open 9, no. 10 (October 10, 2019): e028634. https://doi.org/10.1136/bmjopen-2018-028634.
Vokinger, Kerstin Noëlle, and Aaron S. Kesselheim. “Characteristics of Trials and Regulatory Pathways Leading to US Approval of Innovative vs. Non-Innovative Oncology Drugs.” Health Policy (Amsterdam, Netherlands) 123, no. 8 (August 2019): 721–27. https://doi.org/10.1016/j.healthpol.2019.06.002.
Woods, Beau, Andrea Coravos, and Joshua David Corman. “The Case for a Hippocratic Oath for Connected Medical Devices: Viewpoint.” Journal of Medical Internet Research 21, no. 3 (March 19, 2019): e12568. https://doi.org/10.2196/12568.