Cancer
Moyer H, Bittlinger M, Nelson A, Fernandez L, Sheng J, Wang Y, Del Paggio JC, Kimmelman J. Bypassing phase 2 in cancer drug development erodes the risk/benefit balance in phase 3 trials. Journal of Clinical Epidemiology. 2023 Apr 5.
Ouimet C, Bouche G, Kimmelman J. Diminishing clinical impact for post-approval cancer clinical trials: A retrospective cohort study. Plos one. 2022 Sep 12.
Hutchinson N, Moyer H, Zarin DA, Kimmelman J. The proportion of randomized controlled trials that inform clinical practice. eLife. 2022 Aug 17.
Kane PB, Kimmelman J. Science Forum: Is preclinical research in cancer biology reproducible enough?. Elife. 2021 Dec 7;10:e67527.
Bittlinger M, Bicer S, Peppercorn J, Kimmelman J. Ethical Considerations for Phase I Trials in Oncology. Journal of Clinical Oncology. 2022 Mar 11.
Benjamin DM, Hey SP, MacPherson A, Hachem Y, Smith KS, Zhang SX, Wong S, Dolter S, Mandel DR, Kimmelman J. Principal investigators over-optimistically forecast scientific and operational outcomes for clinical trials. PLoS ONE. 2022.
Oliviero E, Kourkopoulos G, Kimmelman J. Success rates for US and Canadian anticancer drug development efforts in pediatric oncology. Pediatric Blood & Cancer. 2022.
Hutchinson N, Carlisle B, Doussau A, Bosan R, Gumnit E, MacPherson A, Fergusson DA, Kimmelman J. Patient Participation in Clinical Trials of Oncology Drugs and Biologics Preceding Approval by the US Food and Drug Administration. JAMA network open. 2021.
Yu M, Montroy J, Fergusson D, Lalu M, Kimmelman J. Systematic and narrative review lead experts to different cancer trial predictions: a randomized trial. Journal of Clinical Epidemiology. 2020.
Benjamin D, Mandel DR, Barnes T, Krzyzanowska M, Leighl N, Tannock I, Kimmelman J. Can Oncologists Predict the Efficacy of Treatments in Randomized Trials?. The Oncologist. 2020.
Zhang SX, Fergusson D, Kimmelman J. Proportion of Patients in Phase 1 Oncology Trials Receiving Treatments that are Ultimately Approved. Journal of the National Cancer Institute, 2020.
Carlisle BG, Doussau A, Kimmelman J. Patient burden and clinical advances associated with postapproval monotherapy cancer drug trials: a retrospective cohort study. BMJ Open, 2020.
Hutchinson N, Vinarov E, Iasonos A, Kimmelman J. Ethical and Policy Issues for Seamless Phase I Oncology Trials. Journal of Clinical Oncology, 2019.
Sarvas H, Carlisle B, Dolter S, Vinarov E, Kimmelman J. Impact of Precision Medicine on Efficiencies of Novel Drug Development in Cancer. Journal of the National Cancer Institute, 2019.
Carlisle BG, Zheng T, Kimmelman J. Imatinib and the long tail of targeted drug development. Nature Reviews Clinical Oncology, 2019.
Doussau A, Vinarov E, Barsanti-Innes B, Kimmelman J. Comparison between protocols and publications for prognostic and predictive cancer biomarker studies. Clinical Trials,2019.
Carlisle BG, Doussau A, Kimmelman J. Benefit, burden, and impact for a cohort of post-approval cancer combination trials. Clinical Trials, 2019.
Kimmelman J. Phase I trials as therapeutic options: (usually) a betrayal of evidence-based medicine. Nature Reviews Clinical Oncology, 2019.
Pratte M, Ganeshamoorthy S, Carlisle B, Kimmelman J. How well are Phase 2 cancer trial publications supported by preclinical efficacy evidence? International Journal of Cancer, 2019.
Kimmelman J, Waligora M, Lynch HF. Participant Protection in Phase 1 Pediatric Cancer Trials. JAMA Pediatrics, 2018.
Kimmelman J and Tannock I. The paradox of precision medicine. Nature Reviews Clinical Oncology, 2018.
Waligora M, Bala MM, Koperny M, Wasylewski MT, Strzebonska K, Jaeschke RR, Wozniak A, Piasecki J, Agnieszka Sliwka, Mitus JM, Polak M, Nowis D, Fergusson D, Kimmelman J. Risk and surrogate benefit for pediatric Phase I trials in oncology: A systematic review with meta-analysis. PLOS Medicine, 2018.
Kimmelman J, Carlisle B, Gönen M. Drug Development at the Portfolio Level Is Important for Policy, Care Decisions and Human Protections. JAMA, 2017.
Kimmelman J, Resnik DB, Peppercorn J, Ratain MJ. Burdensome Research Procedures in Trials: Why Less is More. Journal of the National Cancer Institute, 2017.
Mattina J, Carlisle B, Hachem Y, Fergusson D, Kimmelman J. Inefficiencies and Patient Burdens in the Development of the Targeted Cancer Drug Sorafenib: A Systematic Review. PLOS Biology, 2017.
Barsanti-Innes B, Hey SP, Kimmelman J. The Challenges of Validating in Precision Medicine: The Case of Excision Repair Cross-Complement Group 1 Diagnostic TestingThe Oncologist, 2016.
Kimmelman J. Is Participation in Cancer Phase I Trials Really Therapeutic? Journal of Clinical Oncology, 2016.
Carlisle B, Demko N, Freeman G, Hakala A, MacKinnon N, Ramsay T, Hey SP, London AJ, Kimmelman J. Benefit, Risk, and Outcomes in Drug Development: A Systematic Review of Sunitinib Journal of the National Cancer Institute, 2015.
Hey SP and Kimmelman, J. Are Outcome-Adaptive Allocation Trials Ethical? Clinical Trials, 2015.
Abadie R, Kimmelman J, Lafleur J, Lemmens T. Consent for Nondiagnostic Research Biopsies: A Pilot Study of Participant Recall and Therapeutic Orientation. IRB, 2014.
Freeman GA, Kimmelman J, Dancey J, Monzon JG. Reporting practices of pharmacodynamic studies involving invasive research procedures in cancer trials. British Journal of Cancer, 2013.
Freeman GA, Kimmelman J. Publication and Reporting Conduct for Pharmacodynamic Analyses of Tumor Tissue in Early Phase Oncology Trials. Clinical Cancer Research, 2012.
Kimmelman J, Nalbantoglu J. Faithful Companions: A Proposal for Neurooncology in Pet Dogs. Cancer Research, 2007.
Neurological Diseases
MacPherson A, Gumnit E, Ouimet C, Hutchinson N, Kieburtz K, Pearson TS, Kimmelman J. Quantifying Patient Investment in Novel Neurological Drug Development.Neurotherapeutics. 2022 Jun 28.
Kane PB, Benjamin DM, Barker RA, Lang AE, Sherer T, Kimmelman J. Comparison of Patient and Expert Perceptions of the Attainment of Research Milestones in Parkinson’s Disease. Movement Disorders. 2020.
Atanasov P, Diamantaras A, MacPherson A, Vinarov E, Benjamin DM, Shrier I, Paul F, Dirnagl U, Kimmelman J. Wisdom of the expert crowd prediction of response for 3 neurology randomized trials. Neurology, 2020.
Kane PB, Benjamin DM, Barker RA, Lang AE, Sherer T, & Kimmelman J. Forecasts for the Attainment of Major Research Milestones in Parkinson’s Disease. Journal of Parkinson’s Disease, 2020.
Feustel AC, MacPherson A, Fergusson DA, Kieburtz K, Kimmelman J. Risks and benefits of unapproved, disease-modifying treatments for neurodegenerative disease. Neurology, 2019.
Kimmelman J. Better to be in The Placebo Arm for Trials of Neurological Therapies?. Cell Transplantation, 2018.
Hakala A, Fergusson D, Kimmelman J. Nonpublication of trial results for new neurological drugs: A systematic review. Annals of Neurology, 2017.
Hey SP, Kimmelman J. The Risk-Escalation Model: A Principled Design Strategy for Early-Phase Trials. Kennedy Institute of Ethics Journal, 2014.
Hey SP & Kimmelman J. The Questionable Use of Unequal Allocation in Confirmatory Trials. Neurology, 2014.
Kimmelman J. Biologics, Ethics and the Human Brain. In: Neuroethics in Practice. Farah M, Chatterjee A, eds. New York: Oxford University Press, 2012.
Kimmelman J, Duckworth K, Ramsay T, Voss T, Ravina B, Emborg ME. Risk of Surgical Delivery to the Basal Ganglia: A Meta-analysis. Movement Disorders, 2011.
Kimmelman J, London AJ, Ravina B, Ramsay T, Bernstein M, Stahnnisch FW, Emborg ME. Launching Invasive, First-in-Human Trials Against Parkinson’s Disease: Ethical Considerations. Movement Disorders, 2009.
Kimmelman J. Ethics in Clinical Trials Involving the Central Nervous System: Risk, Benefit, Justice, and Integrity. In: Clinical Trials in Neurology: From Idea to Implementation. Ravina B, Shoulson I, eds. New York: Cambridge University Press. Pp 173-86.