Preclinical Research
Kimmelman J, Bodilly Kane P, Bicer S, Carlisle BG. Preclinical Assessment for Translation to Humans (PATH): An Ap- proach for Assessing Supporting Evidence for Early Phase Trials and Innovative Care Med. 2024 Oct 11.
Sheng J, Feldhake E, Zarin DA, Kimmelman J. Completeness of clinical evidence citation in trial protocols: A cross-sectional analysis. Med. 2022 Apr 8.
Federico C, Mogil JS, Ramsay T, Fergusson DA, Kimmelman J. A systematic review and meta-analysis of pregabalin preclinical studies. Pain, 2020.
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.
Wieschowski S, Chin W, Federico C, Sievers S, Kimmelman J, Strech D. Preclinical efficacy studies in investigator brochures: Do they enable risk–benefit assessment?PLOS Biology, 2018.
Benjamin D, Mandel DR, Kimmelman J. Can cancer researchers accurately judge whether preclinical reports will reproduce? PLOS Biology, 2017.
Neumann K, Grittner U, Piper S, Rex A, Florez-Vargas O, Karystianis G, Schneider A, Wellwood I, Siegerink B, Ioannidis J, Kimmelman J, Dirnagl U. Increasing efficiency of preclinical research by group sequential designs. PLOS Biology, 2017.
Mattina J, MacKinnon N, Henderson VC, Fergusson D, Kimmelman J. Design and Reporting of Targeted Anti-Cancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy. Cancer Research, 2016.
Kimmelman J and Henderson VC. Assessing risk/benefit for trials using preclinical evidence: a proposal. Journal of Medical Ethics, 2015.
Henderson VC, Demko N, Hakala A, MacKinnon N, Federico C, Fergusson D, Kimmelman J. A meta-analysis of threats to valid clinical inference in preclinical research of sunitinib. eLife, 2015. Henderson et al 2015 Sunitinib Supplemental Raw Data
Federico C, Carlisle B, Kimmelman J, Fergusson D. Late, Never, or Nonexistent: The Inaccessibility of Preclinical Evidence for New Drugs. British Journal of Pharmacology,2014.
Henderson VC, Kimmelman J, Fergusson D, Grimshaw JM, Hackam DG. Threats to Validity in the Design and Conduct of Preclinical Efficacy Studies: A Systematic Review of Guidelines for In Vivo Animal Experiments. PLOS Medicine, 2013.
Kimmelman J, Anderson JA. Should Preclinical Studies be Registered? Nature Biotechnology, 2012.
Kimmelman J, Nalbantoglu J. Faithful Companions: A Proposal for Neurooncology in Pet Dogs. Cancer Research, 2007.
Kimmelman J, Mogil JS, Dirnagl U. Distinguishing between Exploratory and Confirmatory Preclinical Research Will Improve Translation. PLOS Biology, 2014.
Early Phase Trials
Carlisle B, Federico C, Kimmelman J. Trials that say “maybe”: the disconnect between exploratory and confirmatory testing after drug approval, The BMJ, 2018.
Kimmelman J and Federico C. Consider drug efficacy before first-in-human trials.Nature, 2017.
Grankvist H and Kimmelman J. How do researchers decide early clinical trials? Medicine, Health Care and Philosophy, 2016.
Hey SP and Kimmelman J. Are Outcome-Adaptive Allocation Trials Ethical? Clinical Trials, 2015.
Hey SP and Kimmelman J. The Risk-Escalation Model: A Principled Design Strategy for Early-Phase Trials. Kennedy Institute of Ethics Journal, 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.
Hey SP and Kimmelman J. Ethics, Error, and Initial Trials of Efficacy. Science Translational Medicine, 2013.
Anderson JA and Kimmelman J. Are Phase 1 Trials Therapeutic? Risk, Ethics, and Division of Labor. Bioethics, 2012.
Kimmelman J. A Theoretical Framework for Early Human Studies: Uncertainty, Intervention Ensembles, and Boundaries. Trials, 2012.
Anderson JA and Kimmelman J. Extending Clinical Equipoise to Phase 1 Trials Involving Patients: Unresolved Problems. Kennedy Institute of Ethics Journal, 2010.
London AJ and Kimmelman J. Emborg ME. Beyond Access vs. Protection in Trials of Innovative Therapies. Science, 2010.
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 at Phase 0: Clarifying the Issues. Journal of Law, Medicine, and Ethics, 2007.
Kimmelman J. Stable Ethics: Enrolling Non-Treatment Refractory Volunteers in Novel Gene Transfer Trials. Molecular Therapy, 2007.
Late Phase Trials
Hey SP & Kimmelman J. The Questionable Use of Unequal Allocation in Confirmatory Trials. Neurology, 2014.
London AJ, Kimmelman J, Carlisle B. Rethinking Research Ethics: The Case of Postmarketing Trials. Science, 2012.
Kimmelman J. The Social Function of Clinical Equipoise. Clinical Trials, 2012.