Publications

by

Cancer

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 Testing The 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 DogsCancer Research, 2007.


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 TrialsKennedy 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 LaborBioethics, 2012.

Kimmelman J. A Theoretical Framework for Early Human Studies: Uncertainty, Intervention Ensembles, and BoundariesTrials, 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 ConsiderationsMovement Disorders, 2009.

Kimmelman J. Ethics at Phase 0: Clarifying the IssuesJournal of Law, Medicine, and Ethics, 2007.

Kimmelman J. Stable Ethics: Enrolling Non-Treatment Refractory Volunteers in Novel Gene Transfer TrialsMolecular Therapy, 2007.


Forecasting and Prediction

Benjamin D, Mandel DR, Kimmelman J. Can cancer researchers accurately judge whether preclinical reports will reproduce? PLOS Biology, 2017.

Benjamin D and Kimmelman J. The Research Optimist’s Defense, Perspectives in Biology and Medicine, 2016.

Hey S and Kimmelman J. Do We Know Whether Researchers and Reviewers are Estimating Risk and Benefit Accurately? Bioethics, 2016.


Foundations of Research Ethics

London AJ, Kimmelman J, Carlisle B.  Rethinking Research Ethics: The Case of Postmarketing TrialsScience, 2012.

London AJ, Kimmelman J, Emborg ME. Beyond Access vs. Protection in Trials of Innovative Therapies. Science, 2010.


Gene and Cell-Based Interventions

Hey SP and Kimmelman J. The Risk-Escalation Model: A Principled Design Strategy for Early-Phase TrialsKennedy Institute of Ethics Journal, 2014.

Anderson JA and Kimmelman J.  Ethics and Uncertainty: Considerations for the Design and Review of Translational Trials Involving Stem Cells.  In:  Translational Stem Cell Research: Issues Beyond the Debate on the Moral Status of the Embryo. Hug K, Hermerén G, eds.  New York: Springer, 2010.

Kimmelman J. Gene Transfer and the Ethics of First-in-Human Experiments: Lost in Translation. New York: Cambridge University Press, 2009.

Kimmelman J. Ethics of Cancer Gene Transfer Clinical Research.  In W. Walther, U. Stein, eds.  Gene Therapy of Cancer.  Humana Press: Totowa, NJ, 2008.

Kimmelman J. The Ethics of Human Gene TransferNature Reviews—Genetics, 2008.

Kimmelman J. Staunch protections: the ethics of haemophilia gene transfer researchHaemophilia, 2007.

Kimmelman J. Recent developments in gene transfer: risk and ethicsBMJ, 2005.


Informed Consent

Abadie R, Kimmelman J, Lafleur J, Lemmens T. Consent for Nondiagnostic Research Biopsies: A Pilot Study of Participant Recall and Therapeutic Orientation. IRB, 2014.

Braude H and Kimmelman J. The Ethics of Managing Affective and Emotional States to Improve Informed Consent: Autonomy, Comprehension, and Voluntariness. Bioethics, 2012.

Kimmelman J, Lemmens T, Kim SY. Analysis of Consent Validity for Invasive, Nondiagnostic Research Procedures. IRB, 2012

Kimmelman J. The Therapeutic Misconception at 25: Treatment, Research, and Confusion. Hastings Center Report, 2007.


International Research

London AJ and Kimmelman J. Justice in Translation: From Bench to Bedside in the Developing WorldLancet, 2008.

Kimmelman, J. Clinical Trials and SCID Row: The Ethics of Phase 1 Trials in the Developing WorldDeveloping World Bioethics, 2007.


Knowledge, Reporting and Uptake

Hakala A, Fergusson D, Kimmelman J. Nonpublication of trial results for new neurological drugs: A systematic review. Annals of Neurology, 2017.

Hakala A, Fergusson D, Carlisle B, Kimmelman J.  Accessibility of Trial Reports for Drugs Stalling in Clinical DevelopmentThe BMJ, 2015.

Hey SP. Ethics and Epistemology of Accurate Prediction in Clinical Research. Journal of Medical Ethics, 2015.

Hey SP, Kimmelman J. The Risk-Escalation Model: A Principled Design Strategy for Early-Phase TrialsKennedy 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.

Freeman GA and Kimmelman J.  Publication and Reporting Conduct for Pharmacodynamic Analyses of Tumor Tissue in Early Phase Oncology Trials.  Clinical Cancer Research, 2012.

Kimmelman J, Anderson JA. Should Preclinical Studies be Registered?  Nature Biotechnology, 2012.


Late Phase Trials

Hey SP & Kimmelman J. The Questionable Use of Unequal Allocation in Confirmatory TrialsNeurology, 2014.

London AJ, Kimmelman J, Carlisle B.  Rethinking Research Ethics: The Case of Postmarketing Trials.  Science, 2012.

Kimmelman J.  The Social Function of Clinical EquipoiseClinical Trials, 2012.


Neurological Disease

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 TrialsKennedy Institute of Ethics Journal, 2014.

Hey SP & Kimmelman J. The Questionable Use of Unequal Allocation in Confirmatory TrialsNeurology, 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. (in press)


Preclinical Research

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

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.

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 Biotechnolology, 2012.

Kimmelman J, Nalbantoglu J. Faithful Companions: A Proposal for Neurooncology in Pet DogsCancer Research, 2007.

Kimmelman J, Mogil JS, Dirnagl U. Distinguishing between Exploratory and Confirmatory Preclinical Research Will Improve Translation. PLOS Biology, 2014.


Risk and Uncertainty

Shah S, Kimmelman J, Lyerly AD, Lynch HF, Miller FG, Palacios R, Pardo CA, Zorilla C. Bystander Risk, Social Value, and the Ethics of Human Research. Science, 2018.

Hey SP. Ethics and Epistemology of Accurate Prediction in Clinical Research. Journal of Medical Ethics, 2015.

Hey SP, Kimmelman J. The Risk-Escalation Model: A Principled Design Strategy for Early-Phase TrialsKennedy Institute of Ethics Journal, 2014.

Kimmelman J. A Theoretical Framework for Early Human Studies: Uncertainty, Intervention Ensembles, and Boundaries. Trials, 2012.

Kimmelman J, London AJ. Predicting Harms and Benefits in Translational Trials: Ethics, Evidence, and Uncertainty. PLOS Medicine, 2011.

Anderson JA, Kimmelman J. Extending Clinical Equipoise to Phase 1 Trials Involving Patients: Unresolved Problems. Kennedy Institute of Ethics Journal, 2010.

Kimmelman J. Stable Ethics: Enrolling Non-Treatment Refractory Volunteers in Novel Gene Transfer Trials. Molecular Therapy, 2007.

Kimmelman J. Medical Research, Risk and Bystanders. IRB: Ethics and Human Research 2005; 27(4): 1-6. Abstract

Kimmelman J. Valuing Risk: The Ethical Review of Clinical Trial Safety. Kennedy Institute of Ethics Journal, 2004.

Kimmelman J. Ethics, Ambiguity Aversion, and Review of Complex Clinical Trials. Bioethics, 2012.


Operations

Carlisle BG, Kimmelman J, Ramsay T, MacKinnon N. Unsuccessful Trial Accrual and Human Subjects Protections: An Empirical Analysis of Recently Closed Trials. Clinical Trials, 2014.


Clinical Development Process

Carlisle B, Federico C, Kimmelman J. Trials that say “maybe”: the disconnect between exploratory and confirmatory testing after drug approval, The BMJ, 2018.

London AJ, Kimmelman J. Accelerated Drug Approval and Health InequalityJAMA Internal Medicine, 2016

London AJ, Kimmelman J. Point of view: Why clinical translation cannot succeed without failure. eLife, 2015.

Kimmelman J, London AJ. The Structure of Clinical Translation: Efficiency, Information, and Ethics.  Hastings Center Report, 2015.

Wenner DM, Kimmelman J, London AJ. Patient-Funded Trials: Opportunity or Liability? Cell Stem Cell, 2015.


Other

London, A and Kimmelman, J. Clinical Trials in Medical Center Advertising. JAMA Oncology, 2018.

Kimmelman J, Weijer C, Meslin EM. Helsinki Discords: FDA, Ethics, and International Drug Trials. Lancet, 2009.

Kimmelman, J. Investigators as Inventors: Patents, Clinical Research, and Conflict of Interest. Academic Medicine, 2007.

BibTeX

@Manual{stream2013-248,
    title = {Publications},
    journal = {STREAM research},
    author = {STREAM admin},
    address = {Montreal, Canada},
    date = 2013,
    month = jun,
    day = 22,
    url = {http://www.translationalethics.com/publications/}
}

MLA

STREAM admin. "Publications" Web blog post. STREAM research. 22 Jun 2013. Web. 16 Oct 2018. <http://www.translationalethics.com/publications/>

APA

STREAM admin. (2013, Jun 22). Publications [Web log post]. Retrieved from http://www.translationalethics.com/publications/


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