Publications

by

Cancer

Kimmelman J, Carlisle B, Gönen M. Drug Development at the Portfolio Level Is Important for Policy, Care Decisions and Human Protections. JAMA. August 2017. DOI:10.1001/jama.2017.11502

Kimmelman J, Resnik DB, Peppercorn J, Ratain MJ. Burdensome Research Procedures in Trials: Why Less is More. JNCI Feb 17, 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 February 3, 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 JNCI. 2015. DOI: 10.1093/jnci/djv292

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; 36(3): 9-15.

Freeman GA, Kimmelman J, Dancey J, Monzon JG. Reporting practices of pharmacodynamic studies involving invasive research procedures in cancer trials. Br J Cancer 2013.

Freeman GA, Kimmelman J.  Publication and Reporting Conduct for Pharmacodynamic Analyses of Tumor Tissue in Early Phase Oncology Trials.  Clin Canc Res 2012; 18(23). PMID=22912391

Kimmelman J, Nalbantoglu J. Faithful Companions: A Proposal for Neurooncology in Pet Dogs. Cancer Research 2007; 67: 4451-4. Abstract [.pdf]


Early Phase Trials

Kimmelman J and Federico C. Consider drug efficacy before first-in-human trials. Nature 2017 January 31.

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, Kimmelman J. The Risk-Escalation Model: A Principled Design Strategy for Early-Phase TrialsKennedy Institute of Ethics Journal 2014; 24(2): 121-139.

Freeman GA, Kimmelman J, Dancey J, Monzon JG. Reporting practices of pharmacodynamic studies involving invasive research procedures in cancer trials. Br J Cancer 2013.

Hey SP, Kimmelman J.  Ethics, Error, and Initial Trials of Efficacy. Sci Trans Med 2013; 5: 184fs16 [Reprint] [Full text]

Anderson JA, Kimmelman J. Are Phase 1 Trials Therapeutic? Risk, Ethics, and Division of Labor. Bioethics 2012; 28(3):138-46.

Kimmelman J. A Theoretical Framework for Early Human Studies: Uncertainty, Intervention Ensembles, and BoundariesTrials 2012; 13

Anderson JA, Kimmelman J. Extending Clinical Equipoise to Phase 1 Trials Involving Patients: Unresolved Problems. Kennedy Inst Ethics J. 2010; 20(1):75-98.

London AJ, Kimmelman J. Emborg ME. Beyond Access vs. Protection in Trials of Innovative Therapies. Science 2010; 328: 829-30

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; 24: 1893-901. Preprint

Kimmelman J. Ethics at Phase 0: Clarifying the Issues. Journal of Law, Medicine, and Ethics 2007; 35(4): 727-33 Abstract

Kimmelman J. Stable Ethics: Enrolling Non-Treatment Refractory Volunteers in Novel Gene Transfer Trials. Molecular Therapy 2007; 15: 1904-6. Abstract


Forecasting and Prediction

Benjamin D, Mandel DR, Kimmelman J. Can cancer researchers accurately judge whether preclinical reports will reproduce? PLOS Biology, June 2017; 15(6).

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


Foundations of Research Ethics

London AJ, Kimmelman J, Carlisle B.  Rethinking Research Ethics: The Case of Postmarketing Trials.  Science 2012; 336: 544-5. [summary] [reprint] [full text]

London AJ, Kimmelman J. Emborg ME. Beyond Access vs. Protection in Trials of Innovative Therapies. Science 2010; 328: 829-30.


Gene and Cell-Based Interventions

Hey SP, Kimmelman J. The Risk-Escalation Model: A Principled Design Strategy for Early-Phase TrialsKennedy Institute of Ethics Journal 2014; 24(2): 121-139.

Anderson JA, 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).  Pp403-18.

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

Kimmelman J. “Ethics of Cancer Gene Transfer Clinical Research.”  In W. Walther, U. Stein, eds.  Gene Therapy of Cancer.  Humana Press: Totowa, NJ (2008). Pp 423-45.

Kimmelman J. The Ethics of Human Gene Transfer. Nature Reviews—Genetics 2008; 9: 239-44.

Kimmelman J. Staunch protections: the ethics of haemophilia gene transfer research. Haemophilia 2007 14: 5-14.

Kimmelman J. Recent developments in gene transfer: risk and ethics. BMJ 2005 330: 79-82.


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; 36(3): 9-15.

Braude H, Kimmelman J. The Ethics of Managing Affective and Emotional States to Improve Informed Consent: Autonomy, Comprehension, and Voluntariness. Bioethics 2012; 26: 149–156.

Kimmelman J, Lemmens T, Kim SY. Analysis of Consent Validity for Invasive, Nondiagnostic Research Procedures. IRB 2012; 34: 1-7.

Kimmelman J. The Therapeutic Misconception at 25: Treatment, Research, and Confusion. Hastings Centre Report 2007; 6: 36-42. Abstract plus supplementary materials Abstract plus supplementary materials


International Research

London AJ, Kimmelman J. Justice in Translation: From Bench to Bedside in the Developing World. Lancet 2008; 372: 82-5. Preprint

Kimmelman, J. Clinical Trials and SCID Row: The Ethics of Phase 1 Trials in the Developing World. Devel World Bioeth 2007; 7: 483-90.


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 DevelopmentBMJ 2015; 350: h1116.

Hey SP. Ethics and Epistemology of Accurate Prediction in Clinical Research. Journal of Medical Ethics DOI:10.1136/medethics-2013-101868.

Hey SP, Kimmelman J. The Risk-Escalation Model: A Principled Design Strategy for Early-Phase TrialsKennedy Institute of Ethics Journal 2014; 24(2): 121-139.

Freeman GA, Kimmelman J, Dancey J, Monzon JG. Reporting practices of pharmacodynamic studies involving invasive research procedures in cancer trials. Br J Cancer 2013.

Freeman GA, Kimmelman J.  Publication and Reporting Conduct for Pharmacodynamic Analyses of Tumor Tissue in Early Phase Oncology Trials.  Clin Can Res 2012; 18(23).

Kimmelman J, Anderson JA. Should Preclinical Studies be Registered?  Nat Biotechnol 2012; 30: 488-9.


Late Phase Trials

Hey SP & Kimmelman J. “The Questionable Use of Unequal Allocation in Confirmatory Trials.” Neurology. (2014). 82(1):77-79.

London AJ, Kimmelman J, Carlisle B.  Rethinking Research Ethics: The Case of Postmarketing Trials.  Science 2012; 336: 544-5.   [summary] [reprint] [full text]

Kimmelman J.  The Social Function of Clinical Equipoise.  Clin Trials 2012; 9: 630-1.


Neurological Disease

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; 24(2): 121-139.

Hey SP & Kimmelman J. “The Questionable Use of Unequal Allocation in Confirmatory Trials.” Neurology. (2014). 82(1):77-79.

Kimmelman J.  “Biologics, Ethics and the Human Brain.”  In: Neuroethics in Practice.  Farah M, Chatterjee A, eds. New York: Oxford University Press (2012).  Pp 249-61

Kimmelman J, Duckworth K, Ramsay T, Voss T, Ravina B, Emborg ME. Risk of Surgical Delivery to the Basal Ganglia: A Meta-analysis. Mov Disord 2011; 26:  1415-21.

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; 24: 1893-901. Preprint [.pdf]

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

Benjamin D, Mandel DR, Kimmelman J. Can cancer researchers accurately judge whether preclinical reports will reproduce? PLOS Biology 2017; 15(6).

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 March 10, 2017; DOI: 10.1371/journal.pbio.2001307

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 Res 2016; DOI: 10.1158/0008-5472.CAN-15-3455 [Epub ahead of print]

Kimmelman J, Henderson V. Assessing risk/benefit for trials using preclinical evidence: a proposal. Journal of Medical Ethics 2015; DOI: doi:10.1136/medethics-2015-102882

Valerie C Henderson, Nadine Demko, Amanda Hakala, Nathalie MacKinnon, Carole A Federico, Dean Fergusson, Jonathan Kimmelman. A meta-analysis of threats to valid clinical inference in preclinical research of sunitinib. eLife4:e08351. 2015. Henderson et al 2015 Sunitinib Supplemental Raw Data

Valerie C Henderson, Nadine Demko, Amanda Hakala, Nathalie MacKinnon, Carole A Federico, Dean Fergusson, Jonathan Kimmelman. A meta-analysis of threats to valid clinical inference in preclinical research of sunitinib. eLife4:e08351. 2015.

Federico CA, Carlisle B, Kimmelman J, Fergusson DA. Late, Never, or Nonexistent: The Inaccessibility of Preclinical Evidence for New Drugs. British Journal of Pharmacology 2014; DOI: 10.1111/bph.12771.

Henderson, Valerie C., Jonathan Kimmelman, Dean Fergusson, Jeremy M. Grimshaw, Dan G. Hackam. 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?  Nat Biotechnol 2012; 30: 488-9.

Kimmelman J, Nalbantoglu J. Faithful Companions: A Proposal for Neurooncology in Pet Dogs. Cancer Research 2007; 67: 4451-4. Abstract

Kimmelman J, Mogil JS, Dirnagl U. Distinguishing between Exploratory and Confirmatory Preclinical Research Will Improve Translation. PLoS Biology 2014; 12(5): e1001863.


Risk and Uncertainty

Hey SP. Ethics and Epistemology of Accurate Prediction in Clinical Research. Journal of Medical Ethics DOI:10.1136/medethics-2013-101868.

Hey SP, Kimmelman J. The Risk-Escalation Model: A Principled Design Strategy for Early-Phase TrialsKennedy Institute of Ethics Journal 2014; 24(2): 121-139.

Kimmelman J. A Theoretical Framework for Early Human Studies: Uncertainty, Intervention Ensembles, and Boundaries. Trials 2012; 13: 173.

Kimmelman J, London AJ. Predicting Harms and Benefits in Translational Trials: Ethics, Evidence, and Uncertainty. PLoS Medicine 2011; 3: e1001010.

Anderson JA, Kimmelman J. Extending Clinical Equipoise to Phase 1 Trials Involving Patients: Unresolved Problems. Kennedy Inst Ethics J. 2010; 20(1):75-98.

Kimmelman J. Stable Ethics: Enrolling Non-Treatment Refractory Volunteers in Novel Gene Transfer Trials. Molecular Therapy 2007; 15: 1904-6. Abstract

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; 14(4): 369-393.

Kimmelman J. Ethics, Ambiguity Aversion, and Review of Complex Clinical Trials. Bioethics 2012 Jun; 26(5): 242-50.


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

London AJ, Kimmelman J. Accelerated Drug Approval and Health InequalityJAMA Intern Med. 2016. DOI:10.1001/jamainternmed.2016.2534.

London AJ, Kimmelman J. Point of view: Why clinical translation cannot succeed without failure. eLife4:e12844. 2015.

Kimmelman J, London AJ. The Efficiency of Clinical Translation: Science, Policy and Ethics.  Hastings Cent Rep 2015; 45:27-39.

Wenner DM, Kimmelman J, London AJ. Patient-Funded Trials: Opportunity or Liability? Cell Stem Cell 17.2 (2015): 135-137.


Other

Kimmelman J, Weijer C, Meslin EM. Helsinki Discords: FDA, Ethics, and International Drug Trials. Lancet 2009; 373: 13-4.

Kimmelman, J. Investigators as Inventors: Patents, Clinical Research, and Conflict of Interest. Academic Medicine 2007; 82: 24-31.

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. 23 Oct 2017. <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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