Publications

by

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 ApprovedJournal 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 studyBMJ Open, 2020.

Hutchinson N, Vinarov E, Iasonos A, Kimmelman J. Ethical and Policy Issues for Seamless Phase I Oncology TrialsJournal 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 CancerJournal of the National Cancer Institute, 2019.

Carlisle BG, Zheng T, Kimmelman J. Imatinib and the long tail of targeted drug developmentNature Reviews Clinical Oncology, 2019.

Doussau A, Vinarov E, Barsanti-Innes B, Kimmelmam J. Comparison between protocols and publications for prognostic and predictive cancer biomarker studiesClinical Trials, 2019.

Carlisle BG, Doussau A, Kimmelman J. Benefit, burden, and impact for a cohort of post-approval cancer combination trialsClinical 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 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

Yu M, Montroy J, Fergusson D, Lalu MM, Kimmelman J. Matured Forecast Analyses for” Systematic and narrative review lead experts to different cancer trial predictions”. Journal of clinical epidemiology. 2023 May 19:S0895-4356.

Kimmelman J, Mandel DR, Benjamin DM. Predicting Clinical Trial Results: A Synthesis of Five Empirical Studies and Their Implications. Perspectives in Biology and Medicine. 2023;66(1):107-28.

Kane PB, Moyer H, MacPherson A, Papenburg J, Ward BJ, Broomell SB, Kimmleman J. Relationship between lay and expert perceptions of COVID-19 vaccine development timelines in Canada and USA. PloS one. 2022 Feb 15.

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.

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.

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.

Kane PB, Moyer H, MacPherson A, Papenburg J, Ward B, Broomell S, Kimmelman J.  Expert Forecasts of COVID-19 Vaccine Development Timelines. Journal of General Internal Medicine. 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.

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

MacPherson A and Kimmelman J. Ethical development of stem-cell-based interventionsNature Medicine, 2019.

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

Awan FA, Becker AB, Wang Y, Kimmelman J. Participant Recruitment From Low-and Middle-Income Countries for Pivotal Trials of Drugs Approved by the US Food and Drug Administration: A Cross-Sectional Analysis. Annals of Internal Medicine, Dec 2022.

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

Sheng J, Feldhake E, Zarin DA, Kimmelman J. Completeness of clinical evidence citation in trial protocols: A cross-sectional analysis. Med. 2022 Apr 8.

Hutchinson N, Klas K, Carlisle BG, Kimmelman J, Waligora M. How Informative were Early SARS-CoV-2 Treatment and Prevention Trials? A longitudinal cohort analysis of trials registered on clinicaltrials. gov. Plos one. 2022 Jan 21.

Zarin DA, Goodman SN, Kimmelman J. Harms From Uninformative Clinical TrialsJAMA, 2019.

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

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 diseaseNeurology, 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 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.


Preclinical Research

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 studiesPain, 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 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

London AJ, Kane PB, Kimmelman J. Varieties of community uncertainty and clinical equipoise. Kennedy Institute of Ethics Journal. 2023;33(1):1-9

Kim SY, Kimmelman J. Practical steps to identifying the research risk of pragmatic trials. Clinical Trials. 2022 Mar 29.

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.

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

Kane PB, Bittlinger M, Kimmelman J. Individualized therapy trials: navigating patient care, research goals and ethics. Nature Medicine. Oct 12, 2021.

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.

MacPherson A, Hutchinson N, Schneider O, Oliviero E, Feldhake E, Ouimet C, Sheng J, Awan F, Wang C, Papenburg J, Basta NE. Probability of Success and Timelines for the Development of Vaccines for Emerging and Reemerged Viral Infectious Diseases. Annals of Internal Medicine.  Nov 24, 2020.

London AJ, Kimmelman J. Against pandemic research exceptionalismScience, 2020.

Hutchinson N, Vinarov E, Iasonos A, Kimmelman J. Ethical and Policy Issues for Seamless Phase I Oncology TrialsJournal of Clinical Oncology, 2019.

London AJ, Kimmelman J. Clinical Trial Portfolios: A Critical Oversight in Human Research Ethics, Drug Regulation, and Policy. Hastings Center Report, 2019.

MacPherson A, Kimmelman J. Ethical development of stem-cell-based interventionsNature Medicine, 2019.

Federico C, Wang T, Doussau A, Mogil J, Fergusson D, Kimmelman J. Assessment of Pregabalin Postapproval Trials and the Suggestion of Efficacy for New Indications: A Systematic Review. JAMA Internal Medicine, 2018.

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, Carlisle B, Gönen M. Drug Development at the Portfolio Level Is Important for Policy, Care Decisions and Human Protections. JAMA, 2017.

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 AJ, 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 = {Katerina Carayannis},
    address = {Montreal, Canada},
    date = 2013,
    month = jun,
    day = 22,
    url = {https://www.translationalethics.com/publications/}
}

MLA

Katerina Carayannis. "Publications" Web blog post. STREAM research. 22 Jun 2013. Web. 11 Dec 2024. <https://www.translationalethics.com/publications/>

APA

Katerina Carayannis. (2013, Jun 22). Publications [Web log post]. Retrieved from https://www.translationalethics.com/publications/


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