List of works - Jonathan Kimmelman

A Canadian Perspective on Ethics Review and Neuroimaging: Tensions and Solutions ⬇️

scientific article published on July 1, 2011

A meta-analysis of threats to valid clinical inference in preclinical research of sunitinib

scientific article

A systematic review and meta-analysis of pregabalin preclinical studies

scientific article published on 01 April 2020

A theoretical framework for early human studies: uncertainty, intervention ensembles, and boundaries ⬇️

scientific article published on September 22, 2012

Accelerated Drug Approval and Health Inequality

article

Accessibility of trial reports for drugs stalling in development: a systematic assessment of registered trials

scientific article published on 9 March 2015

Against pandemic research exceptionalism

scientific article published on 23 April 2020

Analysis of consent validity for invasive, nondiagnostic research procedures

scientific article published on 01 September 2012

Are outcome-adaptive allocation trials ethical?

scientific article published on 3 February 2015

Are phase 1 trials therapeutic? Risk, ethics, and division of labor

scientific article published on 10 June 2012

Assessing risk/benefit for trials using preclinical evidence: a proposal

scientific article published on 13 October 2015

Assessing the Completeness of Reporting in Preclinical Oncolytic Virus Therapy Studies

scientific article published on 21 May 2019

Assessment of Pregabalin Postapproval Trials and the Suggestion of Efficacy for New Indications: A Systematic Review

scientific article published on 01 January 2019

Battling a thousand points of might.

scientific article published in January 2009

Benefit, Risk, and Outcomes in Drug Development: A Systematic Review of Sunitinib

scientific article

Benefit, burden, and impact for a cohort of post-approval cancer combination trials

scientific article published on 03 October 2019

Better to be in The Placebo Arm for Trials of Neurological Therapies?

scientific article published in April 2018

Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines ⬇️

scientific article published on January 1, 2012

Burdensome Research Procedures in Trials: Why Less Is More

scientific article published in April 2017

Can Oncologists Predict the Efficacy of Treatments in Randomized Trials?

scientific article published on 27 July 2020

Can cancer researchers accurately judge whether preclinical reports will reproduce?

scientific article

Can patient decision aids help people make good decisions about participating in clinical trials? A study protocol

scientific article published on 23 July 2008

Cheap shots and pricey propositions: evidence, disclosure, and treatment of age-related macular degeneration

scientific article published on 01 November 2007

Clinical Trial Portfolios: A Critical Oversight in Human Research Ethics, Drug Regulation, and Policy

scientific article published on 01 July 2019

Clinical Trials in Medical Center Advertising

Clinical development success rates and social value of pediatric Phase 1 trials in oncology

scientific article published on 24 June 2020

Clinical trials and SCID row: the ethics of phase 1 trials in the developing world

scientific article published in December 2007

Comparison between protocols and publications for prognostic and predictive cancer biomarker studies

scientific article published on 05 October 2019

Completeness of clinical evidence citation in trial protocols: A cross-sectional analysis

scientific article published in 2022

Consent for nondiagnostic research biopsies: a pilot study of participant recall and therapeutic orientation

scientific article published in May 2014

Consider drug efficacy before first-in-human trials

scientific article published in January 2017

Decision analysis approach to risk/benefit evaluation in the ethical review of controlled human infection studies

scientific article published on 26 June 2020

Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy

scientific article

Distinguishing between exploratory and confirmatory preclinical research will improve translation

scientific article (publication date: May 2014)

Do We Know Whether Researchers and Reviewers are Estimating Risk and Benefit Accurately?

scientific article published on 16 May 2016

Drug Development at the Portfolio Level Is Important for Policy, Care Decisions and Human Protections

scientific article

Elements of informed consent and decision quality were poorly correlated in informed consent documents

scientific article published on 07 March 2015

Elements of style: consent form language and the therapeutic misconception in phase 1 gene transfer trials

scientific article

Ethical Review and Methodologic Innovation in Phase 1 Cancer Trials-Reply

scientific article published on 01 June 2019

Ethical and Policy Issues for Seamless Phase I Oncology Trials

scientific article published on 26 December 2019

Ethical and policy issues in the clinical translation of stem cells: report of a focus session at the ISSCR Tenth Annual Meeting

scientific article published in December 2012

Ethical considerations of e-cigarette use for tobacco harm reduction

scientific article

Ethical development of stem-cell-based interventions

scientific article published on 03 July 2019

Ethical issues in the development of oncology drugs

scientific article published on 01 October 2018

Ethics at phase 0: clarifying the issues

scientific article published on January 2007

Ethics of Cancer Gene Transfer Clinical Research

article

Ethics of cancer gene transfer clinical research

scientific article published on January 2009

Ethics of controlled human infection to study COVID-19

scientific article published on 07 May 2020

Ethics, Error, and Initial Trials of Efficacy ⬇️

scientific article published on May 8, 2013

Ethics, ambiguity aversion, and the review of complex translational clinical trials

scientific article published on 17 January 2011

Evaluation of Journal Registration Policies and Prospective Registration of Randomized Clinical Trials of Nonregulated Health Care Interventions

scientific article published on 01 May 2019

Extending clinical equipoise to phase 1 trials involving patients: unresolved problems

scientific article published on March 2010

Faithful companions: a proposal for neurooncology trials in pet dogs

scientific article

Forecasts for the Attainment of Major Research Milestones in Parkinson's Disease

scientific article published on 24 April 2020

Group sample sizes in nonregulated health care intervention trials described as randomized controlled trials were overly similar

scientific article published on 19 December 2019

Harms From Uninformative Clinical Trials

scientific article published on 25 July 2019

Helsinki discords: FDA, ethics, and international drug trials

scientific article

How Informative Were Early SARS-CoV-2 Treatment and Prevention Trials? A longitudinal cohort analysis of trials registered on clinicaltrials.gov

scientific article published on 5 September 2021

How do researchers decide early clinical trials?

scientific article published on February 2016

How well are Phase 2 cancer trial publications supported by preclinical efficacy evidence?

scientific article published on 29 May 2019

Imatinib and the long tail of targeted drug development

scientific article published on 01 January 2020

Impact of Precision Medicine on Efficiencies of Novel Drug Development in Cancer

scientific article published on 13 November 2019

Increasing efficiency of preclinical research by group sequential designs

scientific article

Increasing placebo responses over time in U.S. clinical trials of neuropathic pain

scientific article

Inefficiencies and Patient Burdens in the Development of the Targeted Cancer Drug Sorafenib: A Systematic Review

scientific article

Informed consent documents do not encourage good-quality decision making

scientific article published on 25 April 2012

Inventors as investigators: the ethics of patents in clinical trials

scientific article published on 01 January 2007

Is Participation in Cancer Phase I Trials Really Therapeutic?

scientific article published on 19 September 2016

Justice in translation: from bench to bedside in the developing world

scientific article published in July 2008

Launching invasive, first-in-human trials against Parkinson's disease: ethical considerations

scientific article

Medical research, risk, and bystanders

scientific article

Missing the forest: further thoughts on the ethics of bystander risk in medical research.

scientific article

New ISSCR guidelines: clinical translation of stem cell research

scientific article published in The Lancet

Nonpublication of trial results for new neurological drugs: A systematic review.

scientific article published on 9 May 2017

Organ donor intervention trials and the ethical challenge of bystander organ recipients

scientific article published on 01 August 2019

Participant Protection in Phase 1 Pediatric Cancer Trials

scientific article published on 01 January 2019

Patient burden and clinical advances associated with postapproval monotherapy cancer drug trials: a retrospective cohort study

scientific article published on 17 February 2020

Patient-Funded Trials: Opportunity or Liability?

scientific article published on August 2015

Phase I trials as therapeutic options: (usually) a betrayal of evidence-based medicine

scientific article published on 01 December 2019

Policy: Global standards for stem-cell research

scientific article

Position statement on the provision and procurement of human eggs for stem cell research

scientific article published in March 2013

Potential harms from legalization of recreational cannabis use in Canada

scientific article published on 13 February 2019

Preclinical efficacy in therapeutic area guidelines from the U.S. Food and Drug Administration and the European Medicines Agency: a cross-sectional study

scientific article published on 01 October 2018

Preclinical efficacy studies in investigator brochures: Do they enable risk-benefit assessment?

scientific article published on 5 April 2018

Predicting harms and benefits in translational trials: ethics, evidence, and uncertainty

scientific article

Probability of Success and Timelines for the Development of Vaccines for Emerging and Reemerged Viral Infectious Diseases

scientific article published on 24 November 2020

Proportion of Patients in Phase 1 Oncology Trials Receiving Treatments that are Ultimately Approved

scientific article published on 01 April 2020

Protection at the cutting edge: the case for central review of human gene transfer research ⬇️

scientific article published on October 14, 2003

Publication and Reporting Conduct for Pharmacodynamic Analyses of Tumor Tissue in Early-Phase Oncology Trials ⬇️

scientific article published on August 21, 2012

Recent developments in gene transfer: risk and ethics

scientific article

Regulating impact on bystanders in clinical trials: An unsettled frontier

scientific article published on 01 August 2019

Rejoinder

scientific article published on 03 February 2015

Reply to 'Correcting the ASCO position on phase I clinical trials in cancer'

scientific article published on 01 February 2020

Research ethics. Beyond access vs. protection in trials of innovative therapies

scientific article published in May 2010

Research ethics. Rethinking research ethics: the case of postmarketing trials

scientific article published on May 2012

Risk and surrogate benefit for pediatric Phase I trials in oncology: A systematic review with meta-analysis

scientific article published on 20 February 2018

Risk of surgical delivery to deep nuclei: A meta‐analysis ⬇️

scientific article published on May 14, 2011

Risks and benefits of unapproved disease-modifying treatments for neurodegenerative disease

scientific article published on 02 December 2019

SCIENTIFIC COMMUNITY. Confronting stem cell hype

scientific article

Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines

scientific article published on 11 May 2016

Should preclinical studies be registered? ⬇️

scientific article published on June 7, 2012

Stable ethics: enrolling non-treatment-refractory volunteers in novel gene transfer trials

article

Stem cell trials: lessons from gene transfer research

scientific article published on 01 January 2006

The Challenges of Validating in Precision Medicine: The Case of Excision Repair Cross-Complement Group 1 Diagnostic Testing

scientific article

The Efficacy and Safety of Low Molecular Weight Heparin Administration to Improve Survival of Cancer Patients: A Systematic Review and Meta-Analysis

scientific article published on 05 May 2020

The PLOS Biology XV Collection: 15 Years of Exceptional Science Highlighted across 12 Months

scientific article published on 27 February 2019

The Research Optimist's Defense

scientific article

The attitudes of brain cancer patients and their caregivers towards death and dying: a qualitative study

scientific article

The bench is closer to the bedside than we think: Uncovering the ethical ties between preclinical researchers in translational neuroscience and patients in clinical trials.

scientific article

The ethics of human gene transfer

scientific article published in March 2008

The ethics of managing affective and emotional states to improve informed consent: autonomy, comprehension, and voluntariness

scientific article published on October 6, 2010

The paradox of precision medicine

scientific article published on 01 June 2018

The proportion of North American cancer trials that evaluate novel targets

scientific article published on 18 July 2020

The risk-escalation model: a principled design strategy for early-phase trials

scientific article published on June 2014

The secret realm of phase I trials in healthy volunteers

scientific article published on 26 June 2015

The social function of clinical equipoise ⬇️

scientific article published on October 1, 2012

The stem cell market and policy options: a call for clarity.

scientific article

The structure of clinical translation: efficiency, information, and ethics

scientific article published on 27 January 2015

The sublime inertia of informed consent language in early phase clinical trials involving patients

scientific article published on 24 November 2020

The therapeutic misconception at 25: treatment, research, and confusion

scientific article

There is still a place for significance testing in clinical trials

scientific article published on 09 May 2019

Threats to validity in the design and conduct of preclinical efficacy studies: a systematic review of guidelines for in vivo animal experiments

scientific article (publication date: 2013)

Tomorrow, interrupted? Risk, ethics, and medical advance in gene transfer

scientific article

Towards a global human embryonic stem cell bank: differential termination

scientific article

Translational research and the U.S. federal elections.

scientific article

Trials that say "maybe": the disconnect between exploratory and confirmatory testing after drug approval

scientific article published on 20 March 2018

Unsuccessful trial accrual and human subjects protections: an empirical analysis of recently closed trials.

scientific article

Using decision aids may improve informed consent for research

article

Valuing risk: the ethical review of clinical trial safety

scientific article

What Research Ethics (Often) Gets Wrong about Minimal Risk

scientific article published on 01 January 2020

Where Have All the Rodents Gone? The Effects of Attrition in Experimental Research on Cancer and Stroke

scientific article

Why IRBs should protect bystanders in human research

scientific article published on 25 September 2020

Why clinical translation cannot succeed without failure

scientific article

Wisdom of the expert crowd prediction of response for 3 neurology randomized trials

scientific article published on 16 June 2020

List of works by Jonathan Kimmelman

A Canadian Perspective on Ethics Review and Neuroimaging: Tensions and Solutions ⬇️

A meta-analysis of threats to valid clinical inference in preclinical research of sunitinib

A systematic review and meta-analysis of pregabalin preclinical studies

A theoretical framework for early human studies: uncertainty, intervention ensembles, and boundaries ⬇️

Accelerated Drug Approval and Health Inequality

Accessibility of trial reports for drugs stalling in development: a systematic assessment of registered trials

Against pandemic research exceptionalism

Analysis of consent validity for invasive, nondiagnostic research procedures

Are outcome-adaptive allocation trials ethical?

Are phase 1 trials therapeutic? Risk, ethics, and division of labor

Assessing risk/benefit for trials using preclinical evidence: a proposal

Assessing the Completeness of Reporting in Preclinical Oncolytic Virus Therapy Studies

Assessment of Pregabalin Postapproval Trials and the Suggestion of Efficacy for New Indications: A Systematic Review

Battling a thousand points of might.

Benefit, Risk, and Outcomes in Drug Development: A Systematic Review of Sunitinib

Benefit, burden, and impact for a cohort of post-approval cancer combination trials

Better to be in The Placebo Arm for Trials of Neurological Therapies?

Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines ⬇️

Burdensome Research Procedures in Trials: Why Less Is More

Can Oncologists Predict the Efficacy of Treatments in Randomized Trials?

Can cancer researchers accurately judge whether preclinical reports will reproduce?

Can patient decision aids help people make good decisions about participating in clinical trials? A study protocol

Cheap shots and pricey propositions: evidence, disclosure, and treatment of age-related macular degeneration

Clinical Trial Portfolios: A Critical Oversight in Human Research Ethics, Drug Regulation, and Policy

Clinical Trials in Medical Center Advertising

Clinical development success rates and social value of pediatric Phase 1 trials in oncology

Clinical trials and SCID row: the ethics of phase 1 trials in the developing world

Comparison between protocols and publications for prognostic and predictive cancer biomarker studies

Completeness of clinical evidence citation in trial protocols: A cross-sectional analysis

Consent for nondiagnostic research biopsies: a pilot study of participant recall and therapeutic orientation

Consider drug efficacy before first-in-human trials

Decision analysis approach to risk/benefit evaluation in the ethical review of controlled human infection studies

Design and Reporting of Targeted Anticancer Preclinical Studies: A Meta-Analysis of Animal Studies Investigating Sorafenib Antitumor Efficacy

Distinguishing between exploratory and confirmatory preclinical research will improve translation

Do We Know Whether Researchers and Reviewers are Estimating Risk and Benefit Accurately?

Drug Development at the Portfolio Level Is Important for Policy, Care Decisions and Human Protections

Elements of informed consent and decision quality were poorly correlated in informed consent documents

Elements of style: consent form language and the therapeutic misconception in phase 1 gene transfer trials

Ethical Review and Methodologic Innovation in Phase 1 Cancer Trials-Reply

Ethical and Policy Issues for Seamless Phase I Oncology Trials

Ethical and policy issues in the clinical translation of stem cells: report of a focus session at the ISSCR Tenth Annual Meeting

Ethical considerations of e-cigarette use for tobacco harm reduction

Ethical development of stem-cell-based interventions

Ethical issues in the development of oncology drugs

Ethics at phase 0: clarifying the issues

Ethics of Cancer Gene Transfer Clinical Research

Ethics of cancer gene transfer clinical research

Ethics of controlled human infection to study COVID-19

Ethics, Error, and Initial Trials of Efficacy ⬇️

Ethics, ambiguity aversion, and the review of complex translational clinical trials

Evaluation of Journal Registration Policies and Prospective Registration of Randomized Clinical Trials of Nonregulated Health Care Interventions

Extending clinical equipoise to phase 1 trials involving patients: unresolved problems

Faithful companions: a proposal for neurooncology trials in pet dogs

Forecasts for the Attainment of Major Research Milestones in Parkinson's Disease

Group sample sizes in nonregulated health care intervention trials described as randomized controlled trials were overly similar

Harms From Uninformative Clinical Trials

Helsinki discords: FDA, ethics, and international drug trials

How Informative Were Early SARS-CoV-2 Treatment and Prevention Trials? A longitudinal cohort analysis of trials registered on clinicaltrials.gov

How do researchers decide early clinical trials?

How well are Phase 2 cancer trial publications supported by preclinical efficacy evidence?

Imatinib and the long tail of targeted drug development

Impact of Precision Medicine on Efficiencies of Novel Drug Development in Cancer

Increasing efficiency of preclinical research by group sequential designs

Increasing placebo responses over time in U.S. clinical trials of neuropathic pain

Inefficiencies and Patient Burdens in the Development of the Targeted Cancer Drug Sorafenib: A Systematic Review

Informed consent documents do not encourage good-quality decision making

Inventors as investigators: the ethics of patents in clinical trials

Is Participation in Cancer Phase I Trials Really Therapeutic?

Justice in translation: from bench to bedside in the developing world

Launching invasive, first-in-human trials against Parkinson's disease: ethical considerations

Medical research, risk, and bystanders

Missing the forest: further thoughts on the ethics of bystander risk in medical research.

New ISSCR guidelines: clinical translation of stem cell research

Nonpublication of trial results for new neurological drugs: A systematic review.

Organ donor intervention trials and the ethical challenge of bystander organ recipients

Participant Protection in Phase 1 Pediatric Cancer Trials

Patient burden and clinical advances associated with postapproval monotherapy cancer drug trials: a retrospective cohort study

Patient-Funded Trials: Opportunity or Liability?

Phase I trials as therapeutic options: (usually) a betrayal of evidence-based medicine