2017
Gene patents still alive and kicking: their impact on provision of genetic testing for long QT Syndrome in the Canadian Public Healthcare System. Genetics in Medicine. doi:10.1038/gim.2017.43
PRM30-Should decision makers embrace non-constant discounting? Value in Health. https://doi.org/10.1016/j.jval.2015.03.096
Rare Diseases and Resource Allocation Policy: The Role of Canadian Legal Norms. UBC Law Review. http://ubclawreview.ca/issues/vol-49-no-2-august-2016/timothy-caulfield-maeghan-toews-rare-diseases-and-resource-allocation-policy-the-role-of-canadian-legal-and-ethical-norms/
The direct-to-consumer genetic testing fog. Policy Options. http://policyoptions.irpp.org/magazines/may-2017/the-direct-to-consumer-genetic-testing-fog-column-by-timothy-caulfield/
Show drugs work before selling them. Nature. http://www.nature.com/news/show-drugs-work-before-selling-them-1.21582
Inefficiencies and Patient Burdens in the Development of the Targeted Cancer Drug Sorafenib: A Systematic Review. PLoS Biology. http://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.2000487
Consider drug efficacy before first-in-human trials. Nature. http://www.nature.com/news/consider-drug-efficacy-before-first-in-human-trials-1.21384
Human gene editing: revisiting Canadian policy. Regenerative Medicine. http://www.nature.com/articles/s41536-017-0007-2
A Comparison of Four Software Programs for Implementing Decision Analytic Cost-Effectiveness Models. SpringerLink. https://link.springer.com/article/10.1007/s40273-017-0510-8
Prehospital randomised assessment of a mechanical compression device in out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised trial and economic evaluation. Health Technology Assessment. National Institute for Health Research. https://www.ncbi.nlm.nih.gov/pubmed/28393757
Marketing of unproven stem cell-based interventions: A call to action. Science Translational Medicine. http://stm.sciencemag.org/content/9/397/eaag0426
Long-term Results from the Empowering a Multimodel Pathway Toward Health Youth Program, a Multimodel School-Based Approach, Show Marked Reductions Suicidality, Depression, and Anxiety in 6,227 Students in Grades 6-12 (Aged 11-18). Frontiers in Psychiatry. NCBI. https://www.ncbi.nlm.nih.gov/pubmed/28555115
2016
Accelerating Translational Research through Open Science: The Neuro Experiment. PLoS Biology. http://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.2001259
The health economics for regenerative medicine: how payers think and what that means for developers. Mesenchymal Stromal Cells: Translational Pathways to Clinical Adoption. https://www.researchgate.net/publication/306419900_The_Health_Economics_for_Regenerative_Medicine_How_Payers_Think_and_What_That_Means_for_Developers
Rare diseases and resource allocation policy: the role of Canadian legal and ethical norms. UBC Law Review. https://litigation-essentials.lexisnexis.com/webcd/app?action=DocumentDisplay&crawlid=1&doctype=cite&docid=49+U.B.C.+L.+Rev.+789&srctype=smi&srcid=3B15&key=b800224ccc41dde1846c6e1893929ce8
Cancer Drugs Fund 2.0: A Missed Opportunity? Pharmacoeconomics. https://link.springer.com/article/10.1007%2Fs40273-016-0403-2
Precision medicine: drowning in a regulatory soup? Journal of Law and the Biosciences. https://academic.oup.com/jlb/article/3/2/281/1751241/Precision-medicine-drowning-in-a-regulatory-soup
Controversies with Kalydeco: newspaper coverage and the United States of the cycstic fibrosis “wonder drug”. Journal of Cystic Fibrosis. http://www.sciencedirect.com/science/article/pii/S1569199316300157?via%3Dihub
Media portrayal of non-invasive prenatal testing: a missing ethical dimension. Journal of Clinical Outcomes Management. https://jcom.sissa.it/archive/15/02/JCOM_1502_2016_A03
The Mouse that Trolled (Again). Journal of Law and the Biosciences. https://academic.oup.com/jlb/article/3/1/185/1751296/The-mouse-that-trolled-again
Cell therapy licensing: a web for the unwary in Kimble v. Marvel Entertainment? Regenerative Medicine. https://www.futuremedicine.com/doi/10.2217/rme.15.86
Choroideremia Research Report and Perspectives on the Second International Scientific Symposium for Choroideremia. Ophthalmic Genetics. http://www.tandfonline.com/doi/full/10.3109/13816810.2015.1088958
Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines. Stem cell Reports. Cell Press. https://www.ncbi.nlm.nih.gov/pubmed/27185282
Discounting the Recommendations of the Second Panel on Cost-Effectiveness in Health and Medicine. SpringerLink. https://www.ncbi.nlm.nih.gov/pubmed/27943173
Determinants of Change in the Cost-effectiveness Threshold. Medical Decision Making. SAGE Journals. https://www.ncbi.nlm.nih.gov/pubmed/27553208
Comparing Breast Cancer Multiparameter Tests in the OPTIMA Prelim Trial: No Test Is More Equal Than the Others. Journal of the National Cancer Institute. Oxford University Press. https://www.ncbi.nlm.nih.gov/pubmed/27130929
Cost effectiveness and value of information analyses of islet cell transplantation in the management of ‘unstable’ type 1 diabetes mellitus. BMC endocrine disorders. BioMed Central Ltd. https://www.ncbi.nlm.nih.gov/pubmed/27061400
One-year resource allocation, utilisation, costs and quality of life in patients with acute respiratory distress syndrome (ARDS): secondary analysis of a randomised controlled trial. Journal of Intensive Care Medicine. BioMed Central. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4982209/
Undertested and Overpriced: Japan Issues First Conditional Approval of Stem Cell Product. Cell Stem Cell. Elsevier. https://www.ncbi.nlm.nih.gov/pubmed/27058935
2015
Innovating a Canadian innovation ecosystem. Policy Options. http://policyoptions.irpp.org/issues/clearing-the-air/gold-et-al/
The media and access issues: content analysis of Canadian newspaper coverage of health policy decisions. Orphanet Journal of Rare Diseases. http://www.ojrd.com/content/pdf/s13023-015-0320-z.pdf
The gene patent controversy on Twitter: a case study of Twitter users’ responses to the CHEO lawsuit against Long QT gene patents. BMC Medical Ethics. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4548905/pdf/12910_2015_Article_49.pdf
The commercialization of university-based research: Balancing risks and benefits. BMC Medical Ethics. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4605102/pdf/12910_2015_Article_64.pdf
Marginally Scientific? Genetic Testing of Children and Adolescents for Lifestyle and Health Promotion. Journal of Law and the Biosciences. http://jlb.oxfordjournals.org/content/early/2015/11/16/jlb.lsv038.full.pdf
Current Practices and Reform Proposals for the Regulation of Advanced Medicinal Products in Canada. Regenerative Medicine. http://www.ncbi.nlm.nih.gov/pubmed/26237706
The Obesity Gene and the (Misplaced) Search for a Personalized Approach to Our Weight Gain Problems. Wake Forest Journal of Law and Policy. http://lawpolicyjournal.law.wfu.edu/files/2015/03/5-Caulfield_Final.pdf
Commercialisation of Human Genetic Research. Encyclopedia of Life Sciences. http://onlinelibrary.wiley.com/doi/10.1002/9780470015902.a0005651.pub2/abstract
Use and Misuse of Material Transfer Agreements: Lessons from Research, Repositories, and Litigation. PLoS Biology. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4315468/pdf/pbio.1002060.pdf
Bringing regenerative medicines to the clinic: the future for regulation and reimbursement. Regenerative medicine. Future Medicine Ltd. https://www.ncbi.nlm.nih.gov/pubmed/26565607
Use of Bayesian Markov Chain Monte Carlo Methods to Estimate EQ-5D Utility Scores from EORTC QLQ Data in Myeloma for Use in Cost-Effectiveness Analysis. Medical Decision making. Sage. https://www.ncbi.nlm.nih.gov/pubmed/25784746
The use of early decision making and value of information analysis in an adaptive trial design results from the OPTIMA preliminary study. Trials. BioMed Central Ltd. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4659263/
Self-Harm Intervention: Family Therapy (SHIFT), a study protocol for a randomised controlled trial of family therapy versus treatment as usual for young people seen after a second or subsequent episode of self-harm. Trials. BioMed Central Ltd. https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-1007-4
Pressure Ulcer Programme of Research: using mixed methods to identify patient and organisational risk, develop a risk assessment tool and patient-reported outcome Quality of Life and Health Utility measures. NIHR Journals Library. NIHR. https://www.ncbi.nlm.nih.gov/pubmed/26447265
2014
Theory Testing and Implication in Clinical Trials. Philosophy of Science. http://philsci-archive.pitt.edu/11045/1/biomarker_theory_testing-psa.pdf
Are Outcome-Adaptive Allocation Trials Ethical? Clinical Trials. http://ctj.sagepub.com/content/12/2/102
Physician Liability and Non-Invasive Prenatal Testing. J Obstet Gynaecol Can. http://www.jogc.ca/abstracts/full/201410_Commentary_1.pdf
Science Powers Commerce: Mapping the Language, Justifications, and Perceptions of the Drive to Commercialize in the Context of Canadian Research. Canadian Journal of Comparative and Contemporary Law. http://www.cjccl.ca/science-powers-commerce/
Newspaper Coverage of Biobanks. Peer J. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4121587/
Defining medical necessity in an age of personalised medicine: A view from Canada. Bioessays. http://www.ncbi.nlm.nih.gov/pubmed/25059840
It’s not all in the genes. Policy Options. http://policyoptions.irpp.org/issues/old-politics-new-politics/caulfield/
Direct to Consumer Genetic Testing in Canada: should we be concerned. Healthy Debate. http://healthydebate.ca/opinions/direct-consumer-genetic-testing
Some Inconsistencies in NICE’s Consideration of Social Values. Pharmacoeconomics. http://link.springer.com/article/10.1007%2Fs40273-014-0204-4
Determining social values for resource allocation decision-making in cancer care: a Canadian experiment. Journal of Cancer Policy. http://www.sciencedirect.com/science/article/pii/S2213538314000186
Value-Engineered Translation: Developing Biotherapeutics that align with health-system needs. American Journal of Managed Care: Evidence-Based Diabetes Management 20 (Special Issue 10). http://www.ajmc.com/publications/evidence-based-diabetes-management/2014/july-august-2014/Value-Engineered-Translation-Developing-Biotherapeutics-That-Align-With-Health-System-Needs
Should patients be told about incidental findings from genetic testing. Healthy Debate. http://healthydebate.ca/2014/07/topic/genetic-testing-incidental-findings
The Right to Control and Access Genetic Material: Does McInerney Offer a Way Out of the Consent/Withdrawal Conundrum? UBC Law Review. http://www.hli.ualberta.ca/~/media/hli/Research/Docs/2013-09-15_McInerney_website.pdf
Methods for Identifying the Cost-effective Case Definition Cut-Off for Sequential Monitoring Tests: An Extension of Phelps and Mushlin. PharmacoEconomics. http://link.springer.com/article/10.1007%2Fs40273-014-0134-1
Achieving Allocative Efficiency in Healthcare: Nice in Theory, not so NICE in Practice? PharmacoEconomics. http://www.ncbi.nlm.nih.gov/pubmed/24599785
Human genetic research, race, ethnicity and the labeling of populations: recommendations based on an interdisciplinary workshop in Japan. BMC Medical Ethics. http://www.biomedcentral.com/1472-6939/15/33
Methods for Identifying the Cost-effective Case Definition Cut-Off for Sequential Monitoring Tests: An Extension of Phelps and Mushlin. PharmacoEconomics. http://www.ncbi.nlm.nih.gov/pubmed/24488576
Policy recommendations for addressing privacy challenges associated with cell-based research and interventions. BMC Medical Ethics. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3914710/
2013
Reflections on the Cost of “Low-Cost” Whole Genome Sequencing: Framing the Health Policy Debate. PLoS Biology. http://www.plosbiology.org/article/info%3Adoi%2F10.1371%2Fjournal.pbio.1001699
Value-Engineered Translation for Regenerative Medicine: Meeting the Needs of Health Systems. Stem Cells and Development. http://online.liebertpub.com/doi/pdfplus/10.1089/scd.2013.0398
The Paradoxes of Pop Science. Policy Options. Sept – Oct 2013 http://www.irpp.org/en/po/the-age-of-man/the-paradoxes-of-pop-science/
Pressing the Pause Button. Cure Magazine. Sept 2013. http://www.curetoday.com/
Direct-to-consumer genetic testing — where should we focus the policy debate? Medical Journal of Australia. https://www.mja.com.au/journal/2013/198/9/direct-consumer-genetic-testing-where-should-we-focus-policy-debate
Reflections on the Cost of “Low-Cost” Whole Genome Sequencing: Framing the Health Policy Debate. PLoS Biology. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3818164/
Ethics and Genomic Incidental Findings. Science. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3772710/
Policy Uncertainty, Sequencing, and Cell Lines. G3 Genomes. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3737160/
Angelina Jolie’s faulty gene: newspaper coverage of a celebrity’s preventive bilateral mastectomy in Canada, the United States, and the United Kingdom. Genetics in Medicine. http://www.ncbi.nlm.nih.gov/pubmed/24357851
A Canadian screening program for hepatitis C: Is now the time? CMAJ online. http://www.cmaj.ca/content/185/15/1325/reply