Médecine de précision et Evidence-Based Medicine : quelle articulation ?
DOI:
https://doi.org/10.20416/lsrsps.v4i2.683Keywords:
médecine personnalisée, médecine systémique des 4P, médecine de précision, cancérologie, mécanisme, statistique, Evidence-based Medicine, personalised medicine, P4 systems medicine, precision medicine, oncology, mechanism, statisticAbstract
Evidence-Based Medicine (EBM) and Personalized Medicine (PM) share a common goal: reducing the gap between the results of biomedical research and their clinical application. PM is, however, often presented as a “new paradigm” for medicine, just as EBM was in the 1990s. It covers a wide variety of projects but the core idea that generally unites them is the ambition of better taking account of individual specificities than did EBM with its statistical and population-centred approach. In this article, I concentrate on PM in cancerology, the essence of which is to target treatments based on the molecular profile of the patient. This targeting is made possible by gaining better knowledge about the molecular mechanisms of cancers. The classification of patients as a function of their molecular profile entails the creation of patient sub-groups. This creates a problem for the traditional evaluation of therapeutic treatment promoted by EBM, in particular the use of randomized trials using sizeable cohorts. But a better understanding of the mechanisms and the greater precision of treatments could reduce the need for these trials. Does PM thus represent the revenge of a physio-pathological and mechanistic culture in clinical research against the statistical and empirical one of EBM? My objective is to show how current practices of PM leads to epistemological changes in our estimation of what count as relevant types of information and proof in medicine, in particular in the field of therapeutic evaluation. I defend the idea that PM, far from obviating the need for statistical approaches and the search for correlations, ultimately poses new challenges for EBM. PM drives EBM to strengthen the articulation and the integration of statistical and mechanistic data with a view to providing a better service for each patient.
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LILLIE Elizabeth O, PATAY Bradley, DIAMANT Joel, ISSELL Brian, TOPOL Eric J. et SCHORK Nicholas J. 2011. The n-of-1 clinical trial: the ultimate strategy for individualizing medicine? Personalized medicine, 8, 161–173.
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TEIRA, David. 2016. Testing oncological treatments in the era of personalized medicine. In Philosophy of molecular Medicine. Foundational Issues in Research and Practice. London; New York: Routledge. 236–250.
TONELLI, M. R. 1998. The philosophical limits of evidence-based medicine. Academic Medicine: Journal of the Association of American Medical Colleges, 73, 1234–1240.
TRÖLHER, Ulrich. 2012. Chapitre 1. Surmonter l’ignorance thérapeutique : un voyage à travers trois siècles. Sciences & philosophie, 31–53.
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TURSZ Thomas et BERNARDS Rene. 2015. Hurdles on the road to personalized medicine. Molecular Oncology, 9, Clinical Trials for Development of Personalized Cancer Medicine, 935–939.
VAIDYANATHAN, Gayathri. 2012. Redefining clinical trials: the age of personalized medicine. Cell, 148, 1079–1080.
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BERRY, Donald A. 2011. Adaptive Clinical Trials: The Promise and the Caution. Journal of Clinical Oncology, 29, 606–609.
BERRY, Donald A. 2015. The Brave New World of clinical cancer research: Adaptive biomarker-driven trials integrating clinical practice with clinical research. Molecular Oncology 9. Clinical Trials for Development of Personalized Cancer Medicine: 951–959.
BERTOLASO, Maria. 2016. Philosophy of Cancer - A Dynamic and Relational View. Springer.
BILLAUD, Marc. 2012. L’hétérogénéité intratumorale. M/S-Medecine Sciences 28, 1116.
BLUHM, Robyn, and BORGERSON, Kirstin. 2011. Evidence-Based Medicine. In GIFFORD, Fred (dir.), Philosophy of Medicine. Elsevier, 203-238.
CARTWRIGHT, Nancy. 2012. Presidential address: Will this policy work for you? Predicting effectiveness better: How philosophy helps. Philosophy of Science, 79, 973–989.
CARTWRIGHT, Nancy, and MUNRO Eileen. 2010. The limitations of randomized controlled trials in predicting effectiveness. Journal of evaluation in clinical practice, 16, 260–266.
CATENACCI, Daniel V. T. 2015. Next-generation clinical trials: Novel strategies to address the challenge of tumor molecular heterogeneity. Molecular Oncology, 9, Clinical Trials for Development of Personalized Cancer Medicine, 967–996.
CLARKE, Brendan, GILLIES Donald, ILLARI Phyllis, RUSSO Federica, and WILLIAMSON Jon. 2013. The evidence that evidence-based medicine omits. Preventive Medicine, 57, 745–747.
CLARKE, Brendan, GILLIES Donald, ILLARI Phyllis, RUSSO Federica, and WILLIAMSON Jon. 2014. Mechanisms and the evidence hierarchy. Topoi, 33, 339–360.
DALY, Jeanne. 2005. Evidence-based medicine and the search for a science of clinical care. Vol. 12. Univ of California Press.
DE GRANDIS, Giovanni, and HALGUNSET Vidar. 2016. Conceptual and terminological confusion around personalised medicine: a coping strategy. BMC Medical Ethics, 17, 43.
DION-LABRIE, Marianne, FORTIN M. C., HEBERT M. J., and DOUCET H. 2008. Réflexions éthiques sur la médecine personnalisée: l’alliance de la science et de la médecine enfin réalisée? Revista Colombiana de Bioética, 3, 33–56.
DUAN, Naihua, KRAVITZ Richard L., and SCHMID Christopher H. 2013. Single-patient (n-of-1) trials: a pragmatic clinical decision methodology for patient-centered comparative effectiveness re-search. Journal of clinical epidemiology, 66, S21–S28.
EVIDENCE-BASED MEDICINE WORKING GROUP. 1992. Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA: the journal of the American Medical Association, 268, 2420.
FLETCHER, Robert H., FLETCHER Suzanne W., and FLETCHER Grant S. 2012. Clinical epidemiology: the essentials. Lippincott Williams & Wilkins.
GIROUX, Élodie. 2008. L’épidémiologie entre population et individu : quelques clarifications à partir de la notion de la pensée populationnelle’. Bulletin d’Histoire et d’épistémologie des sciences de la vie, 1, 37–52.
GIROUX, Élodie. 2012. De l’épidémiologie de santé publique à l’épidémiologie clinique. Bulletin d’Histoire et d’épistémologie des sciences de la vie, 19, 21–43.
GIROUX, Élodie. 2013. The Framingham study and the constitution of a restrictive concept of risk factor. Social history of medicine, 26, 94–112.
GROENENDIJK, Floris H., and René Bernards. 2014. Drug resistance to targeted therapies: déjà vu all over again. Molecular Oncology, 8, 1067–1083.
GUCHET, Xavier. 2016. La médecine personnalisée: un essai philosophique. Paris : Les Belles Lettres.
GUYATT, G. H., KELLER J. L., JAESCHKE R., ROSENBLOOM, D., ADACHI J.D., and NEWHOUSE, M.T. 1990. The n-of-1 randomized controlled trial: clinical usefulness. Our three-year experience. Annals of internal medicine, 112, 293–299.
GUYATT, G, SACKETT, D., TAYLOR, D. W., CHONG, J., ROBERTS, R., and PUGSLEY, S. 1986. Determining optimal therapy-randomized trials in individual patients. The New England journal of medicine, 314, 889–892.
HOOD, Leroy. 2013. Systems biology and p4 medicine: past, present, and future. Rambam Maimonides medical journal, 4.
HOOD, Leroy, BALLING, Rudi, and AUFFRAY, Charles. 2012. Revolutionizing medicine in the 21st century through systems approaches. Biotechnology Journal, 7, 992–1001.
HOOD, Leroy, and FLORES, Mauricio. 2012. A personal view on systems medicine and the emergence of proactive P4 medicine: predictive, preventive, personalized and participatory. New Biotechnology, 29, Molecular Diagnostics & Personalised Medicine, 613–624.
HOOD, Leroy, and FRIEND, Stephen. 2011. Predictive, personalized, preventive, participatory (P4) cancer medicine. Nature Reviews Clinical Oncology, 8, 184–187.
HOWICK, Jeremy H. 2011. The Philosophy of Evidence-based Medicine. John Wiley & Sons.
HOWICK, Jeremy, GLASZIOU, Paul, and ARONSON, Jeffrey K.. 2013. Problems with using mechanisms to solve the problem of extrapolation. Theoretical medicine and bioethics, 34, 275–291.
IOANNIDIS, John P. A. 2008. Why most discovered true associations are inflated. Epidemiology, 19, 640–648.
IOANNIDIS, John PA. 2009. Limits to forecasting in personalized medicine: an overview. International Journal of Forecasting, 25, 773–783.
IOANNIDIS, John PA, and KHOURY, Muin J. 2013. Are randomized trials obsolete or more important than ever in the genomic era? Genome Medicine 5, 32.
ITHIMAKIN, Suthinee, DAY, Kathleen C., MALIK, Fayaz, ZEN, Qin, DAWSEY, Scott J., BERSANOBEGEY Tom F., QURAISHI Ahmed A., et al. 2013. HER2 Drives Luminal Breast Cancer Stem Cells in the Absence of HER2 Amplification: Implications for Efficacy of Adjuvant Trastuzumab. Cancer Research, 73, 1635–1646.
JOFFE, Michael. 2011. The gap between evidence discovery and actual causal relationships. Preventive Medicine, 53, Special Section: Epidemiology, Risk, and Causation, 246–249.
KEATING, Peter, and CAMBROSIO, Alberto. 2011. Cancer on trial: oncology as a new style of practice. University of Chicago Press.
La CAZE, Adam. 2011. The role of basic science in evidence-based medicine. Biology & Philosophy, 26, 81–98.
LE TOURNEAU, Christophe, BELIN, Lisa, PAOLETTI, Xavier, BIECHE, Ivan, and KAMAL, Maud. 2015. Precision medicine: lessons learned from the SHIVA trial – Authors’ reply. The Lancet Oncology, 16, e581–e582.
LE TOURNEAU, Christophe, KAMAL, Maud, TREDAN, Olivier, DELORD, Jean-Pierre, CAMPONE, Mario, GONCALVES, Anthony, ISAMBERT, Nicolas, et al. 2012. Designs and challenges for personalized medicine studies in oncology: focus on the SHIVA trial. Targeted oncology, 7, 253–265.
DE LEON, Jose. 2012. Evidence-based medicine versus personalized medicine: are they enemies? Journal of clinical psychopharmacology, 32, 153–164.
LILLIE Elizabeth O, PATAY Bradley, DIAMANT Joel, ISSELL Brian, TOPOL Eric J. et SCHORK Nicholas J. 2011. The n-of-1 clinical trial: the ultimate strategy for individualizing medicine? Personalized medicine, 8, 161–173.
MARTIN, Thierry. 2011. Chapitre 2. De la diversité des probabilités. In KUPIEC Jean-Jacques, GANDRILLON Olivier, MORANGE Michel et SILBERSTEIN Marc (dir.), Le hasard au cœur de la cellule. Editions Matériologiques. 60.
MENDELSOHN, John, RINGBORG, Ulrik, and SCHILSKY, Richard. 2015. Innovative clinical trials for development of personalized cancer medicine. Molecular Oncology, 9, Clinical Trials for Development of Personalized Cancer Medicine, 933–934.
NARDINI, Cecilia, ANNONI, Marco, and SCHIAVONE, Giuseppe. 2012. Mechanistic understanding in clinical practice: complementing evidence-based medicine with personalized medicine. Journal of evaluation in clinical practice, 18, 1000–1005.
NELSON, Nicole C., KEATING, Peter, CAMBROSIO, Alberto, AGUILAR-MAHECHA, Adriana, and BASIK, Mark. 2014. Testing devices or experimental systems? Cancer clinical trials take the ge-nomic turn. Social Science & Medicine, 111, 74–83.
OCANA Alberto, AMIR Eitan, VERABADILLO Francisco, SERUGA Bostjan et TANNOCK Ian F.. 2013. Phase III trials of targeted anticancer therapies: redesigning the concept. Clinical Cancer Research: An Official Journal of the American Association for Cancer Research, 19, 4931–4940.
PACI, Angelo, BLETON, Benjamin, HAGGIAG MAZEAU, Dominique, and D’USSEL, Aude. 2013. Médecine personnalisée et cancer. Paris : IGR Press.
PEREIRA, Tiago V., HORWITZ, Ralph I., and IOANNIDIS, John P. A. 2012. Empirical evaluation of very large treatment effects of medical interventions. JAMA, 308, 1676–1684.
PIGNATTI Francesco, JONSSON Bertil, BLUMENTHAL Gideon et JUSTICE Robert. 2015. Assessment of benefits and risks in development of targeted therapies for cancer–the view of regulatory authorities. Molecular oncology, 9, 1034–1041.
PLUTYNSKI, Anya. 2013. Cancer and the Goals of Integration. Studies in History and Philosophy of Science Part C, 466–476.
POKORSKA-BOCCI, Anna, STEWART, Alison, SAGOO, Gurdeep S., HALL, Alison, KROESE, Mark, and BURTON, Hilary. 2014. “Personalized medicine”: what’s in a name? Personalized Medi-cine, 11, 197–210.
ROSE, Geoffrey. 1992. The strategy of preventive medicine. Oxford: Oxford University Press.
RUSSO, Federica, and WILLIAMSON Jon. 2007. Interpreting causality in the health sciences. International studies in the philosophy of science, 21, 157–170.
SACKETT, D L, ROSENBERG, W M, GRAY, J A, HAYNES, R B, and RICHARDSON, W.S. 1996. Evidence based medicine: what it is and what it isn’t. BMJ (Clinical research ed.), 312, 71–72.
SCHWARTZ, Daniel. 1999. Le jeu de la science et du hasard. La statistique et le vivant. Paris : Flammarion.
SHARMA, Manish R., and SCHILSKY, Richard L.. 2011. Role of randomized phase III trials in an era of effective targeted therapies. Nature reviews Clinical oncology, 9, 208–214.
TEIRA, David. 2011. Frequentist versus Bayesian clinical trials. In GIFFORD Fred (ed.), Philosophy of Medicine. Elsevier. 255–297.
TEIRA, David. 2016. Testing oncological treatments in the era of personalized medicine. In Philosophy of molecular Medicine. Foundational Issues in Research and Practice. London; New York: Routledge. 236–250.
TONELLI, M. R. 1998. The philosophical limits of evidence-based medicine. Academic Medicine: Journal of the Association of American Medical Colleges, 73, 1234–1240.
TRÖLHER, Ulrich. 2012. Chapitre 1. Surmonter l’ignorance thérapeutique : un voyage à travers trois siècles. Sciences & philosophie, 31–53.
TSIMBERIDOU, Apostolia-Maria, BRAITEH, Fadi, STEWART, David J., and KURZROCK Razelle. 2009. Ultimate fate of oncology drugs approved by the us food and drug administration without a randomized Trial. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 27, 6243–6250.
TURSZ Thomas et BERNARDS Rene. 2015. Hurdles on the road to personalized medicine. Molecular Oncology, 9, Clinical Trials for Development of Personalized Cancer Medicine, 935–939.
VAIDYANATHAN, Gayathri. 2012. Redefining clinical trials: the age of personalized medicine. Cell, 148, 1079–1080.
VANDENBROUCKE, J P. 1988. Is “the causes of cancer” a miasma theory for the end of the twentieth century? International journal of epidemiology, 17, 708–709.
WEISS, Glen J. 2015. Precision medicine: lessons learned from the SHIVA trial. The Lancet Oncology, 16, e580. .
WORRALL, John. 2002. What Evidence in Evidence-Based Medicine? Proceedings of the Philosophy of Science Association 2002, 316–330.
WORRALL, John. 2007. Evidence in Medicine and Evidence-Based Medicine. Philosophy Compass, 2, 981–8211.
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2018-03-27
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Giroux, Élodie. 2018. “Médecine De précision Et Evidence-Based Medicine : Quelle Articulation ?”. Lato Sensu: Revue De La Société De Philosophie Des Sciences 4 (2). https://doi.org/10.20416/lsrsps.v4i2.683.
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Contemporary issues in personalized medicine
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