Ressource pédagogique : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Journal editor’s viewpoints

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Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Journal editor’s viewpoints Speaker: John JARCHO, Boston, USA, NEJM Discussant: Rita REDBERG, San Francisco, USA, Arch Intern Med Abstract : Biomarker studies have proliferated widely, but the actual impact of most such studies on the practice of medicine is modest. One major underlying problem is a lack of clarity (on the part of both investigators and readers) about what biomarker data can be expected to contribute. In many cases, studies merely demonstrate a statistical association between a putative biomarker and a clinical correlate, but the implications of this association are not made explicit. In some cases, there is an expectation that a new biomarker, if found to correlate with disease, will reveal previously unsuspected or unproven aspects of disease pathogenesis; but scientific discovery is achieved by an association study alone. Novel biomarkers may occasionally improve diagnosis, as with high-sensitivity troponin assays, or guide patient management, as has been suggested for assays for natriuretic peptides. By far the most common type of biomarker study in cardiovascular medicine, however, seeks to associate novel markers with cardiovascular risk. The incremental value of novel biomarkers in this setting has typically been quite limited, and it is important when considering the relationship of a novel biomarker to cardiovascular risk to be clear about how large (or small) the increment actually is. Newer statistical methods such as the integrated discrimination index and net reclassification improvement are helpful in discerning the actual prognostic value of a novel biomarker. Even given a substantial increment in predictive value, however, the question remains whether the improvement in prediction thus attained will justify a change in patient management. L’auteur n’a pas transmis de conflit d’intérêt concernant les données diffusées dans cette vidéo ou publiées dans la référence citée. 9th Global Cardiovascular Clinical Trialists Forum • Paris 2012 ESC Working group on cardiovascular pharmacology and drug therapy International Society of Cardiovascular Pharmacotherapy (ISCP) CardioVascular Clinical Trialists (CVCT) Joint session PERSONALIZED CARDIOVASCULAR MEDICINE AND DRUG DEVELOPMENT: TIME FOR A NEW TRIAL PARADIGM Chairpersons: Juan Carlos KASKI, London, GBR - Bertram PITT, Ann Arbor, USA - Luis RUILOPE, Madrid, ESP - “Drugs, in general, act not on single targets operating in a vacuum, but perturb a complex network of interacting proteins or metabolites to modify the dynamic output of a system that can extend well beyond the pathway in which the original target is operative. Therefore, to develop drugs in this century, one needs to move beyond the  reduction ist biomedical science of Occam, Descartes, Osler, and Ehrlich, and consider the complex biological system within which a drug acts holistically, in its tractable entirety. One needs to apply the principles of systems biology to pharmacology, and thereby establish the new discipline of systems pharmacology.” Dr Joseph Loscalzo, Lewis A. Conner Lecture, Circulation 2012. - “We need to develop a robust, viable business model through which the pharmaceutical industry can move from drug development strategies that are population-based to strategies that focus on increasingly individualized therapies. There needs to be an alignment of incentives that move the industry from conventional blockbuster drugs developed in large populations with single drug targets within which one size fits all toward smaller, better defined systems pharmacologybased molecular pathophenotypes that benefit from these well conceived therapies with minimal risk.” Dr Joseph Loscalzo, Lewis A. Conner Lecture, Circulation 2012. - “Heart Failure is not a disease and we should no longer approve drugs for a heterogeneous broad population, but for a well defined sub-population where we can demonstrate a marked benefit” Dr. Stephen Grant, Deputy Director, Division of Cardiovascular Renal Products, CDER - “Regulatory bodies like the FDA and the EMA will most likely require new trials to scrutinize events (i.e. AMI) very strictly. Well conducted registries will be important in this context so clinicians can report their findings in real life patients. Academic institutions and independent pharmacological and pharmacotherapy associations such as ISCP should provide mechanistic data as to the possible reasons for the detected increased prevalence of MI in some patient groups receiving treatment with direct thrombin inhibitors. Lessons learned with other new pharmacological agents in the past will necessarily require that the medical and pharmacological communities together with industry and regulatory agencies take up the challenge and work synergistically and in synchrony to clarify the side effects and excess MI risk – albeit minimal according to current studies - associated with the newer anticoagulants. - We are all now at the start of a long and winding road that should hopefully take us to better understand the mechanism of action, the therapeutic efficacy and the adverse effects associated with the use of the new anticoagulants. Together we should prevent unnecessary complications that might derive from the use of these important agents in the wrong patient groups.” Juan Carlos Kaski, Cardiovasc Drugs Ther, 2012 Réalisation, production : Canal U/3S et CERIMES Keyword : Cardiovascular Clinical Trialists, Paris, 2012, Cardiovascular prevention, cardiovascular pharmacology, ISCP

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• Sciences médicales. Médecine (610)

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