Jean Pierre Boissel
- Planning of clinical trialsJ P Boissel
Clinical Pharmacology Department, RTH Laennec School of Medicine, Lyon Cedex, France
J Intern Med 255:427-38. 2004..As such, it should meet the fundamentals of scientific discovery that guarantee causality between the observed difference and the intervention. All the planning components are thought according to these fundamentals...
- Bridging the gap between therapeutic research results and physician prescribing decisions: knowledge transfer, a prerequisite to knowledge translationJean Pierre Boissel
Faculté RTH Laennec, Service de Pharmacologie Clinique EA3736, Rue Guillaume Paradin, 69376, Lyon Cedex 08, France
Eur J Clin Pharmacol 60:609-16. 2004..We demonstrate in this article that there are no theoretical or technical obstacles to make the proposed system workable...
- Pharmacogenetics and responders to a therapy: theoretical background and practical problemsJean Pierre Boissel
Clinical Pharmacology Department, Academic Hospital, Lyon, France
Clin Chem Lab Med 41:564-72. 2003..No method is currently both fully adequate and validated. Finally, the predictive models, which we need to identify responders, do not exist in practice. Fortunately, new research approaches have been developed recently...
- [New approaches in pharmacology: numerical modelling and simulation]Jean Pierre Boissel
Service de Pharmacologie Clinique, Faculté RTH Laënnec et Hôpital Cardiologique, Lyon, France
Therapie 60:1-15. 2005..Such approaches are considered in drug innovation and development. They require a multidisciplinary approach, and this will involve modification of the way research in pharmacology is conducted...
- [Therapeutic evaluation and the level proof]Jean-Pierre Boissel
, , 69376 Lyon 08
Rev Prat 54:199-206. 2004
- New insights on the relation between untreated and treated outcomes for a given therapy effect model is not necessarily linearJean Pierre Boissel
Institute for Theoretical Medicine and CNRS UMR5558, RTH Laennec School of Medicine, Rue Guillaume Paradin, 69008 Lyon, France
J Clin Epidemiol 61:301-7. 2008..We have called this relation the effect model. Our objectives were to demonstrate that the relation is general and not necessarily linear...
- Modelling methodology in physiopathologyJean Pierre Boissel
CNRS, UMR5558, Lyon, France
Prog Biophys Mol Biol 97:28-39. 2008..Tools and techniques for integrating the parameter range of experimental values, level of evidence and missing data are needed...
- Using pharmacokinetic-pharmacodynamic relationships to predict the effect of poor complianceJean Pierre Boissel
Department of Clinical Pharmacology, Claude Bernard University and Teaching Hospital, Lyon, France
Clin Pharmacokinet 41:1-6. 2002..A marker of forgiveness would be of some help for doctors deciding which drug to prescribe to patients who are poor compliers...
- A modelling approach to explore some hypotheses of the failure of neuroprotective trials in ischemic stroke patientsMarie Aimée Dronne
Universite de Lyon, Lyon, F 69003, France
Prog Biophys Mol Biol 97:60-78. 2008..It reinforces the hypothesis that histological and morphological differences between rodent and human brains can partly explain the failure of these agents in clinical trials...
- How to measure non-consistency of medical practices with available evidence in therapeutics: a methodological frameworkJean Pierre Boissel
Centre de Recherche en Ingénierie des Connaissances Appliquée à la Thérapeutique Service de Pharmacologie Clinique EA3637, Faculté de médecine RTH Laennec, Universite Claude Bernard, Lyon, Cedex 08, France
Fundam Clin Pharmacol 19:591-6. 2005..All these features should be taken into account for a more accurate and relevant assessment of the distance...
- Mathematical modelling of an ischemic stroke: an integrative approachMarie Aimée Dronne
Service de Pharmacologie Clinique, EA 643, Faculte de Medecine Laennec, Universite Claude Bernard, Lyon, France
Acta Biotheor 52:255-72. 2004....
- Apparent effect on blood pressure is only partly responsible for the risk reduction due to antihypertensive treatmentsJean Pierre Boissel
Service de Pharmacologie Clinique, Claude Bernard University, Faculté RTH Laennec, Rue G Paradin, 69376 Lyon, France
Fundam Clin Pharmacol 19:579-84. 2005..This result suggests that the apparent effect on blood pressure is not the only cause of stroke risk reduction in hypertensive subjects submitted to an antihypertensive medicine...
- Role of astrocytes in grey matter during stroke: a modelling approachMarie Aimée Dronne
UMR 5558, Université Lyon1, CNRS, Institut de Médecine Théorique, Lyon, France
Brain Res 1138:231-42. 2007..A detailed understanding of astrocytic function and influence on neuron survival during stroke is necessary to improve the neuroprotective strategies for stroke patients...
- Treatment of high blood pressure and gain in event-free life expectancyBehrouz Kassai
Department of Clinical Pharmacology, Claude Bernard University, Lyon, France
Vasc Health Risk Manag 1:163-9. 2005..Consideration of absolute risk has been recommended for making decisions concerning preventive treatment in hypertension. We performed simulations to estimate the benefit of antihypertensive therapy over a life-time...
- Clinical trial simulation using therapeutic effect modeling: application to ivabradine efficacy in patients with angina pectorisSylvie Chabaud
Service de Pharmacologie Clinique, Faculté RTH Laennec, Rue Guillaume Paradin, BP 8071, 69376 Lyon, France
J Pharmacokinet Pharmacodyn 29:339-63. 2002....
- The true treatment benefit is unpredictable in clinical trials using surrogate outcome measured with diagnostic testsBehrouz Kassai
Department of Clinical Pharmacology EA 3736, University Hospital of Lyon, Rue Guillaume Paradin, BP 8071, Lyon cedex 08 69376, France
J Clin Epidemiol 58:1042-51. 2005..by the reference standard a valid surrogate? (2) How does the tests accuracy influence the estimate of the treatment benefit on surrogate? (3) Is it possible to correct the measured treatment effect given by results of inaccurate tests?..
- Literature search parameters marginally improved the pooled estimate accuracy for ultrasound in detecting deep venous thrombosisBehrouz Kassai
Clinical Investigation Centre INSERM, Department of Clinical Pharmacology EA 3736, Hôpitaux de Lyon, Universite Claude Bernard Lyon I, Lyon Cedex 08, France
J Clin Epidemiol 59:710-4. 2006..Our objectives were to compare search strategies with and without methodological terms in Medline, to find out how other databases complement Medline, and how these strategies affect the pooled estimates of the accuracy...
- A mathematical model of ion movements in grey matter during a strokeMarie Aimée Dronne
Service de Pharmacologie Clinique, EA 3736, Faculte de Medecine Laennec, Rue Guillaume Paradin, BP 8071, 69376 Lyon, Cedex 08, France
J Theor Biol 240:599-615. 2006..This approach may help to explore new therapeutic strategies in order to reduce stroke damage...
- Revisiting the level of evidence in randomized controlled clinical trials: A simulation approachAgathe Bajard
Universite Lyon 1, Léon Bérard Anticancer Centre, Department of Public Health, Biostatistics and Therapeutic evaluation Unit, Lyon, France
Contemp Clin Trials 30:400-10. 2009..However, evaluating available evidence is often still based on intuitive processes rather than on rigorous scientific analysis...
- A systematic review of the accuracy of ultrasound in the diagnosis of deep venous thrombosis in asymptomatic patientsBehrouz Kassai
Clinical Pharmacology Unit, Rue Guillaume Paradin BP8071 69376, Lyon Cedex 08, France
Thromb Haemost 91:655-66. 2004..Our results suggest that, particularly for proximal veins, ultrasound is accurate for the diagnosis of DVT in asymptomatic postoperative orthopedic patients. More research is needed in other clinical settings...
- SCORE should be preferred to Framingham to predict cardiovascular death in French populationIvanny Marchant
IMTh Institute for Theoretical Medicine CNRS, UMR 5558, Laboratoire de Biometrie et Biologie Evolutive, Service de Pharmacologie Clinique, Lyon, France
Eur J Cardiovasc Prev Rehabil 16:609-15. 2009..Numerous studies have examined the validity of available scores to predict the absolute cardiovascular risk...
- Use of sensitivity functions to characterise and compare the forgiveness of drugsPatrice Nony
Clinical Pharmacology Unit, EA 643, Cardiovascular Hospital, Lyon, France
Clin Pharmacokinet 41:371-80. 2002....
- Physiologically based model of acute ischemic strokeVincent Duval
Department of Clinical Pharmacology, EA643, School of Medicine, Universite Claude Bernard, Lyon, France
J Cereb Blood Flow Metab 22:1010-8. 2002..The model integrated different markers of acute ischemic stroke into a single entity in order to mimic acute ischemic stroke, and has been shown to have a reasonable degree of internal validity...
- Exploration of beneficial and deleterious effects of inflammation in stroke: dynamics of inflammation cellsTaïssia Lelekov-Boissard
Faculte de Medecine Laennec, Universite Claude Bernard Lyon 1, 69372 Lyon Cedex 08, France
Philos Transact A Math Phys Eng Sci 367:4699-716. 2009..This approach may help to explore the respective contributions of the beneficial and deleterious roles of the inflammatory process in stroke, and to study various therapeutic strategies in order to reduce stroke damage...
- A pharmacologically based multiscale mathematical model of angiogenesis and its use in investigating the efficacy of a new cancer treatment strategyFrédérique Billy
Universite de Lyon, F 69000 Lyon, France
J Theor Biol 260:545-62. 2009..This theoretical model may be useful to evaluate the efficacy of therapies targeting angiogenesis, and could therefore contribute to designing prospective clinical trials...
- Reappraisal of metformin efficacy in the treatment of type 2 diabetes: a meta-analysis of randomised controlled trialsRémy Boussageon
Department of General Medicine, Universite Claude Bernard Lyon 1, Lyon, France
PLoS Med 9:e1001204. 2012..Since then, it has been the first-line treatment in overweight patients with type 2 diabetes. However, metformin-sulphonylurea bitherapy may increase mortality...
- New tools to measure discrepancy between prescribing practices and guideline recommendationsCatherine Mercier
Service de Biostatistique, Hospices Civils de Lyon, Lyon, France
J Eval Clin Pract 13:639-46. 2007..To study the performance of a new method designed to measure discrepancy between real prescriptions and evidence-based reference treatments...
- Bioequivalence evaluation of a fixed combination of chloroquine and proguanil in a capsule formulation versus a standard medicationJean François Chaulet
Laboratoire de Biochimie Toxicologie et Pharmacologie de l Hôpital d Instruction des Armées Desgenettes, Lyon, France
Arzneimittelforschung 52:407-12. 2002..Therefore, the use of a single capsule instead of one chloroquine tablet and two proguanil tablets daily can be proposed in order to increase the prophylactic compliance without decreasing the prophylactic efficacy...
- Why don't cancer patients enter clinical trials? A reviewPatrick Castel
ONCORA, Centre Leon Berard, 28 rue Laennec, 69008 Lyon, France
Eur J Cancer 42:1744-8. 2006....
- A simple tool to evoke physicians' real training needsDavid Perol
Department of Public Health, Leon Berard Center, Lyon, France
Acad Med 77:407-10. 2002..However, it should be assessed further by those involved in CME for general practitioners...
- Planning and monitoring of placebo-controlled survival trials: comparison of the triangular test with usual interim analyses methodsJean Sebastien Hulot
Pharmacology Department, Pitie Salpetriere Hospital, Paris, France, Clinical Pharmacology Unit, Lyon Hospitals, Lyons, France
Br J Clin Pharmacol 55:299-306. 2003..This study was conducted to compare the efficiency of two interim analysis procedures, which could be used to allow early termination of a clinical trial...
- Compliance-guided therapy : a new insight into the potential role of clinical pharmacologistsAlexia Blesius
Clinical Pharmacology Department, Cardiovascular Hospital, Lyon 69003, France
Clin Pharmacokinet 45:95-104. 2006..e. drug level measurements, enzyme assays and even genetic sequence data), our study suggests that compliance-guided therapy may represent a potential, evolving way for the individualisation of prescriptions...
- J-shaped relationship between blood pressure and mortality in hypertensive patients: new insights from a meta-analysis of individual-patient dataFlorent Boutitie
Claude Bernard University, Lyon, France
Ann Intern Med 136:438-48. 2002..However, several studies in hypertensive patients receiving treatment have described this relationship as J-shaped, with an increased risk for events in patients with low blood pressure...
- Level of evidence and therapeutic evaluation: need for more thoughtsNadine Bossard
Service de Biostatistique, Centre Hospitalier Lyon Sud, Lyon, France
Fundam Clin Pharmacol 18:365-72. 2004....
- Getting evidence to prescribers and patients or how to make EBM a realityJean-Pierre Boissel
Service de Pharmacologie Clinique/EA643, , Lyon, France
Stud Health Technol Inform 95:554-9. 2003..We conceived a new paradigm and designed an Internet process based on it by which unbiased evidence is brought to doctors in such a format that it can be accessed and used during the visit...
- How to deal with multiple treatment or dose groups in randomized clinical trials? Another approachJean Pierre Boissel
Fundam Clin Pharmacol 21:155-6. 2007..It is better to avoid it by careful thinking prior to beginning the experiment. In fundamental and clinical pharmacology, there are several established concepts that allow researchers to minimize the cases where the issue arises...
- How should therapeutic information be transferred to users?Jean Pierre Boissel
EA 643 Clinical Pharmacology Department, RTH Leannec School of Medicine, Claude Bernard University, Rue Guillaume Paradin 69376 Lyon Cedex 08, France
Fundam Clin Pharmacol 17:495-503. 2003..We suggest that a new approach is possible by reducing the transferred information to its core and integrating it through appropriate representation models into the doctor's decision-making process...
- Absolute benefit, number needed to treat and gain in life expectancy: which efficacy indices for measuring the treatment benefit?Behrouz Kassai
EA 643 Clinical Pharmacology Unit, Claude Bernard University, Facultá RTH Laennec, Rue Guillaume Paradin BP 8071 69376, Lyon 08, France
J Clin Epidemiol 56:977-82. 2003..Considering the gain in event-free life expectancy, low-risk patients benefit more than high-risk patients do, at the expense of a longer treatment exposure. The interpretation of the AB changes depending on follow-up...
- Pulsatile blood pressure component as predictor of mortality in hypertension: a meta-analysis of clinical trial control groupsJerzy Gasowski
Hypertension and Cardiovascular Rehabilitation Unit, Department of Molecular and Cardiovascular Research, University of Leuven, Herestraat 49, B-3000 Leuven, Belgium
J Hypertens 20:145-51. 2002..01). CONCLUSIONS: In hypertensive patients pulse pressure, not mean pressure, is associated with an increased risk of fatal events. This appears to be true in a broad range of patients with hypertension...
- Soluble Fas ligand and atherosclerosis in hypertensive patientsJean-Pierre Boissel
J Hypertens 20:819-20. 2002
- [Meta-analysis of clinical trials: uses and pitfalls]Jean Pierre Boissel
RTH, Laennec, Lyon 1
Bull Acad Natl Med 191:759-70. 2007..Meta-analysis of clinical trials allows all available quantitative evidence on therapeutic efficacy, to be condensed. Critical appraisal of all available evidence is a pillar of clinical science...
- How to anticipate the assessment of the public health benefit of new medicines?Jacques Massol
Phisquare Institute, The Foundation Transplantation, Besancon, France
Therapie 62:427-35. 2007..Finally, because of the PHB's universal dimension, it is suggested that the necessary actions and publications be initiated so that the PHB can be acknowledged at the European level...
- [How should one anticipate the assessment of the public health benefit of new medicines?]Jacques Massol
Institut Phisquare, Fondation Transplantation, Besancon, France
Therapie 62:417-25. 2007
- QxDB: a generic database to support mathematical modelling in biologyBenjamin Ribba
Institute for Theoretical Medicine and Clinical Pharmacology Department, Faculty of Medicine RTH Laennec, University of Lyon, Paradin St, POB 8071, 69376 Lyon Cedex 08, France
Philos Transact A Math Phys Eng Sci 364:1517-32. 2006..We will illustrate this adaptability of QxDB by presenting two examples, the first dealing with modelling in oncology and the second with mechanical properties of cells and tissues...
- Evaluation of two evidence-based knowledge transfer interventions for physicians. A cluster randomized controlled factorial design trial: the CardioDAS StudyEmmanuel Amsallem
Service de Pharmacologie Clinique UMR CNRS 5558, Hopital Cardiologique, 69003 Lyon, France
Fundam Clin Pharmacol 21:631-41. 2007..Passive' transfer seems far less efficient. In addition, the size of the benefit remains small and its consequences limited in practice...
- Risk reduction for stroke and coronary eventsJean-Pierre Boissel
Lancet 359:1249; author reply 1250-1. 2002