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1. Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults

Author

Reginster, Jean-Yves, Beaudart, Charlotte, Al-Daghri, Nasser, Avouac, Bernard, Bauer, Jürgen, Bere, Nathalie, Bruyère, Olivier, Cerreta, Francesca, Cesari, Matteo, Rosa, Mario Miguel, Cooper, Cyrus, Cruz Jentoft, Alfonso J., Dennison, Elaine, Geerinck, Anton, Gielen, Evelien, Landi, Francesco, Laslop, Andrea, Maggi, Stefania, Prieto Yerro, María Concepción, Rizzoli, René, Sundseth, Hildrun, Sieber, Cornel, Trombetti, Andrea, Vellas, Bruno, Veronese, Nicola, Visser, Marjolein, Vlaskovska, Mila, and Fielding, Roger A.

Published
2021
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5. How to measure the net benefit of treatment?

Author

Avouac, Bernard, Borel, Thomas, Boussageon, Rémy, Brun-Strang, Catherine, Braunstein, David, Cazeneuve, Béatrice, Diviné, Marine, Dufour, Patrick, Girerd, Nicolas, Laigle, Valérie, Le Jeunne, Claire, Liard, François, Marsot, Amélie, Montastruc, Jean-Louis, Trinh-Duc, Albert, Vicaut, Eric, Gueyffier, François, Piedbois, Pascal, and Bergmann, Jean-François

Published
2017
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6. Comment mesure-t-on le bénéfice net d’un traitement ?

Author

Avouac, Bernard, Borel, Thomas, Boussageon, Rémy, Brun-Strang, Catherine, Braunstein, David, Cazeneuve, Béatrice, Diviné, Marine, Dufour, Patrick, Girerd, Nicolas, Laigle, Valérie, Le Jeunne, Claire, Liard, François, Marsot, Amélie, Montastruc, Jean-Louis, Trinh-Duc, Albert, Vicaut, Eric, Gueyffier, François, Piedbois, Pascal, and Bergmann, Jean-François

Published
2017
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8. Post-approval Studies in France, Challenges Facing Medical Devices

Author

Levesque, Karine, Coqueblin, Claire, Guillot, Bernard, Aubourg, Lucie, Avouac, Bernard, Carbonneil, Cédric, Cucherat, Michel, Descamps-Mandine, Patricia, Hanoka, Serge, Goldberg, Marcel, Josseran, Anne, Parquin, François, Pitel, Séverine, Ratignier, Christelle, Sechoy, Odile, Szwarcenstein, Karine, Tanti, André, Teiger, Emmanuel, and Thevenet, Nicolas

Published
2014
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14. Contraintes et spécificités de l’évaluation clinique des dispositifs médicaux

Author

Audry, Antoine, Avouac, Bernard, Barna, Alexandre, Denis, Catherine, Frachet, Bruno, Fontes, Isabelle, Gastaldi, Chrystelle, Ghislain, Jean-Claude, Guillot, Bernard, Granger, Muriel, Grumblat, Anne, Josseran, Anne, Luzergues, Gérard, Marguet, Pierre-Olivier, Martinet, Noël, Normand, Nadine, Parquin, François, Pécault, Rémy, Pitel, Sandrine, Roca, Françoise, Romano, Fabrice, Rufach, Emilie, Thiveaud, Dominique, and Vasmant, Daniel

Published
2012
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15. Clinical Evaluation of Medical Devices: Main Constraints and Specificities

Author

Audry, Antoine, Avouac, Bernard, Barna, Alexandre, Denis, Catherine, Frachet, Bruno, Fontes, Isabelle, Gastaldi, Chrystelle, Ghislain, Jean-Claude, Guillot, Bernard, Granger, Muriel, Grumblat, Anne, Josseran, Anne, Luzergues, Gérard, Marguet, Pierre-Olivier, Martinet, Noël, Normand, Nadine, (AFNOR), Parquin, François, Pécault, Rémy, Pitel, Sandrin, Roca, Françoise, Romano, Fabrice, Rufach, Emilie, Thiveaud, Dominique, and Vasmant, Daniel

Published
2012
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20. Études post-AMM : apport dans la réinscription des produits

Author

Allicar, Marie-Pierre, Ameye, Véronique, Avouac, Bernard, Banzet, Marie-Noëlle, Becquemont, Laurent, Blin, Patrick, Duguay, Corinne, Fagnani, Francis, Girault, Danièle, Haim, Muriel, Hamers, Françoise, Lalaude, Olivier, Lamarque, Véronique, Maillere, Patricia, Massol, Jacques, Maugendre, Philippe, Meyer, Arlette, Moreau-Defarges, Thierry, Pathak, Atul, Perillat, Anne, Ravoire, Sophie, Spriet, Alain, Tardieu, Sophie, Teisseire, Bernard, MoniqueWeber, Zanetti, Laura, Molimard, Mathieu, Bamberger, Marion, and Vray, Muriel

Published
2009
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21. Value of Post-Registration Studies for Reimbursement Renewal

Author

Allicar, Marie-Pierre, Ameye, Véronique, Avouac, Bernard, Banzet, Marie-Noëlle, Becquemont, Laurent, Blin, Patrick, Duguay, Corinne, Fagnani, Francis, Girault, Danièle, Haim, Muriel, Hamers, Françoise, Lalaude, Olivier, Lamarque, Véronique, Maillere, Patricia, Massol, Jacques, Maugendre, Philippe, Meyer, Arlette, Moreau-Defarges, Thierry, Pathak, Atul, Perillat, Anne, Ravoire, Sophie, Spriet, Alain, Tardieu, Sophie, Teisseire, Bernard, Weber, Monique, Zanetti, Laura, Molimard, Mathieu, Bamberger, Marion, and Vray, Muriel

Published
2009
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22. Traduction française des recommandations de l’Osteoarthritis Research Society International (OARSI) sur la prise en charge de la gonarthrose et de la coxarthrose

Author

Henrotin, Yves, Marty, Marc, Appelboom, Thierry, Avouac, Bernard, Berenbaum, Francis, Briole, Valérie, Djian, Patrick, Dougados, Maxim, Forestier, Romain, Genevay, Stéphane, Lequesne, Michel, Maheu, Emmanuel, Poiraudeau, Serge, Rannou, François, Richette, Pascal, Spector, Tim, Dubuc, Jean-Emile, and Chevalier, Xavier

Published
2009
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27. Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults

Author

Reginster, Jean Yves, Beaudart, Charlotte, Al-Daghri, Nasser M., Avouac, Bernard, Bauer, Jurgen, Bere, Nathalie, Bruyère, Olivier, Cerreta, Francesca, Cesari, Matteo, Rosa, Mario Miguel, Cooper, Cyrus, Cruz-Jentoft, Alfonso Jose, Dennison, Elaine, Geerinck, Anton, Gielen, Evelien, Landi, Francesco, Laslop, Andrea, Maggi, Stefania, Prieto Yerro, María Concepción, Rizzoli, Rene, Sundseth, Hildrun, Sieber, Cornel, Trombetti, Andrea, Vellas, Bruno, Veronese, Nicola, Visser, Marjolein, Vlaskovska, Mila, and Fielding, Roger A.

Subjects
ddc:616, Clinical trial, Treatment, Sarcopenia, Drug registration, Guidelines, Recommendations
Abstract

Background: in 2016, an expert working group was convened under the auspices of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and formulated consensus recommendations for the conduct of clinical trials for drugs to prevent or treat sarcopenia.Aims: the objective of the current paper is to provide a 2020 update of the previous recommendations in accordance with the evidence that has become available since our original recommendations.Methods: this paper is based on literature reviews performed by members of the ESCEO working group and followed up with face to face meetings organized for the whole group to make amendments and discuss further recommendations.Results: the randomized placebo-controlled double-blind parallel-arm drug clinical trials should be the design of choice for both phase II and III trials. Treatment and follow-up should run at least 6 months for phase II and 12 months for phase III trials. Overall physical activity, nutrition, co-prescriptions and comorbidity should be recorded. Participants in these trials should be at least 70-years-old and present with a combination of low muscle strength and low physical performance. Severely malnourished individuals, as well as bedridden patients, patients with extremely limited mobility or individuals with physical limitations clearly attributable to the direct effect of a specific disease, should be excluded. Multiple outcomes are proposed for phase II trials, including, as example, physical performance, muscle strength and mass, muscle metabolism and muscle-bone interaction. For phase III trials, we recommend a co-primary endpoint of a measure of functional performance and a Patient Reported Outcome Measure.Conclusion: the working group has formulated consensus recommendations on specific aspects of trial design, and in doing so hopes to contribute to an improvement of the methodological robustness and comparability of clinical trials. Standardization of designs and outcomes would advance the field by allowing better comparison across studies, including performing individual patient-data meta-analyses, and different pro-myogenic therapies.

Published
2020

28. Recommendations for an update of the current (2001) regulatory requirements for registration of drugs to be used in the treatment of osteoporosis in postmenopausal women and in men

Author

Reginster, Jean-Yves, Abadie, Eric, Delmas, Pierre, Rizzoli, René, Dere, Willard, van der Auwera, Philippe, Avouac, Bernard, Brandi, Maria-Luisa, Daifotis, Anastasia, Diez-Perez, Adolfo, Calvo, Gonzalo, Johnell, Olof, Kaufman, Jean-Marc, Kreutz, Gottfried, Laslop, Andrea, Lekkerkerker, Fritz, Mitlak, Bruce, Nilsson, Per, Orloff, John, Smillie, Mary, Taylor, Andrew, Tsouderos, Yannis, Ethgen, Dominique, and Flamion, Bruno

Published
2006
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30. Patient preferences for breast cancer treatments: a discrete choice experiment in France, Ireland, Poland and Spain.

Author

Stamuli, Eugena, Corry, Sorcha, Ross, Derek, Konstantopoulou, Thomais, Texeira, Luis, Avouac, Bernard, Debiais, Dominique, Yates, Liz, Behis, Arni, McLoughlin, Ambrose, Stowarzyszeń Amazonki, Federacja, Niewada, Maciej, Casas, Ana, Espin, Jaime, and Advisory board participants from France:, Advisory board participants from Ireland:, Advisory board participants from Poland:, Advisory board participants from Spain:

Abstract

Aim: To understand breast cancer patients' trade-offs when choosing treatments and to identify the most important treatment attributes which drive decisions. Materials & methods: A discrete choice experiment was conducted in France, Ireland, Poland and Spain. Progression-free survival, febrile neutropenia, pain, functional well-being and out-of-pocket payment were the treatment attributes. Results: 371 patients were willing to pay €6896 per year for 1 additional year of progression-free survival, €17,288 per year for perfect functional well-being and €15,138 for one pain-free year. Patients are willing to trade off progression-free survival months for better functional abilities and less pain. Conclusion: Patient preferences should be considered by regulatory agencies, reimbursement bodies, payors and clinicians for best treatment choices for the individuals. [ABSTRACT FROM AUTHOR]

Published
2022
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36. Recommendations for the Registration of Agents to be Used in the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis: Updated Recommendations from the Group for the Respect of Ethics and Excellence in Science

Author

Abadie, Eric C., Devogealer, Jean-Pierre, Ringe, Johann D., Ethgen, Dominique J., Bouvenot, Gilles M., Kreutz, Gottfried, Laslop, Andrea, Orloff, John J., Vanderauwera, Philippe M., Delmas, Pierre D., Dere, Willard H., Branco, Jaime, Altman, Roy D., Avouac, Bernard P., Menkes, Charles J., Vanhaelst, Luc, Mitlak, Bruce H., Tsouderos, Yannis, and Reginster, Jean-Yves L.

Published
2005
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37. Recommendations for the use of new methods to assess the efficacy of disease-modifying drugs in the treatment of osteoarthritis

Author

Abadie, Eric, Ethgen, Dominique, Avouac, Bernard, Bouvenot, Gilles, Branco, Jaime, Bruyere, Olivier, Calvo, Gonzalo, Devogelaer, Jean-Pierre, Dreiser, Renee Lilianee, Herrero-Beaumont, Gabriel, Kahan, Andre, Kreutz, Godfried, Laslop, Andrea, Lemmel, Ernst Martin, Nuki, George, Van De Putte, Leo, Vanhaelst, Luc, and Reginster, Jean-Yves

Published
2004
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40. Moving Towards Accountability for Reasonableness – A Systematic Exploration of the Features of Legitimate Healthcare Coverage Decision-Making Processes Using Rare Diseases and Regenerative Therapies as a Case Study

Author

Wagner, Monika, primary, Samaha, Dima, additional, Casciano, Roman, additional, Brougham, Matthew, additional, Abrishami, Payam, additional, Petrie, Charles, additional, Avouac, Bernard, additional, Mantovani, Lorenzo, additional, Sarría-Santamera, Antonio, additional, Kind, Paul, additional, Schlander, Michael, additional, and Tringali, Michele, additional

Published
2019
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41. Clinical superiority of an innovative two-component compression system versus four-component compression system in treatment of active venous leg ulcers: A randomized trial

Author

Gillet, Jean L, primary, Guex, Jean J, additional, Allaert, François A, additional, Avouac, Bernard, additional, Leger, Philippe, additional, Blaise, Sophie, additional, Marchand, Angélique, additional, Maillard, Hervé, additional, Simon, Magali, additional, Amor, Cyrine B, additional, and Pasqualini, Marion, additional

Published
2019
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42. Who seeks primary care for musculoskeletal disorders (MSDs) with physicians prescribing homeopathic and other complementary medicine? Results from the EPI3-LASER survey in France

Author

Magnier Anne-Marie, Guillemot Didier, Duru Gérard, Massol Jacques, Bénichou Jacques, Rouillon Frédéric, Lert France, Bégaud Bernard, Avouac Bernard, Rossignol Michel, Grimaldi-Bensouda Lamiae, and Abenhaim Lucien

Subjects
Diseases of the musculoskeletal system, RC925-935
Abstract

Abstract Background There is a paucity of information describing patients with musculoskeletal disorders (MSDs) using complementary and alternative medicines (CAMs) and almost none distinguishing homeopathy from other CAMs. The objective of this study was to describe and compare patients with MSDs who consulted primary care physicians, either certified homeopaths (Ho) or regular prescribers of CAMs in a mixed practice (Mx), to those consulting physicians who strictly practice conventional medicine (CM), with regard to the severity of their MSD expressed as chronicity, co-morbidity and quality of life (QOL). Methods The EPI3-LASER study was a nationwide observational survey of a representative sample of general practitioners and their patients in France. The sampling strategy ensured a sufficient number of GPs in each of the three groups to allow comparison of their patients. Patients completed a questionnaire on socio-demographics, lifestyle and QOL using the Short Form 12 (SF-12) questionnaire. Chronicity of MSDs was defined as more than twelve weeks duration of the current episode. Diagnoses and co-morbidities were recorded by the physician. Results A total of 825 GPs included 1,692 MSD patients (predominantly back pain and osteoarthritis) were included, 21.6% in the CM group, 32.4% Ho and 45.9% Mx. Patients in the Ho group had more often a chronic MSD (62.1%) than the CM (48.6%) or Mx (50.3%) groups, a result that was statistically significant after controlling for patients' characteristics (Odds ratio = 1.43; 95% confidence interval (CI): 1.07 - 1.89). Patients seen by homeopaths or mixed practice physicians who were not the regular treating physician, had more often a chronic MSD than those seen in conventional medicine (Odds ratios were1.75; 95% CI: 1.22 - 2.50 and 1.48; 95% CI: 1.06 - 2.12, respectively). Otherwise patients in the three groups did not differ for co-morbidities and QOL. Conclusion MSD patients consulting primary care physicians who prescribed homeopathy and CAMs differed from those seen in conventional medicine. Chronic MSD patients represented a greater proportion of the clientele in physicians offering alternatives to conventional medicine. In addition, these physicians treated chronic patients as consulting rather than regular treating physicians, with potentially important impacts upon professional health care practices and organisation.

Published
2011
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44. RWE in Europe Paper III: A Roadmap for RWE

Author

Gill, Jennifer, Albanell, Joan, Avouac, Bernard, Berger, Karin, Boerlum Kristensen, Finn, Bucher, Heiner, Duncombe, Robert, Fink-Wagner, Antje-Henriette, Hutton, John, Jahnz-Różyk, Karina, Kossler, Ingrid, Podrazilova, Katerina, Spandonaro, Federico, Thomas, Michael, Vaz-Carneiro, Antonio, Wartenberg, Markus, and Kanavos, Panos

Subjects
H Social Sciences (General), H Social Sciences
Abstract

Real world evidence (RWE) has been touted as a remedy for current market access issues, facilitating quicker approvals and increased odds of reimbursement at a good price. It is therefore an attractive avenue for pursuit for manufacturers today. This paper, the third in a series looking at the use of RWE in Europe, outlines the discussions held between key opinion leaders in pricing and reimbursement across a number of European countries at a roundtable-style meeting. The aim of the meeting was to develop a 3-year roadmap, and resulting action plan, of initiatives for the enhanced use of RWE in decision-making in the pharmaceutical industry. Following a series of brainstorming sessions across the areas of commissioning and access, clinical evidence and patients and outcomes, contributors were asked to prioritise the importance of a refined set of initiatives identified in these brainstorming sessions to develop the three-year road map. Finally, four key points from the roadmap were identified for initial action: actively engage in early dialogue with payers on RWE needs; consensus exercise on RWD/E in clinical decisions, develop a definition of patient reported/relevant outcomes and develop a model approach for the collection of patient reported/relevant outcomes data. These action points are seen as the most imperative steps for enhancing the role of RWE. If its use is to become more common addressing these steps, as quickly and efficiently as possible, will be vital for all stakeholders in the pharmaceutical arena.

Published
2017
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45. PP149 Features Of Accountable And Reasonable Processes For Coverage Decision-Making

Author

Wagner, Monika, primary, Samaha, Dima, additional, Casciano, Roman, additional, Brougham, Matthew, additional, Petrie, Charles, additional, Abrishami, Payam, additional, Avouac, Bernard, additional, Kind, Paul, additional, Mantovani, Lorenzo Giovanni, additional, Sarria-Santamera, Antonio, additional, Schlander, Michael, additional, and Tringali, Michele, additional

Published
2018
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46. The use of Real World Evidence in the European context: An analysis of key expert opinion

Author

Gill, Jennifer, Avouac, Bernard, Duncombe, Robert, Hutton, John, Jahnz-Rozyk, Karina, Schramm, Wolfgang, Spandonaro, Federico, Thomas, Michael, and Kanavos, Panos

Subjects
R853.C55 Clinical trials, RA401.5 Drug approval, R Medicine, R Medicine (General)
Abstract

Randomised controlled trials (RCT), traditionally seen as the gold standard in drug approval requirement terms, are becoming more difficult due to, among other reasons, budget constraints, increasing complexities and the shrinking of patient populations. Real world evidence (RWE), data used for decision making that is not derived from traditional RCT, may in future play an increasing role in market access and reimbursement decisions. This paper analyses key pricing and reimbursement stakeholders’ opinions of RWE across five European countries via a focus group-style discussion. Areas probed included regulatory implications and the role of RWE in the study countries, RWE processes and implementation on decision making, meaningful outcomes from RWE and priorities for future focus and industry support. Results showed that RWE was used to some extent in all countries, generally in accelerated access and re-review situations, with accepted endpoints including overall survival, morbidity, avoidable mortality and quality of life among others, but that there were a number of areas where improvement was necessary if RWE use was to become more common place.

Published
2016

47. How to measure the net benefit of treatment?

Author

Gueyffier, François, primary, Piedbois, Pascal, additional, Bergmann, Jean-François, additional, Avouac, Bernard, additional, Borel, Thomas, additional, Boussageon, Rémy, additional, Brun-Strang, Catherine, additional, Braunstein, David, additional, Cazeneuve, Béatrice, additional, Diviné, Marine, additional, Dufour, Patrick, additional, Girerd, Nicolas, additional, Laigle, Valérie, additional, Le Jeunne, Claire, additional, Liard, François, additional, Marsot, Amélie, additional, Montastruc, Jean-Louis, additional, Trinh-Duc, Albert, additional, and Vicaut, Eric, additional

Published
2017
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48. Comment mesure-t-on le bénéfice net d’un traitement ?

Author

Gueyffier, François, primary, Piedbois, Pascal, additional, Bergmann, Jean-François, additional, Avouac, Bernard, additional, Borel, Thomas, additional, Boussageon, Rémy, additional, Brun-Strang, Catherine, additional, Braunstein, David, additional, Cazeneuve, Béatrice, additional, Diviné, Marine, additional, Dufour, Patrick, additional, Girerd, Nicolas, additional, Laigle, Valérie, additional, Le Jeunne, Claire, additional, Liard, François, additional, Marsot, Amélie, additional, Montastruc, Jean-Louis, additional, Trinh-Duc, Albert, additional, and Vicaut, Eric, additional

Published
2017
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49. Effect of an Institutional Medication Adherence Program for Long-Acting Injectable Risperidone on Adherence and Psychiatric Hospitalizations: Evidence From a Prospective Cohort Study

Author

Jalbert, Jessica J., primary, Rossignol, Michel, additional, Astruc, Bernard, additional, Bayle, Franck, additional, Nordon, Clementine, additional, Avouac, Bernard, additional, Rouillon, Frederic, additional, Abenhaim, Lucien, additional, and Grimaldi-Bensouda, Lamiae, additional

Published
2017
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50. Who seeks primary care for sleep, anxiety and depressive disorders from physicians prescribing homeopathic and other complementary medicine? Results from the EPI3 population survey

Author

Grimaldi-Bensouda, Lamiae, Engel, Pierre, Massol, Jacques, Guillemot, Didier, Avouac, Bernard, Duru, Gerard, Lert, France, Magnier, Anne-Marie, Rossignol, Michel, Rouillon, Frederic, Abenhaim, Lucien, and Begaud, Bernard

Subjects
medicine.medical_specialty, business.industry, Epidemiology, Research, Alternative medicine, General Medicine, Mental health, Quality of life (healthcare), Psychotropic drug, Family medicine, medicine, Anxiety, Observational study, Medical prescription, medicine.symptom, business
Abstract

Objectives To describe and compare patients seeking treatment for sleep, anxiety and depressive disorders (SADD) from physicians in general practice (GPs) with three different practice preferences: strictly conventional medicine (GP-CM), mixed complementary and conventional medicine (GP-Mx) and certified homeopathic physicians (GP-Ho). Design and setting The EPI3 survey was a nationwide, observational study of a representative sample of GPs and their patients, conducted in France between March 2007 and July 2008. Participants 1572 patients diagnosed with SADD. Primary and secondary outcomes The patients’ attitude towards complementary and alternative medicine; psychotropic drug utilisation. Results Compared to patients attending GP-CM, GP-Ho patients had healthier lifestyles while GP-Mx patients showed similar profiles. Psychotropic drugs were more likely to be prescribed by GP-CM (64%) than GP-Mx (55.4%) and GP-Ho (31.2%). The three groups of patients shared similar SADD severity. Conclusion Our results showed that patients with SADD, while differing principally in their sociodemographic profiles and conventional psychotropic prescriptions, were actually rather similar regarding the severity of SADD in terms of comorbidities and quality of life. This information may help to better plan resource allocation and management of these common health problems in primary care.

Published
2012

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