1,721,034 research outputs found
Challenges and barriers for the adoption of personalized medicine in Europe: the case of Oncotype DX Breast Recurrence Score® test
No full textPersonalized medicine, aiming to tailor treatments based on individual patient characteristics, holds immense potential in oncology. However, its widespread adoption in Europe faces numerous challenges, as illustrated by the case study of the Oncotype DX Breast Recurrence Score® assay, a genomic test for breast cancer. This manuscript delineates the multifaceted obstacles encountered during the introduction of the Oncotype DX®test (Oncotype DX Breast Recurrence Score test) in Europe from 2004 to 2018. In June 2018, the TAILORx results were published in the New England Journal of Medicine Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med 2018;379:111–21, Sparano JA, Gray RJ, Ravdin PM, Makower DF, Pritchard KI, Albain KS, et al. Clinical and genomic risk to guide the use of adjuvant therapy for breast cancer. N Engl J Med 2019;380:2395–405, and reported that among 6,711 women with hormone-receptor–positive, HER2-negative, node–negative breast cancer and a midrange recurrence score of 11–25 on the Oncotype DX assay, endocrine therapy was not inferior to chemoendocrine therapy, which provides evidence that adjuvant chemotherapy was not beneficial in these patients. Through a comprehensive analysis of clinical evidence, commercial presence, reimbursement mechanisms, guideline recommendations, regulatory pathways, and local experiences, this study sheds light on the intricate dynamics influencing the adoption of personalized medicine technologies. This article examines the various obstacles encountered during the introduction of the Oncotype DX Breast Cancer Assay in Europe from 2004 to 2018. By analyzing clinical evidence, commercial presence, reimbursement mechanisms, guideline recommendations, regulatory pathways, and local experiences, this study reveals the complex factors that influence the adoption of personalized medicine technologies. By highlighting these challenges, this article offers valuable insights into strategies to facilitate the integration of innovative diagnostic tools into clinical practice across Europe, ultimately leading to improved treatment decision-making for cancer patients
Pathogenesis-related proteins as a model of a strictly compartmentalized plant defense system
No full textNext generation sequencing gene panels for targeted therapy in oncology and haemato-oncology
No full text128 p.ill.SCIENTIFIC REPORT .9 -- 1 INTRODUCTION 9 -- 1.1 BACKGROUND 9 -- 1.2 RESEARCH QUESTIONS .13 -- 1.3 GENERAL APPROACH 14 -- 1.4 EVALUATION OF DIAGNOSTIC TESTS 14 -- 2 TOWARDS NEXT GENERATION SEQUENCING PANEL TESTS IN ONCOLOGY .16 -- 2.1 MOLECULAR DIAGNOSTICS USED IN ONCOLOGY 16 -- 2.2 NEXT GENERATION SEQUENCING, THE TECHNOLOGY 18 -- 2.3 INTRODUCTION TO NEXT GENERATION SEQUENCING PANEL TESTS .20 -- 2.3.1 The sequencing revolution 20 -- 2.3.2 Importance of targeted sequencing for exploratory clinical research in oncology 22 -- 2.3.3 New technologies, more options, new challenges 26 -- 2.4 COMPOSITION OF THE NGS PANELS .26 -- 2.4.1 NGS panels for solid tumours 27 -- 2.4.2 NGS panels for hemato-oncology 28 -- 2.4.3 Other considerations for NGS panel selection 28 -- 3 REGULATORY ASPECTS, QUALITY ASSURANCE AND EDUCATIONAL NEEDS 29 -- 3.1 NEED FOR INFORMED CONSENT AND PRE-TEST COUNSELLING 29 -- 3.2 REGULATORY CONTEXT OF MOLECULAR TESTS FOR SOMATIC MUTATIONS 29 -- 3.2.1 Regulations for diagnostic laboratories in Belgium .29 -- 3.2.2 Regulations for in-house methods and in-vitro diagnostics 30 -- 3.3 EXTERNAL QUALITY ASSURANCE OF MOLECULAR TESTS FOR SOMATIC MUTATIONS 32 -- 3.3.1 EQA schemes for Haematological and Solid Tumours.32 -- 3.3.2 Performance of the participating (Belgian) laboratories 33 -- 3.4 QUALITY ASSURANCE OF NGS PANEL TESTS FOR SOMATIC MUTATIONS 37 -- 3.4.1 General considerations and the importance of quality 37 -- 3.4.2 Quality assurance for the wet and dry lab part of NGS 39 -- 3.5 REPORTING OF NGS DATA 44 -- 3.6 NEEDS FOR EDUCATION AND A MULTIDISCIPLINARY EXPERT COMMITTEES.50 -- 4 IMPACT OF TEST ACCURACY ON INCREMENTAL COST-EFFECTIVENESS RATIOS 52 -- 4.1 INTRODUCTION AND SCOPE 52 -- 4.2 METHODOLOGY 52 -- 4.2.1 Search strategy .52 -- 4.2.2 Selection procedure 53 -- 4.2.3 Selection criteria53 -- 4.3 RESULTS 53 -- 4.4 ILLUSTRATIVE EXAMPLES FOR BELGIUM 54 -- 4.4.1 Data sources 54 -- 4.4.2 Results and discussion .55 -- 4.4.3 The relevance of test specificity when applied to NGS panels .59 -- 5 FINANCING OF COMPANION DIAGNOSTICS AND TARGETED THERAPY .61 -- 5.1 THE DISCONNECTION BETWEEN PHARMACEUTICALS AND COMPANION DIAGNOSTIC 61 -- 5.1.1 The need for a companion diagnostic conflicts with traditional drug development .61 -- 5.1.2 Disconnection between reimbursement of companion diagnostics and drugs in Belgium .62 -- 5.2 BILLING CODES FOR MOLECULAR DIAGNOSTICS IN ONCOLOGY IN BELGIUM 63 -- 5.2.1 Evolution of billing codes, overall expenditures and testing volumes 64 -- 5.2.2 Current issues with billing codes 65 -- 5.3 MOLECULAR TESTS BILLED BY TYPE OF TUMOUR DIAGNOSED IN BELGIUM (2010-2011) .68 -- 5.3.1 Aims and methods of analysis by tumour type .68 -- 5.3.2 Selection of tumour types.68 -- 5.3.3 IMA/AIM data .68 -- 5.3.4 Results 69 -- 5.4 CURRENT COST OF NGS PANEL TESTS 73 -- 6 OPTIONS FOR INTRODUCING NGS PANEL TESTS IN THE BELGIAN HEALTHCARE 76 -- APPENDICES 79 -- APPENDIX 1. GLOSSARY 79 -- APPENDIX 2. COMPOSITION OF NGS PANELS 91 -- APPENDIX 3. SEARCH STRATEGIES - IMPACT OF TEST ACCURACY ON ICERS 110 -- APPENDIX 3.1. PUBMED 110 -- APPENDIX 3.2. EMBASE 110 -- APPENDIX 3.3. ECONLIT 111 -- APPENDIX 3.4. CRD NHS DATABASES 112 -- APPENDIX 4. MOLECULAR TESTS BY PATHOLOGY, WITH BILLING CODES 113 -- APPENDIX 5. SELECTED NOMENCLATURE CODES 119 -- REFERENCES 12
Next generation sequencing gen-panels voor gerichte therapie in de oncologie en hemato-oncologie : Synthese
No full text14 p.ill.Kankerbehandelingen op maat, met geneesmiddelen die zeer doelgericht de kanker aanvallen, bieden vandaag reeds voor een aantal kankers een grote meerwaarde ten opzichte van de klassieke, ‘blinde’ chemotherapie. Voorwaarde is dat men de ‘doelwitten’ in de kankercel op een betrouwbare en efficiënte manier kan opsporen. Dit is de rol van de diagnostische testen, ‘companion diagnostics’ genoemd. Het Kankercentrum van het Wetenschappelijk Instituut Volksgezondheid (WIV) en het Federaal Kenniscentrum voor de Gezondheidszorg (KCE) onderzochten de nieuwe Next Generation Sequencing gene panel testen. Ze kunnen meerdere genen gelijktijdig onderzoeken, en dat zorgt voor een stroomversnelling bij de aanpak van kanker. Het vergoeden van de testen binnen het huidige RIZIV-budget lijkt mogelijk als ze gecentraliseerd worden uitgevoerd in gespecialiseerde laboratoria die een voldoende groot aantal testen uitvoeren. Daarnaast moet het garanderen en controleren van hun kwaliteit de grootste prioriteit krijgen.VOORWOORD 1 -- SAMENVATTING 2 -- 1. INLEIDING 3 -- 1.1. ACHTERGROND 3 -- 1.2. ONDERZOEKSVRAGEN 3 -- 1.3. ALGEMENE AANPAK 4 -- 2. NEXT GENERATION SEQUENCING PANELTESTS 4 -- 2.1. STAPPEN BIJ HET UITVOEREN VAN EEN NGS-PANELTEST 4 -- 2.2. BESCHIKBAARHEID VAN NGS-PANELS 5 -- 2.3. VOORDELEN VAN DE NGS-PANELTESTS VOOR HET LABORATORIUM 7 -- 2.4. AANDACHTSPUNTEN 7 -- 2.5. REGELGEVING, KWALITEITSBEWAKING EN EDUCATIE 8 -- 3. ECONOMISCHE ASPECTEN 9 -- 3.1. IMPACT VAN DE TESTACCURAATHEID OP DE KOSTENEFFECTIVITEIT 9 -- 3.2. FACTURATIECODES EN NGS-BEHOEFTEN VOOR BELGIË 11 -- 4. INVOERING VAN NGS-PANELTESTS 12 -- AANBEVELINGEN 1
Tests de Panels de gènes par Next Generation Sequencing pour un traitement ciblé en oncologie et en hématooncologie : Synthèse
No full text14 p.ill.Les nouveaux traitements ‘sur mesure’ du cancer, qui ciblent des étapes très précises du processus tumoral, présentent certains avantages par rapport à la chimiothérapie classique et ‘aveugle’. Mais il y a une condition préalable : identifier les patients chez qui ils seront efficaces. C’est le rôle des tests appelés ‘diagnostics compagnons’. Le Centre du Cancer de l’Institut scientifique de Santé publique (ISP) et le Centre Fédéral d’Expertise des Soins de santé (KCE) ont examiné les panels de tests dits de Next Generation Sequencing, qui analysent plusieurs gènes à la fois, permettant une accélération dans la prise en charge des cancers. Si ces tests sont effectués dans un laboratoire central spécialisé qui en réalise un nombre suffisant, le remboursement de ces tests semble possible dans le budget actuel de l’INAMI. Mais la garantie et le contrôle de leur qualité reste la grande priorité.PRÉFACE 1 -- RÉSUMÉ 2 -- 1. INTRODUCTION 3 -- 1.1. CONTEXTE 3 -- 1.2. QUESTIONS DE RECHERCHE 3 -- 1.3. APPROCHE GENERALE 3 -- 2. PANELS DE GENES PAR NGS 4 -- 2.1. PHASES D’EXÉCUTION DES TESTS DE PANELS DE GÈNES PAR NGS 4 -- 2.2. DISPONIBILITE DES PANELS NGS 5 -- 2.3. AVANTAGES DES TESTS DE PANEL DE GENES PAR NGS POUR LE LABORATOIRE 7 -- 2.4. POINTS D‘ATTENTION 7 -- 2.5. REGLEMENTATIONS, ASSURANCE QUALITE ET FORMATION 8 -- 3. ASPECTS ÉCONOMIQUES 8 -- 3.1. IMPACT DE LA PRECISION DU TEST SUR LE RAPPORT COUT-EFFICACITE 9 -- 3.2. CODES DE FACTURATION ET BESOINS SNG POUR LA BELGIQUE 11 -- 4. INTRODUIRE DES TESTS DE PANEL DE GENES PAR NGS 12 -- RECOMMANDATIONS 1
Going Beyond Counting First Authors in Author Co-citation Analysis
Get PDFThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
Variations on the Author
Get PDF“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
Appropriate Similarity Measures for Author Cocitation Analysis
Get PDFWe provide a number of new insights into the methodological discussion about author cocitation analysis. We first argue that the use of the Pearson correlation for measuring the similarity between authors’ cocitation profiles is not very satisfactory. We then discuss what kind of similarity measures may be used as an alternative to the Pearson correlation. We consider three similarity measures in particular. One is the well-known cosine. The other two similarity measures have not been used before in the bibliometric literature. Finally, we show by means of an example that our findings have a high practical relevance.information science;Pearson correlation;cosine;similarity measure;author cocitation analysis
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