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Evaluation des certains nouveaux traitements du cancer de la prostate et de l’hypertrophie bénigne de la prostate / Caroline Obyn / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2008)
Evaluation des certains nouveaux traitements du cancer de la prostate et de l’hypertrophie bénigne de la prostate [printed text] / Caroline Obyn, Author ; Françoise Mambourg , Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2008 . - vi, 72 p. : ill. ; 30 cm.. - (KCE Reports B. Health Technology Assessment (HTA); 89B) .
ISSN : D/2008/10.273/62 : 0 €
Etude n° : 2008-06
Languages : English (eng) French (fre)
Descriptors: Classification
WJ 762 Prostatic Neoplasms
Indexation
2008-06 ; Prostatic Hyperplasia ; Prostatic Neoplasms ; R89 ; Technology Assessment, Biomedical ; Ultrasound, High-Intensity Focused, TransrectalLink for e-copy: http://doi.org/10.57598/R98B Format of e-copy: .PDF (571 KB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=1704 Copies(0)
Status No copy Évaluation économique des pansements en mousse multicouches siliconés pour la prévention des escarres à l'hôpital / Mattias Neyt / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2023)
Évaluation économique des pansements en mousse multicouches siliconés pour la prévention des escarres à l'hôpital : – Résumé [printed text] / Mattias Neyt , Author ; Christophe de Meester , Author ; Stephan Devriese , Author ; Lysa Marynen, Author ; Dimitri Beeckman, Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2023 . - 21 p. : ill., ; A4. - (KCE Reports B. Health Technology Assessment (HTA); 368BS) .
ISSN : D/2023/10.273/09 : € 0,00
Languages : French (fre)
Descriptors: Indexation
2019-20 ; Cost-Benefit Analysis ; Pressure Ulcer ; prevention and control ; R368 ; Technology Assessment, Biomedical
Classification
WR 598 Pressure UlcerAbstract: Les pansements multicouches siliconés sont utilisés depuis quelques années pour traiter les escarres, complications fréquentes de l’alitement ou de l’immobilisation prolongée. Par contre, leur efficacité comme moyen de prévention n’a été établie que récemment, grâce à un essai clinique financé par KCE Trials. Une nouvelle étude du même Centre fédéral d’Expertise des Soins de Santé (KCE) apporte aujourd’hui la preuve que cette utilisation préventive est non seulement efficace mais aussi coût-efficace. Contents note: PRÉFACE 2 -- SYNTHÈSE 3 -- 1. INTRODUCTION 4 -- 1.1. QU’EST-CE QU’UNE ESCARRE ? 4 -- 1.2. LA PRÉVENTION DES ESCARRES 4 -- 1.3. UNE RECHERCHE HTA QUI S’INSCRIT DANS LES SUITES D’UN ESSAI CLINIQUE 5 -- 2. REVUE DE LA LITTÉRATURE ÉCONOMIQUE 6 -- 3. ÉVALUATION ÉCONOMIQUE POUR LA BELGIQUE 7 -- 3.1. PRESSURE ULCER PREVENTION : RÉSULTATS D’UN ESSAI CLINIQUE BELGE 7 -- 3.1.1. Population 7 -- 3.1.2. Intervention 8 -- 3.1.3. Comparateur 8 -- 3.1.4. Outcome 8 -- 3.1.5. Résultats 8 -- 3.2. DONNÉES COMPLÉMENTAIRES 9 -- 3.3. ANALYSE ÉCONOMIQUE 10 -- 3.3.1. Coûts de la prévention des escarres 10 -- 3.3.2. Coûts du traitement des escarres 10 -- 3.3.3. Résultats 12 -- 4. DISCUSSION ET CONCLUSION 13 -- 4.1. UNE ÉTUDE BASÉE SUR DES DONNÉES BELGES… 13 -- 4.2. .…MAIS LA ROUTE A ÉTÉ LONGUE 13 -- RECOMMANDATIONS 16 Link for e-copy: http://doi.org/10.57598/R368BS Format of e-copy: PDF (2,5 MB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4913 Evaluation of Digital Medical Technologies / Lorena San Miguel / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2023)
Evaluation of Digital Medical Technologies [printed text] / Lorena San Miguel , Author ; Caroline Obyn, Author ; Imgard Vinck , Author ; Christophe de Meester , Author ; Vicky Jespers , Author ; Céline Pouppez, Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2023 . - 219 p. : ill., ; A4. - (KCE Reports, ISSN 2466-6459; 362C) .
ISSN : D/2022/10.273/66 : € 0,00
Languages : English (eng)
Descriptors: Classification
W 82 Biomedical technology (General)
Indexation
Digital Technology ; Insurance, Health, Reimbursement ; R362 ; Technology Assessment, BiomedicalContents note: SCIENTIFIC REPORT 20 -- 1 EVALUATION OF DIGITAL MEDICAL TECHNOLOGIES FOR REIMBURSEMENT 20 -- 1.1 INTRODUCTION 20 -- 1.2 OBJECTIVE AND FOCUS OF THIS RESEARCH 22 -- 1.3 RESEARCH QUESTIONS AND GENERAL METHODS 22 -- 2 CURRENT SITUATION IN BELGIUM 23 -- 2.1 METHODS 23 -- 2.2 THE PILOT PHASE 23 -- 2.2.1 Description of the pilot projects 23 -- 2.2.2 Evaluation of the pilot projects and lessons learned 25 -- 2.3 THE VALIDATION PYRAMID AND MHEALTHBELGIUM 25 -- 2.4 NATIONAL RULES REGARDING CYBERSECURITY, INTEROPERABILITY, AND PRIVACY 29 -- 2.4.1 Cybersecurity 29 -- 2.4.2 Data protection 30 -- 2.4.3 Interoperability 31 -- 2.5 PROCEDURE AND EVALUATION PROCESS FOR THE REIMBURSEMENT OF CERTAIN DIGITAL MEDICAL APPS (LEVELS M3– AND M3+ OF THE PYRAMID) 33 -- 2.5.1 Scope of the current reimbursement framework for mobile health apps 33 -- 2.5.2 Procedure 33 -- 2.5.3 Apps currently under evaluation 37 -- 2.6 POSSIBLE REIMBURSEMENT MECHANISMS 37 -- 2.6.1 Within the compulsory health insurance 37 -- 2.6.2 Other coverage possibilities 39 -- 2.7 ETHICAL, ORGANISATIONAL, PATIENT AND SOCIAL ELEMENTS 42 -- 3 FRAMEWORKS FOR THE EVALUATION OF DIGITAL MEDICAL TECHNOLOGIES 46 -- 3.1 METHODS 46 -- 3.2 GERMANY - FAST-TRACK PROCEDURE FOR DIGITAL MEDICAL TECHNOLOGIES (DIGAS) 48 -- 3.2.1 The framework: Fast-track procedure for digital medical technologies 49 -- 3.2.2 The scope of the framework 49 -- 3.2.3 Conditions and evidence requirements 50 -- 3.2.4 Required study design 52 -- 3.2.5 Obligation to report changes in the DiGA 53 -- 3.2.6 Pricing of DMTs 55 -- 3.2.7 Timing 55 -- 3.2.8 Examples of evaluated DMTs 55 -- 3.2.9 Other reimbursement mechanisms for DMTs 55 -- 3.3 ENGLAND – THE EVIDENCE STANDARDS FRAMEWORK FOR DMTS BY NICE 57 -- 3.3.1 The framework: The Evidence Standards Framework for DMTs (ESF) 58 -- 3.3.2 The scope of the framework 58 -- 3.3.3 Classification of DMTs 58 -- 3.3.4 Conditions and evidence requirements 59 -- 3.3.5 Examples of evaluated DMTs 65 -- 3.3.6 The early deployment standards for evidence generation programmes for DMTs 66 -- 3.3.7 Other aspects: The Digital Technology Assessment Criteria for Health and Social Care 66 -- 3.4 FRANCE – DMT SPECIFIC FRAMEWORKS 68 -- 3.4.1 The frameworks (general and DMT-specific) – An overview 69 -- 3.4.2 Conditions and evidence requirements – An overview 69 -- 3.4.3 DMT specific pathways: Generalised financing for telemonitoring activities (from 2022) - the generic pathway 74 -- 3.4.4 DMT-specific pathways: Temporary early access (« prise en charge anticipée ») of telemonitoring activities and DMTs with therapeutic aim (from 2022) - brand specific pathway 76 -- 3.4.5 Examples of evaluated DMTs 77 -- 3.4.6 Other aspects: Specific information required in application files for medical devices using artificial intelligence 79 -- 3.5 FINLAND – THE DIGI-HTA FRAMEWORK 81 -- 3.5.1 The framework 81 -- 3.5.2 The scope of the framework 82 -- 3.5.3 The domains and criteria of the Digi-HTA 82 -- 3.5.4 The process 85 -- 3.5.5 Conditions and evidence requirements 87 -- 3.5.6 Examples of evaluated DMTs 87 -- 3.6 THE NETHERLANDS 90 -- 3.6.1 The frameworks 91 -- 3.6.2 The scope of the frameworks 93 -- 3.6.3 Conditions and evidence requirements 95 -- 3.6.4 Examples of evaluated DMTs 97 -- 3.6.5 Reimbursement 98 -- 3.7 COUNTRIES CURRENTLY DEVELOPING A FRAMEWORK FOR IMPLEMENTATION 102 -- 3.7.1 Austria – Framework for the evaluation of DMTs under development 102 -- 3.7.2 The framework 103 -- 3.8 CROSS-COUNTRY OVERVIEW: COMPARATIVE TABLE 109 -- 3.8.1 Summary table for the scope and evidence requirements of reimbursement pathways dedicated to digital technologies 109 -- 4 LEGAL CONSIDERATIONS REGARDING CYBERSECURITY, DATA PROTECTION AND INTEROPERABILITY - COUNTRY OVERVIEW OF THE EVALUATION FRAMEWORKS FOR DMTS 114 -- 4.1 METHODS 114 -- 4.2 GERMANY 114 -- 4.2.1 Data protection and data security 115 -- 4.2.2 Frequently identified security deficiencies 118 -- 4.2.3 Interoperability 120 -- 4.3 FRANCE 123 -- 4.3.1 Data protection, data security and interoperability 123 -- 4.4 ENGLAND 125 -- 4.4.1 Data protection, data security and interoperability 125 -- 4.5 FINLAND 128 -- 4.5.1 Data protection, data security and interoperability 128 -- 4.6 THE NETHERLANDS 130 -- 4.6.1 Data protection, data security and interoperability 130 -- 4.7 AUSTRIA 133 -- 4.7.1 Data protection, data security and interoperability 133 -- 4.8 DISCUSSION 137 -- 5 ETHICAL, ORGANISATIONAL, PATIENT AND SOCIAL ELEMENTS TAKEN INTO CONSIDERATION IN EVALUATION FRAMEWORKS OF DMTS 138 -- 5.1 METHODS 139 -- 5.2 GERMANY 139 -- 5.3 ENGLAND 140 -- 5.4 FINLAND 143 -- 5.5 FRANCE 143 -- 5.6 THE NETHERLANDS 145 -- 5.7 AUSTRIA 146 -- 6 ILLUSTRATIVE EXAMPLES OF EVALUATIONS OF DMT 147 -- 6.1 METHODS 147 -- 6.1.1 Selection of case studies 147 -- 6.1.2 Data extraction for cases 148 -- 6.2 RESULTS 148 -- 6.2.1 Deprexis™ 148 -- 6.2.2 Elevida™ 152 -- 6.2.3 Kaia Health™ 155 -- 6.2.4 Moovecare Poumon™ 158 -- 6.2.5 MySugr™ 161 -- 6.2.6 Orla ™ INR Remote Monitoring 163 -- 6.2.7 Sanacoach™ 166 -- 6.2.8 SkinVision™ 169 -- 6.2.9 Sleepio™ 172 -- 6.2.10 ZIO XT™ 174 -- 6.3 DISCUSSION AND CONCLUSIONS 180 -- 6.3.1 Harmonisation across Europe 180 -- 6.3.2 Mismatch of the evidence requirements and available evidence 180 -- 6.3.3 Non-RCT evidence 180 -- 6.3.4 General reimbursement pathway versus DMT specific reimbursement pathway 180 -- 6.3.5 Prioritisation 181 -- 6.3.6 Generic reimbursement lines 181 -- 6.3.7 Stimulating uptake of apps 181 -- 6.3.8 Evidence requirements for risk class I 181 -- 7 STAKEHOLDER CONSULTATION 182 -- 7.1 METHOD 182 -- 7.1.1 Recruitment of stakeholders and experts 182 -- 7.1.2 The survey 182 -- 7.1.3 Analysis of responses: 183 -- 7.2 RESULTS 183 -- 7.2.1 Scoping questions 183 -- 7.2.2 Evidence requirements 186 -- 7.2.3 Cross-country comparison of strengths and weaknesses of frameworks 191 -- 7.2.4 Gaps in the current European frameworks 203 -- 8 DISCUSSION 204 -- 8.1 SCOPE AND FOCUS OF THE ESTABLISHED DMT EVALUATION FRAMEWORKS 204 -- 8.2 EVALUATION AND REIMBURSEMENT OF A DMT IN ISOLATION VERSUS WITHIN A CARE PROCESS 205 -- 8.3 GENERIC LISTING VERSUS NOMINAL LISTING AND EVALUATIONS FOR DMTS 205 -- 8.4 PROCESSES AND RESOURCES FOR EVALUATION 206 -- 8.5 EVIDENCE REQUIREMENTS 206 -- 8.6 TEMPORARY REIMBURSEMENT 208 -- 8.7 TIMING OF PAYMENT 209 -- 8.8 STEPWISE APPROACH 209 -- 8.9 LIMITATIONS 210 -- REFERENCES 211 Link for e-copy: https://doi.org/10.57598/R362C Format of e-copy: PDF (4,5 MB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4874 Evaluation of Digital Medical Technologies / Lorena San Miguel / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2023)
Evaluation of Digital Medical Technologies : Supplement [printed text] / Lorena San Miguel , Author ; Caroline Obyn, Author ; Imgard Vinck , Author ; Christophe de Meester , Author ; Vicky Jespers , Author ; Céline Pouppez, Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2023 . - 77 p. : ill., ; A4. - (KCE Reports. Health Technology Assessment (HTA); 362S) .
€ 0,00
Languages : English (eng)
Descriptors: Classification
W 82 Biomedical technology (General)
Indexation
Digital Technology ; Insurance, Health, Reimbursement ; R362 ; Technology Assessment, BiomedicalContents note: 1. BELGIAN SITUATION 4 -- 1.1. PRESENTATION OF THE 24 PILOT PROJECTS 4 -- 1.2. EVALUATION OF THE 24 PILOT PROJECTS 6 -- 1.3. SOME EXAMPLES OF USE OF DMTS IN THE NIHDI CONTEXT 9 -- 1.3.1. Kinesitherapy at distance 9 -- 1.3.2. Dermatology (HealthConnect SA) 11 -- 1.3.3. Telemonitoring Covid 12 -- 1.3.4. Diabetes convention (FreeStyle Libre Flash Glucose Monitoring System) 14 -- 2. ADDITIONAL COUNTRY SPECIFIC INFORMATION 16 -- 2.1. THE NETHERLANDS 16 -- 2.2. SUMMARY TABLES OF THE SCOPE AND EVIDENCE REQUIREMENTS BY COUNTRY 23 -- 2.3. MMA MODULE FOR HEALTH TECHNOLOGY ASSESSMENT 33 -- 3. IDENTIFIED EXAMPLES OF DMT EVALUATED IN OTHER COUNTRIES 35 -- 4. QUESTIONNAIRE USED FOR THE STAKEHOLDER CONSULTATION 35 -- 5. EU LEGAL FRAMEWORK REGARDING MEDICAL DEVICES 41 -- 5.1. QUALIFICATION AND CLASSIFICATION OF APPS AND THE COMPONENTS OF THE SYSTEM THEY ARE PART OF 42 -- 5.1.1. Qualification of wearables 42 -- 5.1.2. Classification of wearable 44 -- 5.1.3. Qualification of software 45 -- 5.1.4. Classification of software 49 -- 5.1.5. Qualification of non-medical components 51 -- 5.2. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS FOR MEDICAL DEVICES 51 -- 5.3. CLINICAL EVALUATION 52 -- 6. EU LEGAL FRAMEWORK REGARDING CYBERSECURITY, INTEROPERABILITY AND PRIVACY 54 -- 6.1. CYBERSECURITY REQUIREMENTS 55 -- 6.1.1. Cybersecurity aspects in the medical devices Regulations 55 -- 6.1.2. Initiatives to regulate other digital products 57 -- 6.1.3. Cybersecurity obligations for certain public and private organisations (NIS Directives) 57 -- 6.1.4. Standards and certifications 57 -- 6.2. INTEROPERABILITY REQUIREMENTS 58 -- 6.2.1. Interoperability aspects in the Medical Devices Regulation 58 -- 6.2.2. European Health Data Space 58 -- 6.2.3. Standards and certifications 59 -- 6.3. DATA PROTECTION REGULATION 59 -- 6.3.1. General GDPR principles applied to apps 60 -- 6.3.2. Legal ground for data processing 64 -- 6.3.3. Primary vs. secondary purpose 66 -- 6.3.4. Information and rights of the data subject 67 -- 6.3.5. GDPR certifications and Guidelines 69 -- 6.4. QUALITY LABEL FOR MOBILE HEALTH APPLICATIONS 71 Link for e-copy: https://doi.org/10.57598/R362S Format of e-copy: PDF (2,4 MB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4878 Evidence gaps for drugs and medical devices at market entry in Europe and potential solutions / Frank Hulstaert / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2021)
Evidence gaps for drugs and medical devices at market entry in Europe and potential solutions [printed text] / Frank Hulstaert, Author ; Céline Pouppez, Author ; Célia Primus-de Jong, Author ; Kathleen Harkin, Author ; Mattias Neyt , Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2021 . - 221 p. : ill., ; A4. - (KCE Reports. Health Services Research (HSR); 347C) .
ISSN : D/2021/10.273/45 : € 0,00
Languages : English (eng)
Descriptors: Indexation
2019-08 ; Device Approval ; Drug Approval ; Pharmaceutical Preparations ; Prostheses and Implants ; R347 ; Technology Assessment, Biomedical
Classification
WB 102.5 Evidence-based practiceContents note: SCIENTIFIC REPORT 13 -- 1 INTRODUCTION, AIMS AND SCOPE OF THIS REPORT 13 -- 1.1 BACKGROUND 13 -- 1.2 THE REGULATORY SYSTEM OF MEDICINAL PRODUCTS AND MEDICAL DEVICES 17 -- 1.3 HEALTH TECHNOLOGY ASSESSMENT AND COVERAGE OF HEALTHCARE 17 -- 1.4 NEW EU REGULATIONS FOR MEDICAL DEVICES AND PHARMACEUTICALS 19 -- 1.5 AIMS AND SCOPE OF THIS PROJECT 20 -- 2 METHODS 22 -- 3 LEGAL AND ETHICAL CONSIDERATIONS 23 -- 3.1 INTRODUCTION: THE LEGAL AND ETHICAL FRAMEWORKS ON EVIDENCE REQUIREMENTS 23 -- 3.2 METHODOLOGY 24 -- 3.3 APPLICABLE RULES 25 -- 3.4 EVIDENTIARY REQUIREMENTS FOR MEDICINAL PRODUCTS AND MEDICAL DEVICES 28 -- 3.4.1 Ethical rules for the conduct of clinical trials 28 -- 3.4.2 Research and human rights 32 -- 3.4.3 Evidentiary requirements in the marketing authorisation process for medicines 33 -- 3.4.4 Evidentiary requirements in the CE-marking process for high-risk medical devices 47 -- 3.4.5 The role of ethics committees in reviewing the evidence and the Belgian situation 61 -- 3.5 TRANSPARENCY REQUIREMENTS FOR CLINICAL DATA 64 -- 3.5.1 Ethical rules regarding the transparency on clinical trials data 64 -- 3.5.2 Transparency requirements in the regulatory framework for medicines 65 -- 3.5.3 Transparency requirements for Medical devices 69 -- 3.5.4 Transparency of national reimbursement decisions 73 -- 3.5.5 Enforcement and penalties 73 -- 3.6 CONCLUSION / DISCUSSION REGARDING LEGAL FRAMEWORK 75 -- 4 ANALYSIS OF RIZIV-INAMI DOSSIERS 76 -- 4.1 METHODS 76 -- 4.2 FINDINGS 77 -- 4.2.1 Applications for reimbursement of 18 medicinal products 77 -- 4.2.2 Applications for reimbursement of 18 medical devices 81 -- 5 LITERATURE REVIEW 85 -- 5.1 METHODS 85 -- 5.1.1 Search strategy 85 -- 5.1.2 Selection procedure 86 -- 5.1.3 Selection criteria 87 -- 5.2 OVERVIEW OF THE LITERATURE ON MEDICINAL PRODUCTS 87 -- 5.2.1 Introduction 87 -- 5.2.2 Evidence gaps at market entry (and in the post-market period) 93 -- 5.2.3 Evidence gaps and reimbursement decisions 97 -- 5.2.4 Need for more collaboration (e.g. between regulators and HTA bodies) 98 -- 5.2.5 Use of surrogate endpoints 101 -- 5.2.6 Early patient access, conditional marketing authorisation and managed entry agreements 103 -- 5.3 OVERVIEW OF LITERATURE ON MEDICAL DEVICES 105 -- 5.3.1 Introduction 105 -- 5.3.2 The selected publications 109 -- 5.3.3 Recurring issues in the articles: 115 -- 6 DISCUSSION AND POSSIBLE SOLUTIONS 117 -- 6.1 THE TENSION BETWEEN BUSINESS PRIORITIES AND PATIENT BENEFIT 117 -- 6.1.1 The healthcare economy, important but not the scope of this project 117 -- 6.1.2 Hard law or ethical rules to manage business priorities versus patient benefit? 118 -- 6.1.3 The assessment of true innovation requires a direct comparison of patient benefit 119 -- 6.1.4 Horizon scanning and current limitations affecting the impact of early dialogue and common scientific advice 120 -- 6.1.5 The failed promise of post-marketing trials, coverage with evidence development and managed entry agreements 120 -- 6.2 TOWARDS A CLINICAL DEVELOPMENT PATHWAY THAT BETTER MEETS THE DEMANDS OF REGULATORS AND HTA BODIES 124 -- 6.2.1 The need for a better collaboration between regulators and HTA bodies 124 -- 6.2.2 The split between regulators and HTA bodies, an example of inefficient governance? 125 -- 6.3 EVIDENCE GAPS GROUPED ACCORDING TO THE PICOTS FRAMEWORK 125 -- 6.3.1 Population: keep the randomization but include the routine care patients, all evidence in patient subpopulations should be detailed 126 -- 6.3.2 Intervention: knowledge of optimal dose and duration is key, routine care to be reflected as much as possible 126 -- 6.3.3 The (active) comparator: the Helsinki declaration and the EMA 126 -- 6.3.4 Outcomes: focus on patient-relevant outcomes instead of surrogates that are not validated 128 -- 6.3.5 Study design and time periods, the opportunities and risks of relying only on observational real-world data 129 -- 6.3.6 Should the evidence bar be lower for medical devices? 133 -- 6.4 ON TRANSPARENCY AND REPORTING 135 -- 6.4.1 The case of medicinal products 135 -- 6.4.2 The case of medical devices 135 -- 6.5 PUBLISHED POLICY RECOMMENDATIONS 136 -- 7 RECOMMENDATIONS 139 -- 7.1 FOR THE EUROPEAN COMMISSION AND MEMBER STATES GOVERNMENTS 139 -- 7.2 FOR MEDICAL AND SURGICAL SCIENTIFIC SOCIETIES 140 -- 7.3 FOR (HIGH-RISK) MEDICAL DEVICE INDUSTRY 140 -- 7.4 FOR ALL ETHICS COMMITTEES IN BELGIUM AND ABROAD 141 -- 7.5 FOR ALL CONSUMER ORGANISATIONS AND PATIENT ORGANISATIONS 141 -- 7.6 TO RIZIV-INAMI, HTA AGENCIES AND PAYERS 141 -- 7.7 TO RIZIV-INAMI, INTERNATIONAL HTA AGENCIES, AND JOURNAL EDITORS 141 -- APPENDICES 142 Link for e-copy: https://doi.org/10.57598/R347C Format of e-copy: PDF (4,8 MB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4802 Evidence gaps for drugs and medical devices at market entry in Europe and potential solutions / Frank Hulstaert / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2021)
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