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Clinical trials / Tom Brody / London : Elsevier (2016)
Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines [printed text] / Tom Brody . - Second edition. . - London : Elsevier, 2016 . - 896 p. : ill., ; 235x191.
ISBN : 978-0-12-804217-5 : € 62,00
Languages : English (eng)
Descriptors: Indexation
Clinical Trials ; Drug Approval ; Drug Monitoring ; Research Design
Classification
W20.55.C5 - Clinical trialsAbstract: Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=3941 Hold
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Barcode Call number Media type Location Section Status 10273-03215 W20.55.C5 / BRO Book KCE Library (10.124) Available Readers who borrowed this document also borrowed:
Interrupted Time Series Analysis McDowall, David Bayesian approaches to clinical trials and health-care evaluation Spiegelhalter, D. J. Evidence synthesis for decision making in healthcare Sutton, Alexander Categorical data analysis Agresti, Alan Le financement des hôpitaux en Belgique Durant, G. A good life in old age? Organisation for Economic Co-operation and Development, European Commission Survival analysis using the SAS system Allison, Paul David Meta-analysis of controlled clinical trials Whitehead, Anne Models for discrete data Zelterman, Daniel Manuel pour une tarification des interventions hospitalières basée sur les coûts Swartenbroekx, Nathalie Hospital volume, physician volume, and patient outcomes Luft, Harold S. Evaluatierapporten CTG / Commissie tegemoetkoming geneesmiddelen (CTG) = Commission de Remboursement des Médicaments (CRM) / Bruxelles [Belgium] : Rijksinstituut voor Ziekte- en Invaliditeitsverzekering (RIZIV) = Institut National Maladie Invalidité (INAMI) (2008)
Evaluatierapporten CTG [electronic document] / Commissie tegemoetkoming geneesmiddelen (CTG) = Commission de Remboursement des Médicaments (CRM), Author . - Bruxelles [Belgium] : Rijksinstituut voor Ziekte- en Invaliditeitsverzekering (RIZIV) = Institut National Maladie Invalidité (INAMI), 2008.
Languages : Dutch (dut)
Descriptors: Classification
QV 771 Standardization and evaluation of drugs
Indexation
Drug Approval ; Drug Costs ; Drug Evaluation ; Insurance, Health ; Intranets (Computer networks) ; Web portals ; Web ServersAbstract: In het kader van de procedure voor tegemoetkoming van geneesmiddelen moeten de evaluatierapporten, opgesteld door de Commissie tegemoetkoming geneesmiddelen (CTG) vanaf 1 april 2007, online beschikbaar zijn.
Het gaat concreet om:
* de CTG-evaluatierapporten op dag 60 van de procedure
* de reacties van de aanvragende bedrijven
* de CTG-evaluatie van die correspondentie, die plaatsvindt op dag 120 van de terugbetalingsprocedure (de totale procedure bedraagt 180 dagen).
Bepaalde passages geschrapt zijn. Dat gebeurde:
* ofwel op gemotiveerde vraag van het aanvragende bedrijf wegens fabricagegeheim, confidentiële handelsgegevens, patiëntenprivacy of eigendomsrecht van niet eerder gepubliceerde data
* ofwel wegens auteursrechten en copyright van gepubliceerde manuscripten.
Contents note: ALOXI (FR)(Palonosétron) -- ASADISP (NL)(nouvelle dénomination: MERCKASA)(Acide acétylsalicylique) --
BINOCRIT(NL) (Epoetin alfa) -- CERVARIX (FR)(Protéine L1 de Papillomavirus Humain de type 16-18)-- EVOLTRA (NL)(Clofarabine) -- FLEMOXIN SOLUTAB (NL)(Amoxicilline) -- FOSTIMON 75 UI/1 ml (FR)(urofollitropine) -- FOSTIMON 150 UI/1 ml (FR) (urofollitropine) -- GARDASIL (FR) (Papillomavirus humain de type 6, 11, 16, 18) -- INCRELEX (NL) (mécasermine) -- ISENTRESS (FR) (Raltégravir) -- INVEGA (NL)(Paliperidon) -- MIRCERA (FR) (Epoetin bèta) -- NEXAVAR (NL) (Sorafénib) -- OCTANATE (FR)(Facteur VIII de coagulation, humain) -- OCTAPLEX (FR) (Facteurs de coagulation II, VII, IX et X, association) -- RAPTIVA (NL)
(Efalizumab) -- REMODULIN (FR) (Tresprostinil) -- REVLIMID (FR) (Lénalidomide) -- THELIN (FR)
(Sitaxentan) -- TORISEL (FR) (Temsirolimus) -- TYSABRI (NL) (Natalizumab) -- VASOVIST (NL)
(gadofosveset trisodique)Link for e-copy: http://www.inami.fgov.be/drug/nl/drugs/decisions_report/report_crm_cgt/index.htm [...] Format of e-copy: Webpage Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=1382 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)
Evidence gaps for drugs and medical devices at market entry in Europe and potential solutions : Synthese [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 . - 38 p. : ill., ; A4. - (KCE Reports. Health Services Research (HSR); 347CS) .
ISSN : D/2021/10.273/44 : € 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: SUMMARY 1 -- 1. INTRODUCTION, OBJECTIVE AND METHODOLOGY 3 -- 1.1. MARKET ACCESS IS REGULATED AT THE EUROPEAN LEVEL, WHILE REIMBURSEMENT IS DETERMINED BY THE MEMBER STATES. 3 -- 1.1.1. Medicinal products 4 -- 1.1.2. Medical devices 5 -- 1.1.3. Changes in the European regulations 5 -- 1.2. INITIATIVES THAT HAVE INCREASED THE EVIDENCE GAP AND INITIATIVES TO REDUCE THE EVIDENCE GAP 6 -- 1.3. OBJECTIVE OF THIS STUDY AND STUDY QUESTIONS 6 -- 2. ETHICAL AND LEGAL CONSIDERATIONS 9 -- 2.1. ETHICAL STANDARDS ON THE PROVISION OF EVIDENCE AND TRANSPARENCY 9 -- 2.2. EUROPEAN LEGISLATION ON MEDICINAL PRODUCTS 10 -- 2.2.1. Evidence requirements 10 -- 2.2.2. Procedure for the authorisation of clinical studies 10 -- 2.2.3. Transparency requirements 10 -- 2.3. EUROPEAN LEGISLATION ON MEDICAL DEVICES 10 -- 2.3.1. Evidence requirements 11 -- 2.3.2. Authorisation procedure for clinical research 11 -- 2.3.3. Transparency requirements 11 -- 2.4. EUROPEAN EVALUATION OF HEALTH TECHNOLOGY 12 -- 3. ANALYSIS OF THE INAMI/RIZIV DOSSIERS 12 -- 3.1.1. Results for the 18 assessment dossiers for medicinal products 13 -- 3.1.2. Results for the 18 assessment dossiers for medical devices 13 -- 4. LITERATURE STUDY 14 -- 4.1. MEDICINAL PRODUCTS 14 -- 4.2. MEDICAL DEVICES 15 -- 5. DISCUSSION AND POSSIBLE SOLUTIONS 16 -- 5.1. THE SEPARATION BETWEEN REGULATORY BODIES AND HTA BODIES; MORE COLLABORATION NECESSARY 16 -- 5.1.1. Study population requirements 19 -- 5.1.2. Requirements regarding the intervention 19 -- 5.1.3. Requirements regarding the comparator 19 -- 5.1.4. Requirements regarding outcomes 21 -- 5.1.5. Toward more efficient clinical studies; limitations of observational ‘real-world data’ 21 -- 5.1.6. Should the threshold of evidence for medical devices be lower? 22 -- 5.2. TRANSPARENCY REQUIREMENTS 23 -- 5.2.1. For medicinal products 23 -- 5.2.2. For medical devices 23 -- 5.3. PUBLISHED POLICY RECOMMENDATIONS 23 -- RECOMMENDATIONS 27 -- REFERENCES 32 Link for e-copy: https://doi.org/10.57598/R347CS Format of e-copy: PDF (2,48 MB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4803 Flow chart pharmaceutical system (IN- & OUT- patient sector) / Bruxelles [Belgium] : Rijksinstituut voor Ziekte- en Invaliditeitsverzekering (RIZIV) = Institut National Maladie Invalidité (INAMI) (2010)
Flow chart pharmaceutical system (IN- & OUT- patient sector) [printed text] . - Bruxelles [Belgium] : Rijksinstituut voor Ziekte- en Invaliditeitsverzekering (RIZIV) = Institut National Maladie Invalidité (INAMI) : PHIS (Pharmaceutical Health Information System), 2010 . - 1 p.
Languages : English (eng)
Descriptors: Classification
QV 736 Drug industry. Economics of pharmacy. Advertising
Indexation
Belgium ; Drug Approval ; Drug Industry ; Price Regulation ; Reimbursement MechanismsLink for e-copy: http://phis.goeg.at/downloads/library/BE_PHIS_poster_Rome.pdf Format of e-copy: Online [OpenAccess] Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=2288 Future scenarios about drug development and drug pricing / Philippe Vandenbroeck / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2016)
PermalinkFuture scenarios about drug development and drug pricing / Philippe Vandenbroeck / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2016)
PermalinkICH Good Clinical Practice / Marleen Verbeeck / Brussel [Belgium] : European Centre for Clinical Research Training (ECCRT) (2007)
PermalinkMarkttoegang in Europa voor geneesmiddelen en medische hulpmiddelen: gebrek aan bewijs en mogelijke oplossingen / Frank Hulstaert / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2021)
PermalinkMise sur le marché des médicaments et des dispositifs médicaux en Europe : manque de données probantes et solutions possibles / Frank Hulstaert / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2021)
PermalinkPistes pour mieux encadrer l’usage ‘off-label’ des médicaments / Céline Vannieuwenhuysen / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2015)
PermalinkPistes voor een beter omkaderd off-label gebruik van geneesmiddelen / Céline Vannieuwenhuysen / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2015)
PermalinkRapports d’évaluation par la CRM / Commissie tegemoetkoming geneesmiddelen (CTG) = Commission de Remboursement des Médicaments (CRM) / Bruxelles [Belgium] : Rijksinstituut voor Ziekte- en Invaliditeitsverzekering (RIZIV) = Institut National Maladie Invalidité (INAMI) (2008)
PermalinkScénarios futurs pour le développement des médicaments et la fixation de leurs prix / Philippe Vandenbroeck / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2016)
PermalinkToekomstscenario’s voor de ontwikkeling en prijszetting van geneesmiddelen / Philippe Vandenbroeck / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2016)
Permalink