References
- Drummond MF. International guidelines for pharmacoeconomics analyses - vive la différence? 2006. cited 2010 09-Nov-2010 Available from: www.ispor.org/news/articles/dec06/president.asp
- Luce BR, Drummond M, Jönsson B, et al. EBM, HTA, and CER: clearing the confusion. Milbank Q 2010;88(2):256-76
- Borchers AT, Hagie F, Keen CL, et al. The history and contemporary challenges of the US Food and Drug Administration. Clin Ther 2007;29(1):1-16
- Siebert M, Clauss LC, Carlisle M, et al. Health technology assessment for medical devices in Europe. What must be considered. Int J Technol Assess Health Care 2002;18(3):733-40
- Avorn J. Regulation of devices. BMJ 2010;341:c5730
- O’Keeffe K. The Rise of Medtech, in MD+DI. 2011
- Wilkinson J. Chief Executive, EUCOMED, in International Innovation. 2011. Eucomed
- Tarn TY, Smith MD. Pharmacoeconomic guidelines around the world. 2004. cited 2010 09-Nov-2010 Available from: www.ispor.org/news/articles/aug04/PEGuidelines.asp
- International Medical Device Regulators Forum. Global Harmonization Task Force Archive. 2013. cited 2013 Available from: www.imdrf.org/ghtf/ghtf-archives.asp
- U.S. Congress. Federal Food, Drug and Cosmetic Act. Device Evaluation Information. 1938; cited 2010 21/10/2010
- European Commission, Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. 1993
- Yue LQ. Special issue on medical device clinical studies - guest editor’s note. J Biopharm Stat 2008;18(1):1-3
- Psaty BM, Meslin EM, Breckenridge A. A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: opportunities provided by a new IOM report. JAMA 2012;307(23):2491-2
- U.S. Congress. Kefauver-Harris drug amendments. FDAReview.org 1962. cited 2010 09/11/2010 Available from: www.fdareview.org/history.shtml#tenth
- Campbell G. Statistics in the world of medical devices: the contrast with pharmaceuticals. J Biopharm Stat 2008;18(1):4-19
- Centre for devices and radiological health (CDRH). Premarket Notification (510k). 2010 03 September 2010. cited 2010 26 October 2010 Available from: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm#se
- World Health Organisation, Clinical evidence for medical devices: regulatory processes focusing on Europe and the United States of America. Background paper 2010. 3
- Califf RM, Zarin DA, Kramer JM, et al. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA 2012;307(17):1838-47
- Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA 2009;302(24):2679-85
- Black N. Why we need observational studies to evaluate the effectiveness of health care. BMJ 1996;312(7040):1215-18
- Horton R. Offline: a serious regulatory failure, with urgent implications. Lancet 2012;379:1060
- O’Dowd A. UK launches inquiry into safety of PIP breast implants. BMJ 2012;344:e11
- Cohen D. How safe are metal-on-metal hip implants? BMJ 2012;344:e1410
- Dyer C. UK regulator asks cardiologists to report adverse effects of heart device. BMJ 2012;344:e2194
- Torjesen I. Device regulator is told to improve its safety monitoring after breast implant debacle. BMJ 2012;344:e3456
- Voelker R. FDA ponders regulation and innovation. JAMA 2011;305(15):1523-4
- Heneghan C, Thompson M, Billingsley M, et al. Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts. BMJ Open 2011;1(1):e000155
- Eikermann M, Gluud C, Perleth M, et al. Commentary: Europe needs a central, transparent, and evidence based regulation process for devices. BMJ 2013;346:f2771
- European Commission. Regulation of the European Parliament and of the Council on medical devices, and amending directive 2001/83/EC 2012. cited 2014
- Reed SD, Shea AM, Schulman KA. Economic implications of potential changes to regulatory and reimbursement policies for medical devices. J Gen Intern Med 2008;23(Suppl 1):50-6
- Hutton J, Trueman P, Henshall C. Coverage with evidence development: an examination of conceptual and policy issues. Int J Technol Assess Health Care 2007;23(4):425-32
- Medical Services Advisory Committee(MSAC). Overview of Guidelines for the processes supporting the Medical Services Advisory Committee (Version 1.0). 2012. cited 2012 15 October Available from: www.msac.gov.au/internet/msac/publishing.nsf/Content/B8E1F7C44BE7E25BCA257A7D002477C3/$File/Short%20guidelines%20Sept-commentable.pdf
- (NICE), N.I.f.H.a.C.E. Guide to the methods of technology appraisal. 2008. National Institute for Health and Clinical Excellence (NICE); London
- (NICE)., N.I.f.H.a.C.E. Medical Technologies Evaluation Programme (Process Guide). 2011. cited 2012 17 October 2010. Available from: www.nice.org.uk/aboutnice/whatwedo/aboutmedicaltechnologies/MTEPProcessGuideAndMethodsGuide.jsp?domedia=1&mid=67EFA8F7-19B9-E0B5-D4A02970AC0FAAF2
- (NICE)., N.I.f.H.a.C.E. Medical Technologies Evaluation Programme (Methods Guide). 2011. cited 2012 17 October 2012 Available from: www.nice.org.uk/aboutnice/whatwedo/aboutmedicaltechnologies/MTEPProcessGuideAndMethodsGuide.jsp?domedia=1&mid=67F0D04A-19B9-E0B5-D4E26EBDB76BD2D4
- Drummond M, A Griffin R. Tarricone. Economic evaluation for devices and drugs–same or different? Value Health 2009;12(4):402-4
- Taylor RS, Iglesias CP. Assessing the clinical and cost-effectiveness of medical devices and drugs: are they that different? Value Health 2009;12(4):404-6
- Evidence of effectiveness: evaluating its quality, in Valuing health care: costs, benefits, and effectiveness of pharmaceuticals and other medical technologies. Detsky ASSloan FA. Editor 1995. Cambridge University Press; Cambridge, UK: 15-29
- Cookson R, Hutton J. Regulating the economic evaluation of pharmaceuticals and medical devices: a European perspective. Health Policy 2003;63(2):167-78
- McAlister FA, Laupacis A, Wells GA, et al. Users’ Guides to the Medical Literature - XIX. Applying clinical trial results - B. Guidelines for determining whether a drug is exerting (more than) a class effect. JAMA 1999;282(14):1371-7
- Stiegman G, Eggleton J. Pre-clinical testing of spinal implants: safety versus substantial equivalence. 2008. Musculoskeletal Clinical Regulatory Advisers
- Furberg CD, Psaty BM. Should evidence-based proof of drug efficacy be extrapolated to a “class of agents”? Circulation 2003;108(21):2608-10
- Soares MO, Bojke L, Dumville J, et al. Methods to elicit experts’ beliefs over uncertain quantities: application to a cost effectiveness transition model of negative pressure wound therapy for severe pressure ulceration. Stat Med 2011;30(19):2363-80
- Center for Devices and Radiological Health (CDRH), The new 510(k) paradigm. 1998. FDA; US.: Rockville, MD: 15 pp
- Cook JA, Ramsay CR, Fayers P. Using the literature to quantify the learning curve: a case study. Int J Technol Assess Health Care 2007;23(2):255-60
- Ramsay CR, Grant AM, Wallace SA, et al. Statistical assessment of the learning curves of health technologies. Health Technol Assess 2001;5(12):1-79
- Cook JA, Ramsay CR, Fayers P. Statistical evaluation of learning curve effects in surgical trials. Clin Trials 2004;1(5):421-7
- McTaggart-Cowan HM, Marra CA, Yang Y, et al. The validity of generic and condition-specific preference-based instruments: the ability to discriminate asthma control status. Qual Life Res 2008;17(3):453-62
- Drummond MF. Methods for the Economic Evaluation of Health Care Programmes. 2nd ed. 1997. Oxford: Oxford University Press
- Brooks R. EuroQol: the current state of play. Health Policy 1996;37(1):53-72
- Bojke L, Claxton K, Sculpher M, et al. Characterizing structural uncertainty in decision analytic models: a review and application of methods. Value Health 2009;12(5):739-49
- Jackson CH, Bojke L, Thompson SG, et al. A framework for addressing structural uncertainty in decision models. Med Decis Making 2011;31(4):662-74
- Claxton K, Palmer S, Longworth L, et al. Informing a decision framework for when NICE should recommend the use of health technologies only in the context of an appropriately designed programme of evidence development. 2010. [cited 2012 17 October 2012] Briefing document. Available from: www.york.ac.uk/media/che/documents/Briefing%20Documents%20for%20OIR%20Workshop%20(1).pdf
- Roland M, Torgerson DJ. What are pragmatic trials? BMJ 1998;316(7127):285
- Sedrakyan A, Marinac-Dabic D, Normand SL, et al. A framework for evidence evaluation and methodological issues in implantable device studies. Med Care 2010;48(6 Suppl):S121-8
- Uniform and high rates of ascertainment of outcome, in Epidemiology in Medicine. Hennekens CH, Buring JEMayrent SL. Editor 1987. Little, Brown and Company; Boston/Toronto: 191-4
- Lilford RJ, Braunholtz DA, Greenhalgh R, et al. Trials and fast changing technologies: the case for tracker studies. BMJ 2000;320(7226):43-6
- Resnic FS, Wang TY, Arora N, et al. Quantifying the learning curve in the use of a novel vascular closure device: an analysis of the NCDR (National Cardiovascular Data Registry) CathPCI registry. JACC Cardiovasc Interv 2012;5(1):82-9
- King M, Nazareth I, Lampe F, et al. Impact of participant and physician intervention preferences on randomized trials: a systematic review. JAMA 2005;293(9):1089-99
- Arons AM, Krabbe PF. Probabilistic choice models in health-state valuation research: background, theories, assumptions and applications. Expert Rev Pharmacoecon Outcomes Res 2013;13(1):93-108
- Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials 2009;10:9
- Robert C, Casella G. A Short History of Markov Chain Monte Carlo: subjective recollections from incomplete data. Stat Sci 2011;26(1):102-15
- Greenland S, O’Rourke K. On the bias produced by quality scores in meta-analysis, and a hierarchical view of proposed solutions. Biostatistics 2001;2(4):463-71
- Prevost TC, Abrams KR, Jones DR. Hierarchical models in generalized synthesis of evidence: an example based on studies of breast cancer screening. Stat Med 2000;19(24):3359-76
- Greenland S. Multiple-bias modelling for analysis of observational data. J R Stat Soc Ser A Stat Soc 2005;168:267-91
- Spiegelhalter DJ, Best NG. Bayesian approaches to multiple sources of evidence and uncertainty in complex cost-effectiveness modelling. Stat Med 2003;22(23):3687-709
- Turner RM, Spiegelhalter DJ, Smith GC, et al. Bias modelling in evidence synthesis. J R Stat Soc Ser A Stat Soc 2009;172:21-47
- Health. C.f.D.a.R. Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials. 2010. U.S. Department of Health and Human Services Food and Drug Administration; Rockville, MD: 1-50
- Lu G, Ades AE. Combination of direct and indirect evidence in mixed treatment comparisons. Stat Med 2004;23(20):3105-24
- Ades AE, Sculpher M, Sutton A, et al. Bayesian methods for evidence synthesis in cost-effectiveness analysis. Pharmacoeconomics 2006;24(1):1-19
- Ades AE, Welton NJ, Caldwell D, et al. Multiparameter evidence synthesis in epidemiology and medical decision-making. J Health Serv Res Policy 2008;13(Suppl 3):12-22
- O’Hagan A, et al. Uncertain Judgements: Eliciting Experts’ Probabilities. 2006. Chichester, UK: John Wiley & Sons Ltd
- Garthwaite PH, Kadane JB, O’Hagan A. Statistical methods for eliciting probability distributions. J Am Stat Assoc 2005;100(470):680-700
- Daneshkhah A, Oakley JE. Eliciting multivariate probability distributions. 2010. [cited 2010 16 Nov 2010]. Available from: www.jeremy-oakley.staff.shef.ac.uk/
- Oakley JE. Eliciting univariate probability distributions. 2010. [cited 2010 16 Nov 2010]. Available from: www.jeremy-oakley.staff.shef.ac.uk/
- Pibouleau L, Chevret S. Bayesian statistical method was underused despite its advantages in the assessment of implantable medical devices. J Clin Epidemiol 2011;64(3):270-9
- (NICE)., N.I.f.H.a.C.E. Frequently asked questions about NICE’s Medical Technologies Evaluation Programme. 2012. cited 2012 19 October 2012. Available from: www.nice.org.uk/media/1D9/5F/Medical_technologies_evaluation_programme_-_frequently_asked_questions.pdf
- NICE. Guide to the methods of technology appraisal. 2008. National Institute for Clinical Excellence; London
- NICE. Diagnostics assessment programme manual. 2013
- Soares MO, et al. Negative pressure wound therapy for severe pressure ulcers: evidence synthesis and the value of further research. Wound Repair Regen 2011;19(2):A52
- Maisel WH. Semper fidelis–consumer protection for patients with implanted medical devices. N Engl J Med 2008;358(10):985-7
- (AHRQ), A.o.H.R.a.Q. Registry of Patient Registries (RoPR) Policies and Procedures. 2012. cited 2012 17 October 2012. Available from: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?productid=1115&pageaction=displayproduct
- Lamph S. Regulation of medical devices outside the European Union. J R Soc Med 2012;105(Suppl 1):S12-21
- EUnetHTA. EUnetHTA Joint Action 2 (2012-2015). 2012. Available from: www.eunethta.eu/activities/EUnetHTA%20Joint%20Action%202%20%282012-15%29/eunethta-joint-action-2-2012-2015
- MedtecHTA. Methods for health technology assessment of medical devices: a European Perspective. 2013. Available from: www.medtechta.eu/wps/wcm/connect/Site/MedtecHTA/Home
- ECRIN. European Clinical Research Infrastructures Network. 2012. Available from: www.ecrin.org/
- Advance HTA. Re-thinking the future of health technology assessment. 2013. Available from: www.advance-hta.eu/
- GHTF Study Group 1. Information document concerning the definition of the term “medical device” 2005. The Global Harmonization Task Force