Internal Market, Industry, Entrepreneurship and SMEs; Medical Devices/growth/sectors/ medical-devices, 2016. ,
Regulatory approval of new medical devices: cross sectional study, BMJ, vol.353, p.2587, 2016. ,
DOI : 10.1136/bmj.i2587
Commentary: Europe needs a central, transparent, and evidence based regulation process for devices, BMJ, vol.346, issue.may07 3, p.2771, 2013. ,
DOI : 10.1136/bmj.f2771
Pioneering surgical innovations in Germany, Der Chirurg, vol.109, issue.1, pp.423-455, 2016. ,
DOI : 10.1016/j.zefq.2015.05.016
Evidence-based clinical practice: Overview of threats to the validity of evidence and how to minimise them, European Journal of Internal Medicine, vol.32, pp.13-21, 2016. ,
DOI : 10.1016/j.ejim.2016.03.020
Barriers to the conduct of randomised clinical trials within all disease areas, Trials, vol.497, issue.7451, p.360, 2017. ,
DOI : 10.1038/497557a
URL : https://hal.archives-ouvertes.fr/inserm-01572262
A systematic literature review of evidence-based clinical practice for rare diseases: what are the perceived and real barriers for improving the evidence and how can they be overcome? Trials ,
Evidence-based practice within nutrition: what are the barriers for improving the evidence and how can they be dealt with?, Trials, vol.11, issue.10, p.425, 2017. ,
DOI : 10.1007/s11306-014-0750-y
URL : https://hal.archives-ouvertes.fr/inserm-01588782
Cluster Randomized Trials, Medical Care, vol.45, issue.Suppl 2, pp.29-37, 2007. ,
DOI : 10.1097/MLR.0b013e31806728c4
Methodological choices for the clinical development of medical devices, Medical Devices: Evidence and Research, vol.7, pp.325-359, 2014. ,
DOI : 10.2147/MDER.S63869
Need for expertise based randomised controlled trials, BMJ, vol.330, issue.7482, p.88, 2005. ,
DOI : 10.1136/bmj.330.7482.88
EAES recommendations on methodology of innovation management in endoscopic surgery, Surgical Endoscopy, vol.146, issue.Suppl 6, pp.1594-615, 2010. ,
DOI : 10.7326/0003-4819-146-9-200705010-00155
Michael Lauer Co-Publishes Perspective Piece on Randomized Registry Trials. 2013. http://www.nhlbi.nih. gov/news/spotlight/fact-sheet/dr-michael-lauer-co-publishes-perspectivepiece-randomized-registry-trials, 2016. ,
IDEAL framework for surgical innovation 1: the idea and development stages, BMJ, vol.346, issue.jun18 3, p.3012, 2013. ,
DOI : 10.1136/bmj.f3012
IDEAL-D: a rational framework for evaluating and regulating the use of medical devices Conventional versus laparoscopic cholecystectomy and the randomized controlled trial. Cholecystectomy Study Group, BMJ. Br J Surg, vol.35378, issue.2, pp.150-154, 1991. ,
Randomised, prospective, single-blind comparison of laparoscopic versus small-incision cholecystectomy, The Lancet, vol.347, issue.9007, pp.989-94, 1996. ,
DOI : 10.1016/S0140-6736(96)90143-9
Open, small-incision, or laparoscopic cholecystectomy for patients with symptomatic cholecystolithiasis. An overview of Cochrane Hepato-Biliary Group reviews, Cochrane Database Syst Rev, vol.336, issue.7644, p.8318, 2010. ,
DOI : 10.1001/archsurg.134.3.308
The Necessity of Randomized Clinical Trials, British Journal of Medicine and Medical Research, vol.3, issue.4, pp.453-1468, 2013. ,
DOI : 10.9734/BJMMR/2013/3208
Randomize the first patient, N Engl J Med, vol.296, issue.2, p.107, 1977. ,
H??rden bei Studien mit Medizinprodukten, Zeitschrift f??r Evidenz, Fortbildung und Qualit??t im Gesundheitswesen, vol.106, issue.5, pp.315-324, 2012. ,
DOI : 10.1016/j.zefq.2012.05.002
Orthopaedic Surgeons Prefer to Participate in Expertise-based Randomized Trials, Clinical Orthopaedics and Related Research, vol.78, issue.7, pp.1734-1778, 2008. ,
DOI : 10.1056/NEJM198707163170304
Framework for design and evaluation of complex interventions to improve health, BMJ, vol.321, issue.7262, pp.694-700, 2000. ,
DOI : 10.1136/bmj.321.7262.694
A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensus, Journal of Clinical Epidemiology, vol.58, issue.12, pp.1233-1273, 2005. ,
DOI : 10.1016/j.jclinepi.2005.05.004
Reported Methodologic Quality and Discrepancies between Large and Small Randomized Trials in Meta-Analyses, Annals of Internal Medicine, vol.135, issue.11 ,
DOI : 10.7326/0003-4819-135-11-200112040-00010
Correction: Reported Methodologic Quality and Discrepancies between Large and Small Randomized Trials in Meta-Analyses, Annals of Internal Medicine, vol.149, issue.3, p.219, 2008. ,
DOI : 10.7326/0003-4819-149-3-200808050-00023
Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study, BMJ, vol.336, issue.7644, pp.601-606, 2008. ,
DOI : 10.1136/bmj.39465.451748.AD
Influence of Reported Study Design Characteristics on Intervention Effect Estimates From Randomized, Controlled Trials, Annals of Internal Medicine, vol.157, issue.6, pp.429-467, 2012. ,
DOI : 10.7326/0003-4819-157-6-201209180-00537
Blinded interpretation of study results can feasibly and effectively diminish interpretation bias, Journal of Clinical Epidemiology, vol.67, issue.7, pp.769-72, 2014. ,
DOI : 10.1016/j.jclinepi.2013.11.011
Blinding during data analysis and writing of manuscripts, Controlled Clinical Trials, vol.17, issue.4, pp.285-90, 1996. ,
DOI : 10.1016/0197-2456(95)00263-4
The Cochrane Handbook for Systematic Reviews of Interventions, 2011. ,
DOI : 10.1002/9780470712184
Benefits of and barriers to involving users in medical device technology development and evaluation, International Journal of Technology Assessment in Health Care, vol.3, issue.01, pp.131-138, 2007. ,
DOI : 10.1111/1540-5885.340276
Evaluation of the Learning Curve in Laparoscopic Colorectal Surgery, Annals of Surgery, vol.242, issue.1, pp.83-91, 2005. ,
DOI : 10.1097/01.sla.0000167857.14690.68
Industry Bias in Randomized Controlled Trials in General and Abdominal Surgery, Annals of Surgery, vol.264, issue.1, pp.87-92, 2016. ,
DOI : 10.1097/SLA.0000000000001372
Industry sponsorship and research outcome, Cochrane Database Syst Rev, vol.2, 2017. ,
Transparency and Registration in Clinical Research in the Nordic Countries, Oslo: Nordic Trial Alliance, 2015. ,
Reporting of Patient-Reported Outcomes in Randomized Trials, JAMA, vol.309, issue.8, pp.814-836, 2013. ,
DOI : 10.1001/jama.2013.879
Methods Guide for Effectiveness and Comparative Effectiveness Reviews Agency for Healthcare Research and Quality Available from: https://effectivehealthcare.ahrq.gov/topics/cer-methods-guide/overview, p.2014, 2017. ,
Health technology assessment for medical devices in Europe. What must be considered, Int J Technol Assess Health Care, vol.18, issue.3, pp.733-773, 2002. ,
A European perspective - the European clinical research infrastructures network, Annals of Oncology, vol.22, issue.Suppl 7, pp.44-53, 2011. ,
DOI : 10.1093/annonc/mdr425
Standardising outcomes for clinical trials and systematic reviews, Trials, vol.34, issue.2, p.39, 2007. ,
DOI : 10.1111/j.1523-536X.2006.00145.x
Clinical Trial Regulation, 2017. ,
Sharing Clinical Trial Data ??? A Proposal from the International Committee of Medical Journal Editors, New England Journal of Medicine, vol.374, issue.4, pp.384-390, 2016. ,
DOI : 10.1056/NEJMe1515172
Annex IX of the EU Directive 93, EEC, vol.42, 2017. ,
Evidence-informed recommendations to reduce dissemination bias in clinical research: conclusions from the OPEN (Overcome failure to Publish nEgative fiNdings) project based on an international consensus meeting, BMJ Open, vol.348, issue.5, p.6666, 2015. ,
DOI : 10.1136/bmj.g3768
How to Make More Published Research True, PLoS Medicine, vol.51, issue.7145, p.1001747, 2014. ,
DOI : 10.1371/journal.pmed.1001747.t002
Rescuing US biomedical research from its systemic flaws, Proceedings of the National Academy of Sciences, vol.10, issue.3, pp.5773-5780, 2014. ,
DOI : 10.1187/cbe.11-02-0013
Meta-research: Evaluation and Improvement of Research Methods and Practices, PLOS Biology, vol.505, issue.7485, p.1002264, 2015. ,
DOI : 10.1371/journal.pbio.1002264.t002
Blind analysis: Hide results to seek the truth, Nature, vol.526, issue.7572, pp.187-196, 2015. ,
DOI : 10.1038/526187a