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- The Royal College of Physicians of Edinburgh: James Lind Library.([Available online at])http://wwwjameslindlibraryorg/Date: 2003
- Commentary: the evolution of methods to assess the effects of treatments, illustrated by the development of treatments for diphtheria, 1825–1918.Int J Epidemiol. 2013; 42: 662-676
- Studier over den statistiske undersøgelsesmetode som hjælpemiddel ved terapeutiske undersøgelser [Studies on the statistical study design as an aid in therapeutic trials] (http://www.jameslindlibrary.org/illustrating/records/studier-over-den-statistiske-undersogelsesmetode-som-hjaelpemid/key_passages).Bibl Laeger. 1897; 89: 1-40
- Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years.Trials. 2007; 8: 7
- The Cochrane Library.([Avaiable at])
- Description of the project.([Available from])
Durisic S, Garattini S, Rath A, Neugebauer EAM, Laville M, Jakobsen JC, Kubiac C, DeMotes-Mainard J, Gluud C: Common barriers to the conduct of randomised clinical trials - the Europeean Clinical Research Infrastructure (ECRIN) perspective Trials, 2016 [to be submitted].
Rath A, Ngwabyt S, Durisic S, Garattini S, Neugebauer EAM, Laville M, Jakobsen JC, Kubiac C, DeMotes-Mainard J, Gluud C: Specific barriers to the conduct of randomised clinical trials within rare diseases — the Europeean Clinical Research Infrastructure (ECRIN) perspective Trials, 2016 [to be submitted].
Neugebauer EAM, Rath A, Durisic S, Garattini S, Laville M, Jakobsen JC, Kubiac C, DeMotes-Mainard J, Gluud C: Specific barriers to the conduct of randomised clinical trials on medical devices — the Europeean Clinical Research Infrastructure (ECRIN) perspective Trials, 2016 [to be submitted].
Laville M, Neugebauer EAM, Rath A, Durisic S, Garattini S, Jakobsen JC, Kubiac C, DeMotes-Mainard J, Gluud C: Specific barriers to the conduct of randomised clinical trials on nutrition - the Europeean Clinical Research Infrastructure (ECRIN) perspective Trials, 2016 [to be submitted].
- The Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0. The Cochrane Collaboration.([Available from])Date: 2011
- Evidence at a glance: error matrix approach for overviewing available evidence.BMC Med Res Methodol. 2010; 10: 90
- The necessity of randomized clinical trials.Br J Med Res. 2013; 3: 1453-1468
- Evaluating non-randomised intervention studies.Health Technol Assess. 2003; 7 ([iii-x]): 1-173
- The number of patients and events required to limit the risk of overestimation of intervention effects in meta-analysis-a simulation study.PLoS One. 2011; 6e25491
- Hepatology may have problems with putative surrogate outcome measures.J Hepatol. 2007; 46: 734-742
- Increasing value and reducing waste in biomedical research regulation and management.Lancet. 2014; 383: 176-185
- How to increase value and reduce waste when research priorities are set.Lancet. 2014; 383: 156-165
- Avoidable waste in the production and reporting of research evidence.Lancet. 2009; 374: 86-89
- Reducing waste from incomplete or unusable reports of biomedical research.Lancet. 2014; 383: 267-276
- Biomedical research: increasing value, reducing waste.Lancet. 2014; 383: 101-104
- Increasing value and reducing waste in biomedical research: who's listening?.Lancet. 2016; 387: 1573-1586
- How to make more published research true.PLoS Med. 2014; 11e1001747
- Clinical trials: what a waste.BMJ. 2014; 349: g7089
- Increasing value and reducing waste in research design, conduct, and analysis.Lancet. 2014; 383: 166-175
- Why most published research findings are false.PLoS Med. 2005; 2e124
- How to read clinical journals.Can Med Assoc J. 1982; 126: 1373
- Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs.Syst Rev. 2006; 333
- The thresholds for statistical and clinical significance — a five-step procedure for evaluation of intervention effects in randomised clinical trials.BMC Med Res Methodol. 2014; 14
- Thresholds for statistical and clinical significance in systematic reviews with meta-analytic methods.BMC Med Res Methodol. 2014; 14: 120
- Discordance between meta-analyses and large-scale randomized, controlled trials. Examples from the management of acute myocardial infarction.Ann Intern Med. 1995; 123: 873-877
- The need for large-scale randomized evidence without undue emphasis on small trials, meta-analyses, or subgroup analyses.JAMA. 2009; 302: 2361-2362
- Is meta-analysis the platinum standard of evidence?.Stud Hist Philos Biol Biomed Sci. 2011; 42: 497-507
- Intersection of systematic review methodology with the NIH reproducibility initiative.Environ Health Perspect. 2014; 122: A176-A177
- Obtaining evidence by a single well-powered trial or several modestly powered trials.Stat Methods Med Res. 2016; 25: 538-552
- Demystifying trial networks and network meta-analysis.BMJ. 2013; 346: f2914
- Efficacy of new generation antidepressants: differences seem illusory.PLoS One. 2013; 8e63509
- Impact of reporting bias in network meta-analysis of antidepressant placebo-controlled trials.PLoS One. 2012; 7e35219
- The PRISMA extension statement for reporting of systematic reviews incorporating network meta-analyses of health care interventions: checklist and explanations.Ann Intern Med. 2015; 162: 777-784
- Preferred reporting items for a systematic review and meta-analysis of individual participant data: the PRISMA-IPD statement.JAMA. 2015; 313: 1657-1665
- Comparison of evidence of treatment effects in randomized and nonrandomized studies.JAMA. 2001; 286: 821-830
- Agreement of treatment effects for mortality from routinely collected data and subsequent randomized trials: meta-epidemiological survey.BMJ. 2016; 352: i493
- Randomize the first patient.N Engl J of Med. 1977; 296: 107
- Are mortality differences detected by administrative data reliable and actionable?.JAMA. 2013; 309: 1410-1411
- Statistical Development of Quality in Medicine.Wiley, 2007
- Influence of reported study design characteristics on intervention effect estimates from randomized controlled trials: combined analysis of meta-epidemiologic studies.Health Technol Assess. 2012; 16: 1-82
- Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study.BMJ. 2008; 336: 601-605
- Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials.Ann Intern Med. 2012; 157: 429-438
- The prevention and treatment of missing data in clinical trials.N Engl J Med. 2012; 367: 1355-1360
- Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls.BMJ. 2009; 338
- Systematic review of the empirical evidence of study publication bias and outcome reporting bias.PLoS One. 2008; 3e3081
- Reporting bias group: systematic review of the empirical evidence of study publication bias and outcome reporting bias — an updated review.PLoS One. 2013; 8e66844
- Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.JAMA. 2004; 291: 2457-2465
- The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration.BMJ. 2009; 339: b2700
- Transaprency and registration in clinical research in the Nordic countries.Nordic Trial Alliance, NordForsk, 2015: 1-108
- Industry sponsorship and research outcome.Coch Database Syst Rev. 2012; 12MR000033
- Developing core outcome sets for clinical trials: issues to consider.Trials. 2012; 13: 132
- Driving up the quality and relevance of research through the use of agreed core outcomes.J Health Serv Res Policy. 2012; 17: 1-2
- Patient involvement in health research: a contribution to a systematic review on the effectiveness of treatments for degenerative ataxias.Soc Sci Med. 2009; 69: 920-925
- Identifying the clinical domains of fibromyalgia: contributions from clinician and patient Delphi exercises.Arthritis Rheum. 2008; 59: 952-960
- Composite outcomes in randomized trials - greater precision but with greater uncertainty?.JAMA. 2003; 289: 2554-2559
- Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review.BMJ. 2010; 341: c3920
- ICH E9 guideline ‘statistical principles for clinical trials’: a case study.Stat Med. 2003; 22 ([discussion 13-17]): 1-11
- Non-inferiority trials are unethical because they disregard patients' interests.Lancet. 2007; 370: 1875-1877
- Dissemination and publication of research findings: an updated review of related biases.Health Technol Assess. 2010; 14 ([ix-xi, 1-193]): iii
- All Trials Registered, All Results Reported.([avaiable at])
- Relation of completeness of reporting of health research to journals' endorsement of reporting guidelines: systematic review.BMJ. 2014; 348: g3804
- Some main problems eroding the credibility and relevance of randomized trials.Bull NYU Hosp Jt Dis. 2008; 66: 135-139
- Clinical trials should begin and end with systematic reviews of relevant evidence: 12 years and waiting.Lancet. 2010; 376: 20-21
- Bringing it all together: Lancet-Cochrane collaborate on systematic reviews.Lancet. 2001; 357: 1728
- Putting clinical trials into context.Lancet. 2005; 366: 107-108
- on the Community code relating to medicinal products for human use (Consolidated version: 16/11/2012).6 November 2001
- How can we regulate medicines better?.BMJ. 2007; 335: 803-805
- The scientific community should lobby to be able to apply for drug licences.BMJ. 2012; 344e3553
- Good Pharma.Palgrave Macmillan, 2015
- Honorary and ghost authorship in high impact biomedical journals: a cross sectional survey.BMJ. 2011; 343: d6128
- Berlin JA et al: SPIRIT 2013 statement: defining standard protocol items for clinical trials.Ann Intern Med. 2013; 158: 200-207
- CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials.Ann Int Med. 2010; 152: 726-732
- Sample size calculations in clinical research.2nd ed. Chapman & Hall/CRC Biostatistics Series. Chapman and Hall/CRC, 2007
- Interim analysis: the alpha spending function approach.Stat Med. 1994; 13: 1341-1356
- A statistical paradox.Biometrika. 1957; 44: 187-192
- Repeated confidence intervals for group sequential clinical trials.Control Clin Trials. 1984; 5: 33-45
- Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analysis.J Clin Epidemiol. 2008; 61: 763-769
- User manual for trial sequential analysis (TSA).Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen, Denmark2011: 1-115 ([Available from http://www.ctu.dk/tsa])
- Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis.J Clin Epidemiol. 2008; 61: 64-75
- The impact of study size on meta-analyses: examination of underpowered studies in Cochrane reviews.PLoS One. 2013; 8e59202
- The knowledge system underpinning healthcare is not fit for purpose and must change.BMJ. 2015; 350: h2463
- Estimating required information size by quantifying diversity in random-effects model meta-analyses.BMC Med Res Methodol. 2009; 9: 86
- Re: the knowledge system underpinning healthcare is not fit for purpose and must change — reponses to the opposing viewpoints of Roberts and colleagues and Tovey and colleagues.BMJ. 2015;
- Sequential methods for random-effects meta-analysis.Stat Med. 2011; 30: 903-921
- Discrete sequential boundaries for clinical trials.Biometrika. 1983; 70: 659-663
- Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analysis.J Clin Epidemiol. 2008; 61: 763-769
- Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses.Lancet. 1999; 354: 1896-1900
- Bias in meta-analysis detected by a simple, graphical test.BMJ. 1997; 315: 629-634
- Operating characteristics of a rank correlation test for publication bias.Biometrics. 1994; 50: 1088-1101
- Trim and fill: a simple funnel-plot-based method of testing and adjusting for publication bias in meta-analysis.Biometrics. 2000; 56: 455-463
- Empirical assessment of effect of publication bias on meta-analyses.BMJ. 2000; 320: 1574-1577
- Epidemiology and reporting characteristics of systematic reviews.PLoS Med. 2007; 4e78
- Systematic review finds overlapping reviews were not mentioned in every other overview.J Clin Epidemiol. 2014; 67: 368-375
- Assessment of methodological quality of primary studies by systematic reviews: results of the metaquality cross sectional study.BMJ. 2005; 330: 1053
- Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases.Cochrane Database Syst Rev. 2012; 3CD007176
- A GRADE Working Group approach for rating the quality of treatment effect estimates from network meta-analysis.BMJ. 2014; 349: g5630
- New developments in the conduct and management of multi-center trials: an international review of clinical trial units.Fundam Clin Pharmacol. 1995; 9: 284-289
- No surgical innovation without evaluation: the IDEAL recommendations.Lancet. 2009; 374: 1105-1112