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Evidence of comparative efficacy should have a formal role in European drug approvals
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Evidence of comparative efficacy should have a formal role in European drug approvals (2011)Evidence of comparative efficacy should h…Ensuring safe and effective drugs: who can do what it takes? (2011)Ensuring safe and effective d…Availability of Comparative Efficacy Data at the Time of Drug Approval in the United States (2011)Availability of Comparative E…Access to clinical trial data (2011)Access to clinical trial dataRelative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers (2010)Relative efficacy of drugs: a…Methodological problems in the use of indirect comparisons for evaluating healthcare interventions: survey of published systematic reviews (2009)Methodological problems in th…How can we regulate medicines better? (2007)How can we regulate medicines…Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization (2006)Availability of comparative t…An update on the first decade of the European centralized procedure: how many innovative drugs? (2006)An update on the first decade…Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis (2019)Design characteristics, risk …Cochrane Handbook for Systematic Reviews of Interventions (2008)Searching for unpublished trials in Cochrane reviews may not be worth the effort (2009)Reporting bias in medical research - a narrative review (2010)How can we improve the interpretation of systematic reviews? (2011)Most systematic reviews of adverse effects did not include unpublished data (2016)Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review (2016)Efficacy, safety, and cost of new anticancer drugs (2002)The price of innovation: new estimates of drug development costs (2003)High drug prices are not justified by industry’s spending on research and development (2023)Current landscape of innovative drug development and regulatory support in China (2025)Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias (2008)Dissemination and publication of research findings: an updated review of related biases (2010)Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists (2011)SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials (2013)SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials (2013)SPIRIT 2013 Statement: defining standard protocol items for clinical trials. (2015)The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials (1997)Combination of direct and indirect evidence in mixed treatment comparisons (2004)Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies (2007)Access to orphan drugs despite poor quality of clinical evidence (2010)What principles should govern the use of managed entry agreements? (2011)Generating comparative evidence on new drugs and devices after approval (2020)Regulating pharmaceuticals in Europe : striving for efficiency, equity and quality (2004)Regulating Pharmaceuticals in Europe: Striving for Efficiency, Equity and Quality (2005)A Proposal for Radical Changes in the Drug-Approval Process (2006)Comparative Effectiveness Research: A Progress Report (2010)Relative Effectiveness Assessment of Pharmaceuticals: Similarities and Differences in 29 Jurisdictions (2012)Estimation of Potential Savings Through Therapeutic Substitution (2016)Scientific ignorance: Probing the limits of scientific research and knowledge production (2019)The Combination of Estimates from Different Experiments (1954)Meta-analysis in clinical trials (1986)GRADE guidelines: 8. Rating the quality of evidence—indirectness (2011)Graphical Tools for Network Meta-Analysis in STATA (2013)A GRADE Working Group approach for rating the quality of treatment effect estimates from network meta-analysis (2014)Evaluating Drugs after Their Approval for Clinical Use (1993)Cutting the cost of drug development? (2004)Priority medicines for Europe and the world (2004)CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials (2010)The Cochrane Collaboration's tool for assessing risk of bias in randomised trials (2011)RoB 2: a revised tool for assessing risk of bias in randomised trials (2019)Prices and clinical benefit of cancer drugs in the USA and Europe: a cost–benefit analysis (2020)The revised Cochrane risk of bias tool for randomized trials (RoB 2) showed low interrater reliability and challenges in its application (2020)Reliability of the revised Cochrane risk-of-bias tool for randomised trials (RoB2) improved with the use of implementation instruction (2021)
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References

  • 2009Methodological problems in the use of indirect comparisons for evaluating healthcare interventions: survey of published systematic reviews396 cited
  • 2010Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers174 cited
  • 2011Availability of Comparative Efficacy Data at the Time of Drug Approval in the United States71 cited
  • 2006An update on the first decade of the European centralized procedure: how many innovative drugs?68 cited
  • 2007How can we regulate medicines better?58 cited
  • 2006Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization54 cited
  • 2011Ensuring safe and effective drugs: who can do what it takes?43 cited
  • 2011Access to clinical trial data27 cited

Cited by

  • 2019Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis251 cited

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