The Magic of Randomization versus the Myth of Real-World Evidence.

The Magic of Randomization Nonrandomized observational analyses have been promoted as alternatives to randomized clinical trials. However, randomization ensures balance between groups, whereas nonr...

[1]  B. Zinman,et al.  Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. , 2019, The New England journal of medicine.

[2]  Jacqueline Corrigan-Curay,et al.  Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness. , 2018, JAMA.

[3]  Erin Hammers Forstag,et al.  Examining the Impact of Real-World Evidence on Medical Product Development , 2018 .

[4]  M. Landray,et al.  Increasing the use of mobile technology–derived endpoints in clinical trials , 2018, Clinical trials.

[5]  Edward S. Kim,et al.  Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement. , 2017, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[6]  Sebastian Schneeweiss,et al.  When and How Can Real World Data Analyses Substitute for Randomized Controlled Trials? , 2017, Clinical pharmacology and therapeutics.

[7]  Adam Cohen,et al.  Improving public health by improving clinical trial guidelines and their application , 2017, European heart journal.

[8]  D. Waters,et al.  PCSK9 Inhibition to Reduce Cardiovascular Risk: Tempering Expectations. , 2017, Circulation research.

[9]  Peter Sandercock,et al.  Interpretation of the evidence for the efficacy and safety of statin therapy , 2016, The Lancet.

[10]  M. Landray,et al.  Enhancing clinical evidence by proactively building quality into clinical trials , 2016, Clinical trials.

[11]  L. Trinquart,et al.  Comparison of central adjudication of outcomes and onsite outcome assessment on treatment effect estimates. , 2016, The Cochrane database of systematic reviews.

[12]  Christopher B. Granger,et al.  Registry-based randomized clinical trials—a new clinical trial paradigm , 2015, Nature Reviews Cardiology.

[13]  I. Roberts,et al.  Applying results from clinical trials: tranexamic acid in trauma patients , 2014, Journal of Intensive Care.

[14]  M. Lauer,et al.  The imperative of overcoming barriers to the conduct of large, simple trials. , 2014, JAMA.

[15]  Gary Gensler,et al.  Central site monitoring: Results from a test of accuracy in identifying trials and sites failing Food and Drug Administration inspection , 2014, Clinical trials.

[16]  Jennifer G. Robinson,et al.  Use of Medicare Data to Identify Coronary Heart Disease Outcomes in the Women’s Health Initiative , 2014, Circulation. Cardiovascular quality and outcomes.

[17]  M. Landray,et al.  Randomized clinical trials--removing unnecessary obstacles. , 2013, The New England journal of medicine.

[18]  S. Bojesen,et al.  Statin use and reduced cancer-related mortality. , 2012, The New England journal of medicine.

[19]  Sheena McCormack,et al.  The potential for central monitoring techniques to replace on-site monitoring: findings from an international multi-centre clinical trial , 2012, Clinical trials.

[20]  Gordon H Guyatt,et al.  Credibility of claims of subgroup effects in randomised controlled trials: systematic review , 2012, BMJ : British Medical Journal.

[21]  R. Kurzrock,et al.  Equipoise lost: ethics, costs, and the regulation of cancer clinical research. , 2010, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[22]  S. Yusuf,et al.  Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs , 2009, Clinical trials.

[23]  Zhigang Duan,et al.  Limits of observational data in determining outcomes from cancer therapy , 2008, Cancer.

[24]  Douglas G Altman,et al.  Ensuring trial validity by data quality assurance and diversification of monitoring methods , 2008, Clinical trials.

[25]  Jonathan A C Sterne,et al.  The impact of residual and unmeasured confounding in epidemiologic studies: a simulation study. , 2007, American journal of epidemiology.

[26]  Paul Glasziou,et al.  When are randomised trials unnecessary? Picking signal from noise , 2007, BMJ : British Medical Journal.

[27]  F. Song,et al.  Evaluating non-randomised intervention studies. , 2003, Health technology assessment.

[28]  AndrewJ. S. Coats MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20 536 high-risk individuals: a randomised placebocontrolled trial , 2002, The Lancet.

[29]  J. Ioannidis,et al.  Comparison of evidence of treatment effects in randomized and nonrandomized studies. , 2001, JAMA.

[30]  S. Jasko,et al.  Therapy , 1881, The American journal of dental science.

[31]  I. Ford,et al.  Long-Term Safety and Efficacy of Lowering Low-Density Lipoprotein Cholesterol With Statin Therapy 20-Year Follow-Up of West of Scotland Coronary Prevention Study , 2016 .

[32]  Timothy L Lash,et al.  A most stubborn bias: no adjustment method fully resolves confounding by indication in observational studies. , 2010, Journal of clinical epidemiology.