Everything about Randomized controlled trial

🧭 Start here: a 6-step reading path

1. Read the overview: Randomized controlled trialA 5-minute orientation
2. Skim a recent paper: A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver FibrosisInfluential work since 2022
3. Pick up a classic book: Randomization in clinical trialsThe most-reprinted book on the subject
4. Read the landmark paper: Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results From the Women's Health Initiative Randomized Controlled TrialCited 12,895 times
5. Go sideways: Allocation concealmentA closely related topic
6. Go sideways: Blinded experimentA closely related topic

🏆 Landmark papers (most cited)

• Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results From the Women's Health Initiative Randomized Controlled Trial

  Writing Group for the Women's Health Initiative Investigators · 2002 · JAMA: The Journal of the American Medical Association · 12,895 citations

• Recommendations for examining and interpreting funnel plot asymmetry in meta-analyses of randomised controlled trials

  J. A. C. Sterne, A. J. Sutton, J. P. A. Ioannidis · 2011 · BMJ · 6,975 citations

• MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20 536 high-risk individuals: a randomised placebocontrolled trial

  · 2002 · The Lancet · 6,425 citations

• Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial

  Yung-Jue Bang, Eric Van Cutsem, Andrea Feyereislova · 2010 · The Lancet · 6,243 citations

• A Randomized Trial of Intensive versus Standard Blood-Pressure Control

  The SPRINT Research Group · 2015 · New England Journal of Medicine · 5,639 citations

• Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial

  Roy S Herbst, Paul Baas, Dong-Wan Kim · 2016 · The Lancet · 5,439 citations

• Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial

  Ann-Lii Cheng, Yoon-Koo Kang, Zhendong Chen · 2009 · The Lancet Oncology · 4,942 citations

• A Multicenter, Randomized, Controlled Clinical Trial of Transfusion Requirements in Critical Care

  Paul C. Hébert, George Wells, Morris A. Blajchman · 1999 · New England Journal of Medicine · 4,270 citations

🆕 Influential since 2022

• A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis

  Stephen A. Harrison, Pierre Bedossa, Cynthia D. Guy · 2024 · New England Journal of Medicine · 2,158 citations

• Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial

  Hisashi Saji, Morihito Okada, Masahiro Tsuboi · 2022 · The Lancet · 1,612 citations

• Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial

  Robin Kate Kelley, Makoto Ueno, Changhoon Yoo · 2023 · The Lancet · 1,162 citations

• The revised JBI critical appraisal tool for the assessment of risk of bias for randomized controlled trials

  Timothy Hugh Barker, Jennifer C. Stone, Kim Sears · 2023 · JBI Evidence Synthesis · 1,101 citations

• SGLT2 inhibitors in patients with heart failure: a comprehensive meta-analysis of five randomised controlled trials

  Muthiah Vaduganathan, Kieran F Docherty, Brian L Claggett · 2022 · The Lancet · 977 citations

📚 Books worth reading

• Randomization in clinical trialsWilliam F. Rosenberger · 2002
• Cluster randomised trialsHayes, Richard J. DSc., Lawrence H. Moulton · 2008
• Randomised controlled clinical trialsChristopher J. Bulpitt · 1983
• Randomized controlled trialsAlejandro R. Jadad, Alehandro R. Jadad · 2007
• The breast cancer warsBarron H. Lerner · 2001
• Evidence-based outcome researchChristine Maguth Nezu, Arthur M. Nezu · 2007
• Modern adaptive randomized clinical trialsOleksandr Sverdlov · 2015
• 📕How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related ResearchMichael J. Campbell, Stephen J. Walters · 2014

Ranked by number of editions on Open Library, a rough measure of how lasting a book is.

🔗 Related topics

• Allocation concealment In a randomized experiment, allocation concealment hides the sorting of trial participants into treatment groups so that this knowledge cannot be exploited…
• Blinded experiment In a blind or blinded experiment, information that could influence participants or investigators is withheld until the experiment is completed. Blinding…
• Hierarchy of evidence A hierarchy of evidence, comprising levels of evidence (LOEs), that is, evidence levels (ELs), is a heuristic used to rank the relative strength of results…
• Evidence-based medicine Evidence-based medicine (EBM), sometimes known within healthcare as evidence-based practice (EBP), is "the conscientious, explicit and judicious use of…
• Analysis of clinical trials Clinical trials are medical research studies conducted on human subjects. The human subjects are assigned to one or more interventions, and the investigators…
• Jadad scale The Jadad scale, sometimes known as Jadad scoring or the Oxford quality scoring system, is a procedure to assess the methodological quality of a clinical…
• George Lewith George Lewith (12 January 1950 – 17 March 2017) was a professor at the University of Southampton researching alternative medicine and a practitioner of…
• Intention-to-treat analysis In medicine, an intention-to-treat (ITT) analysis of the results of a randomized controlled trial is based on the initial treatment assignment and not…