Readers' Toolbox  |   January 2020
Novel Clinical Trial Designs to Improve the Efficiency of Research
Author Notes
  • From the Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic (D.I.S.); and the Department of Anaesthesiology and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, Australia (P.S.M.).
  • Submitted for publication January 10, 2019. Accepted for publication August 9, 2019.
    Submitted for publication January 10, 2019. Accepted for publication August 9, 2019.×
  • Address correspondence to Dr. Myles: Alfred Hospital, Commercial Road, Melbourne, Victoria 3004, Australia. p.myles@alfred.org.au. Information on purchasing reprints may be found at www.anesthesiology.org or on the masthead page at the beginning of this issue. Anesthesiology’s articles are made freely accessible to all readers, for personal use only, 6 months from the cover date of the issue.
Article Information
Cardiovascular Anesthesia / Critical Care / Ethics / Medicolegal Issues / Infectious Disease / Patient Safety / Pharmacology / Respiratory System / Quality Improvement / Readers' Toolbox
Readers' Toolbox   |   January 2020
Novel Clinical Trial Designs to Improve the Efficiency of Research
Anesthesiology 1 2020, Vol.132, 69-81. doi:https://doi.org/10.1097/ALN.0000000000002989
Anesthesiology 1 2020, Vol.132, 69-81. doi:https://doi.org/10.1097/ALN.0000000000002989
Abstract

SUMMARY: Large randomized trials provide the highest level of clinical evidence. However, enrolling large numbers of randomized patients across numerous study sites is expensive and often takes years. There will never be enough conventional clinical trials to address the important questions in medicine. Efficient alternatives to conventional randomized trials that preserve protections against bias and confounding are thus of considerable interest. A common feature of novel trial designs is that they are pragmatic and facilitate enrollment of large numbers of patients at modest cost. This article presents trial designs including cluster designs, real-time automated enrollment, and practitioner-preference approaches. Then various adaptive designs that improve trial efficiency are presented. And finally, the article discusses the advantages of embedding randomized trials within registries.