Literature DB >> 29531086

Standards for design and measurement would make clinical research reproducible and usable.

Kay Dickersin1, Evan Mayo-Wilson2.   

Abstract

We find standards useful in everyday life and in science, although we do not always follow them. Adopting new standards can be expensive, so there may be a strong incentive to maintain the status quo rather than adopt new standards. The scientific community has many standards encompassing both doing clinical research and reporting it, including standards for design and measurement. Although existing research standards have improved both research and its reporting, we need to unify existing standards and to fill the gaps between steps throughout the research process. Existing gaps include implementation of standards and links between standards for study registration (to know about all studies undertaken), study protocols (to identify the preplanned study design and methods), data collection (to assess outcomes that are important and comparable across studies), dissemination of findings (to know the results of previous studies), data sharing (to make best use of existing data), and evidence synthesis (to draw appropriate conclusions from the body of evidence). The scientific community must work together to harmonize existing standards, to ensure that standards are kept up to date, to check that standards are followed, and to develop standards where they are still needed. A unified system of standards will make our work more reproducible.

Keywords:  clinical trials; data sharing; open science; scientific standards; systematic reviews

Mesh:

Year:  2018        PMID: 29531086      PMCID: PMC5856499          DOI: 10.1073/pnas.1708273114

Source DB:  PubMed          Journal:  Proc Natl Acad Sci U S A        ISSN: 0027-8424            Impact factor:   11.205


  50 in total

1.  Clinical trial registration: a statement from the International Committee of Medical Journal Editors.

Authors:  Catherine D DeAngelis; Jeffrey M Drazen; Frank A Frizelle; Charlotte Haug; John Hoey; Richard Horton; Sheldon Kotzin; Christine Laine; Ana Marusic; A John P M Overbeke; Torben V Schroeder; Hal C Sox; Martin B Van Der Weyden
Journal:  JAMA       Date:  2004-09-08       Impact factor: 56.272

2.  How to access and process FDA drug approval packages for use in research.

Authors:  Erick H Turner
Journal:  BMJ       Date:  2013-10-14

3.  Trial Reporting in ClinicalTrials.gov - The Final Rule.

Authors:  Deborah A Zarin; Tony Tse; Rebecca J Williams; Sarah Carr
Journal:  N Engl J Med       Date:  2016-09-16       Impact factor: 91.245

Review 4.  Clinical trials and systematic reviews addressing similar interventions for the same condition do not consider similar outcomes to be important: a case study in HIV/AIDS.

Authors:  Ian J Saldanha; Tianjing Li; Cui Yang; Jill Owczarzak; Paula R Williamson; Kay Dickersin
Journal:  J Clin Epidemiol       Date:  2017-02-27       Impact factor: 6.437

5.  The ClinicalTrials.gov results database--update and key issues.

Authors:  Deborah A Zarin; Tony Tse; Rebecca J Williams; Robert M Califf; Nicholas C Ide
Journal:  N Engl J Med       Date:  2011-03-03       Impact factor: 91.245

6.  Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research.

Authors:  Thomas G Pickering; John E Hall; Lawrence J Appel; Bonita E Falkner; John Graves; Martha N Hill; Daniel W Jones; Theodore Kurtz; Sheldon G Sheps; Edward J Roccella
Journal:  Circulation       Date:  2005-02-08       Impact factor: 29.690

7.  Reducing waste from incomplete or unusable reports of biomedical research.

Authors:  Paul Glasziou; Douglas G Altman; Patrick Bossuyt; Isabelle Boutron; Mike Clarke; Steven Julious; Susan Michie; David Moher; Elizabeth Wager
Journal:  Lancet       Date:  2014-01-08       Impact factor: 79.321

8.  SPIRIT 2013 statement: defining standard protocol items for clinical trials.

Authors:  An-Wen Chan; Jennifer M Tetzlaff; Douglas G Altman; Andreas Laupacis; Peter C Gøtzsche; Karmela Krleža-Jerić; Asbjørn Hróbjartsson; Howard Mann; Kay Dickersin; Jesse A Berlin; Caroline J Doré; Wendy R Parulekar; William S M Summerskill; Trish Groves; Kenneth F Schulz; Harold C Sox; Frank W Rockhold; Drummond Rennie; David Moher
Journal:  Ann Intern Med       Date:  2013-02-05       Impact factor: 25.391

9.  Developing core outcome sets for clinical trials: issues to consider.

Authors:  Paula R Williamson; Douglas G Altman; Jane M Blazeby; Mike Clarke; Declan Devane; Elizabeth Gargon; Peter Tugwell
Journal:  Trials       Date:  2012-08-06       Impact factor: 2.279

Review 10.  A methodological approach for assessing the uptake of core outcome sets using ClinicalTrials.gov: findings from a review of randomised controlled trials of rheumatoid arthritis.

Authors:  Jamie J Kirkham; Mike Clarke; Paula R Williamson
Journal:  BMJ       Date:  2017-05-17
View more
  6 in total

1.  Call for Action: Journals Need to Insist on Full Reporting of the Analytical Characteristics of Biomarkers.

Authors:  Zhen Zhao; David B Sacks
Journal:  Lab Med       Date:  2021-01-04

2.  Reproducibility of research: Issues and proposed remedies.

Authors:  David B Allison; Richard M Shiffrin; Victoria Stodden
Journal:  Proc Natl Acad Sci U S A       Date:  2018-03-12       Impact factor: 11.205

3.  Toward more rigorous and informative nutritional epidemiology: The rational space between dismissal and defense of the status quo.

Authors:  Andrew W Brown; Stella Aslibekyan; Dennis Bier; Rafael Ferreira da Silva; Adam Hoover; David M Klurfeld; Eric Loken; Evan Mayo-Wilson; Nir Menachemi; Greg Pavela; Dale Schoeller; Colby J Vorland; Leah D Whigham; David B Allison
Journal:  Crit Rev Food Sci Nutr       Date:  2021-10-22       Impact factor: 11.208

4.  'All hands-on deck', working together to develop UK standards for public involvement in research.

Authors:  Sally Crowe; Ade Adebajo; Hothan Esmael; Simon Denegri; Angela Martin; Bob McAlister; Barbara Moore; Martin Quinn; Una Rennard; Julie Simpson; Paula Wray; Philippa Yeeles
Journal:  Res Involv Engagem       Date:  2020-09-16

5.  Opportunities for selective reporting of harms in randomized clinical trials: Selection criteria for non-systematic adverse events.

Authors:  Evan Mayo-Wilson; Nicole Fusco; Hwanhee Hong; Tianjing Li; Joseph K Canner; Kay Dickersin
Journal:  Trials       Date:  2019-09-05       Impact factor: 2.279

6.  Detection of early cartilage degeneration in the tibiotalar joint using 3 T gagCEST imaging: a feasibility study.

Authors:  Daniel B Abrar; Christoph Schleich; Sven Nebelung; Anja Müller-Lutz; Karl Ludger Radke; Miriam Frenken; Julia Stabinska; Alexandra Ljimani; Hans-Jörg Wittsack; Gerald Antoch; Bernd Bittersohl; Tobias Hesper
Journal:  MAGMA       Date:  2020-07-28       Impact factor: 2.310

  6 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.