Skip to content

ACN - 101321555 | ABN - 39101321555

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

AHRECS icon
  • Home
  • About Us
    • Consultants
    • Services
  • Previous Projects
  • Blog
  • Resources
  • Feeds
  • Contact Us
  • More
    • Request a Quote
    • Susbcribe to REM
    • Subscribe to VIP
Menu
  • Home
  • About Us
    • Consultants
    • Services
  • Previous Projects
  • Blog
  • Resources
  • Feeds
  • Contact Us
  • More
    • Request a Quote
    • Susbcribe to REM
    • Subscribe to VIP
Exclude terms...
Aboriginal and Torres Strait Islander
AHRECS
Analysis
Artificial Intelligence
Arts
Australia
Authorship
Belief
Beneficence
Big data
Biobank
Bioethics
Biomedical
Biospecimens
Breaches
Cartoon/Funny
Case studies
Clinical trial
Collaborative research
Conflicts of interest
Consent
Controversy/Scandal
Controversy/Scandal
Creative
Culture
Data management
Database
Dual-use
Essential Reading
Ethical review
Ethnography
Evaluative practice/quality assurance
First People
Fraud
Gender
Genetics
Good practice
Guidance
Honesty
HREC
Human research ethics
Humanities
Institutional responsibilities
International
Journal
Justice
Links
Media
Medical research
Merit and integrity
Methodology
Monitoring
New Zealand
News
Online research
Peer review
Performance
Primary materials
Principles
Privacy
Protection for participants
Psychology
Publication ethics
Questionable Publishers
Research ethics committees
Research integrity
Research Misconduct
Research results
Researcher responsibilities
Resources
Respect for persons
Sample paperwork
sd
Serious Adverse Event
Social Science
SoTL
Standards
Supervision
Training
Vulnerability
Young people
Exclude news

Sort by

Human Research Ethics Research Integrity

Characteristics of registered clinical trials assessing treatments for COVID-19: a cross-sectional analysis (Papers: Hemalkumar B Mehta, et al | June 2020)

Posted by saviorteam in Human Research Ethics on July 25, 2020
Keywords: Clinical trial, Human research ethics, Medical research, Merit and integrity, Protection for participants, Researcher responsibilities, Respect for persons

The Linked Original Item was Posted On June, 9 2020

Abstract
Objectives The coronavirus disease 2019 (COVID-19) pandemic has prompted many initiatives to identify safe and efficacious treatments, yet little is known regarding where early efforts have focused. We aimed to characterise registered clinical trials assessing drugs or plasma treatments for COVID-19.

Design, setting and participants
Cross-sectional analysis of clinical trials for the treatment of COVID-19 that were registered in the USA or in countries contributing to the WHO’s International Clinical Trials Registry Platform. Relevant trial entries of drugs or plasma were downloaded on 26 March 2020, deduplicated, verified with reviews of major medical journals and WHO websites and independently analysed by two reviewers.

Main outcome(s)
Trial intervention, sponsorship, critical design elements and specified outcomes

Results Overall
201 clinical trials were registered for testing the therapeutic benefits of 92 drugs or plasma, including 64 in monotherapy and 28 different combinations. Only eight (8.7%) products or combinations involved new molecular entities. The other test therapies had a wide range of prior medical uses, including as antivirals, antimalarials, immunosuppressants and oncology treatments. In 152 trials (75.7%), patients were randomised to treatment or comparator, including 55 trials with some form of blinding and 97 open-label studies. The 49 (24.4%) of trials without a randomised design included 29 single armed studies and 20 trials with some comparison group. Most trial designs featured multiple endpoints. Clinical endpoints were identified in 134 (66.7%) of trials and included COVID-19 symptoms, death, recovery, required intensive care and hospital discharge. Clinical scales were being used in 33 (16.4%) trials, most often measures of oxygenation and critical illness. Surrogate endpoints or biomarkers were studied in 88 (42.3%) of trials, primarily assays of viral load. Although the trials were initiated in more than 17 countries or regions, 100 (49.8%) were registered in China and 78 (37.8%) in the USA. Registered trials increased rapidly, with the number of registered trials doubling from 1 March to 26 March 2020.

Conclusions
While accelerating morbidity and mortality from the COVID-19 pandemic has been paralleled by early and rapid clinical investigation, many trials lack features to optimise their scientific value. Global coordination and increased funding of high-quality research may help to maximise scientific progress in rapidly discovering safe and effective treatments.

Ehrhardt, S., Moore, T.J., Segal, J.B. & G Alexander, G.C. (2020) Characteristics of registered clinical trials assessing treatments for COVID-19: a cross-sectional analysis. BMJ Open doi: 10.1136/bmjopen-2020-039978
Publisher: https://bmjopen.bmj.com/content/10/6/e039978

Related Reading

Research on covid-19 is suffering “imperfect incentives at every stage” (Papers: Stephen Armstrong | May 2020)

The carnage of substandard research during the COVID-19 pandemic: a call for quality (Papers: Katrina A Bramstedt | October 2020)

Evidence, rationality, and ignorance: Agnotological issues in COVID-19 science (Papers: Carlos Magno Castelo Branco Fortaleza | September 2020)

Sponsorship bias in clinical trials: growing menace or dawning realisation? (Papers: Tom Jefferson | April 2020)

Covid-19 Research Scandals Illustrate What’s Wrong With Science – Elemental (Dana G Smith | August 2020)

Related Links

  • About the contributors
  • About the keywords
  • Suggest a resource
  • Report problem/broken link
  • Request a Take Down

Compiled here are links, downloads and other resources relating to research integrity and human research ethics. more…

Resources Menu

Four hands solving a jigsaw against the sun blazing out of a cloudy sky

Research Integrity

  • Codes, guidelines, policies and standards
  • Guidance and resource material
  • Papers
  • Books
  • In the news

Human Research Ethics

  • Codes, guidelines, policies and standards
  • Guidance and resource material
  • Papers
  • Books
  • In the news

Research Ethics Monthly Receive copies of the Research Ethics Monthly directly
by email. We will never spam you.

  • Home
  • Services
  • About Us
  • Contact Us
Menu
  • Home
  • Services
  • About Us
  • Contact Us
  • Company
  • Terms Of Use
  • Copyright
  • Privacy Policy
  • Disclaimer
Menu
  • Company
  • Terms Of Use
  • Copyright
  • Privacy Policy
  • Disclaimer
  • Support
  • Contact Us
  • Site Map
Menu
  • Support
  • Contact Us
  • Site Map

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Facebook-f
Twitter
Linkedin-in