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Truth in research labelling.

John H Noble1

  • 1Emeritus Professor, State University of New York at Buffalo, 508 Rio Grande Loop, Georgetown, Texas 78633-4786, USA., jhnoblejr@icloud.com.

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Summary
This summary is machine-generated.

A petition seeks to amend US law to prevent post hoc adjustment of randomized controlled trial (RCT) results. This aims to enhance the integrity of biomedical science and evidence-based medicine.

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Area of Science:

  • Biomedical Ethics
  • Regulatory Science
  • Clinical Trial Methodology

Background:

  • A loophole in Section 801 of the Public Health Services Act permits post hoc adjustment of randomized controlled trial (RCT) results.
  • Discrepancies exist between RCT results reported to the Food and Drug Administration (FDA), ClinicalTrials.gov, and medical journals.
  • This practice raises concerns about the integrity of published research and evidence-based medicine.

Purpose of the Study:

  • To describe the background and rationale of a petition to amend Section 801 of the Public Health Services Act.
  • To examine the ethical justifications for closing the loophole allowing post hoc adjustment of RCT results.
  • To address reservations from the World Association of Medical Editors (WAME) regarding the petition.

Main Methods:

  • Analysis of the petition's rationale, assumptions, and ethical support (deontological, consequentialist, casuist).
  • Review of evidence supporting the petition's assertions.
  • Examination of World Association of Medical Editors (WAME) reservations and counter-evidence.
  • Discussion of the impact of neoliberal, anti-regulatory philosophy on biomedical science integrity.

Main Results:

  • The petition argues for closing a legal loophole that allows manipulation of randomized controlled trial (RCT) results.
  • Ethical theories support the petition's proposed remedy for ensuring data integrity.
  • Evidence challenges the World Association of Medical Editors' (WAME) reservations, suggesting some journals may enable publication of adjusted results.

Conclusions:

  • Amending Section 801 is crucial to prevent post hoc adjustment of RCT results and uphold scientific integrity.
  • Medical journals may be complicit in publishing adjusted trial outcomes, undermining evidence-based medicine.
  • A shift towards anti-regulatory governance poses a threat to biomedical research integrity and evidence-based medicine.