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Related Concept Videos

Clinical Trials01:16

Clinical Trials

6.6K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
6.6K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

114
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
114
Hazard Ratio01:12

Hazard Ratio

78
The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
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International multistakeholder consensus statement on post-publication integrity issues in randomized clinical trials

Khalid Saeed Khan1, Mohamed Fawzy2, Patrick Chien3

  • 1University of Granada, CIBERESP, Madrid, Spain.

International Journal of Gynaecology and Obstetrics: the Official Organ of the International Federation of Gynaecology and Obstetrics
|January 31, 2025
PubMed
Summary
This summary is machine-generated.

Increasing retractions of randomized clinical trials (RCTs) due to misconduct allegations prompted an international consensus. This study established guidelines for post-publication integrity, aiming to prevent concerns and improve misconduct investigations in RCTs.

Keywords:
post‐publicationrandomized clinical trialresearch integrity

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Area of Science:

  • Clinical Trials
  • Research Integrity
  • Publication Ethics

Background:

  • The frequency of randomized clinical trial (RCT) retractions following allegations of post-publication misconduct is rising globally.
  • This trend necessitates a standardized approach to address integrity concerns and ensure the reliability of published research.

Purpose of the Study:

  • To establish an international multistakeholder consensus on managing post-publication integrity concerns specific to randomized clinical trials (RCTs).
  • To develop evidence-based policies and guidelines for preventing and investigating misconduct allegations in RCT publications.

Main Methods:

  • A prospective registration and evidence synthesis of 89 articles on post-publication integrity concerns.
  • A multidisciplinary stakeholder group of 48 participants from 18 countries engaged in a two-round Delphi survey and a hybrid consensus development meeting.
  • Consensus was achieved on 84 statements covering various aspects of research integrity, from journal instructions to investigation protocols.

Main Results:

  • Consensus was reached on 84 statements after rigorous Delphi surveys and a consensus meeting.
  • The statements address general integrity aspects, journal policies, editorial processes, complaint handling, investigation procedures, and sanctions.
  • Specific guidance was developed for critical appraisal, systematic reviews of RCTs, and future research recommendations.

Conclusions:

  • This international consensus provides a framework for policies aimed at preventing post-publication integrity issues in RCTs.
  • The established guidelines will aid in improving the investigation of misconduct allegations, thereby enhancing research integrity.
  • The consensus statement serves as a crucial resource for journals, editors, researchers, and institutions involved in RCT publication.