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Data presentation in industry-sponsored cardiac device trials.

Baskaran Chandrasekar1

  • 1Department of Cardiology, Chest Diseases Hospital, PO Box 4082, Safat, 13041, Kuwait.

Indian Heart Journal
|January 26, 2025
PubMed
Summary

Industry-sponsored clinical trials may downplay unfavorable data. Key findings not supporting desired outcomes were often moved to supplementary sections, receiving less attention in landmark cardiac device trials.

Keywords:
Cardiogenic shockHeart failureMitral regurgitation

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Area of Science:

  • Medical device research
  • Clinical trial analysis
  • Publication bias

Background:

  • Industry influence in clinical trials is recognized, extending to authorship and data analysis.
  • Concerns exist regarding the presentation of analyzed data that may not align with desired study outcomes.
  • Unfavorable data may be de-emphasized in published trial results.

Purpose of the Study:

  • To analyze data presentation practices in landmark cardiac device trials.
  • To investigate the prominence of unfavorable data in industry-funded studies.
  • To assess potential publication bias in the reporting of cardiac device trial results.

Main Methods:

  • Review of data presentation in the DanGer Shock trial and the COAPT trial.
  • Analysis of where data not favoring intended outcomes were placed within publications.
  • Assessment of the extent of discussion allocated to such data in the main text.

Main Results:

  • Key data not aligning with favorable study outcomes were often relegated to supplementary sections.
  • Unfavorable findings received significantly less attention and discussion compared to positive results.
  • This practice was observed in landmark trials for two widely used cardiac devices.

Conclusions:

  • Industry-funded cardiac device trials may obscure unfavorable data by placing it in less prominent sections.
  • Publication bias in reporting may affect the perceived efficacy and safety of medical devices.
  • Further scrutiny of data presentation in industry-sponsored research is warranted.