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  11. Outcome Reporting Bias In Clinical Trials Researching Disease-modifying Therapy In Patients With Multiple Sclerosis

Outcome Reporting Bias in Clinical Trials Researching Disease-Modifying Therapy in Patients With Multiple Sclerosis

Cynthia M C Lemmens1, Suzan van Amerongen1, Eva M Strijbis1

  • 1From the Department of Neurology (C.M.C.L.), Haaglanden Medical Center, The Hague; and Department of Neurology (S.A., E.M.S., J.K.), Amsterdam Neuroscience, Amsterdam UMC, Vrije Universiteit Amsterdam, The Netherlands.

Neurology
|February 26, 2024

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View abstract on PubMed

Summary
This summary is machine-generated.

Selective outcome reporting bias is common in multiple sclerosis (MS) clinical trials, with 95% showing discrepancies between registered and published results. This bias affects the validity of findings for immunomodulatory drugs in MS research.

Area of Science:

  • Clinical Trials Methodology
  • Neurology
  • Pharmaceutical Research

Background:

  • Outcome reporting bias, where trial publication depends on clinical significance, compromises research validity.
  • Immunomodulatory drug research for multiple sclerosis (MS) has expanded significantly.
  • Assessing outcome reporting bias in MS immunomodulatory drug trials is crucial.

Purpose of the Study:

  • To investigate the extent of outcome reporting bias in multiple sclerosis (MS) clinical trials.
  • To identify potential factors contributing to this bias in immunomodulatory drug research.

Main Methods:

  • Identified MS clinical trials registered on ClinicalTrials.gov (post-Sept 2007, pre-2019).
  • Extracted study design, funding, and outcome data from registry.
  • Compared registered outcomes with published outcomes to detect discrepancies.

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Main Results:

  • Of 535 trials, 101 had publications; 95% showed outcome reporting discrepancies.
  • 26 publications had discrepancies in primary outcomes; 44% of published secondary outcomes were not registered.
  • Late registration and outcome amendments were common; non-industry and open-label trials showed trends towards bias.

Conclusions:

  • Selective outcome reporting is highly prevalent in disease-modifying drug trials for MS.
  • Strategies to mitigate outcome reporting bias are needed to improve research integrity.