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Participant Heterogeneity of Psoriasis Interventional Trials.

Shuntong Kang1,2,3,4,5,6, Dingyao Zhang7, Bo Zhang3

  • 1Key Laboratory of Shaanxi Province for Craniofacial Precision Medicine Research, College of Stomatology, Xi'an Jiaotong University, Xi'an, China.

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PubMed
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Participant heterogeneity in psoriasis randomized clinical trials (RCTs) is significantly influenced by national income. Trials in lower-income countries generally show better participant adherence, impacting intervention efficacy globally.

Keywords:
HeterogeneityNational incomePsoriasisRandomized clinical trialsWorldwide

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Area of Science:

  • Dermatology
  • Clinical Trials
  • Health Economics

Background:

  • Participant heterogeneity impacts intervention efficacy in clinical trials.
  • Factors driving participant heterogeneity in psoriasis randomized clinical trials (RCTs) are not well understood.
  • Participant adherence is a key indicator of heterogeneity in RCTs.

Purpose of the Study:

  • To explore participant heterogeneity in psoriasis RCTs, focusing on participant adherence.
  • To identify factors influencing participant adherence across different national income levels.

Main Methods:

  • Systematic literature search of interventional psoriasis RCTs up to July 2021.
  • Inclusion of peer-reviewed articles and registered trials from databases and registries.
  • Meta-analyses to calculate the risk ratio of participant adherence between intervention and control groups.

Main Results:

  • 1,714 trials met inclusion criteria; national income uniquely influenced withdrawal rates.
  • Participant adherence varied significantly by country's national income.
  • Trials in low- and middle-income countries exhibited better adherence and more constant withdrawal ratios compared to high-income countries.

Conclusions:

  • National income is an unexpected driver of participant heterogeneity in global psoriasis RCTs.
  • Results from high-income countries require careful interpretation due to confounding factors.
  • Rigorous single-country trials are essential for developing localized clinical management strategies.