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Background and purpose <p>Premature discontinuation and non-publication of clinical trials constitute a waste of limited public resources and create ethical dilemmas for trial participants, clinicians, and the public. This study investigated the rates of discontinuation and non-publication of clinical trials related to small-cell lung cancer (SCLC) treatment.</p> Methods <p>We conducted a cross-sectional review of ClinicalTrials.gov to screen clinical trials examining anticancer therapies for SCLC between 2006 and 2020. Discontinuation was determined by recruitment status and a comparison between expected and actual enrollment sizes. The publication status was determined through a systematic search of PubMed, Embase, and Google Scholar.</p> Results <p>The study included 154 clinical trials. Of these, 79 (51.3%) were prematurely discontinued, and 27 were discontinued for preventable reasons (i.e., poor recruitment, organizational/strategic reasons, and limited resources). Multicenter recruitment (OR 0.227, 95% CI 0.077–0.673, <i>P</i> = 0.007) and Asian principal investigators (OR 0.324, 95% CI 0.114–0.924, <i>P</i> = 0.035) were independently associated with a reduced probability of premature discontinuation. In contrast, industry-funded clinical trials were independently associated with a reduced probability of preventable discontinuation (OR 0.237, 95% CI 0.080–0.698, <i>P</i> = 0.009). To date, 43 of the 154 trials (27.9%) remained unpublished. When considering reasons for discontinuation, preventable discontinuation (OR 0.044, 95% CI 0.014–0.144, <i>P</i> &lt; 0.001) and industry funding (OR 0.118, 95% CI 0.031–0.448, <i>P</i> = 0.002) were independently associated with a reduced probability of publication, whereas multicenter (OR 6.302, 95% CI 1.783–22.271, <i>P</i> = 0.004) and international recruitment (OR 5.358, 95% CI 1.467–19.566, <i>P</i> = 0.011) were independently associated with an increased probability of publication.</p> Interpretation <p>Premature discontinuation and non-publication are common in SCLC-related clinical trials and warrant further attention.</p>

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Clinical trials in small-cell lung cancer treatment: a cross-sectional analysis of trial discontinuation and non-publication

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月26日

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  • Haiyong Chen,
  • Kengqiang Lin,
  • Zujian Dai,
  • Shan Pan

摘要

Background and purpose

Premature discontinuation and non-publication of clinical trials constitute a waste of limited public resources and create ethical dilemmas for trial participants, clinicians, and the public. This study investigated the rates of discontinuation and non-publication of clinical trials related to small-cell lung cancer (SCLC) treatment.

Methods

We conducted a cross-sectional review of ClinicalTrials.gov to screen clinical trials examining anticancer therapies for SCLC between 2006 and 2020. Discontinuation was determined by recruitment status and a comparison between expected and actual enrollment sizes. The publication status was determined through a systematic search of PubMed, Embase, and Google Scholar.

Results

The study included 154 clinical trials. Of these, 79 (51.3%) were prematurely discontinued, and 27 were discontinued for preventable reasons (i.e., poor recruitment, organizational/strategic reasons, and limited resources). Multicenter recruitment (OR 0.227, 95% CI 0.077–0.673, P = 0.007) and Asian principal investigators (OR 0.324, 95% CI 0.114–0.924, P = 0.035) were independently associated with a reduced probability of premature discontinuation. In contrast, industry-funded clinical trials were independently associated with a reduced probability of preventable discontinuation (OR 0.237, 95% CI 0.080–0.698, P = 0.009). To date, 43 of the 154 trials (27.9%) remained unpublished. When considering reasons for discontinuation, preventable discontinuation (OR 0.044, 95% CI 0.014–0.144, P < 0.001) and industry funding (OR 0.118, 95% CI 0.031–0.448, P = 0.002) were independently associated with a reduced probability of publication, whereas multicenter (OR 6.302, 95% CI 1.783–22.271, P = 0.004) and international recruitment (OR 5.358, 95% CI 1.467–19.566, P = 0.011) were independently associated with an increased probability of publication.

Interpretation

Premature discontinuation and non-publication are common in SCLC-related clinical trials and warrant further attention.