Characteristics and Research Waste Among Randomized Clinical Trials in Gastric Cancer
Jun Lu1,2,3,4, Bin-Bin Xu1,2,3,4, Li-Li Shen1,2,3,4
1Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.
Importance:
The results of numerous large randomized clinical trials (RCTs) have changed clinical practice in gastric cancer (GC). However, research waste (ie, unpublished data, inadequate reporting, or avoidable design limitations) is still a major challenge for evidence-based medicine.
Objectives:
To determine the characteristics of GC RCTs in the past 20 years and the presence of research waste and to explore potential targets for improvement.
Design, Setting, And Participants:
In this cross-sectional study of GC RCTs, ClinicalTrials.gov was searched for phase 3 or 4 RCTs registered from January 2000 to December 2019 using the keyword gastric cancer. Independent investigators undertook assessments and resolved discrepancies via consensus. Data were analyzed from August through December 2020.
Main Outcomes And Measures:
The primary outcomes were descriptions of the characteristics of GC RCTs and the proportion of studies with signs of research waste. Research waste was defined as unpublished data, inadequate reporting, or avoidable design limitations. Publication status was determined by searching PubMed and Scopus databases. The adequacy of reporting was evaluated using the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline checklist. Avoidable design limitations were determined based on existing bias or lack of cited systematic literature reviews. In the analyses of research waste, 125 RCTs that ended after June 2016 without publication were excluded.
Results:
A total of 262 GC RCTs were included. The number of RCTs increased from 25 trials in 2000 to 2004 to 97 trials in 2015 to 2019, with a greater increase among RCTs of targeted therapy or immunotherapy, which increased from 0 trials in 2000 to 2004 to 36 trials in 2015 to 2019. The proportion of RCTs that were multicenter was higher in non-Asian regions than in Asian regions (50 of 71 RCTs [70.4%] vs 96 of 191 RCTs [50.3%]; P = .004). The analysis of research waste included 137 RCTs, of which 81 (59.1%) were published. Among published RCTs, 65 (80.2%) were judged to be adequately reported and 63 (77.8%) had avoidable design defects. Additionally, 119 RCTs (86.9%) had 1 or more features of research waste. Study settings that included blinding (odds ratio [OR], 0.56; 95% CI, 0.33-0.93; P = .03), a greater number of participants (ie, ≥200 participants; OR, 0.07; 95% CI, 0.01-0.51; P = .01), and external funding support (OR, 0.22; 95% CI, 0.08-0.60; P = .004) were associated with lower odds of research waste. Additionally, 35 RCTs (49.3%) were referenced in guidelines, and 18 RCTs (22.2%) had their prospective data reused.
Conclusions And Relevance:
To our knowledge, this study is the first to describe the characteristics of GC RCTs in the past 20 years, and it found a research waste burden, which may provide evidence for the development of rational RCTs and reduction of waste in the future.
Insights
Research waste, including unpublished data and poor reporting, is prevalent in gastric cancer (GC) randomized clinical trials (RCTs). Factors like blinding and larger participant numbers can reduce this waste, improving evidence quality.
Area of Science:
- Oncology
- Clinical Trials
- Evidence-Based Medicine
Background:
- Gastric cancer (GC) clinical practice is influenced by randomized clinical trials (RCTs).
- Research waste, encompassing unpublished data, inadequate reporting, and design flaws, remains a significant obstacle in evidence-based medicine for GC.
- Addressing research waste is crucial for advancing GC treatment strategies.
Purpose of the Study:
- To characterize gastric cancer (GC) randomized clinical trials (RCTs) conducted over the past two decades.
- To identify and quantify the extent of research waste within GC RCTs.
- To pinpoint areas for improvement in the design and reporting of future GC RCTs.
Main Methods:
- A cross-sectional study analyzing phase 3 or 4 GC RCTs registered on ClinicalTrials.gov from January 2000 to December 2019.
- Systematic searches of PubMed and Scopus databases to determine publication status.
- Evaluation of reporting adequacy using the Consolidated Standards of Reporting Trials (CONSORT) checklist and assessment of avoidable design limitations.
Main Results:
- A total of 262 GC RCTs were identified, with a notable increase in trials for targeted therapy and immunotherapy.
- Research waste was identified in 86.9% of analyzed RCTs, with common issues including inadequate reporting (80.2%) and design defects (77.8%).
- Factors such as multicenter design (in non-Asian regions), blinding, larger participant numbers (≥200), and external funding were associated with reduced research waste.
Conclusions:
- This study provides the first comprehensive overview of GC RCT characteristics over 20 years.
- A substantial burden of research waste exists within GC RCTs, highlighting the need for improved research practices.
- Findings offer evidence-based targets for developing more rational RCTs and minimizing research waste in gastric cancer research.
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