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Advancing randomized controlled trials of vascular anomalies: an analysis of trial waste
Hongrui Chen1, Rui Chang1, Yuxi Chen1
1Department of Plastic & Reconstructive Surgery, Shanghai Ninth People's Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine, 639 Zhizaoju Road, Shanghai, 200011, China.
Abstract:
A series of randomized controlled trials (RCTs) have advanced the therapeutic approaches for vascular anomalies (VA). However, a notable obstacle in applying the findings of these trials to real-world patient care is trial waste (TW). To date, the extent of TW in RCTs for VA is not clear. In June 2024, we searched the ClinicalTrials database using the entity names defined by ISSVA classification as search terms. We documented the data available and then explored PubMed and Scopus for the publication status. Reporting adequacy was evaluated using the CONSORT checklist. Design limitations were analyzed based on bias risk and whether the article referenced a relevant systematic review. One hundred fifty-nine RCTs met the inclusion criteria. The majority of RCTs focused on benign VA (81.1%) and utilized pharmacotherapy (79.9%). Over 90% of these trials were conducted in North America, Europe, and Asia as single-center studies (68.6%), with funding primarily from official institutions (83.7%). The analysis of TW excluded 61 RCTs completed after June 2020 that remained unpublished. Among the remaining 98 RCTs, 53 were published, 41 had adequate reporting, and 16 had design limitations. In total, 67 RCTs exhibited at least one characteristic of TW. The 31 RCTs without waste tended to enroll more participants (P = 0.014) and conduct studies across multiple centers (P < 0.001) and countries (P = 0.022). Multicenter participation (P = 0.028) emerged as an independent protective factor against TW.
Conclusion:
We delineated the features of 159 VA RCTs and revealed that 68.4% of them exhibited TW. The diverse traits of the different TW indicators identified could serve as valuable insights for conducting future VA RCTs more rationally and efficiently.
What Is Known:
• Currently, a number of RCTs have been conducted on vascular anomalies (VA). However, there has been no study analyzing the situation of trial waste in VA-related RCTs.
What Is New:
• This study is the first to describe the characteristics of VA-related RCTs globally over the past 20 years and has identified a high burden of trial waste in this field. Multicenter participation was an independent protective factor against trial waste.
Insights
Trial waste (TW) is a significant issue in vascular anomalies (VA) research. This study found that 68.4% of VA randomized controlled trials (RCTs) exhibit trial waste, with multicenter participation being a protective factor.
Area of Science:
- Vascular anomalies research
- Clinical trial methodology
- Evidence-based medicine
Background:
- Randomized controlled trials (RCTs) are crucial for advancing therapeutic approaches in vascular anomalies (VA).
- Trial waste (TW), the inefficiency in clinical trials, poses a significant obstacle to applying research findings to patient care.
- The extent and characteristics of TW in VA-related RCTs have not been previously analyzed.
Purpose of the Study:
- To delineate the features of VA-related RCTs globally over the past 20 years.
- To identify the prevalence and characteristics of trial waste (TW) in VA RCTs.
- To determine factors associated with reduced trial waste in this field.
Main Methods:
- A comprehensive search of the ClinicalTrials database was conducted in June 2024 using ISSVA classification terms for VA.
- Publication status was assessed via PubMed and Scopus, and reporting adequacy was evaluated using the CONSORT checklist.
- Design limitations were analyzed based on bias risk and reference to systematic reviews, with 159 RCTs meeting inclusion criteria.
Main Results:
- The majority of the 159 included RCTs focused on benign VA (81.1%) and used pharmacotherapy (79.9%), predominantly conducted in North America, Europe, and Asia as single-center studies (68.6%).
- Of the 98 published RCTs, 67 (68.4%) exhibited at least one characteristic of trial waste.
- RCTs without waste were more likely to enroll more participants and be conducted across multiple centers and countries; multicenter participation was an independent protective factor against TW.
Conclusions:
- A substantial proportion of VA RCTs (68.4%) suffer from trial waste.
- Identifying and understanding the diverse indicators of TW is essential for improving the rationality and efficiency of future VA RCTs.
- Multicenter collaboration is a key strategy to mitigate trial waste in vascular anomalies research.
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