Related Experiment Video
Updated: Jun 23, 2025
A Melanoma Patient-Derived Xenograft Model
Published on: May 20, 2019
Characteristics and research waste of randomized controlled trials in melanoma
Hongrui Chen1, Bin Sun1, Chen Hua1
1Department of Plastic & Reconstructive Surgery, Shanghai Ninth People's Hospital, affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Background:
Numerous large-scale randomized controlled trials (RCTs) have propelled melanoma treatment strategies. Research waste presents a significant challenge in translating the outcomes of RCTs into clinical practice. Currently, research waste has not been reported in melanoma-related RCTs.
Objectives:
To determine research waste in RCTs for melanoma.
Methods:
In January 2024, we searched ClinicalTrials.gov for phase III and phase IV RCTs registered from January 2000 to December 2023, using 'melanoma' as the keyword. We recorded the information listed on the website and searched PubMed and Scopus for the publication and citation status of the RCTs. A completed RCT requires at least 47 months of preparation time for publication; hence, RCTs completed after December 2019 but not yet published were excluded from the analysis of publication status.
Results:
In total, 165 RCTs were included in the analysis. Melanoma RCTs primarily studied pharmacological interventions, with the registrations for immunotherapy increasing annually. In the analysis of research waste, 103 RCTs were included, of which 41 (41 of 103, 39.8%) were unpublished. Of the 62 published RCTs, 19 (19 of 62, 31%) reported insufficiently, and 19 had avoidable design flaws (19 of 62, 31%). Ultimately, 64 RCTs (64 of 103, 62.1%) were judged to have research waste. Registration after 2010, conducting studies in multiple countries, using multiple drug interventions, and having survival as the primary outcome were independent protective factors against research waste. Thirty-four RCTs (34 of 62, 55%) were cited by guidelines, and 21 RCTs (21 of 62, 34%) reused their prospective data.
Conclusions:
We describe the characteristics of phase III and phase IV RCTs related to melanoma conducted over the past 2 decades. We identified a substantial degree of research waste. The protective factors against research waste revealed in this study can provide references for the rational and efficient conduct of new RCTs in the future.
Insights
Research waste is prevalent in melanoma clinical trials, with nearly 40% of randomized controlled trials (RCTs) remaining unpublished. Identifying factors that prevent research waste can improve future melanoma research efficiency.
Area of Science:
- Oncology
- Clinical Research Methodology
- Biostatistics
Background:
- Randomized controlled trials (RCTs) are crucial for advancing melanoma treatment.
- Research waste, defined as the inefficiency in the generation and use of research knowledge, is a significant barrier in translating trial outcomes to clinical practice.
- No prior reports have quantified research waste in melanoma-specific RCTs.
Purpose of the Study:
- To systematically assess the extent of research waste in phase III and phase IV randomized controlled trials (RCTs) for melanoma.
- To identify characteristics and factors associated with research waste in melanoma RCTs.
Main Methods:
- A comprehensive search of ClinicalTrials.gov was conducted for phase III and IV melanoma RCTs registered between January 2000 and December 2023.
- Publication and citation status were evaluated using PubMed and Scopus.
- Research waste was defined by criteria including non-publication, insufficient reporting, and avoidable design flaws, excluding trials completed after December 2019 due to publication lag.
Main Results:
- Of 103 analyzed RCTs, 39.8% were unpublished, and 62.1% exhibited research waste.
- Among published trials, 31% had insufficient reporting, and 31% had avoidable design flaws.
- Factors such as later registration (post-2010), multinational conduct, multiple drug interventions, and survival as primary outcomes were associated with reduced research waste.
Conclusions:
- A substantial proportion of melanoma RCTs experience research waste, impacting the efficient advancement of treatment strategies.
- Understanding protective factors against research waste is essential for optimizing the design and execution of future clinical trials.
- These findings offer valuable insights for improving the rational and efficient conduct of new melanoma RCTs.
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