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Early discontinuation and results reporting of robot-assisted surgery studies registered on ClinicalTrials.gov: a
Youlin Long1,2, Tengyue Hu3, Zixin Yang3
1Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, PR China.
Objectives:
In this study, we aimed to investigate the characteristics of robot-assisted surgery studies registered on ClinicalTrials.gov and identify factors associated with early trial discontinuation and timely results reporting.
Design:
We searched ClinicalTrials.gov to identify interventional studies on robot-assisted surgery on 24 May 2021. All structured information of the potential studies was downloaded and reviewed. A descriptive analysis was performed. Logistic and Cox regression analyses were respectively performed to determine the significance of the association of study characteristics with results reporting and early discontinuation.
Results:
A total of 529 interventional studies on robot-assisted surgery were included, with 45 studies reporting results and 54 studies being stopped early. Of the 289 due studies, only 45 (16%) had submitted their results, and only 6 (2%) had submitted their results within the 1-year deadline. Funding source was associated with results reporting: academic funded were 63% less likely than industry to report results (OR=0.37, 95% CI: 0.16 to 0.83, p=0.02). Studies related to device feasibility were associated with greater risk of early discontinuation compared to treatment-related studies (HR=2.30, 95% CI: 1.08 to 4.89, p=0.03). Surprisingly, National Institutes of Health-funded studies were at greater hazard of discontinuation compared to industry-funded studies (HR=3.30, 95% CI: 1.09 to 10.00, p=0.04).
Conclusions:
There was poor compliance with results reporting requirements for robot-assisted surgical studies. It is important that investigators remain informed about the regulatory requirements, and should be helped to develop a sense of responsibility for reporting results. Also, they need to ensure the careful design of the study protocol and adequate resources to reduce the risk of early discontinuation.
Insights
Robot-assisted surgery trials show poor results reporting and high early discontinuation rates. Academic funding and study design impact reporting and discontinuation, highlighting a need for improved compliance and protocol design.
Area of Science:
- Robotics in Medicine
- Clinical Trial Design and Analysis
- Surgical Innovation
Background:
- Robot-assisted surgery (RAS) represents a significant advancement in minimally invasive procedures.
- Understanding the landscape of RAS clinical trials is crucial for assessing their progress and impact.
- Factors influencing trial outcomes, such as results reporting and early discontinuation, require investigation.
Purpose of the Study:
- To characterize robot-assisted surgery studies registered on ClinicalTrials.gov.
- To identify factors associated with early trial discontinuation in RAS.
- To determine factors linked to timely results reporting for RAS trials.
Main Methods:
- A comprehensive search of ClinicalTrials.gov for interventional RAS studies was conducted.
- Data from 529 identified studies were analyzed descriptively.
- Logistic and Cox regression models were employed to assess associations with results reporting and early discontinuation.
Main Results:
- Only 16% of due RAS studies reported results, with just 2% meeting the 1-year deadline.
- Academic funding was associated with a 63% lower likelihood of results reporting compared to industry funding.
- Feasibility studies and National Institutes of Health (NIH) funding increased the risk of early discontinuation.
Conclusions:
- Robot-assisted surgery trials exhibit inadequate compliance with results reporting mandates.
- Investigators need enhanced awareness of regulatory requirements and a stronger sense of responsibility for reporting.
- Careful study protocol design and sufficient resources are essential to mitigate early trial discontinuation.
