Neurology trial registrations on ClinicalTrials.gov between 2007 and 2018: A cross-sectional analysis of characteristics, early discontinuation, and results reporting

Turner, Brandon E.; Magnani, Christopher J.; Frolov, Alexander A.; Weeks, Brannon T.; Steinberg, Jecca R.; Huda, Naureen; Shah, Lochan M.; Zuroff, Leah; Gu, Ben; Rasmussen, Hannah; Edwards, Jeffrey; Save, Akshay; Shen, Max; Ren, Mark; Bryant, Barry R.; Qian, Ma; Feng, Austin Y.; Liang, Amy; Santini, Veronica

doi:10.1016/j.jns.2021.117579

Cited by 7 publications

(21 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“… 12 In some specific fields (such as neurology and late-stage cardiovascular trials), the overall results reporting rates were within the range of 22%–41%. 5 12 19–23 Again, the results reporting rates within 1 year of primary completion in the previous studies were within the range of 13%–15%. 14 19 These proportions are higher than results from our current study on robot-assisted surgery, and this may relate to different national requirements or incentives for timely dissemination in a registry.…”

Section: Discussionmentioning

confidence: 79%

“…Additionally, the classification method of the funder is essentially identical to previously published methods. 5 18 …”

Section: Methodsmentioning

confidence: 99%

“…2 3 Robot-assisted surgery has become more and more widely applied in surgical specialties, and massive clinical studies were triggered. 4 A large number of observational studies and randomised controlled trials costing a lot of human, physical and financial resources 5 compared robot-assisted surgery with laparoscopic surgery, video-assisted surgery or open surgery, but the results have been inconsistent. 6 …”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Early discontinuation and results reporting of robot-assisted surgery studies registered on ClinicalTrials.gov: a research on research study

Long

Yang

et al. 2023

BMJ Open

View full text Add to dashboard Cite

ObjectivesIn 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.DesignWe 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.ResultsA 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).ConclusionsThere 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.

show abstract

Section: Discussionmentioning

confidence: 79%

“…Additionally, the classification method of the funder is essentially identical to previously published methods. 5 18 …”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Early discontinuation and results reporting of robot-assisted surgery studies registered on ClinicalTrials.gov: a research on research study

Long

Yang

et al. 2023

BMJ Open

View full text Add to dashboard Cite

show abstract

“…Compared with nongynecologic studies, gynecology trials show similar frequency of completion, results reporting, and publication. 19,20,33 Nearly half of trials that are discontinued early lack a reason for early termination. The limited information on early discontinuation hinders research transparency and our ability to parse out the nuances that lead to successful completion.…”

Section: Discussionmentioning

confidence: 99%

Early Discontinuation, Results Reporting, and Publication of Gynecology Clinical Trials From 2007 to 2020

Steinberg

Magnani

Turner

et al. 2022

Obstetrics &Amp; Gynecology

Self Cite

View full text Add to dashboard Cite

show abstract

“…Interventional clinical trials in neurology have grown over time, from 1,208 in 2008 to 2,278 in 2017, with academic funding showing the most growth. 1 However, despite these novel therapeutics, the rate of positive clinical trials tends to be low in neurology. 2 The development of neurologists willing to advance the field is of integral importance.…”

mentioning

confidence: 99%

Emerging Subspecialties in Neurology: A Career as a Clinical Trialist in Neurology

Saver

Perlman

2022

Neurology

View full text Add to dashboard Cite

The recent therapeutic advances in the field of neurology highlight the importance of ongoing clinical trials. However, while clinical research in neurology has remained relatively stable over the last 10 years, there has been an interval decrease in neuroscience applicants for NIH funding, which has raised concerns about the pipeline and future of clinical research in neurology. Those interested in such a career can begin by identifying a preclinical neuroscience advance that has yet to be translated into clinical trial work or a clinical area of need based upon conversations with patients and families. Once such an area of interest is identified, seeking mentors either at one’s own local institution or via networking at conferences is important in developing the necessary skills pertaining to clinical trial conduct and design as well as in gaining access to the relevant professional networks. There is also a myriad of training opportunities, such as the NINDS Clinical Trials Methodology Course, Masters of Science in Clinical Research, and certificate programs that offer formal training. Additional considerations for advancing in this career include exploring the potential for secondary publications using data available from prior clinical trials or serving as a sub-investigator. Challenges in pursuing such a career include the relatively low rate of positive outcomes compared with other fields and consistent salary support throughout one’s career. Overall, a career as a clinical trialist in neurology is rewarding, as one is able to participate in advancing the field and offer potentially new treatments to their patients.

show abstract

Neurology trial registrations on ClinicalTrials.gov between 2007 and 2018: A cross-sectional analysis of characteristics, early discontinuation, and results reporting

Cited by 7 publications

References 17 publications

Early discontinuation and results reporting of robot-assisted surgery studies registered on ClinicalTrials.gov: a research on research study

Early discontinuation and results reporting of robot-assisted surgery studies registered on ClinicalTrials.gov: a research on research study

Early Discontinuation, Results Reporting, and Publication of Gynecology Clinical Trials From 2007 to 2020

Emerging Subspecialties in Neurology: A Career as a Clinical Trialist in Neurology

Contact Info

Product

Resources

About