TY - JOUR
T1 - Neurology trial registrations on ClinicalTrials.gov between 2007 and 2018
T2 - A cross-sectional analysis of characteristics, early discontinuation, and results reporting
AU - Turner, Brandon E.
AU - Magnani, Christopher J.
AU - Frolov, Alexander
AU - Weeks, Brannon T.
AU - Steinberg, Jecca R.
AU - Huda, Naureen
AU - Shah, Lochan M.
AU - Zuroff, Leah
AU - Gu, Ben Jiahe
AU - Rasmussen, Hannah
AU - Edwards, Jeffrey G.
AU - Save, Akshay V.
AU - Shen, Max
AU - Ren, Mark
AU - Bryant, Barry R.
AU - Ma, Qian
AU - Feng, Austin Y.
AU - Liang, Amy C.
AU - Santini, Veronica E.
N1 - Funding Information:
Brandon E. Turner MD certifies that none of the contributing authors have any conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript. Funding/Support and role of the sponsor: No funding or other financial support was received.
Publisher Copyright:
© 2021 Elsevier B.V.
PY - 2021/9/15
Y1 - 2021/9/15
N2 - Background: Increasing neurological disease burden and advancing treatment options require clinical trials to expand the evidence base of clinical care. We aimed to characterize neurology clinical trials registered between October 2007 and April 2018 and identify features associated with early discontinuation and results reporting. Methods: We compared 16,994 neurology (9.4%) and 163,714 non-neurology comparison trials registered to ClinicalTrials.gov. Trials therapeutic focus within neurology was assigned via combination programmatic and manual review. We performed descriptive analyses of trial characteristics, cox regression of early discontinuation, and multivariable logistic regression for results reporting within 3 years of completion. Results: Most neurology trials were academic-funded (58.5%) followed by industry (31.9%) and US-government (9.6%). Neurology trials focused more on treatment than prevention compared to non-neurology studies. Of neurology trials, 11.3% discontinued early, and 32.2% of completed trials reported results by April 30, 2018. In multivariable analysis accounting for time-to-event, neurology trials were at lower risk of discontinuation than non-neurology trials (adjusted hazard 0.83, p < 0.0001). Both academic and government-funded trials had greater risk of discontinuation than industry (adjusted hazard 0.57 and 0.46, respectively). Among completed trials, government-funded studies (adjusted odds ratio 2.12, p < 0.0001) had highest odds of results reporting while academic trials reported less (adjusted odds ratio 0.51, p < 0.0001). Conclusions: Funding source is associated with trial characteristics and outcomes in neurology. Improvements in trial completion and timely dissemination of results remain urgent goals for the field.
AB - Background: Increasing neurological disease burden and advancing treatment options require clinical trials to expand the evidence base of clinical care. We aimed to characterize neurology clinical trials registered between October 2007 and April 2018 and identify features associated with early discontinuation and results reporting. Methods: We compared 16,994 neurology (9.4%) and 163,714 non-neurology comparison trials registered to ClinicalTrials.gov. Trials therapeutic focus within neurology was assigned via combination programmatic and manual review. We performed descriptive analyses of trial characteristics, cox regression of early discontinuation, and multivariable logistic regression for results reporting within 3 years of completion. Results: Most neurology trials were academic-funded (58.5%) followed by industry (31.9%) and US-government (9.6%). Neurology trials focused more on treatment than prevention compared to non-neurology studies. Of neurology trials, 11.3% discontinued early, and 32.2% of completed trials reported results by April 30, 2018. In multivariable analysis accounting for time-to-event, neurology trials were at lower risk of discontinuation than non-neurology trials (adjusted hazard 0.83, p < 0.0001). Both academic and government-funded trials had greater risk of discontinuation than industry (adjusted hazard 0.57 and 0.46, respectively). Among completed trials, government-funded studies (adjusted odds ratio 2.12, p < 0.0001) had highest odds of results reporting while academic trials reported less (adjusted odds ratio 0.51, p < 0.0001). Conclusions: Funding source is associated with trial characteristics and outcomes in neurology. Improvements in trial completion and timely dissemination of results remain urgent goals for the field.
KW - ClinicalTrials.gov
KW - Neurology
KW - Randomized control trials
KW - Research funding
UR - http://www.scopus.com/inward/record.url?scp=85111257991&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85111257991&partnerID=8YFLogxK
U2 - 10.1016/j.jns.2021.117579
DO - 10.1016/j.jns.2021.117579
M3 - Article
C2 - 34332371
AN - SCOPUS:85111257991
SN - 0022-510X
VL - 428
JO - Journal of the Neurological Sciences
JF - Journal of the Neurological Sciences
M1 - 117579
ER -