Characteristic and Early Discontinuation of Obsessive-Compulsive Disorder Trials Registered on ClinicalTrials.gov

Abstract

Objective: This study aimed to analyze the characteristics and reasons of early discontinuation of obsessive-compulsive disorder (OCD) trials registered on ClinicalTrials.gov.Methods: OCD trials and relevant publications were searched on ClinicalTrials.gov and PubMed, respectively. The characteristics and details regarding the timely publication of trials were recorded. Cox regression analysis was used to explore factors associated with the early discontinuation of OCD trials.Results: The analysis included 298 OCD therapy trials. Most investigations recruited <100 patients and were more likely to involve adults. Of all OCD studies identified, 67.8% were randomized and 61.4% were blind (single- or double-blind). Universities and hospitals were recorded as the two primary locations in the majority of trials. A total of 155 trials (52%) were completed; however, only 29% of those were published. Of the published trials, >70% were published at least 1 year after completion. Behavioral therapy trials were the most common type of major treatment-aimed OCD trials (39%), followed by drug trials (35.1%) and device/procedure trials (24.7%). The univariate Cox regression analysis indicated that drug trials [hazard ratio (HR) = 2.56, 95% confidence interval (CI): 1.21–5.43], absence of collaborators (HR = 3.87, 95% CI: 1.62–9.26), and sponsorship by industry (HR = 3.97, 95% CI: 1.49–10.53) were risk factors for early discontinuation of OCD trials. Further multivariate Cox regression showed that drug trials (HR = 3.93, 95% CI: 1.71–9.08) and absence of collaborators (HR = 5.17, 95% CI: 1.97–13.54) were independent risk factors for early trial discontinuation of OCD trials. The sensitivity analysis confirmed these results. Non-drug trials (OR = 3.32, 95% CI: 1.21–9.11), absence of collaborators (OR = 3.25, 95% CI: 1.10–9.60), and non-blinded trials (OR = 5.23, 95% CI: 1.05–26.2) were independent risk factors for unreported results in registry.Conclusion: The diagnosis and prevention of OCD are rarely investigated in trials. Underreporting and delayed reporting remain major problems. The type of intervention and participation of collaborators are associated with early discontinuation of OCD trials.

Result reporting and early discontinuation of sepsis trials registered on ClinicalTrials.gov

“…12 Poor enrollment (38.8%, n = 33) and lack of efficiency (n = 13) are the most common reason, which is slightly different from several previous studies (lack of efficiency replaced funding problem in second place). 18,24,25 One possible explanation is that there's no specific management of sepsis and the consequentially constant low success rate. 26,27 Poor enrollment is commonly discussed in premature discontinuation.…”

“…13 In univariate analysis, industry sponsorship and the primary purpose of treatment were factors related to timely result reporting and compliance with some previous studies to some extent. 18,25,31 Trials blinding to participants are at lower risk of lack of reporting, probably because the unawareness of participants can suppress interference of subjective factors and at lower risk of bias, [32][33][34] and blinding of patients in critical care trials is recommended according to a study by Martin, Guillaume et al 35 Phase IV trials were more like to underreport results than early phase trials (Phases I-III), opposite to the analysis by Bashir et al 31 Phase IV trials aim to study the efficiency, rare adverse reactions and consistency of US Food and Drug Administration (FDA)-approved drugs, 36 so one possible reason is that they may be more subject to individual factors of participants which may influence results collating and interpretation.…”

“…Participants are assigned to groups providing different interventions or placebo or no interventions. 18 Two investigators screened each trial independently. Trials only mentioned sepsis in their background were excluded.…”

“…20,21 According to the requirements of the National Institution of Health (NIH) regulations and trial reporting policies, the results of trials should be published within 12 months from primary completion; otherwise, the publication will be considered delayed. 18 And for the sample sizes, we classified enrollment of 0-99 as a small sample size and enrollment more than or equal to 100 as a big sample size. We only analyzed results reporting for trials completed before July 8, 2021 to ensure a full 12-month reporting window.…”

Contrast‐enhanced ultrasound studies registered on ClinicalTrials.gov: A cross‐sectional analysis of characteristics, early discontinuation, and reporting results

“…The funding sources were divided into the industry, NIH and others, following the criteria of previous studies. 5…”