Discontinuation and nonpublication of pediatric otolaryngology clinical trials

Austin L Johnson; Trevor Torgerson; Mopileola Tomi Adewumi; Micah Kee; Clay Farahani; Daniel J Wehrmann; Carrie L Francis; Matt Vassar

doi:10.1016/j.ijporl.2021.110972

Discontinuation and nonpublication of pediatric otolaryngology clinical trials

Int J Pediatr Otorhinolaryngol. 2021 Dec:151:110972. doi: 10.1016/j.ijporl.2021.110972. Epub 2021 Nov 10.

Authors

Austin L Johnson¹, Trevor Torgerson², Mopileola Tomi Adewumi², Micah Kee², Clay Farahani³, Daniel J Wehrmann⁴, Carrie L Francis⁵, Matt Vassar²

Affiliations

¹ Oklahoma State University Center for Health Sciences, Tulsa, OK, USA. Electronic address: austin.johnson14@okstate.edu.
² Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
³ Oklahoma State University Medical Center, Department of Otolaryngology, Tulsa, OK, USA.
⁴ University of Nebraska Medical Center, Department of Otolaryngology, Omaha, NE, USA.
⁵ University of Kansas Medical Center, Department of Otolaryngology, Kansas City, KS, USA.

PMID: 34773883
DOI: 10.1016/j.ijporl.2021.110972

Abstract

Objectives: Randomized controlled trial (RCT) discontinuation and nonpublication are potential mechanisms of waste in resources and lead to decreased advancement of medical science and compromised ethical issues in all specialties. However, the prevalence of discontinued or unpublished RCTs regarding common pediatric otolaryngology disorders and interventions remains unclear.

Study design: Cross-sectional analysis.

Methods: Retrospective analysis of common pediatric otolaryngology RCTs registered in ClinicalTrials.gov up until November 2, 2018. Data were collected from the registry, and publication status was identified. If a reason for trial discontinuation or nonpublication was not identified through a systematic search, corresponding trialists were contacted through email.

Results: After exclusion, 260 RCTs were included for analysis. Analysis found 198 (76%) RCTs were completed, and 62 (24%) trials were discontinued. The most commonly reported reasons for RCT discontinuation were program termination by sponsor or management (7/24; 29.2%), lack of participant enrollment, difficulty recruiting, or slow accrual (7/24; 29.2%). A total of 192 (192/260; 73.8%) published RCTs and 68 (68/260; 26.2%) unpublished RCTs were identified. Twenty-six (26/62; 42%) of the discontinued RCTs reached publication, while 36 (58%) remained unpublished. Regarding the completed RCTs, 166 of 198 (83.8%) completed trials reached publication, while 32 (32/198; 16.2%) remained unpublished after trial completion.

Conclusions: Approximately 1 in 4 of included RCTs were discontinued or did not reach publication. Findings suggest further guidance is needed for RCTs regarding common pediatric otolaryngology disorders and interventions.

Level of evidence: NA.

Keywords: Clinical trials; Discontinuation; Pediatric otolaryngology; Publication; Randomized controlled trials.

MeSH terms

Child
Clinical Trials as Topic
Cross-Sectional Studies
Humans
Otolaryngology*
Publishing*
Registries
Retrospective Studies