0827: Unpublished Clinical Trials of Major Rheumatic Diseases

Connor Pedersen¹, Mike Putman², Erin Valley¹, Kathryn Henry³, Ali Duarte-Garcia⁴, Shikha Singla⁵ and Shannon Tai¹, ¹Medical College of Wisconsin, Milwaukee, WI, ²The Medical College of Wisconsin, Milwaukee, WI, ³Medical College of Wisconsin, Manitowoc, WI, ⁴Mayo Clinic, Rochester, MN, ⁵MCW, Fox Point, WI

Background/Purpose: Randomized controlled trials (RCTs) provide high-quality evidence for treatment efficacy, but many RCTs remain unpublished. The objective of this study was to describe the proportion of unpublished RCTs in rheumatology and to identify factors associated with publication.

Methods: Registered RCTs for 5 rheumatic diseases (systemic lupus erythematosus, vasculitis, spondyloarthritis, Sjögren's syndrome, and psoriatic arthritis) with over 30 months since study completion were identified using ClinicalTrials.gov. Index publications were identified by NCT ID numbers and structured text searches of publication databases. The results of unpublished studies were identified in abstracts and press releases; reasons for non-publication were assessed by surveying corresponding authors.

Results: Out of 203 studies that met eligibility criteria, 17.2% remained unpublished, representing data from 4,281 trial participants. Higher proportions of published trials were phase 3 RCTs (57.1% vs 28.6% unpublished, p < 0.05) or had a positive primary outcome measure (64.9% vs 25.7% unpublished, p < 0.001), and in a multivariable cox proportional hazards model, a positive outcome was independently associated with publication (HR 1.55, CI 1.09-2.22). Corresponding authors of unpublished trials commonly cited ongoing preparation of the manuscript (50.0%), sponsor/funder issues (40.0%), and unimportant/negative result (20.0%) as reasons for lack of publication.

Conclusion: Nearly one in five RCTs in rheumatology remain unpublished two years after trial completion, and publication is associated with positive primary outcome measures. Efforts to encourage universal publication of rheumatology RCTs and reanalysis of previously unpublished trials should be undertaken.
Table 1: Characteristics associated with publication in study RCTs

Figure 1 (A): Outcome of Rheumatology RCTs, Stratified by Disease State; Figure 1 (B): Publication Status of Rheumatology RCTs, Stratified by Disease State

Figure 2 (A): Time to Publication by Trial Outcome; Figure 2 (B): Time to Publication by Trial Phase
Disclosures: C. Pedersen, None; M. Putman, AstraZeneca, AbbVie/Abbott, Novartis; E. Valley, None; K. Henry, None; A. Duarte-Garcia, None; S. Singla, None; S. Tai, None.