Background/Purpose: Timely publication of randomized controlled trials (RCTs) is crucial for their potential impact on patient care. We assessed the publication timeliness of drug therapy RCTs of inflammatory arthritis.

Methods: The print issues (or online issues for online-only journal) of the 10 highest impact factor (IF) rheumatology journals publishing original research and 5 highest IF internal medicine journals for the years 2013-2014 were searched using Medline. Original parallel-design, non-phase-1 RCTs reports of drug therapy for inflammatory arthritis with clinical primary outcome(s) were eligible. RCT completion dates were retrieved either from the manuscript or the respective trial registry information in the manuscript. The dates of manuscript submission, acceptance, first online publication, and publication in a print issue were used to calculate the intervals in the publication process of study RCTs. RCT characteristics associated of with the time from trial completion to first (online or print) and final (typically print) available version were assessed.

Results: Eligibility criteria were met by 67 RCTs. The study conditions were rheumatoid arthritis (68.7%), spondyloarthropathy (20.9%), gout (6%) and others (4.5%). Experimental drug manufacturer fully or partially funded 56 (83.6%) RCTs. All RCTs had trial registry information (ClinicalTrials.gov for (58[86.6%]) RCTs). The experimental interventions included biologics (73.1%), small molecule (14.9%), traditional disease modifying agent ([10.4%), and other (1.5%). Most trials were multicenter (92.5%) and multinational (56.7%). RCT completion date was obtained from the manuscript for 16 (23.8%) and trial registry record for 49 (73.1%) RCTs. Some dates such as manuscript submission and acceptance were unreported for nearly 45% RCTs. Table shows the different time intervals in the publication process. The first available version was published within a year of completion for 8 (12%) and within 2 years for 39 (58%) RCTs. Final available version of RCTs with positive results (statistically significant result favoring the experimental intervention) was available earlier [median (IQR): 25.5 (21.7-35) months for positive vs 32.5 (26.6-44.5) months, p = 0.04]. No significant differences were noted in the time from RCT completion to first or final publication according to study condition, funding source, experimental intervention type, and whether the RCT was multicenter or multinational.

Conclusion: There is a considerable time lag between the completion and publication of RCTs. Several crucial dates needed to assess the publication timeliness were unavailable in the manuscripts. Clinical trial registries enabled publication timeliness assessment. Advance online publication helps in early availability of trial results.

Table. Different intervals from RCT completion to final publication.

*RCTs with available data, **months

« Back to 2017 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/publication-timeliness-of-the-randomized-controlled-trials-of-drug-therapy-for-inflammatory-arthritis/