Stalled Clinical Trials in Rheumatology

Recent data published in Rheumatology indicates that nearly one in five rheumatology RCTs (Randomized Clinical Trials) are still unpublished (thirty) 30 months after completion.

Publication of trial data in rheumatology very much appears to correlate with positive results, and after more than 2 years some 20% of completed trials remain unpublished per the authors.

From the article:

“We first considered this study after seeing a similar trend in trials of rheumatoid arthritis, where a substantial portion of registered [randomized clinical trials (RCTs)] went unpublished,” Connor Pedersen, a medical student at the Medical College of Wisconsin, told Healio. “Positive outcomes among RA trials were also highly associated with publication, which was concerning for publication bias. Our goal was to expand this kind of study to other rheumatologic diseases that are less represented among trials in order to get a more complete picture of the state of publication in rheumatology.“

Pederson and colleagues searched for five rheumatic diseases, including lupus, vasculitis, spondyloarthritis, Sjögren’s syndrome and psoriatic arthritis. The analysis focused on the period from Feb. 20, 2000, through Dec. 31, 2018. Trials were excluded if they were observational, were interventional with non-random subject allocation, extension studies or were phase 1 or 4.

The assessment revealed a total of 203 studies that met the criteria, of which 17.2% were unpublished. Data from these trials included information on 4,281 patients. Overall, published trials were more likely to be phase 3 studies — 57.1% published compared with 28.6% unpublished (P < .05) — or have a positive primary outcome measure — 64.9% published vs. 25.7% unpublished (P < .001).

A Phase 3 study A tests the safety and how well a new treatment works compared with a standard treatment. For example, phase 3 clinical trials may compare which group of patients has better survival rates or fewer side effects.

Per the researchers, “The problem of nonpublication among registered RCTs is not limited solely to rheumatoid arthritis, but is present in multiple rheumatologic diseases.  Trials with positive outcomes were more likely to be published than those with negative outcomes, which is a trend we’ve come to see in other medical fields and is concerning for publication bias. This bias could inflate the treatment’s presumed efficacy or mask potential harms.”

Remission Medical offers virtual clinical trials support nationwide to Pharmaceutical companies and CROs.