Reproducibility and rigor in rheumatology research

Abstract

The pillars of scientific progress in rheumatology are experimentation and observation, followed by the publication of reliable and credible results. These data must then be independently verified, validated, and replicated. Peer and journal-specific technical and statistical reviews are paramount to improving rigor and reproducibility. In addition, research integrity, ethics, and responsible conduct training can help to reduce research misconduct and improve scientific evidence. As the number of published articles in rheumatology grows, the field has become critical for determining reproducibility. Prospective, longitudinal, randomized controlled clinical trials are the gold standard for evaluating clinical intervention efficacy and safety in this space. However, their applicability to larger, more representative patient populations with rheumatological disorders worldwide could be limited due to time, technical, and cost constraints involved with large-scale clinical trials. Accordingly, analysis of real-world, patient-centered clinical data retrieved from established healthcare inventories, such as electronic health records, medical billing reports, and disease registries, are increasingly used to report patient outcomes. Unfortunately, it is unknown whether this clinical research paradigm in rheumatology could be deployed in medically underserved regions.

Keywords: clinical trials; ethics; real-world data; registry; research integrity; responsible conduct.