Research agenda for SLE trials
| Domains of improvement | Key elements for improvement |
| Education and training | Provide an overview of the landscape and current status of clinical trials in SLE. Develop training programmes for investigators to enhance their understanding of SLE and promote standardised assessment and data collection techniques. |
| Outcome measures and end points | Investigate novel and more clinically relevant outcome measures and end points. Systematic assessment of CLE by photographs at screening and at relevant end points to exclude cutaneous mimickers and objectively confirm CLE improvement. |
| Inclusion of real-world evidence | Explore the use of electronic health records for collecting real-world evidence. Investigate ways to integrate real-world evidence into traditional clinical trial methodologies to accurately reflect real-world cohorts of patients with SLE. Establish and promote collaborative patient registries for long-term data collection. Leverage registry data to identify long-term treatment outcomes and safety profiles. |
| Improved trial designs | Perform head-to-head trials; add active comparative arms in phase III trials. Implement adaptive trial designs to optimise resource allocation and increase efficiency. Explore Bayesian methods for adaptive randomisation and sample size adjustments. Investigate the feasibility of basket/umbrella trials to assess multiple interventions simultaneously. |
| Patient stratification and personalised medicine | Investigate potential molecular and genetic biomarkers (or combination of biomarkers with AI) for patient stratification and prediction of individual treatment response. |
| Novel imaging techniques | Investigate the use of imaging modalities (eg, MSK ultrasound, MRI) for more accurate assessment of disease activity. |
| Drug repurposing | Evaluate the potential for repurposing existing drugs for SLE treatment. |
| Enhanced patient engagement | Involve patients in the design of clinical trials (patient-centric trial design) to ensure relevance and feasibility. Implement initiatives to raise awareness among patients (particularly among ethnic minorities) and the public about the importance of clinical trial participation. |
| Digital health technologies | Evaluate the use of digital health technologies for remote monitoring and data collection. Develop digital strategies to enhance patient adherence and engagement throughout the trial. Use AI to assess CLE improvement based on digital photographs. |
| International collaboration and legal issues | Promote international collaboration of policymakers to harmonise regulatory requirements. Facilitate data and resource sharing to accelerate SLE research. |
AI, artificial intelligence; CLE, cutaneous lupus erythematosus; MSK, musculoskeletal.