During the recent SCOPE Summit Europe 2023, a remarkable session unfolded where Raul Castellanos Moreira, Rheumatology Medical Lead for Spain & Portugal, Bristol Myers Squibb (BMS), showcased innovative strides in integrating real-world evidence (RWE) into clinical trial designs and clinical trial patient recruitment. This article will delve into the insights presented by BMS on the utilization of electronic health records (EHRs) and advanced analytics to enhance the clinical trial process.
Leveraging Real-World Data
BMS emphasized the transformational power of EHRs in clinical research, particularly in patient recruitment and study efficiency. They reported the collection of EHRs from over 3 million patients across seven hospitals, amounting to more than 64 million electronic files. This vast repository of both structured and unstructured data is a testament to the potential that lies within existing healthcare systems for clinical trial optimization.
Addressing Heterogeneity in Clinical Trials
One of the key challenges in clinical trials is the heterogeneity of patient populations. BMS’s presentation highlighted their approach to this issue by using advanced natural language processing (NLP) and machine learning (ML) techniques to analyze EHRs. This method allows for the characterization of patient profiles and the calculation of disease prevalence despite the diversity of languages and dialects in Spain, where multiple official languages exist.
Methodology and Results
BMS described their methodology for calculating prevalence, utilizing phone bots for recruitment and telephonic screening, which resulted in a response rate of 15% and a confirmed case prevalence of 0.69%. They also reported a study that characterized 13,958 rheumatoid arthritis cases, showcasing the ability of AI to manage and analyze large volumes of data efficiently.
Innovations in Clinical Trial Patient Recruitment
BMS provided an in-depth look at its clinical trial patient recruitment strategy, which involved multiple stages, including media coverage, letter recruitment, telephone screening, and rheumatologist visits. The data revealed a prevalence rate of 0.5% for rheumatoid arthritis (RA) and confirmed 11 RA patients with a positive predictive value of 5.9%. This multi-faceted approach demonstrates BMS’s commitment to identifying and enrolling eligible patients in clinical studies effectively.
Impact on Clinical Trials
The insights shared by BMS at the SCOPE Summit point toward a future where AI and RWE are integral to clinical trial design and execution. By harnessing the power of existing EHRs and applying sophisticated analytics, BMS is leading the way in reducing patient burden and enhancing trial efficiency. Their work underlines the importance of a tailored approach to clinical trial patient recruitment and the need for a robust understanding of the factors influencing patient participation.
Bristol Myers Squibb’s presentation at SCOPE Summit Europe 2023 has provided a compelling glimpse into the future of clinical trials. Using real-world data, advanced analytics, and a nuanced understanding of patient populations is setting the stage for more effective, patient-centric clinical trials. As the industry moves forward, the insights and methodologies developed by BMS will undoubtedly serve as valuable benchmarks for innovation in clinical trial design.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.