Real World Data and Real World Evidence
Clinical research that effectively combines clinical trial data with real world evidence (RWE) of drug effectiveness, safety, or variability across subpopulations has become essential in supporting drug development and regulatory submissions.
Patient and subject-reported outcomes as well as experiential data are now required endpoints for certain regulatory approvals in vaccines, epilepsy, migraine or Crohnís disease. Additionally, biomarkers, subgroups, and other response predictor models derived from trial or real-world data offer more informed guidance on subsequent trial designs, mitigating future study risks.
Beyond its impact on improving patient care and clinical trial designs, real world data (RWD) and evidence also influences product development and lifecycle management decisions for drug, device and diagnostic manufacturers. For example, many in vitro diagnostic tests including genetic, genomic, proteomic, clinical, and combination biomarkers require proof of clinical and real-world utility in order to be considered reimbursable by insurers including Medicare.
At Emmes, we strive to enhance your clinical research by leveraging a wide spectrum of validated, contemporaneous real-world data sources to support your prospectively defined analysis plans, regulatory submissions and product development goals. And we recognize the importance of applying ethical and quality standards to real-world data acquisition and analysis. Our dedicated team of data managers, data scientists, and biostatisticians seek to identify, mitigate, and account for bias that could negatively impact inference from your studies involving real-world data.
We also share your concern regarding recruitment challenges and small sample sizes in rare disease clinical trials. From rare disease study recruitment to control-arm data acquisition and post-marketing commitments our RWE/RWD team is your partner, consistently finding ways to expand your access to comprehensive sources of RWD and RWE that enhance your Phase I-IV studies, registries and other clinical research endeavors.