Healthcare stakeholders must look beyond anecdotes to support their decisions and value propositions. Verifiable, replicable and statistically significant datasets are generated through studies.
Studies in turn support clinical decision-making, reimbursement, standards of care, practice growth, product development and regulatory compliance. inCytes™ makes it easy to capture and analyze all the real-world evidence for your clinical studies in one centralized platform.
Real-World EVIDENCE Studies
A good study design unites clinical/scientific hypotheses with corresponding outcomes data. The “gold standard” for studies has traditionally been the randomized, controlled, double-blinded trial – the RCT.
However, the U.S. Department of Health and Human Services has recognized that other forms of study formats are often even more effective. Real-world evidence studies are now required for many regulators purposed by national legislation and healthcare. These data for clinical trial can be easily obtained through a real-world evidence software
. . . .Studies derived from well-designed and well-performed patient registries can provide a real-world view of clinical practice, patient outcomes, safety, and clinical, comparative, and cost-effectiveness, and can serve a number of evidence development and decision-making purposes. . . .
U.S. Department of Health and Human Services. Agency For Healthcare Research and Quality, 2020
Challenges With Traditional Studies
Conducting randomized controlled trials (RCTs) is beyond the budget and capabilities of most organizations, except for large product manufacturers or research centers. Moreover, such studies are often less useful for many broader population segments, depriving patients of many safe and effective treatments.
Real-world studies, including pragmatic, n of 1, investigator-initiated, practical and other formats, can be easily obtained through a real-world evidence platform
REAL-WORLD EVIDENCE STUDY DESIGN
An efficient and value-added study begins with its design. Circles combines clinical and scientific expertise, longitudinal observational protocols, inclusion and exclusion criteria, statistical significance and scalability. The designs of the real-world evidence studies can be as simple or complex as desired by Investigators and Sponsors.
EXECUTION OF the REAL-WORLD EVIDENCE STUDY
Many studies fail due to poor execution of good designs. Circles in inCytes™
enable efficient real-world evidence collection and aggregation, multi-center administration, data auditability, multi-lingual support, regulatory compliance, robust report generation, data control and security, and 24/7 accessibility of the platform.
Real-world evidence platform studies often involve products orprocedures that interest both commercial and non-profit funding sources. Those sources may provide funding as Sponsors, or support studies through “Investigator Initiated Trials
”. Circles represent an efficient and ethical path between Investigators and Funders.