The need for robust, accessible, and patient-centric Real-World Evidence (RWE) in clinical studies and research is growing. Still, fragmented systems and siloed data have historically hindered researchers and sponsors from implementing the full potential of RWE. A study conducted by Aspen Technology revealed that 48 percent of the 400 surveyed global pharma organizations reported having data silos. Aspen Technology’s Vice President remarked, “Information silos are often created by lack of connectivity between data sources across departments, which can hinder efficiencies across the product lifecycle.”1 Today, unified cloud-based software platforms are providing solutions to help clinicians, stakeholders, and partners tackle the challenges of data quality and accessibility in HEOR studies and site-based, site-less, and hybrid projects.
Let’s explore RWE and learn about the integrated tools and customizable workflows that unified systems offer sponsors and participants, ultimately leading to higher-quality data and richer insights.
RWE: What It Is and Why It’s Important
Real-world data (RWD) is a vast collection of information about patients’ health journeys, gathered from electronic records, claims, registries, wearables, and even patients–raw snapshots of healthcare experiences. But RWD’s true power lies in what we can derive from it: real-world evidence, or RWE.
Simply put, RWE is the insight gleaned from analyzing RWD. Through the interpretation of numbers and patterns, researchers get a glimpse into the “real world” of healthcare beyond the controlled settings of clinical studies.2 RWE has become increasingly crucial for the following reasons:
- Real-world generalizability:Unlike traditional trials with strict inclusion criteria, RWE studies capture a broader range of patients – diverse backgrounds, comorbidities, and real-life treatment patterns. This leads to findings more applicable to everyday healthcare situations.3
- Speed and affordability:Unified cloud-based platforms are faster and less expensive than traditional methods and enable sponsors, clinicians and participants to answer questions swiftly and cost-effectively.
- Rare diseases and real-world treatment:Studying rare diseases can be challenging, but RWE packs powerful insights, helping researchers better understand these conditions and track patients’ responses to treatments in actual practice.
- Decentralized trials:Integrating RWE into decentralized trials, where participants interact remotely, allows for broader reach and more inclusive data collection.
Key Components of a Unified System
Efficiently managing projects within clinical or research domains requires a streamlined approach to data collection to uphold the integrity of RWE derived from it. Advanced software systems are an effective means to achieve this. These systems often include the following core components:
- ePRO (electronic Patient Reported Outcomes):Capture comprehensive PRO data through validated instruments, custom surveys, and electronic diaries. This allows for both quantitative and qualitative insights into participant experiences.
- eCOA (electronic Clinician-Observed Assessments):Empower healthcare providers to contribute valuable clinical data seamlessly within the platform, ensuring a holistic view of patient health.
- EDC (Electronic Data Capture):Manage clinical trial data efficiently using powerful EDC modules that house electronic Case Report Forms (eCRFs) for enrollment, monitoring, and informed consent.
Benefits of Cloud Technology
Today, the cloud is more than just a data storage solution. Cloud technology enables advanced software systems to host vast amounts of data for projects, including site-based, site-less, and hybrid studies, HEOR and DCT Phase I-III Studies, Drug and Disease Registries, Phase IV PMR Studies, and Post Market Projects.
Platforms like EmpiraMed use the cloud to streamline research by centralizing data, offering remote access, and enabling collaboration. Researchers can use mobile apps, wearables, and online surveys for remote data capture, increasing study accessibility. These platforms seamlessly integrate data from physical and remote participants, providing a comprehensive view for deeper insights while serving as secure hubs for stakeholder communication and accommodating varying data loads with scalable storage and processing power. These platforms also allow personalized patient journeys through customizable workflows, enhancing engagement with integrated gamification tools.
Addressing Integration
Unified platforms eliminate the need for niche or partial systems, but, in some cases, existing systems might be integral to a team’s workflow. According to responses to Industry Standard Research (ISR) surveys, sponsors and CROs reported frustration with delays in data reconciliation, which are often caused by having to download data from various electronic sources.4 In these instances, seamless integration can be crucial for efficiency, ensuring seamless data accessibility without disrupting established processes.
EmpiraMed’s platform, for example, offers extensive capabilities to connect with diverse systems, including those from CROs, other EDCs, telemedicine providers, and even wearable devices. Whether you’re conducting decentralized trials with a central platform or utilizing established systems that need connection, the platform can adapt to your specific needs.
Next-Level RWE
Cloud-based software platforms are more robust than ever. These systems can consolidate disparate data sources, give researchers access to comprehensive datasets, and facilitate cross-functional collaboration. As a result, researchers can conduct holistic analyses that capture a broader range of patient experiences and outcomes.
These platforms offer data governance and quality assurance mechanisms to improve the accuracy, reliability, and consistency of real-world data. Advanced data validation algorithms, standardized data models, and quality control checks help identify and mitigate data errors, inconsistencies, and biases, enhancing the integrity and trustworthiness of the RWE generated from these platforms.
Next-level RWE is happening now with the growing adoption of unified systems. Using these tools, researchers can uncover hidden patterns, correlations, and trends within large-scale datasets, enhancing the depth and granularity of insights derived from RWE to benefit stakeholders and participants alike.
About EmpiraMed
EmpiraMed (www.empiramed.com) is a pioneer in digital clinical technology. We utilize flexible and configurable plug and play modules in a unified cloud environment capturing Real World Evidence in Clinical Trials and Post Market Studies for decentralized and virtual clinical trials.
Our technology orchestrates and easily operationalizes any protocol to quickly deploy site-based, site-less, or hybrid clinical trials specific for your therapeutic areas. Unique participant-centered gamification and incentivization increases participation and retention >3X the industry standard to maximize projects success.
References
- Data silos threaten efficiency levels for nearly half of pharma businesses. European Pharmaceutical Manufacturer. Published February 13, 2023. Accessed February 7, 2024. https://pharmaceuticalmanufacturer.media/pharma-manufacturing-news/latest-pharmaceutical-manufacturing-news/data-silos-threaten-efficiency-levels-for-nearly-half-of-pha/
- Khosla S, White R, Medina J, et al. Real world evidence (RWE) – a disruptive innovation or the quiet evolution of medical evidence generation? F1000Research. 2018;7:111. doi:https://doi.org/10.12688/f1000research.13585.2
- Hou J, Zhao R, Gronsbell J, et al. Generate Analysis-Ready Data for Real-world Evidence: Tutorial for Harnessing Electronic Health Records With Advanced Informatic Technologies. Journal of Medical Internet Research. 2023;25:e45662-e45662. doi:https://doi.org/10.2196/45662
- How Can Electronic Data Capture Better Serve Decentralized Clinical Trials? www.clinicalleader.com. Accessed February 8, 2024. https://www.clinicalleader.com/doc/how-can-electronic-data-capture-better-serve-decentralized-clinical-trials-0001