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Conducting Decentralized Clinical Studies

With Smart Consumer Technology, InterSystems IRIS for Health, and HL7 FHIR

father holding young son while on a telehealth call with the peditrician

Getting enough people to enroll and participate to the end of a clinical study is a major challenge. Most studies fail to enroll enough subjects to even begin. And if you can’t enroll enough people, you certainly can’t gather enough data to ensure statistically sound results.
Today, researchers are addressing these challenges by decentralizing studies – offering components of the study to the patient at home, instead of requiring participants to visit study sites. As of 2021, 48%-95% of research sites report using at least one form of decentralized technology.1

InterSystems IRIS for Health™ data platform supports decentralized and hybrid study models, enabling researchers to gather data from study participants, connected remote, wearable, or implanted medical devices, and electronic health records, health information exchanges, and other sources. Combined and transformed by InterSystems IRIS for Health into a single consistent format, such as HL7® FHIR® (FHIR), this data becomes the foundation for analysis and a comprehensive perspective on patient health and treatment effectiveness. Researchers in pharma, life sciences, and MedTech organizations can create a virtuous circle of feedback that drives continuous improvements in research, care, and outcomes.

Create a virtuous circle where device and other real-world data, aggregated, transformed, and delivered by InterSystems, helps drive continuous improvement in research, analytics, patient care and outcomes - Diagram
Create a virtuous circle where device and other real-world data, aggregated, transformed, and delivered by InterSystems, helps drive continuous improvement in research, analytics, patient care and outcomes.

Customer Use Case: Medical Device Maker

A major medical device maker conducted a decentralized study supported by InterSystems IRIS for Health data platform to gain a full, multi-dimensional view of therapy effectiveness. InterSystems IRIS for Health aggregated and transformed device, performance, time series, patient reported outcomes, and electronic health record data into FHIR format, and prepared it for access through the SQL already familiar to data scientists. Using InterSystems IRIS for Health, the data scientists gained the context they needed around the raw device data to answer critical questions using predictive and operational analytics. The platform and smart consumer technology enabled this customer to:

  • Conduct a decentralized clinical study efficiently to validate and improve device performance
  • Illuminate factors influencing variations in disease course among patients
  • Provide guidance to clinicians on personalizing patient treatment
  • Increase the value of the patient monitoring program

InterSystems IRIS for Health

InterSystems IRIS for Health can make studies more diverse and easier to participate in by gathering data from the subject at home, as well as devices and the hospital or clinic. By aggregating and normalizing diverse data types for analytics, machine learning, and AI systems, it helps researchers answer questions about treatment performance and function, track patient progress, and identify study issues before they become problems.


1 - McKinsey and Company, “No place like home? Stepping up the decentralization of clinical trials.”
https://www.mckinsey.com/industries/life-sciences/our-insights/no-place-like-home-stepping-up-the-decentralization-of-clinical-trials

Další Zdroje, Které By Se Vám Mohly Líbit

Oct 31, 2024
BLOOR Research Opinion Article
This article from UK Analyst Bloor Research recognises the capabilities and advantages of InterSystems IRIS data platform as an "innovative and powerful data management platform" and it’s Smart Data Fabric capabilities offering a market differentiator.
Oct 30, 2024
A Benchmarking System to Spark Companies to Action
Download the Report
Oct 10, 2024
Get Your Data AI-Ready and Simplify Development and Deployment
Unleash the power of AI in healthcare with InterSystems solutions for seamless FHIR integration and development.
Sep 30, 2024
Video Overview
InterSystems OMOP is a cloud-based software-as-a-service designed to streamline healthcare research by automating the integration and transformation of clinical data into the OMOP format. This solution simplifies the creation of research data repositories and ensures easy data ingestion, transformation, and secure storage, accelerating the discovery of actionable insights and innovations in healthcare.
Aug 09, 2024
A CHIME Thought Leadership Roundtable
At a CHiME Roundtable, executives from leading HCOs came together to discuss how artificial intelligence revolutionize clinical care.
May 02, 2024
Digital Health Insights
Secure and clean FHIR data can help providers produce valuable insights to improve population health outcomes and personalized care.
Apr 05, 2024
A CHIME Thought Leadership Roundtable
At a CHiME Roundtable, executives from leading HCOs came together to discuss how they are addressing the shift to consumerism and creating digital experiences that meet – and exceed – rising expectations.
Feb 13, 2024
FHIR Use Cases
Practical applications for FHIR and real-world examples of how FHIR connects disparate systems, accelerates digital transformation, and increase data insights.
Feb 05, 2024
Marshfield Clinic Health System
Mitchell Kwiatkowski, Chief Data & Analytics Officer at Marshfield Clinic Health System, explains the company’s IT overhaul and how AI can be used ethically.
Feb 05, 2024
CHIME Digital Health Most Wired Survey
The Digital Health Most Wired Survey and Interoperability and Population Health In the tumultuous landscape within which healthcare operates, the annual CHIME Digital Health Most Wired (DHMW) survey is a significant “north star” that healthcare organizations (HCOs) have relied upon for years. Widely known for the annual Most Wired recognition awards, the DHMW survey provides healthcare leaders a comprehensive profile of digital health usage in U.S. HCOs and a reliable resource by which to benchmark their own digital health progression.

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