With reliance on wearables, remote monitoring and other advanced solutions on the rise, sites and sponsors are faced with managing data flowing from a range of complex sources. Oracle Health Sciences has launched its Clinical One Data Collection Cloud Service to help clinical research professionals manage these diverse data sources on one unified platform.
Jim Streeter (JS), global vice president of life science product strategy with Oracle Health Sciences, recently spoke with Outsourcing-Pharma (OSP) about the rapid evolution of clinical trial data management, increasing adoption of decentralized trial technology, and how managing all of these complex pieces requires a new approach to data collection.
OSP: Could you please explain how EDC is starting to fall short for modern clinical trials?
JS: There are two main reasons why EDC is falling short for modern clinical trials.
First, traditional EDC systems were built to mirror paper data collection, which was fine 20 years ago, but is insufficient for today’s clinical trials and those of the future. Every day, clinical trials are incorporating more virtual components, becoming more decentralized, and focusing on the patient, which means the sources and variety of data being collected is no longer limited to traditional form data.
In addition, this data is often flowing in real-time, and sites and study team want to be able to review this data immediately to draw insight and make decisions. Study teams need a platform that can handle all this data from wearables, patient apps, electronic health records, etc. Legacy EDC systems are simply not equipped to handle this demand.
Second, today’s EDC systems were built as stand-alone solutions, independent of other people, processes and data in clinical trials. When you think about where we are and how we got here, it actually makes sense; 30 years ago, everything was collected on paper for clinical trials.
Then, software providers emerged with point solutions to address specific business processes, which resulted in EDC, CTMS, and IRT systems, to name a few. These solutions were better than paper, but they were all developed independently, which has resulted in a mess of siloed point solutions that don’t work together.
For a single trial, sites and study teams may deal with up to 30 different systems, all with separate credentials, training, interfaces, support, validations, upgrades, and builds. Not only is this inefficient and painful for users, it introduces the potential for data quality issues and unnecessary risk to your clinical trial.
Today’s clinical teams need a single, unified platform where they can do everything they need to do – not separate systems for data collection, randomization, etc.
OSP: Could you please share some of the factors driving up trial costs?
The setup of integrated eClinical systems is becoming more expensive and complex and is driving setup costs through the roof. Just setting up a single study can cost $2.5M or more and can add 12 weeks to a trial timeline.
Also, outdated systems can create redundancies in workflow which leads to inconsistencies or missing data and forces more work which has to be redone, or done for a first time, creating delays and driving up costs.
Major factors include:
- Integration and monitoring of data between siloed systems
- Volume and veracity of data required to run trials
- Data quality issues
- Siloed systems which drive more integration and reconciliation of duplicate data
- Complexity of clinical trials
- Multiple setup of systems
OSP: Could you please tell us some of the ways in which the Clinical One Data Collection Cloud Service improves upon EDC?
One way Clinical One Data Collection improves upon traditional EDC is that Clinical One is a single unified platform that was built to support all people, processes and data involved in a clinical trial. With Clinical One, data collection activity happens in the same environment as randomization and trial supplies management activity, for example, so sites can randomize, dispense drugs, and collect patient data in one place, which makes their job a lot easier.
Clinical One provides capabilities (not point solutions stitched together), a unified workflow, a single study build, self-service control, event-based data collection and a single source of truth. Because of a capabilities approach Clinical One Data Collection can be configured to conduct simple to complex clinical trials which eliminates the need for multiple EDC systems.
Also, Clinical One Data Collection allows study teams to collect data from any source – forms, wearable sensors, patient apps, electronic health records (EHR), labs – and harmonizes it in a single place. This expanded data gives sites and study teams a more complete picture of the patient’s experience, and ultimately, the safety and efficacy of the investigative therapy, allowing them to make better decisions.
A major component of Clinical One to support data from anywhere is the Digital Gateway which allows for users to configure and monitor external data collection from any source.
Clinical One comes with embedded smart training simplifying the management of sites/user training. Training is built into each capability as short two- or three-minute snippet videos that the system tracks if a user is trained or not and can ensure that they have watched the training ; one benefit of this the training is actually on the screen as part of help functionality so that if a user need to refresh themselves on how to do something they can do it quickly without having to search out training material.
Clinical One uses built-in test logs to speed up the setup and user acceptance testing of individual studies and mid-study updates. This eliminates many of the redundant testing and reduces both the time to release a study and the resources needed to test a study.
OSP: What else would you like to add?
Oracle Health Sciences was an early pioneer in eClinical, and over the course of two decades, we have come to intimately understand the technology needs of all trial types—from the simplest to the most complex, across all therapeutic areas. But, we also learned that study teams and sites want more, with less; they want more patient information, more clinical insight, and more control, with less system complexity and burden.
This is what we are delivering with Clinical One—the most advanced eClinical platform, built from experience, to support the most complex trials in the simplest, most user-friendly way.