The eSource Ecosystem: Making Decentralized, Traditional, and BYOD Trials Your Reality
By now, it should be clear to everyone that hybrid trials are here to stay. Our customers are seeing the benefits, and now others are taking notice.
But what defines these trials? And what are the best practices and best resources to really make them work?
The foundation is eSource – more specifically, direct data capture (DDC), as opposed to EDC. From complicated ClinROs to BYOD, Clinical Ink has pioneered and set the bar for decentralized and traditional trials, and I can tell you that it takes a thoroughly proven, tightly integrated technology toolkit to coordinate all the disparate tasks involved in these trials.
This blog explains what DDC is and how it’s really the only methodology that will afford you the flexibility, speed, site efficiency, and data quality you need to make your trials successful.Whatever You Want to Call It, It's All About Flexible Options
Decentralized and traditional trials; televisits; bring your own device (BYOD) — whatever the method, at the end of the day, it’s all about enabling choices for sponsors, sites, and especially, patients. Variety is the spice of today’s clinical trials. Hybrid data collection requires a little bit of everything.
Hybrid Data Collection
What does this mean for eSource DDC ecosystems? Here are some considerations:
- Your eSource ecosystem must allow for a flexible choice of televisit solutions. Most sites are already using televisit solutions and the path of least resistance for both site and patient is to keep using the solution they’re used to.
- Ensure there is an integrated, easy-to-use helpdesk with a single number that sites know to call, or live chat.
- Utilize solutions that enable direct data capture regardless of patient location — at home, in the clinic, or on the go.
- Empirical evidence supports better compliance when patients use their own devices, so embrace a BYOD approach when possible, but be ready to supply devices, if needed.
- Translations and hardware can be the biggest bottlenecks, so it’s important to engage with stakeholders and get buy-in early.
There are numerous ways in which eSource DDC enhances your ability to run a remote trial successfully. This system:
- Expands your ability to recruit patients
- Expands your ability to retain patients
- Reduces burden on patients
- Increases patient compliance for performing tasks
- Alerts sites when patients omit tasks and activities, allowing sites to follow up proactively
- Enables extremely flexible study design
- Makes study implementation and coordination easy
- Eases reporting
- Speeds availability of results
- Improves data quality
Rapid Conversion of Complex, On-Site Studies to Virtual: A Case Study for Clinical Ink's Lunexis™ DDC Platform
- Two Phase II studies + two Phase III studies
- 2,000 patients
- 250+ sites
- Neurologic therapeutic area with numerous assessments
All assessments were originally designed to be done on-site, but patients apprehensive about visiting a research site were being lost or slow to enroll. The study needed to pivot to enable the collection of nearly 10 different assessments from home.
Build and deploy 10 different collection forms for use at home as quickly as possible. Allow patients to use their own devices if they were able.
The Action Steps
- Proactively reach out to license holders to get early buy-in.
- Build all patient-completed forms and engagement content, such as SF-36, HADS, LEC-5, etc.
- Embrace our agile study development approach with, at most, two rounds of user acceptance testing (UAT) as we have done in well over 100 studies across varied disciplines.
Designed, developed, and deployed all four studies in 10 days (standard: 8-10 weeks)
Enable a Complete, Flexible, and Adaptable Journey for Patients and Sites
Direct data capture (DDC) and electronic data capture (EDC) may sound the same. A closer look reveals fundamental differences with crucial implications for clinical research workflows, data quality, visibility, and timelines.
Clinical Ink’s integrated Lunexis eSource technology platform makes it easy to rapidly deploy an integrated, convenient eSource solution that provides anytime, anywhere access to your study data. We deliver more than fast, clean data — we deliver confidence. Not only are your sites and patients assured of an easier experience, but our system facilitates success at NDA filing by promoting correct study conduct and documentation with remote monitoring and purpose-built, strategically designed workflows.
Topics: eSource DDC