Handling Complexity in GI Trials ⁠— a Purpose-Built eCOA/ePRO Solution: The GI Library

Two doctors review data on a tablet.

The accelerating complexity of gastroenterology protocols has exceeded the capacity of most electronic clinical outcome assessments (eCOAs) — including both electronic patient-reported outcomes (ePROs) and clinician-reported outcomes (ClinROs) — to adapt. Patients are overwhelmed, sites are overburdened, and Sponsors struggle with data quality and integrity.

At Clinical ink, we offer a better path–one that brings data, technology, and patient science together. We’ve spent years designing our GI eCOA library. Deployed and customized on demand, our technology integrates ePRO/patient engagement solution for patients at home, a full-service site tablet for ClinROs and PROs collected at visits, and an intuitive reporting portal for remote monitoring and data surveillance providing complete healthcare system integration. 

Clinical ink Knows the Typical GI eCOA/ePRO Requirements (and Stumbling Blocks)

Data collection for the GI therapeutic area is known to be particularly complex, with on-site questionnaires for both patients and clinicians, plus extensive patient input at home. Eligibility decisions are commonly based on data from all these sources and derived through complex calculations based on compliance. Data quality also depends on verified patient compliance. The challenge is to simplify the recording of all this data, ensure patients do what they need to and stay motivated, and make the information easily accessible to support trial decisions. Fundamentally:

1. GI patient burden is real

Staying motivated to complete the detailed, high-volume, schedule-and-event-driven diaries is a huge hurdle for GI patients. To address this challenge Clinical ink includes a full-scale patient engagement strategy in our ePRO application.

2. Site-based questionnaires can be a chore

Clinical ink questionnaires are purposefully clear and intuitive, requiring the least possible intervention by site personnel.

3. Clinicians must review disparate data to complete questionnaires

Clinical ink automatically integrates data into a tablet-based ClinRO workflow to simplify the site staff and clinician experience.

4. Strict patient compliance must be verified by site staff

When ePRO data represents the primary efficacy data, questionnaire completion is critical. Clinical ink ePRO technology automatically reports on screening criteria compliance and executes any necessary calculations, saving site staff and clinicians from having to determine these results — such as eligibility scores — manually.

Data Access in Real-Time Allows Clinicians and Sponsors to Monitor and Support

A doctor sitting next to her laptop uses her tablet.

Data outputs, such as eligibility criteria and average daily pain, are summarized into summary reports that site users, clinicians, and Sponsors can access in near real-time. These reports eliminate the need to seek out disparate sources to make randomization decisions related to ePRO criteria.

Enhanced Functionality Reduces Build Times, Improves User Experience

Clinical ink’s proprietary eCOA authoring tool supports agile design and a collaborative build process. Iterative, prototype-driven design allows study teams to rapidly create highly functional applications. Lengthy build times and stressful review cycles — commonplace for GI trials — are avoided, while Sponsors gain confidence in overall study success.

Real-Time Alerts Ensure Compliance as Part of a Robust Patient Engagement Strategy

Beyond reporting, summary alerts notify site and study staff when patients exceed acceptable thresholds for compliance. Alerts are deployed as part of an outreach to support patients at risk of becoming non-compliant. This approach can increase the chances that subjects will remain eligible, even with the stringent compliance requirements.

Once patients are enrolled, the challenge becomes to keep them engaged, adherent to their visit schedules, and compliant with their questionnaires. At Clinical ink we’ve developed a completely unified patient engagement and ePRO experience, whether on provisioned or BYOD devices. This dynamic patient engagement solution is mobile-optimized, content-rich, image-driven, and targeted to drive key, critical behaviors and provide necessary study information at crucial moments.

Sponsor, Site, and Patient Burden Summary

Key GI ePro/eCOA Study Challenge

Lengthy/Complex RequirementsPatient TrainingDaily Questionnaires
Confusing UATComplex EligibilityEvent/Episodic Questionaires
Time to Go-LiveCompliance MonitoringEvent Criteria
ReportingInventoryEvent History
Data DeliveringReportingVisit Schedule
Data QualityData QualityVisit Activity

 A Better Experience for Patients, Sponsors, and Clinicians with eCOA and ePRO

Conducting gastroenterology clinical trials in the same way over and over simply because it’s the way it’s been done before doesn’t work for indications as complex as GI. Our innovative technology is your GPS to high-quality data. However complex the protocol, Clinical ink technology helps ensure that the patient, study team, and site feels in control, regardless of whether you intend to publish a case study on gastrointestinal diseases.  Contact us to find out more about how we can help you.

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