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Handling complexity in GI trials ⁠— a purpose-built eCOA/ePRO solution

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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.

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 the decisions that must be made during the course of the trial. Fundamentally:

1. Patient burden is possibly the largest challenge in GI trials

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

2. Helping patients with site-based questionnaires can be a chore

Questionnaires must be clear and intuitive, requiring the least possible intervention by site personnel.

3. Clinicians must review disparate data to complete questionnaires

Often, decisions are based on review of disparate data. The challenge is to ensure all data to be reviewed is easily accessible. This can be done by automatically integrating data into the tablet-based ClinRO workflow to simplify the site staff and clinician experience.

4. Strict patient compliance must be verified

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

Clinical Ink used its knowledge of those challenges to design its GI Therapeutic Library. Deployed and customized on demand, the Lumenis GI Library integrates an 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.

Data access in real time allows clinicians and sponsors to monitor and support

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 ePRO/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. Such an approach can increase the chances that subjects will remain eligible even with the stringent compliance requirements so common in this therapeutic area.

Once patients are enrolled, the challenge becomes to keep them engaged, adherent to their visit schedules, and compliant with their questionnaires. Clinical Ink developed a 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.

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Lumenis: A better experience for patients, sponsors, and clinicians

Conducting 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. Clinical Ink’s GI Library offers a new, better way to gather high-quality data. However complex the protocol, Clinical Ink supports these solutions without overwhelming the study team, confusing the patient, or overburdening the site. 

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