By Kyle Hogan and Co-Author Kim Romanello
Gastroenterology trials have been growing in number and complexity for years. Current trial solutions rely heavily on electronic clinical outcome assessments (eCOA) including both electronic patient-reported outcomes (ePRO) and clinician-reported outcomes (ClinRO) to improve data quality and integrity. Eligibility decisions based on data from both sources and derived through calculations based on compliance and complex scoring are increasingly common. Further, the accelerating complexity of GI protocols has far outpaced the eCOA industry in simplifying trial solutions for that complexity. Patients are overwhelmed, sites are overburdened, and sponsors are struggling to achieve even modest enhancements in the site and patient experience.
Fortunately, there’s a better path. At Clinical Ink, we’ve spent years aligning our product design tools and service delivery methodologies specifically to a GI Therapeutic Library Solution. This GI Library, which we deploy and customize on demand, is powered by the Lunexis™ technology platform. Our system 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 and fully customizable reporting portal for remote monitoring and data surveillance.
This paper describes the complexity of GI trials in detail and shows how our solution is designed to overcome their significant, but typical, challenges. Our intimate knowledge of and experience with this therapeutic area enables a better deployment experience and improved trial conduct.