CRF Health Partners Innovative US Biotech with TrialMax eCOA Solution for Phase III Prostate Oncology Study
CRF Health announced that its TrialMax Slate solution has been selected by a US biotech company for a global Phase III prostate cancer study. The large-scale trial will involve up to 1000 screened patients across 75+ sites and 10+ countries. The therapy targets an aggressive form of prostate cancer, where other treatment options have failed, involving seriously ill cancer patients.
This sponsor required an electronic clinical outcome assessments (eCOA) provider to support their goal of collecting clinical endpoint data electronically to uphold data quality and integrity; and to ensure that the solution simplified site activities and was able to address the challenges associated with patient-reported outcome measure (PROM) completion in clinical trials involving very ill patients. TrialMax Slate is designed to make site-based eSource data collection easy for site teams and patients. The dedicated tablet solution ensures the correct instruments are delivered at the appropriate study visits, reducing protocol compliance errors, and enhances data quality and completeness through in-build logic checking. Using the tool reduces site administrative burden associated with PROM and clinician-reported outcome (ClinRO) data collection, and ensures data is available for clinician review in real-time during each patient visit.
In oncology studies, particularly those involving very ill patients or those exposed to treatments with severe side effect profiles, patients face unique challenges in their ability to complete elements of the study. This could be as a result of experiencing pain, fatigue, nausea or other aspects related to their condition or its treatment while being asked to provide responses to one or more PRO instruments. TrialMax Slate’s easy-to-navigate interface helpfully guides instrument entry, enables patients to stop and re-start where necessary, and provides a portable solution that allows patients to complete sensitive questionnaires comfortably, privately and accurately.
The sponsor sought a powerful tool for site staff to help them drive high PROM-compliance and generate clean data in this significant trial. TrialMax Slate’s dashboard displays the schedules and status of patient visits, highlighting required and incomplete questionnaires and supporting rescheduled or remote visits. In addition, the platform offers the ability to issue email and SMS (text message) appointment reminders to patients seamlessly through the interface; and investigators can also access on-tablet tutorials and study-specific instructions at any time for training and reference.
“Our best-in-class eCOA solution provides a truly patient-centric experience for optimal protocol compliance. As compliance was the sponsor’s top priority, and their oncology patients needed an easy solution to use, we’re delighted this biotech sponsor selected CRF Health as their eCOA vendor,” commented Rachael Wyllie, CRF Health’s CEO. “We appreciate the magnitude of this study and our partner’s sole novel compound. All studies are important and significant to us – we don’t just partner with large, global pharmaceutical companies – we are proud to apply our ethos of transparency, project support and expertise to drive quality subject data regardless of company size.”