Invivodata ePRO research shows efficacy of Amitiza on IBS-C

PITTSBURGH Invivodata, which provides electronic patient reported outcomes solutions and services for global clinical research, recently announced that its ePRO solutions—DiaryPRO and SitePRO—captured primary efficacy data that supported the recent Food and Drug Administration’s supplemental approval of Sucampo Pharmaceutical Amitiza 8 mcg twice daily for the treatment of irritable bowel syndrome with constipation in women 18 years of age and older.

Invivodata designed and implemented a combination of site-based and field-based ePRO data capture systems to collect efficacy data for Sucampo’s phase 2 and 3 trials of Amitiza for IBS-C treatment. Throughout the trials, researchers used SitePRO, an in-clinic solution, to determine subject eligibility. Trial subjects then used DiaryPRO, invivodata’s field-based ePRO system, to record daily assessments plus SitePRO to record weekly in-clinic assessments of disease severity and symptom relief. Throughout the trials, data collected from both systems were integrated and easily accessible to study staff on invivodata’s comprehensive ePRO management system.

“We are very pleased with invivodata’s contributions to this program and their ability to accurately capture the critical data we needed to support FDA supplemental approval of Amitiza,” said Gayle Dolecek, senior vice president of research and development at Sucampo Pharmaceuticals. “Their staff was very knowledgeable about the scientific and practical aspects of PRO data collection, and their processes were found to be regulatory compliant during an FDA audit of their systems and practices, which was an important component of this approval.”