SAN DIEGO, September 15, 2022 – ProSciento, Inc., a specialty clinical research organization (CRO) focused exclusively on metabolic diseases, will present data related to the NASH PASS (NASH Patient Access and Screening Strategies) registry at the NAFLD Summit of the European Association for the Study of the Liver (EASL), being held in Dublin and online from September 15-17.
The NASH PASS registry is a research database from a growing and well-characterized population that is a powerful tool to analyze and inform study design development, facilitating enrollment for NAFLD clinical trials. The result of this analysis helps better understand this population, increasing access to it. It also provides a pathway for further research and educational opportunities in earlier identification of the NAFLD patient population.
Poster presentation details are as follows:
- Abstract #: P07-04
- Title: NASH PASS®: a Registry to Inform Study Design and Accelerate Patient Enrollment
- Authors: Alejandra Macias Pulido, Heidi Guthrie, Marcus Hompesch, Michelle Mazuranic
The data presented demonstrate the NASH PASS registry as a platform to model study design criteria in a community-based population to favorably accelerate clinical development programs. ProSciento’s experience applying this model has resulted in expedited study start-up of interventional clinical trials by more than 1 month on average, reduced screen failures by 15-30%, and increased enrolment rate to more than double compared to industry average.
NASH PASS is a cross-sectional diagnostic study and registry-based IRB-approved clinical research protocol with detailed prospective data collection on subsets of participants. Individuals at high risk for developing NAFLD or NASH are invited to undergo comprehensive screening to determine disease status. Participants can be followed for up to 10 years. NASH PASS data was utilized to analyze baseline characteristics of individuals at high risk for developing NAFLD. Sample t-tests were performed to compare differences among Type 2 diabetic (T2DM) and non-diabetic participants.
About ProSciento, Inc.
ProSciento is the leading specialized clinical research organization (CRO) focused on NASH, diabetes, obesity, and related metabolic diseases. ProSciento works with biopharma companies worldwide to support their outsourced clinical research needs with comprehensive and customized services for multinational, early development clinical trial programs. Founded in 2003, ProSciento has conducted more than 325 clinical studies for diabetes, NASH, and obesity, and has contributed to the development of numerous approved metabolic drugs and devices on the global marketplace. For more information, please visit www.prosciento.com.
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