NASH Patient Access 2

Contributing to NASH Science and Improving Enrollment in NASH Clinical Trials

ProSciento’s NASH PASS™ is a streamlined, science-driven clinical development platform, leveraging more than a decade of NASH therapeutic and operational expertise, and overcoming complex challenges inherent in NASH clinical trials. The NASH PASS™ program streamlines and substantially improves site selection, patient access and enrollment for NASH clinical trials. The NASH PASS™ platform is also an important, evolving tool to enhance scientific knowledge of NALFD and NASH disease progression, as well as gain insight into the utility of diagnostic and prognostic biomarkers for clinical research.

The NASH PASS™ platform integrates three science-driven elements: a proprietary screening methodology, an IRB-approved clinical protocol, and a searchable NASH registry.

The NASH PASS™ Methodology and Clinical Protocol:

The methodology at the foundation of the NASH PASS™ program was developed and fine-tuned over the last decade within ProSciento’s early phase metabolic CRU. It is now exported in a highly controlled manner at strategic clinical trial sites across the U.S. The NASH PASS™ methodology utilizes clinical assessments, vibration controlled transient elastography (VCTE) FibroScan™ imaging, proprietary predictive algorithms, and data compilation and analysis. The IRB-approved clinical protocol utilizing this methodology is managed by ProSciento’s team of experts and conducted at pre-qualified clinical provider locations, providing patients an opportunity to participate in clinical research through their existing healthcare providers.

The NASH PASS™ Patient Data Registry and its Impact on Clinical Trial Enrollment and NASH Science:

The NASH PASS™ patient data registry is a powerful tool to improve enrollment for NAFLD and NASH clinical trials. The registry compiles real-time and longitudinal data of pre-screened patients ready for enrollment and pre-qualified sites ready for an expediated study launch. For study sponsors, the benefits include streamlined site selection; expedited study start-up within 3 months; an average 31% reduction in screen failures; and up to 40% of patients enrolled in the first three months.

Because of the nature of the data, the NASH PASS™ registry is also an important instrument to enhance scientific knowledge of NAFLD and NASH disease progression and the utility of diagnostic and prognostic biomarkers. In clinical study design, the registry is also used to analyze how I/E parameters affect enrollment outcomes.

What is NASH PASS™:

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Scientific Methodology

Developed and led by scientific team with unparalleled experience and expertise in NASH clinical research 

  • Robust scientific methodology
  • Contributing to understanding of disease progression and utility and development of biomarkers
  • Developed and validated in collaboration with academic thought leaders
  • Led by team of experts with deep expertise and experience in NASH

Clinical Study Protocol

IRB-approved protocol to enroll patients at select clinical trial sites

  • Proprietary predictive algorithms + clinical assessments + FibroScan™ 
  • Patient screening conducted through their trusted provider relationship
  • Confirmed patient diagnoses enriched with broad range assessments

Patient Registry

Searchable patient data utilized for NASH clinical trial enrollment and analysis of disease progression

  • Research motivated patients, ready for enrollment
  • Powerful impact on enrollment and timeline of interventional studies
  • Searchable real-time and longitudinal data to optimize I/E criteria

Scientific Methodology

Developed and led by scientific team with unparalleled experience and expertise in NASH clinical research 

  • Robust scientific methodology
  • Contributing to understanding of disease progression and utility and development of biomarkers
  • Developed and validated in collaboration with academic thought leaders
  • Led by team of experts with deep expertise and experience in NASH

Clinical Study Protocol

IRB-approved protocol to enroll patients at select clinical trial sites

  • Proprietary predictive algorithms + clinical assessments + FibroScan™ 
  • Patient screening conducted through their trusted provider relationship
  • Confirmed patient diagnoses enriched with broad range assessments

Patient Registry

Searchable patient data utilized for NASH clinical trial enrollment and analysis of disease progression

  • Research motivated patients, ready for enrollment
  • Powerful impact on enrollment and timeline of interventional studies
  • Searchable real-time and longitudinal data to optimize I/E criteria

NASH PASS™ Impact on Timelines, Cost and Enrollment:

industry-table-logoNASH-Pass-Logo
RegulatoryTypically 6 MONTHS
Often site selection is extended to outside the US for added patient access, increasing cost and time
nash-arrow-lt nash-arrow-rt1 MONTH utilizing NASH PASS-engaged sites in the US, thereby reducing associated regulatory costs
Study StartSite selection alone is generally 4 MONTHS nash-arrow-ltnash-arrow-rtSites selected and prequalified in the NASH PASS registry available for immediate start

All sites screening in < 3 MONTHS
Enrollment DELAYS due to enrollment difficulties and resulting protocol amendments, often to adjust I/E criteria nash-arrow-ltnash-arrow-rtFront-load enrollment with up to 40% of patients enrolled in the first three months

100% ENROLLMENT on time when utilizing NASH PASS for I/E parameters

Contact us at bd@prosciento.com to evaluate how the NASH PASS™ program can improve clinical trial enrollment outcomes based on your specific clinical endpoints.

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