For nearly two decades, C-Path has been providing the legal, scientific, and regulatory infrastructure to generate a unique neutral environment for stakeholders in the medical product development ecosystem to collaborate. This collaboration has resulted in solutions that include clinical outcome assessment tools, clinical trial simulators and other quantitative tools, plus data resources and analytic platforms. These tools and platforms help de-risk decision making in the development and regulatory review process of novel medical products. Below you’ll find links and details on C-Path’s current and accessible tools and platforms.
Tools
Alzheimer’s Disease Clinical Trial Simulation Tool
A clinical trial simulation tool to help optimize clinical trial design for mild and moderate AD, using ADAS-cog as the primary cognitive endpoint. The tool is based on a drug-disease-trial model that describes disease progression, drug effects, dropout rates, placebo effect, and relevant sources of variability
Alzheimer’s Pre-dementia Clinical Trial Enrichment Tool
A quantitative clinical trial enrichment tool to help optimize clinical trial design in the pre-dementia stages of Alzheimer’s disease, using CDR-SB as the primary endpoint. The tool is based on a disease progression model, which integrates baseline hippocampal volume, the effect of patient drop-out and relevant sources of variability.
Integrated Parkinson’s Database
CPP’s Integrated Parkinson’s Database is a comprehensive collection of observational and clinical studies related to Parkinson’s. It has been curated, standardized to CDISC SDTM format and is accessible to qualified external users, serving as a source of information to aid in the development of treatments for Parkinson’s.
Early Motor Parkinson’s DAT Clinical Trial Enrichment Tool
A quantitative clinical trial enrichment tool to help optimize clinical trial design in the early-motor stages of Parkinson’s disease, using MDS-UPDRS part III as the primary endpoint. The tool is based on a disease progression model, which integrates baseline dopamine transport imaging, the effect of patient drop-out and relevant sources of variability.
Platforms
PRO Consortium Measures and Licensing
The mission of the PRO Consortium is to establish and maintain a collaborative framework with appropriate stakeholders for the qualification of patient-reported outcome measures and other clinical outcome assessment tools that will be publicly available for use in clinical trials where COA-based endpoints are used to support product labeling claims. On this site, you will find information regarding available measures covering different therapeutic areas.
RDCA-DAP
The Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP) promotes the sharing of existing patient-level data and encourages the standardization of new data collection. By integrating data in a format suitable for analytics, RDCA-DAP accelerates the understanding of disease progression (including sources of variability to optimize the characterization of subpopulations), clinical outcome measures and biomarkers, and facilitates the development of mathematical models of disease and innovative clinical trial designs.
CODR: Critical Path to TB Drug Regimens (CPTR) Database of CDC studies
The CODR database contains, but is not limited to data on drug susceptibility, demographics, MTB diagnostic testing, concomitant medications, adverse events, and TB symptoms and relapse. All data have been remapped to a common data standard (CDISC SDTM v3.2) such that all the data can be analyzed across all studies.
TB-Platform for Aggregation of Clinical TB Studies (TB PACTS)
The TB-PACTS data platform is designed to catalyze and accelerate TB research by curating and standardizing Phase III tuberculosis (TB) clinical trial data and making this data publicly available to qualified researchers. Researches can access and analyze data in aggregate, or filter and view individual patient-level data from the REMoxTB, RIFAQUIN and OFLUTUB clinical trials. Additional trial data may be available in the future. This initiative represents a collaborative partnership between the Special Progamme for Research and Training in Tropical Diseases (TDR), the TB Alliance, St. George’s University of London, Case Western University, the British Medical Research Council and C-Path.
For more information on the tools and platforms above, visit the individual links or email info@c-path.org.