Tools & Platforms

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.

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.

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.

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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.

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.

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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.

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.

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Islet Autoantibody Clinical Trial Enrichment Tool

This quantitative clinical trial enrichment tool helps optimize clinical trial design for therapies to prevent or delay diagnosis of T1D, using islet AAs with other relevant clinical features. This tool was created to dramatically increase the power of a trial, relative to similarly designed unenriched trials, potentially facilitating smaller, shorter, and more efficient trials.

This quantitative clinical trial enrichment tool helps optimize clinical trial design for therapies to prevent or delay diagnosis of T1D, using islet AAs with other relevant clinical features. This tool was created to dramatically increase the power of a trial, relative to similarly designed unenriched trials, potentially facilitating smaller, shorter, and more efficient trials.

clinical trials

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.

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.

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Rare Disease Clinical Outcome Assessment Resource

The Rare Disease COA Resource provides information on published COAs that have the potential to be used to support efficacy endpoints in treatment trials for rare diseases. The Resources is an initiative of C-Path’s Rare Disease Clinical Outcome Assessment (COA) Consortium, a public-private partnership focused on optimizing COA selection during drug development for rare diseases.

The Rare Disease COA Resource provides information on published COAs that have the potential to be used to support efficacy endpoints in treatment trials for rare diseases. The Resources is an initiative of C-Path’s Rare Disease Clinical Outcome Assessment (COA) Consortium, a public-private partnership focused on optimizing COA selection during drug development for rare diseases.

Data Sharing

Critical Path For Alzheimer’s Disease Database

The database contains, but is not limited to, demographic information, APOE4 genotype, concomitant medications, and cognitive scales (MMSE and ADAS-Cog). Limited treatment-arm data and limited AD biomarker data (biofluids, tau or amyloid positron emission tomography (PET), EEG data) is available. All data has been remapped to a common data standard (CDISC SDTM v3.1.2) such that all the data can be analyzed across all studies.

The database contains, but is not limited to, demographic information, APOE4 genotype, concomitant medications, and cognitive scales (MMSE and ADAS-Cog). Limited treatment-arm data and limited AD biomarker data (biofluids, tau or amyloid positron emission tomography (PET), EEG data) is available. All data has been remapped to a common data standard (CDISC SDTM v3.1.2) such that all the data can be analyzed across all studies.

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Duchenne Regulatory Science Consortium Database

Duchenne Muscular Dystrophy Data is fully de-identified and compliant to the terms and conditions specified by the data owners. Within the public-accessible database, datasets are integrated, so researchers will not be able to identify participants of the studies or the specific trial from which individual participant observations originate.

Duchenne Muscular Dystrophy Data is fully de-identified and compliant to the terms and conditions specified by the data owners. Within the public-accessible database, datasets are integrated, so researchers will not be able to identify participants of the studies or the specific trial from which individual participant observations originate.

Neuromuscular disease

Friedreich’s Ataxia Integrated Clinical Database (FA-ICD)

Friedreich’s ataxia (FA) is a debilitating, life-shortening, degenerative neuromuscular disorder. It is the most common form of hereditary ataxia, affecting approximately 1 in every 50,000 people in the United States and Europe (FA is primarily found in white, Hispanic, and Southeast Asian populations; incidence is very rare in other racial groups).

Friedreich’s ataxia (FA) is a debilitating, life-shortening, degenerative neuromuscular disorder. It is the most common form of hereditary ataxia, affecting approximately 1 in every 50,000 people in the United States and Europe (FA is primarily found in white, Hispanic, and Southeast Asian populations; incidence is very rare in other racial groups).

Database

Integrated Parkinson’s Database

CPP’s Integrated Parkinson’s Database is a comprehensive collection of observational and clinical studies related to Parkinson’s. The database includes integrated and standardized data from both PD observational studies and randomized clinical trials and contains thousands of participants’ data, anonymized and deidentified.

CPP’s Integrated Parkinson’s Database is a comprehensive collection of observational and clinical studies related to Parkinson’s. The database includes integrated and standardized data from both PD observational studies and randomized clinical trials and contains thousands of participants’ data, anonymized and deidentified.

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Multiple Sclerosis Outcome Assessments Consortium (MSOAC) Placebo Database

The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) Placebo Database presently includes 2465 individual patient records from 9 clinical trials. This version 1.0 includes records from relapsing-remitting, secondary progressive, and primary progressive forms of MS.

The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) Placebo Database presently includes 2465 individual patient records from 9 clinical trials. This version 1.0 includes records from relapsing-remitting, secondary progressive, and primary progressive forms of MS.

Multiple Sclerosis

Polycystic Kidney Disease Outcomes Consortium Database

The Polycystic Kidney Disease Outcomes Consortium database consists of de-identified data from three longitudinal observational patient registries. The data have been standardized and aggregated into a common format using a Clinical Data Interchange Standards Consortium (CDISC) Standard Data Tabulation Model (SDTM) structure.

The Polycystic Kidney Disease Outcomes Consortium database consists of de-identified data from three longitudinal observational patient registries. The data have been standardized and aggregated into a common format using a Clinical Data Interchange Standards Consortium (CDISC) Standard Data Tabulation Model (SDTM) structure.

PKD

The Rare Disease Cures Accelerator-Data and Analytics Platform (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.

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.

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TB Platform for the Aggregation of Preclinical Experiments Data (TB-APEX)

The TB-APEX data platform is designed to catalyze and accelerate TB research by curating and standardizing preclinical study data and making this data publicly available to qualified researchers.

The TB-APEX data platform is designed to catalyze and accelerate TB research by curating and standardizing preclinical study data and making this data publicly available to qualified researchers.

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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. Researchers 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.

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. Researchers 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.

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