Programs
- Biomarker Data Repository (BmDR)
- Critical Path For Alzheimer's Disease (CPAD)
- Critical Path for Parkinson's (CPP)
- Critical Path to TB Drug Regimens (CPTR)
- Duchenne Regulatory Science Consortium (D-RSC)
- Data Collaboration Center (DCC)
- Electronic Patient-Reported Outcome Consortium (ePRO Consortium)
- Huntington’s Disease Regulatory Science Consortium (HD-RSC)
- International Neonatal Consortium (INC)
- Multiple Sclerosis Outcome Assessments Consortium (MSOAC)
- Polycystic Kidney Disease Outcomes Consortium (PKD)
- Patient-Reported Outcome Consortium (PRO Consortium)
- Predictive Safety Testing Consortium (PSTC)
- Type 1 Diabetes Consortium (T1D)
- TB-Platform for Aggregation of Clinical TB Studies (TB-PACTS)
- Transplant Therapeutics Consortium (TTC)
Biomarker Data Repository
C-Path is developing a repository for data on novel translational safety biomarkers from drug development programs, with the goal of accelerating qualification of novel biomarkers as new tools for drug developers. This initial pilot focuses on kidney safety biomarkers.
Critical Path For Alzheimer's Disease
The Critical Path For Alzheimer’s Disease (CPAD) is a public-private partnership aimed at creating new tools and methods that can be applied to increase the efficiency of the development process of new treatments for Alzheimer disease (AD) and related neurodegenerative disorders with impaired cognition and function.
Critical Path for Parkinson's
Created in partnership with Parkinson’s UK, one of the world’s largest charity funders of Parkinson’s research, the Critical Path for Parkinson’s Consortium (CPP) was launched on October 14, 2015.
Critical Path to TB Drug Regimens
The CPTR initiative is dedicated to delivering a safer, more efficacious, and faster-acting tuberculosis (TB) regimen by developing and promoting innovative regulatory science essential for supporting new combination drug development in collaboration with its partners across industry, academia, and government.
Duchenne Regulatory Science Consortium
D-RSC supports collaborative research through shared data access and development of drug development tools.
Data Collaboration Center
Developing data solutions for scientific research.
Electronic Patient-Reported Outcome Consortium
The Electronic Patient-Reported Outcome (ePRO) Consortium provides scientific leadership and best practice recommendations surrounding electronic data capture technologies and services that support the collection of patient-focused outcomes data in clinical trials.
Huntington’s Disease Regulatory Science Consortium
Created in partnership with CHDI Foundation and the Critical Path Institute, HD-RSC was launched on March 28, 2018, with the aim of accelerating the regulatory approval of Huntington’s disease therapies.
International Neonatal Consortium
Launched on May 19, 2015, INC is C-Path’s ninth consortium – a global collaboration formed to forge a predictable regulatory path for evaluating the safety and effectiveness of therapies for neonates.
Multiple Sclerosis Outcome Assessments Consortium
Launched in December, 2012, MSOAC is another dynamic partnership formed to promote consensus science. Created jointly with the National Multiple Sclerosis Society, MSOAC will collect, standardize, and analyze data about MS with the goal of qualifying a new measure of disability as a primary or secondary endpoint for future trials of MS therapies.
Polycystic Kidney Disease Outcomes Consortium
C-Path's Polycystic Kidney Disease (PKD) Outcomes Consortium is a collaborative partnership whose research leads to discovery of treatments for PKD.
Patient-Reported Outcome Consortium
The Patient-Reported Outcome Consortium supports patient-focused drug development by obtaining qualification of clinical outcome assessment tools that measure how patients feel and function in their everyday lives as a result of treatment.
Predictive Safety Testing Consortium
C-Path's Predictive Safety Testing Consortium (PSTC) serves as a neutral third party in the independent assessment and validation of drug safety tests.
Type 1 Diabetes Consortium
The T1D Consortium is working to qualify islet autoimmunity antibodies as prognostic biomarkers to be used in the development of therapies for the treatment, and ultimately the prevention, of type 1 diabetes.
TB-Platform for Aggregation of Clinical TB Studies
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.
Transplant Therapeutics Consortium
Co-founded by the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS), the Transplant Therapeutics Consortium (TTC) is a collaboration between the transplant community, industry, and regulatory agencies, and is managed and supported by Critical Path Institute (C-Path).
Creating and testing Alzheimer’s disease tools to facilitate drug development
Collaborating to develop instruments that measure the patient’s perspective
Developing and qualifying PRO instruments with the FDA for use in clinical trials
Qualifying biomarkers to identify patients for type 1 diabetes prevention clinical trials
Supporting collaborative research through shared data access and development of drug development tools
Friedreich’s Ataxia Integrated Clinical Database (FA-ICD)
Bringing together experts with a range of skills to explore how patients view their therapy
Accelerating approval of Huntington’s therapeutics
Working with the FDA and medical product firms to assess patient outcomes
Collaborating to develop tools to accelerate drug development in transplantation
Developing standards for assessing outcomes in clinical trials of MS therapies
Qualifying instruments for use in clinical trials to evaluate treatment benefit
Enriching our understanding of the effect of interventions on how patients feel and function
Areas of Focus
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Accelerating the path
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Alzheimer’s Disease
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Asthma
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Data Collaboration
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Depression
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Diabetes
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Drug Safety
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Duchenne Muscular Dystrophy
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Friedreich’s Ataxia
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Functional Dyspepsia
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Huntington’s Disease
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Irritable Bowel Syndrome
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Kidney Transplant
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Multiple Sclerosis
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Non-Small Cell Lung Cancer
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Parkinson’s Disease
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Polycystic Kidney Disease
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Rheumatoid Arthritis
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Tuberculosis
Critical Path Institute, founded in 2005 in Tucson, Arizona, is an independent, nonprofit organization dedicated to bringing together experts from regulatory agencies, industry, and academia to collaborate and improve the medical product development process. More…
Past Events
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May 16, 2019 Best Practices for Avoiding Paper Backup When Implementing Electronic Approaches to Patient-Reported Outcome Data Collection in Clinical Trials (May 16, 2019) -
May 16, 2019 Poster presentation at the 2019 Arizona Alzheimer’s Consortium Annual Scientific Conference, May 16, 2019, Tempe, AZ -
May 1, 2019 - May 3, 2019 2019 Annual INC Neonatal Scientific Workshop -
Apr 24, 2019 - Apr 25, 2019 Tenth Annual Patient-Reported Outcome Consortium Workshop -
Apr 17, 2019 - Apr 18, 2019 2019 PSTC Japan Safety Biomarker Conference -
Mar 13, 2019 - Mar 16, 2019 Poster presentation at the American Society for Clinical Pharmacology & Therapeutics Meeting, March 13-16, 2019, Washington, DC
Successes
- COA Qualification from FDA for Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD)
- Qualification of drug-induced kidney injury (DIKI) clinical safety biomarker, composite measure
- COA Qualification from FDA for the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
- C-Path receives COA qualification from FDA for the Symptoms of Major Depressive Disorder Scale (SMDDS)
- C-Path’s PKDOC Secures EMA Qualification Opinion for Enrichment Biomarker in ADPKD
- C-Path’s PKDOC Secures FDA Qualification for Enrichment Biomarker in ADPKD
- Regulatory Support For Autosomal Dominant Polycystic Kidney Disease Biomarker
- C-Path Opportunities Table
- EMA Qualifies ‘Hollow Fiber System’ For Anti-Tuberculosis Drug Development
- FDA and EMA issue first-of-their-kind Letters of Support for two Kidney Biomarkers
News
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Jun 11, 2019 C-Path’s PSTC Releases Points to Consider Outlining Recommendations for Analytical Validation of Assays Used in Qualifying Biomarkers
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May 2, 2019 C-Path, CDISC Release Therapeutic Area Standard to Drive Research Forward for Clostridium Difficile Associated Diarrhea -
Apr 16, 2019 C-Path, CDISC Develop Therapeutic Area Standard to Foster More Efficient and Meaningful Research for HIV -
Apr 9, 2019 C-Path Receives Qualification from FDA for the Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) -
Mar 26, 2019 Critical Path Instituteと医薬品医療機器総合機構、初のバイオマーカープロジェクトで協力
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Mar 26, 2019 Critical Path Institute and Japan’s Pharmaceuticals and Medical Devices Agency Collaborate on First-of-its-Kind Biomarker Project