Critical Path for Alzheimer’s Disease Consortium Database (CPAD AD/MCI)

https://c-path.org/programs/cpad/

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 leading to treatments for neurodegenerative diseases that progress to dementia with the shared characteristics of Alzheimer disease (AD), the most common and devastating form of dementia globally.

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). FA is autosomal recessive, single gene disorder, caused by mutations in the FXN gene. Loss of balance and coordination is the most common presenting symptom typically beginning between the ages of 5 and 15 years with progression of symptoms leading to loss of ambulation and independence of all activities of daily living.  Adult or late onset FA is less common, affecting <25% of diagnosed individuals, and can occur anytime during adulthood.  While neurological features of the disease are fully penetrant, affecting 100% of those diagnosed, it is a multi-system disease. Two thirds of patients also develop cardiomyopathy, more than half develop severe scoliosis and 10-20% develop diabetes. The mean age at death is 35 years due to cardiac complications in greater than 50% of individuals.

More information can be found at http://curefa.org

FA-ICD Mission:

Launched in February 2019, the Friedreich’s Ataxia Integrated Clinical Database (FA-ICD) is designed to catalyze and accelerate Friedreich’s ataxia (FA) research and drug development by curating and standardizing FA clinical trial and natural history data into CDISC format, and making this data publicly available to qualified researchers. These researchers can access and analyze data in aggregate, or filter and view individual de-identified patient-level data from four clinical trials and a large FA natural history study. Additional data may be available in the future.

FA-ICD Partnership:

This initiative represents a collaborative partnership between the Friedreich’s Ataxia Research Alliance (FARA) and Critical Path Institute (C-Path), with a goal of expanding the FA-ICD platform by engaging with other data contributors to secure additional datasets.

FA-ICD Content:

Approved researchers can access de-identified patient-level data from placebo arms of four clinical trials and a natural history study, including:

Trial data is anonymized in the database, so researchers will not be able to ascertain which data came from which trial, and they will not be able to identify participants in any study.

FA-ICD also contains data from the FARA-funded Friedreich’s Ataxia Clinical Outcome Measure Study conducted by the Collaborative Clinical Research Network (CCRN). The CCRN has collected natural history data on over 1,000 FA patients. The natural history for over 500 patients goes back more than 5 years and has more than 250 patients with baseline visits before 18 years of age.

Information about these studies may be found by clicking here.

Additional data is expected to be made available in the future.

FA-ICD Access:

FA-ICD catalogs completed FA clinical trials and natural history data and makes it available to qualified researchers. Access to the patient level data is by request only and subject to review and approval by the FA-ICD Steering Committee. To request access, you must agree to the Terms and Conditions for Use and submit a Request for Access application detailing how the data will be used, who will access the data and any plans for publishing work informed by the data. The Terms and Conditions can be accessed here.

For more information on FA-ICD, including “Frequently Asked Questions” and how your organization can contribute data, please contact Jane Larkindale at jlarkindale@c-path.org.

Access the FA-ICD platform

The platform for FA-ICD is hosted by the Critical Path Institute Online Data Repository (CODR).

C-Path has a decade of experience in data standards development, platform development and hosting, patient-level data privacy stewardship, data platform security, and controlled access methodology.

C-Path currently provides secure hosting for data collected from more than 100 clinical trials, over 60,000 subjects, and nine different therapeutic areas, totaling more than 200 million data points.

Important information about FA-ICD content and access:

• The data platform contains, but is not limited to:
  • Demographic data
  • Friedreich’s Ataxia Rating Scale (FARS)
  • International Co-operative Ataxia Rating Scale (ICARS)
  • Activities of Daily Living Scale
  • Functional Disability Scale
  • 25-Foot Walk
  • 9-Hole Peg Test
  • Modified Fatigue Impact Scale (MFIS)
  • MOS Pain Effects Scale (PES)
  • Bladder Control Scale (BLCS)
  • Bowel Control Scale (BWCS)
  • Impact of Visual Impairment Scale (IVIS)
  • Sloane low contrast letter acuity scale. (LCLA)
  • SF-10 and SF-36
  • Vital signs
  • ECG
  • Echocardiogram
  • Genetic mutation
• C-Path has fully anonymized all data.
• Researchers must agree to the Terms and Conditions for Use of the FA-ICD data platform and submit an online application form to request access to the data platform.
• The FA-ICD Steering Committee approves data access for external users.
• The Resources tab within FA-ICD contains information to help users understand and make use of the platform capabilities.

Important information about data standardization:

• C-Path has normalized all data to the CDISC Study Data Tabulation Model (CDISC SDTM) to enable researchers to analyze the data in aggregate.
• FA-ICD provides basic information on how data are structured using CDISC. Knowledge of SDTM is required for effective use of the data. Information and training about SDTM are available through the CDISC website; researchers who receive access to FA-ICD will find a link to the CDISC website on the Resources tab.

A summary of detailed concepts captured by SDTM domains contained in the FA-ICD is provided in the table below.

*Note: The FARS is located in the FT domain because the answers to the questions are governed by the duration/number of times a patient could perform the task. The ICARS is located in the RS domain because the answers are more subjectively answered by the clinician/technician who is observing the patient performing the task.

MSOAC Placebo Data (Multiple Sclerosis Outcome Assessments Consortium Database): An aggregated database of placebo arms from clinical trial datasets. Data contained in the data base are Placebo arms from clinical trial datasets, which were contributed by industry members of MSOAC, are aggregated in the MSOAC Placebo Database. The 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 C-Path Data Collaboration Center (DCC) database contains, but is not limited to, data on demographics, medical history, performance outcome measures [e.g. Timed 25 Foot Walk (T25FW), 9-Hole Peg Test (9HPT), Paced Auditory Serial Addition Test (PASAT), Low Contrast Visual Acuity (LCVA)], clinician reported outcome measures [e.g. Expanded Disability Status Scale (EDSS)], patient reported outcome measures [e.g. 36-Item Short Form Health Survey (SF-36)], relapse information, and MS type (e.g. relapsing-remitting).

Integrated Parkinson’s Database

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. The database covers over 600 variables, such as demographic information, clinical measures, medication usage data, dropouts, and more.

The CPP integrated database is rich in patient-level outcome measures and includes item level patient level data. It contains limited biomarker and genetics data and does not include data collected using digital health technologies. In accordance with the Data Contribution Agreements between CPP and data contributors, CPP is obligated to protect the identity of the individual datasets and provides access to the datasets in aggregate withmasked study identifiers.

Access CPP data
Learn more

We would like to thank our collaborators for their generous contributions to the CPP integrated Parkinson’s Database. View acknowledgements.

PKD (Polycystic Kidney Disease Consortium Database) is a standardized database of aggregated data from three longitudinal observational patient registries.

The Polycystic Kidney Disease (PKD) Outcomes Consortium is a successful collaboration between Critical Path Institute (C-Path), the PKD Foundation, Clinical Data Interchange Standards Consortium (CDISC), four leading academic medical centers (Tufts University, University of Colorado Denver, Emory University, and Mayo Clinic), and three pharmaceutical companies. Its mission is to develop tools and promote research that will lead to the discovery of treatments for PKD and improve the lives of all it affects. The Consortium is led by C-Path and funded through a grant from the PKD Foundation and philanthropic donations. Additionally, a representative from the U.S. Food and Drug Administration (FDA) serves as an active advisor to the Consortium.