The MSOAC platform can handle data in multiple formats. We typically ask contributors to create a zip package (or set of zip packages) of all the files to simplify the transfer, but the zip files can contain various different file formats. We typically receive clinical data as text, csv/xls or SAS transport files. Supporting information can be PDF, text, Word or other document formats.
MSOAC Database
The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) Placebo Database presently includes 2465 individual patient records from nine clinical trials. This version 1.0 includes records from relapsing-remitting, secondary progressive, and primary progressive forms of MS.
MSOAC Database
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 nine clinical trials. This version 1.0 includes records from relapsing-remitting, secondary progressive, and primary progressive forms of MS.
Data contained in this database:
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 nine 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), nine-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).
How the data are standardized:
The data are re-mapped to the current Clinical Data Interchange Standard Consortium (CDISC) foundational standard (SDTMIG v3.2). Knowledge of SDTM is necessary for effective interpretation of these data.
All data are fully anonymized and de-identified. Also, the individual clinical trials are not identified in this pooled placebo database.
What is NOT in the C-Path DCC database:
- Treatment data
- Standard-of-care or active comparator data
- Imaging data
Accessibility
The MSOAC Placebo data is available to qualified researchers who submit, and are approved for, a request for access.
FAQs
Is there a fee for using this site?
There is no fee to use the site.
What data is contained in this data platform?
Details related to data content are made available to registered users of the platform. The platform contains placebo arm data from MS clinical trials, which includes data on demographics, medical history, performance outcome measures [e.g. Timed 25 Foot Walk (T25FW), nine-Hole Peg Test (nine HPT), 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).
| SDTM Domain | Data Elements |
| Clinical Events (CE) | All relapse events (severity, duration) |
| Concomitant Medications (CM) | Dexamethasone, Methylprednisolone, Prednisolone, Prednisone |
| Demographics (DM) | Age, Gender, Race, Country |
| Disposition (DS) | Early withdrawal reason and study day |
| Findings About Medical History (FAMH) | Number of relapses before study |
| Functional Tests (FT) | T25FW, nine HPT, PASAT, SDMT |
| Medical History (MH) | MS Diagnosis, MS Type, General medical history |
| Ophthalmic Examinations (OE) | Visual acuity (including LCVA) |
| Questionnaires (QS) | EDSS, FSS, SF-36, SF-12, BDI |
| Reproductive System Findings (RP) | Pregnancy tests |
| Subject Characteristics (SC) | Dominant hand |
| Subject Disease Milestones (SM) | Confirmed relapses |
| Trial Disease Milestones (TM) | Study definition of relapse |
How are the data standardized?
All data have been remapped to a common data standard (CDISC STDMIG v3.2) to maximize utility of aggregated data for statistical analysis. All data are fully anonymized.
How and when can I contribute my data to the MSOAC platform?
Individuals, organizations, institutions, and countries (health ministries, national MS programs, etc.) are encouraged to contribute clinical study data. In addition to the study dataset, submitting organizations will be requested to provide information regarding study methodology and demographic data for their submissions. Please contact Lynn Hudson for additional information.
Will I still own the data that I am contributing to the MSOAC data platform?
Yes, data ownership is always retained by the data contributor. The data contributor signs a data contribution agreement that allows the contributor to specify the conditions of data use.
What measures are in place to ensure data platform security?
MSOAC policies for data transfer, validation, processing, and access meet or exceed industry standards. The following features are in place to ensure that the data is safe and secure:
- Data Contribution Agreement
- Secure file transfer
- Operating System hardening and security updates
- Host-based intrusion detection/prevention system
- Anti-malware protection
- Automated log monitoring and alert system
- Data encryption, de-identification, and anonymization
- Data access controls for incoming server, investigational database, analysis datasets
- Data backup and disaster recovery
- Data provenance – changes to data will be traceable and auditable throughout its lifecycle
- Multi-factor authentication
- Multi-tier network structure
- File integrity monitor
In what format should I contribute my data to the MSOAC effort?
