Network |
Sentinel |
CNODES |
PCORnet |
Primary goal |
Act as a resource for the US government and other
interested parties to evaluate safety and expand the role of real-world
data in regulatory decisions |
Use collaborative, population-based
approaches to provide rapid answers to questions about drug safety and
effectiveness |
Improve US capacity to conduct health research,
particularly comparative effectiveness research (CER) by creating a
large, highly representative network for conducting clinical outcomes
research |
Main users of the network |
The US Food and Drug Administration |
The
Canadian Drug Safety and Effectiveness Network |
PCORnet is a national
resource allowing a wide array of investigators and research funders to
request queries |
Total individuals covered and data partners |
More than 228 million
individuals at 16 data partners including fee-for-service claims
databases, hospital networks, and large health plans in the US |
More
than 100 million individuals from 10 data partners: 8 Canadian
provinces, 1 US fee-for-service database, and the UK CPRD system |
Integrated record or claims data for more than 70 million individuals
across 8 large Clinical Research Networks and 2 Health Plan Research
Networks in the US |
Data format |
Data is maintained in the Sentinel Common Data Model in
SAS |
Data format varies, with many partners adopting a common data
model |
All PCORnet Network Partners operate under a shared PCORnet
Common Data Model |
Analysis |
SAS code is written at the Sentinel Operations Center and
then distributed as a “package” to each data partner. After the code
is run, data sets with outcome and treatment are returned to SOC for
final analysis |
After finalizing queries, CNODES creates a central
project team. This team creates a scientific protocol that provides
detailed analytic instructions and receives ethics board approval. This
scientific protocol is then used to write site-specific analytic
protocols and code |
Study teams and analysis plans are assembled to
meet the needs of the individual study. Analysis of the distributed
query data may be performed centrally, by participating network
partners, or by individual participating sites |
Consolidation and reporting |
Results are presented as network-wide
estimates, with the option to present partner-specific estimates;
analytic code and results are posted online |
Partner-specific estimates
are returned to the central team. These results can be presented
separately or combined with meta-analytic techniques |
Results of the
distributed queries are returned to the central team for a given study.
Results may be reported separately or aggregated together centrally,
depending on the protocol |