Streamlined Clinical Trial Infrastructure with Collaborative Leadership
SIREN Trial Recruitment and
Pipeline
Adaptable open clinical trial infrastructure
Collaborative leadership (typically multiple PI)
Respectful of investigators’ ownership and control of
the science
Sharing of operational and statistical responsibilities
Facilitating successful implementation and data
integrity
Clinical Trial Summary
and Rough Budget
Trial Ideas
(from
anybody)
Scientifically and
Clinically
Important
Questions and
Observations
Institute
Pre-
approval
to submit
Grant
application(s)
Collaborative
Grant
Application
and Protocol
Development
with input
from Sites,
Patients, and
Others
NIH Study
Section
Revise
Grant Award
Grant Award to
Scientific PI’s
Institution with
major
subaward to
CCC
DCC may be
paired grant or
subaward
depending on
Institute
Begin discussions with
NIH program officers
early
NIH program officers will
evaluate the fit for the
Institute
Begin discussions with SIREN leadership early as
well.
SIREN leadership will evaluate fit for the
network, contribute to concept, and relay to
site PI’s
SIREN will NOT be a layer of scientific peer
review
Institute
Council
Trials in the Pipeline
•
ICECAP
–
Duration of hypothermia after OOH cardiac arrest
–
Recently reviewed at NHLBI study section
•
HATTRIC
–
What is the optimal dose of tPA for massive PE
–
U34 planning grant approved for funding
Investigators working with the network still submit and receive the grant application for the trial at their institution. The grant recipient contracts with the CCC to provide operational/site management and enrollments, and with the DCC to provide data management and statistical support.
Investigators working with the network provide scientific leadership to the trial as PI's and study chairs. Investigators at the CCC and DCC contribute to the scientific, trial management, and statistical leadership usually in Multiple PI roles.
A work scope defining specific responsibilities is established early on that is specific to each trial.
Adaptable and open clinical trial infrastructure emphasizing collaborative leadership with shared responsibilities for successful trial implementation and data integrity. Encourages respectful ownership by investigators while engaging with NIH and SIREN to develop and fund important trials, including those in the pipeline for cardiac arrest and pulmonary embolism treatments.
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SIREN Trial Recruitment and Pipeline Adaptable open clinical trial infrastructure Collaborative leadership (typically multiple PI) Respectful of investigators ownership and control of the science Sharing of operational and statistical responsibilities Facilitating successful implementation and data integrity
Begin discussions with NIH program officers early Scientifically and Clinically Important Questions and Observations NIH Study Section NIH program officers will evaluate the fit for the Institute Revise Institute Council Trial Ideas (from anybody) Grant application(s) Clinical Trial Summary and Rough Budget Grant Award Institute Pre- approval to submit Collaborative Grant Application and Protocol Development with input from Sites, Patients, and Others Grant Award to Scientific PI s Institution with major subaward to CCC Begin discussions with SIREN leadership early as well. SIREN leadership will evaluate fit for the network, contribute to concept, and relay to site PI s DCC may be paired grant or subaward depending on Institute SIREN will NOT be a layer of scientific peer review
Trials in the Pipeline ICECAP Duration of hypothermia after OOH cardiac arrest Recently reviewed at NHLBI study section HATTRIC What is the optimal dose of tPA for massive PE U34 planning grant approved for funding
