Download Duke Clinical Research Institute

From Cardiac Safety To SAFE PCI
Mitchell W. Krucoff, MD, FACC
Professor, Medicine/Cardiology
Duke University Medical Center
Director, Cardiovascular Devices Unit
Co-Director, CSRC
Duke Clinical Research Institute
Cardiac Safety
[name of file], 1
Research Consortium
Cardiac Safety Research Consortium (CSRC):
A Critical Path Public Private Partnership
FDA-Duke Memo Of Understanding 2005
 Pre-competitive focus

Multi-stakeholder perspectives
 Regulatory/public health landscape
 “Thinktank-incubator” processes:
1.
Barrier identification
2.
Prioritization
3.
Partnered solutions
http://www.fda.gov/oc/initiatives/criticalpath/
4.
Proof-of-concept
projects
http://www.cardiac -safety.org
Trans-Radial Education,
Assessment &Training
The TREAT Initiative *
Obligatory Device-Drug Safety Interaction:
Impact of device technique on drug safety
*CSRC SOC Approved Research Project
www.cardiac-safety.org
[name of file], 3
The TREAT Initiative Launch 2010
www.cardiac-safety.org
TransRadial Education, Assessment & Therapy:
June 2010
Regulatory

FDA:
 CDER
 CDRH
 OC OWH
Federal

NIH

AHRQ
Academia

Duke

Harvard

Cleveland Clinic
Societies

ACC

SCAI

ESC

SOLACI
Industry

Abbott

Medtronic

Terumo

Columbia

Emory

Cordis/J&J

Johns Hopkins

The MEDCO

Mayo Clinic


Wash Hrt Ctr
Eli Lilly
(Daichi)

Sanofi/BMS
www.cardiac-safety.org
 Fruit of pre-competitive PPP (cardiac
safety FDA-Duke critical path
program)
 First & only USA PCI study of women
 Unique public health concern
 POC for unique research
infrastructure
http://www.clinicaltrials.gov/ct2/show/NCT01406236?term=safe+pci+for+women&rank=1
CSRC Consensus White Papers
www.cardiac-safety.org
NIH-NCRI: Linking to the ACC-NCDR for SAFE
RCT Efficiency in a “River” of E-Information
 Index hosp:

Pt descriptors

Medications

Procedural details

Adverse events
 65% workload reduction
Building on SAFE PCI for Women:
SAFE STEMI for Seniors

Public health: Radial vs. Femoral Intervention
 Women
 Seniors

Regulatory:
 OWH
 IDE extension

RCT operations: linked registry efficiencies
 Short term F/U: NCRI-NCDR Cath PCI
Index hosp: descriptors, meds, procedure, SAEs
 Long term F/U: CMS Claims Data (Seniors)
1 year death, MI, stroke

Collaborating Partners:
 ACC, CSRC, DCRI, FDA-OWH, NIH, Medical Device & Drug
Industry
 ACC, CMS, CSRC, DCRI, FDA-CDRH, NHLBI, NIA, Medical
Device & Drug Industry
MDEpiNet

Dr. Danica Marinac-Dabic (FDA)

Dr. Arthur Sedrakyan (Cornell)

Dr. Sharon-Lise Normand (Harvard)

Dr. Mitchell Krucoff (Duke)
http://www/fda/gov/MDEpiNet
Overview of Today’s Agenda

Plenary: Partnered Approaches to
Improving Data Quality & Efficiency

SAFE PCI for Women

Lunch

SAFE STEMI for Seniors
 Scientific issues
 Operational issues
From Cardiac Safety To SAFE PCI
Mitchell W. Krucoff, MD, FACC
Professor, Medicine/Cardiology
Duke University Medical Center
Director, Cardiovascular Devices Unit
Co-Director, CSRC
Duke Clinical Research Institute
Cardiac Safety
[name of file], 12
Research Consortium