The Cardiac Safety Research Consortium CSRC View Mitchell W Krucoff MD FACC Professor MedicineCardiology Duke University Medical Center Director Cardiovascular Devices Unit CoDirector CSRC ID: 799755
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Slide1
Collaboration, Cardiac Safety And Children:The Cardiac Safety Research Consortium (CSRC) View
Mitchell W. Krucoff, MD, FACCProfessor, Medicine/CardiologyDuke University Medical CenterDirector, Cardiovascular Devices UnitCo-Director, CSRCDuke Clinical Research Institute
Slide2Mission, who we are, how we workCardiac Safety Research Consoritum
(CSRC)
Slide3Addressing Therapeutic Innovation in the USA
R&D Spending & New Rx Applications10 Year Trends
http://
www.fda.gov
/
oc
/initiatives/
criticalpath
/
2004
Slide4Cardiac Safety in Regulatory Science:
Rare but catastrophic events
2006
FDA-Duke MOU
Cardiac Safety Research Consortium
Slide5The CSRC Public-Private Partnership MODEL
DCRI
MOU
PT. GROUPS
ACADEMIA
INDUSTRY
PROFESSIONAL
ORGANIZATIONS
NON-PROFIT
STATE, OTHER
FDA
PUBLIC-PRIVATE CONSORTIUM
NEUTRAL GROUND
COMMITMENT
ADM. INFRASTRUCTURE
:
HELP ESTABLISH WG/SC
CONTRACTS MGNT
COORDINATE MEETINGS
FINANCIAL OVERSIGHT
IDENTIFY MUTUAL PRORITIES
POOL RESOURCES/EXPERTISE
DEFINE ROLES/RESPONSIBILITIES
GAP ANALYSES (WHAT’S KNOWN?)
CO-DEVELOP
PROPOSALS
BUDGETS
TIMELINES
RFPs
PPP
STEERING COMMITTEES
WORKING GROUPS
IMPLEMENT
PROJECTS
Mortara Instrument
CRADA
Slide6Partnering OrganizationsDIAHESI
ACC-NCDRICOSNIHAHAFDAHealth CanadaPMDA Japan
Slide7Member Companies 2016Abbott
AbbVieAliveCorAmgenAMPSAstra ZenecaAlCorBayerBioclinicaBiomedical Systems
Boehringer IngelheimCardiocoreCardioNetCelerion
Chiesi PharmaCytoVasDabi, LtdDaiichi
Duck Flats Pharma
Eli
Lilly
Epidemico
Gilead Sciences
G.E. Health Care
Global Instrumentation
GlaxoSmithKline
InVivo
Sciences
Johnson & Johnson
Medifacts
Medpace
Medtronic
Merck
Monebo
Mortara
Insrument
Merck
Nabios
GmbH
OBS Medical
Perspective Informatics
Pfizer,
Inc
Portola
Quintiles
RocheSalixSanofi AventisTakedaTaylor MicrotechVince & Associates
Slide8CSRC BasicsRegulatory mission: CV safety concernsUnique partnership of stakeholders
DialogueCollaboration & trustConsensusThinktank/incubators:To talk and to listen To do….
Slide9CSRC Consensus White Papers
Slide10CSRC 2006-2016 Ten Year Report
Slide11Pediatric Drug & Device Safety: 2010 A Complex Equipoise
Slide12Complexities of Pediatric Safety:“Normal” from conception thru adolescence
A matrix of change:GrowthMetabolicHormonalPsychosocial developmentExercise and exertionDrugs and devices
On-target and off-target effectsEthical considerations & research (consent)
Slide13September 30, 2014
NCAA Cardiac Task Force Meeting
Indianapolis September 23-24, 2014
Slide14Maron
B et al, Circulation. 2014;130:1303-1334
Lawless C et al, JACC. 2014;60:2146-71
T
echnology use
False positives
False negatives
Additional testing
Developmental impact
Quality
Cost
Slide15CSRC Consensus Focus on Pediatric Safety:Unmet needs for screening & for therapeutic innovations
Defining “normal”Most kids screened are normal variantsEnhanced definition of normal enhance detection of abnormal (sensitivity & specificity)“Normal” kids is an information signature, not a single technologyUnderstanding “normal” in kids requires follow-up
Slide16CSRC: Developing consensus in place of contention
Start with what’s easiest:To agree uponTo do
Listen
for what we can do together that no one of us could do alone
Tolerate imperfection
Slide17Screening: what can we all easily agree to?
Screening programs are active nationally:Private foundationsAcademic centersNCAA
We can do better working together than any one can do separately
Primary “flaw” in national screening: inconsistency
What’s good for screening (
normals
) is good for regulatory
We can get better
without being perfect
Slide18What could we make better (not “perfect”)?Enhance consistency of data content/structure across
actice screening efforts Define contemporary, age-related “normals” criteria
Automate technology wherever possible
Blood pressure
ECG
Echo
L
ower cost, higher consistency data
Automate follow-up wherever possible
I-phone apps
EHR
For insight into “healthy”
Slide19Collaboration, Cardiac Safety And Children:The Cardiac Safety Research Consortium (CSRC) View
Mitchell W. Krucoff, MD, FACCProfessor, Medicine/CardiologyDuke University Medical CenterDirector, Cardiovascular Devices UnitCo-Director, CSRCDuke Clinical Research Institute