?? Collaborations for hypothermia research ??

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?? Collaborations for hypothermia research ??

• Target disorder
• Different technologies
• Treatment protocols
• Basic/translational/clinical

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The NIH Roadmap Four themes emerged

• Revolutionary Methods of Research
• New Pathways to Discovery
• Multi-disciplinary Research Teams of the Future
• Re-engineering the Clinical Research Enterprise

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Collaborations

• Why do it? Sum of the parts.
• What NIH does
• Disease specific (SPORs, SCORs, etc.)
• Investigator-initiated P50, P01
• Clinical trials networks
• Large clinical trials

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Bioengineering Research Partnerships

• PAR-03-032 expires August 23, 2003
• Trans-NIH
• Technology plus biological system
• Hypothermia Lance Becker, NHLBI

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National Institute of General Medical
Scienceswww.nigms.gov

• Integrative and collaborative approaches to
  research
• Must involve investigators at different
  institutions and must introduce new collaborative
  and interactive activities
• 300,000
• GLUE grants
• Much larger
• Not available in 2003 ???? 2004

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Specialized Program of Translational Research in
Acute Stroke

• PAS-01-092 P50 mechanism
• Establish a network of centers 3 centers now
• Collaboration between EMS, ED, Neurology,
  Radiology
• Phase I trial of endovascular hypothermia w/wo
  tPA (Patrick Lyden at UCSD)

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NINDS Initiative in Translational Research

• NINDS Cooperative Program in Translational
  Research (PAR-02-139)
• NINDS Institutional Center Core Grants to Support
  Neuroscience Research (PAR-02-059)

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NINDS Cooperative Program

• Translational Research Conferences (U13)
• Single-Component Translational Research Projects
  (U01)
• Multi-Component Translational Research Projects
  (U54)
• 5 years negotiate budget milestones involve
  NINDS program directors

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Clinical trials are collaborations

• Field Administration of Stroke Treatment -
  Magnesium (FAST-MAG) Trial A Randomized,
  Double-Blind, Placebo Controlled Trial of
  Neuroprotective Magnesium Sulfate Therapy for
  Acute Stroke Administered Within 2 Hours of Onset
  by Paramedics in the Field
• UCLA Stroke Center USC Department of Emergency
  Medicine Los Angeles County Fire Department
  Paramedic System Los Angeles City Fire
  Department Paramedic System
• R01, 1 PI

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Priorities for Clinical Collaboration

• Follow a good pre-clinical lead
• Timing/duration of target mechanism
• Timing/duration of intervention
• Mechanism exists in human disease
• Outcome measures show an effect
• Patients available

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Trials in Consortia

• Phase I/II and NINDS Pilot trials
• Fixed sample size
• Staged designs
• Selection trials
• NOT underpowered Phase III
• Phase III Outcomes clinically meaningful

Types of trials
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Brain injury

• Mechanisms complex and interrelated
• Timing may be unique
• Injuries heterogenous
• Individual differences among patients
• Multiple therapies or staged therapy

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Conferences to assess a field

• Expert recommendations often include formation of
  groups to tackle specific problems or development
  of guidelines.
• NHLBI workshops
• PULSE (post-resuscitation initial utility in
  life saving efforts)
• Neurocognitive outcome after CABG
• Working group on trauma research
• NINDS
• Clinical trials in brain injury

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Consensus needed?

• Methods of hypothermia
• Intervention parameters
• Disorders to be treated Patient characteristics
• ? Preventing hyperthermia
• Additional therapies
• Comparability among trials

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Collaborations

• Advantages
• Results quicker
• Compare results
• Educate investigators
• Raise standard of care or state-of-the-art
• Do the BIG experiment

• Disadvantages
• Expense
• Logistics
• Personnel intensive
• Locked-in syndrome
• Whos in charge?
• Flexibility limited

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consensus opinion/position reached by a group
as a whole or by majority will. General agreement
or accordconsortium association or
combinationfor the purpose of engaging in a
joint venture. A cooperative arrangement among
groups or institutionscollaborate to work
together, especially in a joint intellectual
effort
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