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?? Collaborations for hypothermia research ??. Target disorder Different technologies Treatment protocols Basic/translational/clinical. The NIH Roadmap: Four themes emerged. Revolutionary Methods of Research New Pathways to Discovery Multi-disciplinary Research Teams of the Future

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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

    • NOTunderpowered 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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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

Who’s in charge?

Flexibility limited

Collaborations


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con·sen·sus:opinion/position reached by a group as a whole or by majority will. General agreement or accordcon·sor·ti·um: association or combination…for the purpose of engaging in a joint venture. A cooperative arrangement among groups or institutionscol·lab·o·rate: to work together, especially in a joint intellectual effort


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