NHLBI CLINICAL RESEARCH NETWORKS

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NHLBI CLINICAL RESEARCH NETWORKS

• Gail G. Weinmann, M.D.
• Division of Lung Diseases

2
NHLBI Approach to Clinical Research

• Investigator initiated single clinical study
  (R01)
• - Single center
• - Multi-center
• Institute initiated
• Multi-center, single clinical trials (RFP/RFA)
• Multiple single-center trials (RFP/RFA)
• Bench-to-bedside collaboration (SCCOR)
• Clinical research networks (RFA/RFP)

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What is a Clinical Research Network?
Flexible Mechanism that includes

• Multiple clinical centers
• One data coordinating center
• Agreement to collaborate in the development and
  conduct of multiple intervention protocols over 5
  years

4
Why Clinical Networks?

• Networks fill a gap
• Address important management questions and
  clinical topics most relevant to clinical
  practice
• Able to rapidly address multiple, related
  questions
• Networks are efficient
• Share resources (expertise, infrastructure, data
  analyses, results dissemination)
• Allow recruitment of adequate patient numbers,
  especially for uncommon conditions
• Allow rapid development and conduct of multiple
  protocols
• Rapid discoveries contribute to future protocols
• Provide critical mass and development of skills
  in clinical research

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Protocol Concept to Implementation
NHLBI / Investigator Initiated (R01)
Finalize Protocol, DSMB, etc.
Council
Submit R01
Peer Review
Funding
Protocol Starts (?)
NIH Guide
Council
BEE
12
16
0
4
8
9
-7
Months
Time Saved
ACRN Network
7 Months
PRC Approval
SC Concept Review
Protocol Starts
PRC Review
DSMB Review
12
9
4
8
0
Months
6
Key Components of a Clinical Research Network
Sponsor NHLBI Program Division
Data and Safety Monitoring Board
Protocol Review Committee
Steering Committee
Clinical Centers Collaborators
Data Coordinating Center
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Role of Steering Committee

• Main governing body for network
• Establish subcommittees (e.g. P P, Q/C, etc)
• Identify topics for study
• Set priorities
• Design, implement and interpret all studies
• Publish findings
• Assure compliance with network policiesand
  procedures

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Protocol Development/Selection
Protocol Review Committee
DSMB Oversight
Intra-Center Proposal
Steering Committee
Protocol Implementation Conduct
Protocol Working Group
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Selected Elements for Establishing A Clinical
Network

• Multi-center studies to assure access to
  sufficient pts.
• Multiple clinical research questions exist and
  could be addressed
• Resources available for multiple protocols
• Availability of well trained clinical
  investigators
• Availability of Institute staff to assure high
  quality management

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NHLBI Clinical Research Networks
Adult Asthma
Acute Respiratory Distress Syndrome
Childhood Asthma
Thalassemia
Pediatric Heart Disease
Blood and Marrow Transplant
Transfusion Medicine Hemostasis
COPD
Resuscitation Outcomes Consortium
Pulmonary Fibrosis
Sickle Cell Disease
Heart Failure
Cardiovascular Cell Therapy
Cardiothoracic Surgical Investigations
CVRN in Community Based Care
AsthmaNet
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DLD Networks in the 21st Century Workshop (May
2007)

• Recommendations
• maintain the focus on improving clinical care but
  allow more research question flexibility
• develop mechanisms to facilitate and promote
  scientific exchange across clinical research
  programs
• structure networks to maximize efficiency
• promote shared use of resources and
  standardization among networks
• promote training
• facilitate rapid dissemination of research
  findings

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• Letter of Intent December 30, 2008
• Application Receipt Date January 30, 2009

http//grants.nih.gov/grants/guide/rfa-files/RFA-H
L-08-010.html
http//grants.nih.gov/grants/guide/rfa-files/RFA-H
L-08-011.html
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New AsthmaNet Research Objectives

• Clinical management questions across all ages
• Proof of concept or mechanistic studies
• Dissemination of research findings collaboration
  with NHLBI's Division of Applied Research
  Discoveries
• Harmonize and standardize phenotyping,
  procedures, data elements, outcomes for use
  across programs
• Establish links with other NIH resources (GCRC,
  CTSAs)
• Training collaborations across centers

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Ideas for CTSA-Network collaboration

• Augment existing resources
• - recruitment infrastructure
• space, equipment for clinical studies
• - statistical and analytic support for
  secondary papers
• Complement existing resources
• Provide missing expertise (Regulatory experience,
  research ethics, standardization, harmonization)
• Training of investigators
• Community interaction (research participation,
  diffusion of results, effectiveness research)
• Promote scientific exchange intra- and intercenter