The Financing of Clinical Trials

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The Financing of Clinical Trials

• Scott Janis, Ph.D.
• National Institutes of Health
• NINDS Clinical Trials Group

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Total NIH Budget
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NIH Extramural Award Mechanisms
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Review Process for a Grant Application
National Institutes of Health
Institution
Principal Investigator
Center for Scientific Review
Assign to IC IRG/Study Section
Initiates Research Idea
Submits Application

Study Section
Review for Scientific Merit
Institute
Evaluate for Relevance
Allocates Funds
Advisory Councils and Boards
Conducts Research
Recommend Action
Institute Director
Takes final action
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NIH FY 2004 Clinical Trials by Institute
(dollars in thousands)
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Drug Discovery Contracts SMA FDA-Approved Drugs
Assay Development
Non- Interventional Clinical Research Epidemiolog
y Genetics Radiology
Pre-clinical Drug Development Cooperative Agreemen
ts
Animal Models of Neurodegenerative Disease
Stroke pre-clinical Consortium
Basic Science
NEPTUNE Pilot Trial Network
Pilot Studies
SPOTRIAS
Clinical Trial Cooperative Agreements
Emergency Network
Completed Trials
NET-PD
CRC
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Pilot Study Grant

• Purpose to provide specific data about an
  intervention necessary to design a subsequent
  efficacy trial.
• Mechanism R01 through PAR -03-174.
• Limit 3 years and generally lt 350K/yr.
• Review IC review

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Planning Grant

• Purpose to finalize the study protocol, to
  develop a detailed manual of operations and set
  of data collection forms, and to organize a group
  of clinical investigators.
• Limit 12 mos. and 150,000 (total).
• Mechanism R34 through PA -03-054.
• Review IC review.

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Efficacy Trial Grant

• Purpose to compare the efficacy of a new
  treatment intervention in humans relative to a
  control.
• Mechanism R01 and U01.
• Review IC review.

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Clinical Research Resources
NINDS Clinical Research Web-site
http//www.ninds.nih.gov/clinicalresearch
Patient Access Database
http//www.clinicaltrials.gov