INTRODUCTORY STATEMENT AND GENERAL …
PTN CONCEPT PROPOSAL TITLE:
CLINICAL PHASE:
INVESTIGATOR(S):
INSTITUTION(S):
PRODUCT (S): drug of Interest name(s)
FORMULATION(S): study drug formulation (eg. injection, tablet, topical), name of manufacture company
___________________________________________________________
APPROVED INDICATION(S):
Adult: include label information. Study drug injection is indicated for the treatment of (disease, condition)
Pediatric: include label information. Safety and effectiveness in pediatric patients (age range) have not been established
BACKGROUND AND SIGNIFICANCE (include existing evidence, if applicable):
To Include:
• Public health impact of indication/disease
• Role/use of therapeutic of interest in indication/disease of interest in adults, children, other populations
• Provide information to justify proposed extrapolation plan, if any: pharmacokinetics, safety, and efficacy
HYPOTHESIS: add the specific extrapolation plan proposed
SPECIFIC AIMS: to expand the currently labeled indication in xxx to children of xxx age by…
PRIMARY TRIAL OBJECTIVE: Characterize the pharmacokinetics of intravenous xxx in children xxx of age
SECONDARY TRIAL OBJECTIVE: Determine the safety profile of intravenous xxx in children xxx of age.
EXPLORATORY TRIAL OBJECTIVE(S): Obtain preliminary efficacy data for intravenous xxx in children xxx of age.
RESEARCH DESIGN AND METHODS
Study population:
Study design:
Rationale for study design:
Rationale for dose selection:
Inclusion criteria:
Exclusion criteria:
Randomization:
Study intervention:
Duration of subject participation:
Primary outcome measures:
Secondary outcome measures:
Exploratory outcome measures (if applicable):
Sample size:
Proposed schedule of assessments:
Number of sites:
REFERENCES:
E-mail completed template to DCRI PTN Program Manager PTN-Program-Manager@dm.duke.edu for PTN Steering Committee review.
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NOTES
Black font – standard section
Blue font – instructions
Green font – sample texts
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