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

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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

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Blue font – instructions

Green font – sample texts

Open the attachment below to see submission /review process

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