Concept Development – Investigator Initiative

Via NSGO-CTU

Procedure to initiate
Investigator-initiated trials
via NSGO-CTU

NSGO-CTU promotes the development of investigator-initiated studies from study concept to full study

NSGO-CTU is dedicated to the development of new clinical trials and fostering our member’s research studies.

Below you can find the Concept Development Form, which is used for submitting new study proposals to NSGO-CTU.

The form provides a checklist to aid investigators in preparing their concept for submission to NSGO-CTU. Please ensure that your concept addresses the points noted herein.

Guidelines for completing your Study Concept

CONCEPT TITLE
– Should be in the PICO format (i.e. the title should hold information on the Participants, Intervention and Comparison groups, and the Outcomes of the trial)

 

BACKGROUND AND SIGNIFICANCE
− Have you addressed the scientific validity?
− Is it an important question?
− Size of population defined?
− Sufficient rationale to proceed?
− Is it clinically relevant?

 

STUDY SUMMARY
− Aims: Are they clearly stated?
− Trial objectives: Do the objectives match the aims?
− Hypothesis: Are they clearly stated? Do they match aims and objectives?
− Endpoints: Are the endpoints measurable? Are they suitable to answer trial questions?

 

STUDY DESIGN AND STATISTICS
− Phase of study stated?
− Is design appropriate to address the question?
− Are treatment arms clearly described?
− What is the sample size estimate?
− Is the sample size justified in terms of primary endpoint?
− Is the study likely to detect a clinically significant difference?
− Has a statistician reviewed the study design?
− Is the study feasible? Outline the proposed sources of subjects and estimated recruitment rates

 

SUBJECT POPULATION
− Target population and setting should be described briefly 

− Main inclusion criteria – are they clearly stated and clinically relevant?

 

STUDY INTERVENTION
− Briefly describe actions to be taken

 

FUNDING
− Is there any financial support for the study?

 

OTHER
− Is there a translational research component?
− Have QOL and Health Economics assessments been included?
− Is there collaborative support from other trials groups?

 

Concept Development Form

Please ensure that your concept addresses the points noted in the Concept Development Form.

A checklist is provided below to aid investigators in preparing their concept for submission to NSGO-CTU.

Study summary:
Drug and sponsoring:
NSGO-CTU involvement requested:
Study Chair
Investigator(s):
Investigators’ names should be supplied in the surname-last format with the initial in capital.
Institutional affiliations should be indicated with superscript numbers following the author’s name.
All affiliations should contain institution, city and country.