Transcript ISTRUZIONI PER PREPARARE POSTER DA ESPORRE A …

Agenzia Italiana del Farmaco - Italian Medicines Agency
Rome, ITALY
Independent Research on Drugs: the Call for Proposals
Form for the Suggestion of Topics for
The Call for Proposals of the
Independent Research on Drugs - 2007
IDENTIFICATION OF MEDICAL RESEARCH
TOPICS:
 Hearings with scientific and health institutions
 Ad hoc web site to receive spontaneous suggestions from
researchers through a standard form
Name ____________ Surname _________________Institution__________________________
1. Title [Max 200 characters] _____________________________________________________
2. Main aim of the suggestion:
□ Efficacy
□Safety/ADR
□ Other_______________
□Promotion of prescribing appropriateness
SELECTION
3. The suggestion is about drug(s):
Name of the drug / therapeutic category [Max 100 characters] ____________________________
□ Reimbursed by NHS & patent
□Reimbursed by NHS & Off patent
□ Approved / designed by EMEA as an orphan drug
□ Other_________________________
The evaluation process mirrors the accredited standard of
internationally recognised scientific institutions and is based
on a two step process.
4. Disease / condition [Max 100 characters].__________________________________________
THE TWO
PROCESS
STEPS
OF
THE
FIRST STEP: “Letters of intent” are submitted by researchers
and evaluated by the AIFA Research and Development
Committee (R&DC).
5. Study population: □Paediatric □Adult □Geriatric □Pregnant Women
6. Hypothesis of the study field: □ GPs
□ Surgery
□ Other______________
□ Other_____________
7. Abstract [Max 3.000 characters]. __________________________________________________
8. Key words (no more than 5)
SECOND STEP: Full protocols admitted and evaluated by an
independent study session involving national and international
experts.
Study protocols are ranked by final score and the available
funds are distributed accordingly.
1. ________ 2. _________ 3. _________4. _________ 5. ______
THE PROCEDURE OF THE CALL
FOR PROPOSALS
A TRANSPARENT PROCESS: DEALING WITH
POTENTIAL CONFLICTS OF INTEREST
HEARINGS
R&DC ASSESSES
SUGGESTIONS
Referees should abstain from participating in the revision
process of a specific protocol (e.g., abstain from voting), if
he/she:
 Is involved in one of the working units of the study
SPONTANEUS
SUGGESTIONS
(through web site)
IDENTIFICATION OF TOPICS
 Belongs to the same institution of the principal investigator
(PI)
SUBMISSION OF
LETTERS OF
INTENT (LoI)
 Has collaborated in research projects with the PI for the last
5 years
 Has or will have a direct advantage from the study approval
I STEP: EVALUATION OF LoI
 Has any other perception of conflict of interest
FOLLOW UP OF FUNDED PROTOCOLS
OBJECTIVE:
 To promote research quality and reduce bureaucracy
(formalities)
BY THE R&DC
THE TWO
STEPS OF THE SUBMISSION OF FINAL
SELECTION
PROTOCOLS
PROCESS
METHODS:
 Monitoring activity; training course; site visits
 Scientific and administrative reports
 Workshop to present the main findings
 Publications
II STEP: STUDY SESSION FOR THE
EVALUATION OF STUDY PROTOCOLS
SELECTION OF PROTOCOLS
TO BE FUNDED
CONCLUSIONS
By adopting a rigorous and transparent evaluation process it is possible to support independent research in areas of interest
for the NHS and where commercial support is insufficient.
Research & Development Unit - ricerca&[email protected]
Salvatore Caruso, Alessia Cirilli, Alessandra Correggia, Lucia Masiero, Luciano Sagliocca, Giuseppe Traversa