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.

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

Form for the Suggestion of Topics for The Call for Proposals of the

Independent Research on Drugs - 2007

Name ____________ Surname _________________Institution__________________________

1. Title [Max 200 characters] _____________________________________________________

2. Main aim of the suggestion:□ Efficacy □Safety/ADR □Promotion of prescribing appropriateness □ Other_______________

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_________________________

4. Disease / condition [Max 100 characters].__________________________________________

5. Study population: □Paediatric □Adult □Geriatric □Pregnant Women □ Other______________

6. Hypothesis of the study field: □ GPs □ Surgery □ Other_____________

7. Abstract [Max 3.000 characters]. __________________________________________________

8. Key words (no more than 5) 1. ________ 2. _________ 3. _________4. _________ 5. ______

THE TWO STEPS OF THE SELECTION PROCESSThe evaluation process mirrors the accredited standard of internationally recognised scientific institutions and is based on a two step process.

FIRST STEP: “Letters of intent” are submitted by researchers and evaluated by the AIFA Research and Development Committee (R&DC).

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.

Independent Research on Drugs: the Call for Proposals

A TRANSPARENT PROCESS: DEALING WITH POTENTIAL CONFLICTS OF INTERESTReferees 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

Belongs to the same institution of the principal investigator (PI)

Has collaborated in research projects with the PI for the last 5 years

Has or will have a direct advantage from the study approval

Has any other perception of conflict of interest

IDENTIFICATION OF TOPICS

HEARINGSSPONTANEUS SUGGESTIONS

(through web site)R&DC ASSESSES SUGGESTIONS

SUBMISSION OF LETTERS OF INTENT (LoI)

I STEP: EVALUATION OF LoI

BY THE R&DC

SUBMISSION OF FINAL PROTOCOLS

II STEP: STUDY SESSION FOR THE EVALUATION OF STUDY PROTOCOLS

SELECTION OF PROTOCOLS TO BE FUNDED

THE TWO STEPS OF THE SELECTION PROCESS

THE PROCEDURE OF THE CALL FOR PROPOSALS

FOLLOW UP OF FUNDED PROTOCOLS OBJECTIVE:

To promote research quality and reduce bureaucracy (formalities)

METHODS: Monitoring activity; training course; site visits Scientific and administrative reports Workshop to present the main findings Publications

Agenzia Italiana del Farmaco - Italian Medicines Agency

Rome, ITALY

Research & Development Unit - ricerca&sviluppo@aifa.gov.it

Salvatore Caruso, Alessia Cirilli, Alessandra Correggia, Lucia Masiero, Luciano Sagliocca, Giuseppe Traversa