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 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 characters]. __________________________________________________ 8. Key words (no more than 5) 1. ________ 2. _________ 3. _________4. _________ 5. ______ THE TWO STEPS OF THE SELECTION PROCESS The 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 INTEREST 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  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 HEARINGS SPONTANEUS 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 - Salvatore Caruso, Alessia Cirilli, Alessandra Correggia, Lucia Masiero, Luciano Sagliocca, Giuseppe Traversa