Italy plans to attract more early-stage clinical trials

Three Italian medicines and industry organisations have joined forces to boost early-stage clinical research in the country.

Medicines agency AIFA, health institute ISS and Assobiotec, the Italian biotech industry association, have drafted a seven-point plan to make it easier for companies to carry out Phase I and Phase II trials.

These measures will be introduced on an experimental basis for a period of 12 months.

They include:

Evaluation times for Phase I trial applications (currently carried out at ISS) to be maintained and pre-submission hearings to be provided free-of-charge to assist in the preparation of clinical trial application dossiers;

Fees for pre-submission assessment and authorisation of Phase I trials to be wavered for all companies that do not already have drugs on the market;

AIFA will organise on-site visits at short notice to ensure companies are in a position, from an authorisation and regulatory point of view, to produce its new products;

AIFA will organise training courses for operators involved in the preparation of clinical trial application dossiers;

Regional health administrations will be asked to create efficient authorisation procedures for early stage trails after ethical committees have approved them;

Contents of the agreement will be publicised among all biotech and pharmaceutical companies and relevant clinical trial organisations;

Assobiotec will publicise the initiative among all biotechnology firms to ensure that early stage clinical trials for at least half of all molecules currently at the discovery or pre-clinical stage are carried out in Italy.

Roberto Gradnik, Assobiotec's president and executive vice-president at Merck Serono, said the move would simplify procedures, remove bureaucratic barriers and increase the amount of early stage research carried out in Italy. But more needs to be done if the biotech industry is not to face serious funding difficulties in the next couple of years, he said.

"The competitiveness of our country is in the hands of our institutions which can and must do a lot to ensure, from a global point of view, Italy is chosen as country to invest in," he said.