Commentary

A harmonized and efficient clinical research environment would benefit patients and enhance European competitiveness


Abstract


Background. Implementation of the EU Regulation No. 536/2014 through national guidelines is a great opportunity to make sponsors reconsider Europe as a prime location for clinical trials.

Methods. In November 2014, a Panel of clinical researchers and representatives of the pharmaceutical industry, patient organisations and Italian regulatory agency discussed potential advances fostering Italian competitiveness in terms of clinical research. As a case study, this analysis of the Italian situation can be representative of the average European situation.

Results. Features characterising Italian clinical research patterns were analysed. Considerable engagement and cooperation by all stakeholders is required in addition to a well-structured interaction between National Authorities and ethical committees to comply with the strict timeframes mandated by the new Regulation.

Conclusions. In the Panel’s view, harmonisation of the approval process and strengthening of clinical site performance are mandatory to provide a good return on investment in Europe for the pharmaceutical industry, access for patients to innovative treatments and new resources for clinical sites.                                                                                                                                                                  


Keywords


Clinical trials, regulation, harmonisation, clinical excellence

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