Since the introduction of the new European Regulation 236/2014, some restrictions have applied to the traditional role of nonprofit foundations in the field of clinical trials, posing relevant limits regarding their possibility to conduct profit studies. In fact, at a European level, there is not such a distinction between profit and non-profit studies. This is the reason why Italian nonprofit organizations will have to come to terms with many constraints that may affect the way they can manage and conduct clinical trials.
To deal with such problems,
EMN Trial Office was created in Italy. This company was founded in 2017 in Turin (formerly known as EMN Research Italy), and it is the first social company (from Italian jurisdiction “impresa sociale”) working in clinical research on multiple myeloma in Italy. Because of its nature, this social company is entitled to conduct profit studies, overcoming the limitations of nonprofit foundations in Italy. Consequently, results deriving from profit clinical trials can also be used by pharmaceutical companies to foster clinical research advances and to offer effective treatments to patients.
Various professionals have come together to create
EMN Trial Office: legal experts, labor consultants, accountants, as well as operative personnel already involved in the field of clinical trials on multiple myeloma. A distinctive feature of Italian social companies is that any profit derived from the conduction of clinical trials is not distributed to the company partners, but it is re-invested in the fundamental activities of the company, thus to further support clinical research.
EMN Trial Office closely collaborates with central
EMN in the Netherlands. EMN, that is the European Myeloma Network, is a big group including hematologists and leading investigators of Europe: Pieter Sonneveld, president of the EMN in the Netherlands and professor at the Erasmus University Hospital in Rotterdam; Mario Boccadoro, professor at the University of Torino - Città della Salute e della Scienza di Torino Hospital, secretary of the central EMN foundation and chairman of the Working Group EMN Italy; Herman Einsele, University hospital of Würzburg; Heinz Ludwig, Wilhelminen Cancer Research Institute in Vienna; Meletios A. Dimopoulos, University of Athens; Jesus San-Miguel, Clinical University Hospital of Salamanca. The central EMN has various branches in the different European countries, and EMN Research Italy represents the Italian branch of this large European network.
To optimize the management of
EMN Trial Office, besides the Board of Directors, this social company also includes a Scientific Committee and the Working Group EMN Italy with its specific Scientific Commissions.