Clinical Trials, Data Protection and Patient Empowerment in the Era of the New EU Regulations

Anastassia Negrouk, Denis Horgan, Alessandra Gorini, Ilaria Cutica, Lada Leyens, Sebastian Schee Genannt Halfmann, Gabriella Pravettoni

Research output: Contribution to journalArticlepeer-review


Cancer clinical trials and, in general, cancer clinical research by definition need a multi-modality approach. It is not enough to discover and register new drugs. To get cancer under control requires us to perform complex clinical studies that integrate drugs, companion diagnostics, new or improved surgical procedures and new radiotherapy approaches as well as, most importantly, to integrate all available information. This includes biological material and, of increasing importance, large amounts of data using big data technologies. To personalise treatment, genetic data are more and more frequently used. Therefore, the general approach is holistic. Legislators, on the other hand, work in a silo mentality; the needs of clinical research are poorly understood, and legislation focuses on either health care or the commercialisation of a product, and not on clinical research. In the last 2 years the EU has drafted several major regulations touching on clinical trials, in vitro diagnostics, medical devices and data protection, all of which will impact clinical research, although the silo mentality makes the overall framework inconsistent and potentially highly damaging to the EU's capacity to make rapid progress in the field of personalised medicine.

Original languageEnglish
Pages (from-to)386-395
Number of pages10
JournalPublic Health Genomics
Issue number6
Publication statusPublished - Dec 1 2015


  • Clinical trials
  • Data protection
  • EU regulations
  • Patient empowerment

ASJC Scopus subject areas

  • Genetics(clinical)
  • Public Health, Environmental and Occupational Health


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