Anonymizing and redacting clinical reports: a new paper on Applied Clinical Trials

On December 18, 2017, Massimo Zaninelli, Erika Ornago, and Antonio Ferrari published the peer-reviewed paper Anonymization and Redaction of Clinical Trials According to the EU Regulation on the online magazine Applied Clinical Trials.EMA-sets-clear-rules-for-drug-firms-seeking-clinical-data-redactions_wrbm_large

The paper analyses the normative references of the European Union, the EMA guidelines and the published literature regarding the anonymisation of clinical studies and the redaction of Commercially Confidential Information (CCI). It proposes a critical interpretation of the procedures required to anonymise the registration dossiers and to request the removal of any possible CCI from the studies that today are published on and, starting from 2019, will be available in the future EMA site.

Furthermore, based on the experience of the authors, the paper underlines the opportunity for sponsors to devote adequate resources to the activities described, to cope with the volume of operations resulting from the procedures of anonymisation and redaction of the clinical reports.