Applied Clinical Trials publishes the paper Transparency: The EU Prospective
The paper describes the legal framework of the Clinical Trial Transparency according to the rules established by the European Union authorities. Moreover, it deals with the main CTT activities, including the general procedures of anonymization and reduction of the commercially confidential information. Finally, it outlines an original approach to the drafting of the layperson summary that reconciles all the information required by the EU legislation with an order of priorities modulated on the patient’s needs of understanding.
The paper received a positive comment on behalf of Bob Paarlberg, Chair of the DIA CTD Community.