Originally, the EMA planned to finalise the policy in late 2013 with a view to implementing it in January 2014. The Agency now says it will "continue to work with stakeholders, including industry, academia and civil societies, to further clarify and fine-tune the proposed rules to achieve the broadest possible consensus”.
The EMA announced that this further work would be guided by a set of principles agreed with the EMA's management board on 12 December. These principles include "a stepwise approach for implementation with, as a first step, preparation for the publication of clinical study reports redacted as appropriate, the development of a methodology for de-identification of patients, and the definition of a standard format for the submission of data".
The principles also aim to introduce measures that address the risk of "possible unfair commercial use of data whilst ensuring proactive and non-selective access (‘use control’ not ‘access control’)."
The policy on publication of and access to clinical-trial data and an implementation plan will be discussed at the March meeting of the EMA's management board.