The European Medicines Agency (EMA) has published the note of the conference held in London a few weeks ago, about its plans for proactive publication of clinical trial data.
It is now setting up five advisory groups and inviting self-nominations from people to join these. You will find the following listing of the advisory groups, plus a form to fill out if you wish to put yourself forward, by going to this link. But I thought it would be helpful to cut-and-paste the descriptions of the groups as on the website.
|Protecting patient confidentiality||How can the Agency ensure through its policy that patient and other personal information will be adequately protected, i.e. that patients cannot be retroactively identified when clinical-trial data are released, and that applicable legislation, standards, and rules regarding personal data protection will be respected?|
|Clinical-trial-data formats||How can the Agency ensure through its policy that clinical-trial data can be shared, in the interests of public health, in a clear and understandable format that enables appropriate analyses and a swift implementation without undue burden to stakeholders?|
|Rules of engagement||Are there rules or conditions that should be in place before an external stakeholder can download clinical-trial data (e.g. formal acceptance of the need to respect personal data rules, uploading of analysis plans etc.)?|
|Good analysis practice||Are there good-analysis-practice guidelines that the Agency could ask external requestors of data to consider or be aware of, and that the Agency can apply when confronted with additional analyses from external parties?|
|Legal aspects||Are there any legal aspects other than personal data protection that need to be addressed when drafting the Agency’s policy? Are there exceptional circumstances under which data can be claimed to be commercially confidential?|