Statement on disclosure of results of clinical trials

In a recent statement, the Federal Ministry of Health, in federal bulletin Nr. 127, explains the legal requirements for the publication of the results of clinical trials, according to §42b of the German drug law.

This recently passed law, which went into effect on January 1st 2011, requires sponsors of clinical trials to submit the summarized results to the federal authorities 6 or 12 months (depending on requirements) after completion of the study. The results are then to be published in a data bank. Many questions regarding the actual implementation, though, remained unanswered.

In reaction to these unanswered questions, the Federal Health Department has issued a general notification which is intended to clarify existing questions and to make the implementation more uniform. In addition to the clarification of which clinical trials are affected by this law and which deadlines are to be met, the reader is also informed that data may be submitted in either German or English. The ICH-3 format shall be used and is roughly specified in the attachment. However, it still remains unclear how detailed the information posted will be. Future bulletins will tell how things develop.

Last Modified: 09-27-2011