Publication of clinical trial data and results continues to be a hot topic in the EU. A recent BMJ article investigated the level of compliance with the European Commission’s requirement that the results of all trials are published within 12 months of completion. The Commission guidance expands on the obligations in the Clinical Trials Directive, and states that for all trials (paediatric and non-paediatric), result-related information should be supplied and made public within 12 months of the completion of the trial (not after grant of the marketing authorisation), including a summary of the results and conclusions.

The retrospective cohort study found that despite the Commission guidance, of the 7,274 trials where results were due, only 49.5% reported results, although trials with a commercial sponsor were substantially more likely to post results than those with a non-commercial sponsor (68.1% compared to 11.0%).

Continue Reading Update on Clinical Trials Transparency in the EU

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has recently published a new version of its Code of Practice that will come into force on January 1, 2019, updating the current Code of 2012. IFPMA members, including the EFPIA and PhRMA, must incorporate the new provisions into their own codes by this date, to the extent necessary.

In addition to the text of the Code, the IFPMA has provided detailed guidance on the key amendments made. First, the Code is now underpinned by a guiding Ethos that replaces the previous iteration’s ‘Guiding Principles’. Secondly, several provisions have been updated, notably the section on gifts. We highlight the key changes below.

Continue Reading The new IFPMA Code of Practice