A new manual aims to assist universities across Europe in making their clinical trial results public.
It provides practical, step-by-step guidance on how to meet EU regulatory requirements and adopt WHO best practices, drawing on the experiences of successful universities in six European countries.
NOTE: Hyperlinks did not work In the version of the manual that was originally uploaded here. This blog now links to the fully functional manual.
Just over a year ago, a report showed that at least 778 clinical trials run by 30 European universities were missing results on the European trial registry, in violation of EU transparency rules.
Since then, many universities have begun the process of uploading their missing trial results. However, these universities have often worked in isolation, with little sharing of experiences.
The new manual aims to make this journey easier for universities.
It draws on interviews with 18 people who have been driving improvements in clinical trial reporting at 13 different institutions in six European countries, and incorporates dozens of tips and tricks that they learnt along the way.
While the European trial registry EudraCT is the manual’s main focus, it also discusses on how to manage data on other trial registries.
Click on the image below to access the full document.
The manual is published by the BIH QUEST Center in Berlin, which already ran a workshop on the topic in late 2019. It was written by TranspariMED’s founder, who holds a position as part-time Research Fellow at QUEST.
The manual is published under a Creative Commons license, so it can be freely shared and reproduced.