Last week, the BIH QUEST Center in Berlin brought together leading European universities for a clinical trial reporting workshop.
Four experts from UK universities gave practical guidance on how to establish oversight over university trial portfolios and upload results onto trial registries.
Many universities are currently in violation of European transparency rules on clinical trial reporting, and fall far short of WHO best practices in the field. A recent warning from regulators and critical media coverage have put the problem on the agenda within universities. Many institutions are keen to overcome the problem, but unsure how they can do so.
This blog summarises the workshop. You can download all presentations and materials by clicking here.
Module 1. Evolving transparency requirements
QUEST research fellow (and TranspariMED founder) Till Bruckner provided a quick overview of legal, regulatory and funder requirements. In particular, he emphasised that every single clinical trial listed on the European registry is required to post its results there.
Module 2. Strengthening and implementing institutional policies
Patricia Burns from TASC (Scotland) described how a review of registry entries highlighted problems with both trial registration and results reporting, and how her university subsequently developed and implemented new policies and Standard Operating Procedures to deal with the problem.
Participants then scored their own universities' policies using the WHO best practices checklist. The wide range of responses was striking – some universities already had numerous items in place, others hardly any at all.
Module 3. Establishing institutional oversight over trial portfolios
Birgit Whitman shared her experiences with setting up oversight systems at Bristol and Birmingham universities, and described the work flow, and discussed resource requirements and time frames.
While establishing central oversight over trial portfolios is essential, discussions indicated that there are two different approaches to managing actual data entry into trial registries: Either a dedicated university staff member directly enters all the data, or each individual researcher enters his/her own trial data with active support from specialised staff.
Modules 4+5. Quick wins on the European trial registry
Universities often find the EU trial registry EudraCT daunting. In two brief sessions, experienced users described “quick wins” that allow universities to substantially improve their performance at little cost:
Birgit Whitman flagged that for trials completed prior to July 2013, universities can simply post results by uploading journal articles, rather than entering data in tabular format, and outlined the process.
Patricia Burns highlighted that universities can make results reporting far easier by taking registry data requirements into account during the initial design and subsequent management of clinical trials.
Module 6. Reporting post 2014 trial results on the European registry
Due to its badly designed interface, it can be difficult and very time-consuming to upload results onto the EudraCT registry. Jackie Pullen of King’s Health Partners, whose team has posted over 100 results in recent months, shared numerous tips and tricks for successfully navigating the system and getting trial results out there as rapidly as possible.
Module 7. Managing trials listed on Clinicaltrials.gov
Angelika Kristek from Imperial College ran a module on trial registration and reporting on Clinicaltrials.gov. Workshop participants were able to practice navigating the interface on their laptops during the session.
Module 8. Designing a roadmap to excellence
To round off the day, participants working in small groups determined the steps their own universities would need to take to ensure that in future, all clinical trials report their results on time. Creating strong systems typically requires taking several technical and administrative steps, some earlier than others.
The resulting lists of steps produced by the four groups varied considerably, maybe reflecting the diversity of universities present. They are reproduced below (or download them here).
Side event. Dialogue with EMA: Making EudraCT more user friendly
During a side event, two experienced registry managers shared their experiences of EudraCT with the European Medicines Agency representative, and discussed ways in which the system could be improved (see also this paper). Going forward, QUEST will compile a list of the suggested improvements and share them with EMA for follow-up.
Universities wishing to improve their clinical trial registration and reporting can download all workshop presentations and materials.
Additional useful material and links can be found under the heading "Transparency Tools" on the TranspariMED website.
Note: In addition to 24 staff from universities in Germany, Denmark, France, Italy, and Cyprus, and 4 trainers from UK universities, representatives from Cochrane Germany, the German CTU network (KKS-Netzwerk) and the European Medicines Agency also attended the workshop. QUEST covered the costs of the event. QUEST researchers Peter Grabitz and Till Bruckner jointly facilitated the event.