German universities accelerate their clinical trial reporting as legal deadline looms
With legal reporting requirements due to come into force early next year, German universities are making rapid progress on clearing their backlogs of missing drug trial results.
New data show that institutions have by now made public an estimated 56% of their due clinical trial results on the European trial registry, and are continuing to upload additional results at high speed.
STRONG PROGRESS IN RECENT MONTHS
Over the past half year alone, German universities have uploaded another 131 results to the registry. As the chart below shows, 22 out of the 29 largest academic institutions in the country have made additional results public between March and August 2021. The Charite in Berlin alone has added 40 results.
PERFORMANCE VARIES STRONGLY ACROSS INSTITUTIONS
Leipzig has essentially completed the process of clearing its backlog of missing results. TU Munich and Cologne are rapidly approaching the finishing line, as are some of the smaller universities.
The chart below provides a rough overview of how far each university has progressed. The largest trial sponsor, Charite, has already reported 82 due results (green), with an estimated 20 results left to go (red). A further 103 Charite trials are estimated not to be due yet; they are either ongoing or were only completed recently. LMU Munich, the second-largest player, is lagging behind. It has only reported 11 due trials, while an estimated 28 results are still missing.
Overall, German universities have launched 1,399 drug trials. Half of those trials are estimated have been completed more than a year ago. Of those due trials, 387 now have results. An estimated 310 results are still missing from the registry.
POSITIVE TREND SET TO CONTINUE
The positive trend is expected to continue for the foreseeable future:
From 31 January 2022 onwards, there will be a legal requirement for universities to upload the results of drug trials in Germany and all other European Union countries. From that point onwards, universities that fail to make results public on time will be breaking the law and risking fines.
One of the two German regulators, BfArM, has already written to trial sponsors across the country to remind them of their obligation to report results. (TranspariMED has filed a Freedom of Information request to get more details about this excellent initiative.)
Till Bruckner, founder of TranspariMED, said:
“It is wonderful to see so many universities taking their responsibilities towards patients, science and society seriously. Hopefully Germany’s regulators will encourage the minority of laggards to rapidly upload their missing results before they find themselves on the wrong side of the law.”
“Looking forward, German medical research funders DfG and BMBF should seriously consider IQWIG’s proposal to cut off public funding for institutions that fail to make trial results public. Invisible trial results are a waste of taxpayers’ money as well as a danger to public health.”
Universities can find useful resources to support their trial reporting efforts on the TranspariMED website.
Important note on methodology: Some of the figures above are estimates, and do not precisely capture individual universities’ trial portfolios.
Because some universities have failed to clean up their data on the registry, information on the registry about the status and completion dates of their trials can be unreliable. In order to enable comparison across all universities using a single methodology, TranspariMED worked from the (conservative) assumption that half of all trials in each university’s portfolio have been completed at least a year ago and thus are due to report results. Data for Leipzig was manually adjusted.
TranspariMED follows the EU Trial Tracker’s long-standing approach of only counting trials as “due with results” if their trial status is “completed” or “terminated” and they have a trial completion date in the protocol. This leads to a slight undercounting of results available on the registry. Universities can easily fix this issue by contacting the responsible regulator and asking it to update the information on such trials in the registry.
The charts above only show the performance of the 29 German universities with more than 10 drug trials in their portfolios. Numbers cited in the text are based on data for all German universities, including the smaller ones.
All data and estimates are based on data from Oxford University's EU Trials Tracker, manually extracted on 22 September 2021. The data reflecting EUCTR registry data as of 01 September 2021. Estimates were calculated by TranspariMED. Any errors are those of TranspariMED alone.