German universities make rapid progress on clinical trial reporting

German universities have made strong progress in clinical trial transparency in recent months, new data show, but some institutions are in danger of being left behind. German medicines regulators appear to be doing little to promote compliance with transparency rules.

IMPRESSIVE PROGRESS BY SOME UNIVERSITIES

During the first nine months of 2020, German universities uploaded 154 clinical trial results, a dramatic increase from the only 32 results that were uploaded during the preceding five years combined.

So far, 18 out of 31 universities have already made progress on tackling the problem, some at an astounding pace.

The Charite and TU Munich are leading the race to upload clinical trial results. They have each posted the results for 23 drug trials over the past nine months, closely followed by Leipzig (18 trials), Heidelberg (17) and Cologne (14).

SOME UNIVERSITIES ARE FALLING BEHIND

The 13 institutions at the bottom of the chart have made no visible progress so far.

They jointly owe the public results for at least 111 of their clinical trials. (The actual number is almost certainly significantly higher, as many completed trials in their portfolios are still falsely marked as ‘ongoing’, and thus do not appear as overdue in public data.)

The University of Dresden alone is responsible for posting the results of at least 21 trials, but has not made a single trial result public on the registry yet. A university employee recently informed TranspariMED that Dresden plans to fix this, but that its efforts have been delayed due to the pandemic. It is unclear whether the other universities at the bottom of the chart are also working to make their missing results public.

Universities that fail to put strong systems into place risk becoming ineligible for research funding in the future.

Funders are increasingly becoming aware of the high price tag of medical research waste. The Wellcome Trust and other funders have started monitoring their grantees’ reporting performance. In future, Horizon Europe grantees will probably be required to meet strict trial reporting requirements that universities without adequate systems may not be able to meet.

FINISHING LINE IN SIGHT FOR SOME UNIVERSITIES

Some institutions appear to be on track to completely clear their backlogs of unreported clinical trials by the end of this year.

For example, Leipzig University has already uploaded 19 of its 22 verifiably due trial results, achieving a stellar reporting rate of 88%. Only two Leipzig trials still have inconsistent data. Click on the image below to explore Leipzig’s portfolio in detail.

Dusseldorf University is also close to the finishing line. With a reporting rate of 80%, it only has one remaining trial that is verifiably overdue, plus four trials with inconsistent data.

TU Munich too might be able to resolve its legacy portfolio issues before the end of the year. With a reporting rate of 80%, it still struggles with a significant number of trials that have inconsistent data, but it has already uploaded the results of most of those trials.

Once German regulatory agencies have cleaned up the remaining inconsistencies, Munich’s portfolio will look even more impressive. (Universities cannot change the status or completion dates of trials by themselves, they have to ask their national medicines regulators to do this for them.)

GERMAN REGULATORS ARE NOT PROMOTING TRANSPARENCY

German medicines regulators appear to be doing little to promote compliance with long-standing transparency rules.

In response to Freedom of Information requests, responsible regulators BfArM and Paul-Ehrlich-Institut recently admitted that they have still not contacted any pharmaceutical companies or universities to remind them of their transparency obligations. (Germany is unusual in that it has two responsible regulators, with each overseeing different types of drug trials.)

Medicines regulators in other European countries, including Austria, Denmark and the UK, are already actively working with trial sponsors to improve their compliance. Anecdotal evidence suggests that such efforts significantly improve universities’ compliance with transparency rules.

UPDATE 06 Oct 2020: The Danish Medicines Agency has just announced that it will take to court institutions that fail to make their trial results public. Full statement here.

There is overwhelming evidence that hidden clinical trial results harm patients, undermine public health, and waste public money [German language version here], and German universities have been obliged to make public the results of their drug trials on the European registry since 2014. However, the rules were widely ignored until December 2019, when broad media coverage of a report by TranspariMED and BUKO Pharma-Kampagne brought the issue to public attention.

Over the coming months, this blog will continue to track German universities’ progress, and German regulators’ actions.

European universities seeking to improve their performance can access TranspariMED’s collection of transparency tools.

Note on methodology: This blog follows up on a December 2019 report and a May 2020 update, using the same methodology based on EU Trials Tracker data. Readers can search the Tracker themselves to see the current performance and portfolio of their local university. The data above cover all German university medical centers, except for the universities of Greifswald, Kiel, Mannheim and Witten-Herdecke. These were not included in the chart as none of their drug trials have become due to report results yet.