Austria: Rapid progress on clinical trial reporting
Led by Europe’s largest academic trial sponsor, Austrian universities are now making their clinical trial results public at an impressive pace. In parallel, national medicines regulator BASG is intensifying its efforts to promote clinical trial transparency.
Overall, Austria’s 14 largest sponsors have made 37% of their due trial results public, compared to just 18% a year ago. Results are still missing for 233 long-completed trials.
Over the past year, the country’s three major medical universities alone have uploaded 65 trial results onto the European trial registry:
Medical University Vienna has already made 33 results public on the registry, and is adding more results every month.
The universities of Graz and Innsbruck are also making rapid progress. Both seem on track to achieve a reporting rate of 100% by the end of this year.
Around two thirds of all drug trials involving Austrian patients are run by universities, hospitals and public bodies. With a portfolio of over 400 drug trials, Medical University Vienna is the largest non-commercial sponsor of drug trials in the entire European Union. Its strong commitment to transparency sets a positive example for major sponsors across the continent.
On the downside, 7 of the 14 largest sponsors in Austria have not uploaded a single trial result over the past year.
One of these sponsors, ABCSG, told Cochrane Austria that the Austrian medicines regulator had never contacted them about their overdue results, leaving them unaware of the problem. ABCSG immediately pledged upload all missing results as soon as possible. (See the report for ABCSG's full response.)
The case of ABCSG is not unusual. TranspariMED frequently encounters trial sponsors across Europe that are willing to become transparent, but have never been contacted by their national regulators. However, in Austria this came as a surprise because BASG, the country’s national regulator, has been actively supporting compliance.
Austrian national regulator BASG pledges to contact trial sponsors over missing results
BASG commented that:
"It is quite worrying that a major sponsor still claims to have been unaware of their legal obligation and was expecting to be reminded by the BASG. We agree that [post pandemic] the efforts to achieve transparency now need to be taken up again. The following actions are therefore planned:
Sponsors of completed trials for which results are overdue will be contacted by the BASG based on a EudraCT DWH report. This report has to be produced by EMA as the host of the EudraCT database and EU Clinical Trials Register.
The BASG will include a reminder in the confirmation of receipt for the End-of-Trial notification that a clinical trial summary report needs to be posted together with information on timelines and modalities."
Reactions by trial sponsors and medical groups
A spokesperson for Medical University Vienna said:
"Through the close collaboration between the [national] regulator, ethics committee, the clinical trial unit, principal investigators and the university we have succeeded in significantly improving our performance."
A spokesperson for Medical University Graz said:
"The Medical University of Graz targets a 100% completion rate, and efforts will continue until this target is reached. When principal investigators wish to start a trial under the sponsorship of the Medical University of Graz, this new trial will only be approved after checking the EU Clinical Trials Register and ensuring that either no reporting is due or that there is a legitimate reason for any delay in reporting."
Barbara Nussbaumer-Streit, co-director of Cochrane Austria, said:
“The trend towards better reporting is welcome. However, we should not forget that two thirds of trial results are still missing. This can lead to delays in the development of new and effective therapies, and thereby harms patients.”
Gerald Gartlehner, co-director of Cochrane Austria, said:
"Missing clinical trial results can lead to patients receiving ineffective therapies because doctors lack important information."
Till Bruckner, founder of TranspariMED, said:
“The speed of progress at the medical universities of Vienna, Graz and Innsbruck is impressive. We hope that Austrian medicines regulator BASG will ensure that all other Austrian institutions follow their example as rapidly as possible, to ensure that no trial gets left behind.”
The current surge in trial reporting in Austria started in early 2020, when a report flagging hundreds of missing trial results was widely covered by national media. The current report tracks the progress of the same 14 trial sponsors over the past year. Both reports were published jointly by Cochrane Austria, Transparency International Austria, and TranspariMED.
The full report can be downloaded below. It contains the unabriged responses of multiple stakeholders, including trial sponsors not cited in this blog.
Universities and hospitals that wish to improve their clinical trial reporting can find useful tools on the TranspariMED website.
