Most major European research institutions now uploading missing clinical trial results
The vast majority of Europe’s 26 largest universities and hospitals are now actively working to make the results of their clinical trials of medicines public, a new report by Cochrane Austria, Health Action International and TranspariMED shows.
Only a few years ago, most major institutions were completely ignoring European Union transparency guidelines, leading to thousands of drug trial results being reported late or not at all. This left large gaps in the medical evidence base that put patients at risk, and raised concerns about weak research ethics and the waste of public money.
New data show that at least 21 of 26 major institutions are now tackling the problem by uploading missing results onto the European clinical trial registry as required. So far, they have uploaded results for 641 trials, an estimated 28% of all due results.
With 198 results uploaded, Europe’s largest non-commercial trial sponsor, the Medical University Vienna, leads in terms of absolute reporting performance, followed by KU Leuven (85 results) and the Charite (82 results).
In terms of relative performance, Medical University Vienna is also far ahead, with an estimated reporting rate of 96%. While Vienna and some other institutions started the process long ago and have already made significant progress, most are still at an early stage, with large backlogs of unreported trials left to clear.
Note: The methodology used here understates EORTC's reporting performance, which is probably around 90%.
Gerald Gartlehner, co-director of Cochrane Austria, said:
"Medical University of Vienna, one of Europe’s largest medical universities, has demonstrated that with will and effort, positive change towards transparency and excellence is readily achievable."
ITALY AND NETHERLANDS LAGGING BEHIND
Registry data suggest that only five institutions are not making any progress yet. These institutions are all located in Italy and the Netherlands:
Agostino Gemelli University Poly
AOU di Bologna, P.S. Orsola-Malpini
Instituto Nazionale dei Tumori
University of Groningen
Leiden University
UPDATE 07 October 2021: A representative of Bologna (new name: IRCCS Azienda Ospedaliero - Universitaria di Bologna) told the BMJ that the institution "would work to address the problem as soon as possible".
Also, BMJ reports that Istituto Nazionale dei Tumori's scientific director "is checking the state of play in all trials that it has sponsored from 2010, and a compliance procedure has been sent to all of the institute’s study teams."
TranspariMED strongly welcomes these positive initiatives from Bologna and Milan, and will track their progress over time.
A recent TranspariMED report found that 90% of Dutch trials and 83% of Italian trials approved up to 2015 were missing results from the European registry.
The Italian medicines agency AIFA has been widely criticised for not even contacting institutions that violate the rules. The responsible Dutch regulator, CCMO, has previously stated that it has actively reached out to institutions to remind them of their obligations, but that it still lacks the legal powers to force them to make trial results public.
REGULATORS SET TO TAKE ACTION EARLY NEXT YEAR
National medicines regulators across the European Union will acquire legal powers to sanction institutions that fail to make drug trial results public at the end of January 2022.
While there are efforts underway to improve trial reporting at the European level, decisions on when and how to fine institutions that continue to break the law will be taken at the national level.
In the United States, the Food and Drug Administration has recently started imposing fines of $10,000 for each day that trial results remain unreported.
Ellie White, Policy Advisor at Health Action International, said:
"While progress has clearly been made - and that should be applauded - research institutions and regulators shouldn't be patting themselves on the back yet. "
"As long as clinical trial transparency obligations are not fully met across Europe, trial sponsors are letting down patients and wasting taxpayer money by leaving gaps in the medical evidence base."
Till Bruckner, founder of TranspariMED, said:
"It is wonderful that so many prominent institutions across the whole of Europe are making rapid progress on filling their evidence gaps. However, thousands of trials run by smaller pharmaceutical companies and universities are still missing results."
"Next year, national regulators will gain the power to impose fines. Doctors and patients should demand that regulators make full use of those powers to ensure that no trial is left behind."
The full report by Cochrane Austria, Health Action International and TranspariMED can be downloaded here:
Note on methodology: The data on percentages of due trial results reported per institution provided in the charts above are based on estimates, and therefore deviate from data displayed by the EU Trials Tracker. Please see the methodology section of the full report for more details.