Major French, Spanish and Dutch institutions lag behind in clinical trial transparency

Major medical research institutions in France, Spain and the Netherlands are lagging behind their peers in making clinical trial results public, a new study shows.


ONLY 4% OF TRIAL RESULTS PUBLIC IN FRANCE


The five largest non-commercial clinical trial sponsors in France had made less than 4% of due trial results public as required by long-standing rules adopted to protect patients and public health. Their peers in Spain (10%) and the Netherlands (20%) also routinely failed to follow the rules.


In contrast, the largest five sponsors in the UK had made nearly 94% of due trial results public. Top sponsors in Belgium (67%) and Germany (58%) also performed comparatively well. The numbers in the study are based on EU Trials Tracker data from early May 2021.


On average, 55% of due trials run by 50 major sponsors and nine large collaborative groups had results available.


In terms of data inconsistencies in the European trial registry EudraCT, Italy (49%) and Spain (29%) performed exceptionally weakly. The UK (3.3%) and Austria (8.8%) performed best on this metric.


TRIAL REPORTING SURGED IN EUROPE 2018-2021


Looking at 49 major non-commercial sponsors first assessed in January 2018, the study found an increase of from 147 to 1,332 results for due trials on the registry by May 2021, highlighting the considerable progress many institutions have made, notably in the UK.


“Additional resources from non-commercial sponsors, and increased attention from national regulators, could make a huge difference in the completeness of the evidence-base” on medicines in Europe, the authors note.


They suggest that:


Research ethics committees could request investigators to report whether trial results have been posted on the EudraCT when examining ongoing studies or considering approvals for new studies. Reminders, such as personalized emails, have been shown to improve reporting rates on ClinicalTrials.gov."


"Regulations in individual countries could also be issued to penalize sponsors who fail to report the results on EudraCT, as Denmark announced in 2019… The timely reporting of trial results benefits patients, investigators, clinicians, and policymakers across the world.”


All data and code for the study are available on GitHub.


WEAK REGULATORS AND STRONG SPONSORS


European Union rules require the results of all drug trials to be made public on the EudraCT trial registry within one year of trial completion, but enforcement rests with national medicines regulators, many of which have been slow to take action.


A TranspariMED report published in October 2021 found that the vast majority of large universities and hospitals are now working to upload missing results, but that most still have a long way to go until they achieve full compliance.


Even in countries where sponsors perform weakly overall, there are already some very strong performers, such as Centre Léon Bérard in France (nominal reporting rate 100%), University of Navarra in Spain (70%), and Radboudumc in the Netherlands (58%).


The long-standing failure of national medicines regulators to effectively enforce European transparency rules fuels costly research waste, harms patients, slows down medical progress, and undermines public health.



Note: TranspariMED’s report and the study discussed above collected data at different points in time, and used different methodologies to determine institutional performance, so their figures are not directly comparable. However, both support the same overall conclusion: UK sponsors perform exceptionally well, while many sponsors in France, Spain and the Netherlands significantly lag behind.


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