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The hopes for increased transparency in clinical research beginning to take shape as sponsors get up to speed with new reporting obligations.
The European clinical trial regulation is inching into place as sponsors become more familiar with its requirements—and meet the two-month-old obligation to register all new drug trials in the regulation's Clinical Trials Information (CTIS) system. Initially, the website gives access to information on a limited number of trials, but the volume of trial-related information is increasing as sponsors and regulators use CTIS to initiate and oversee trials. The explicit aims of the regulation include easing liaison with national regulators while a trial is ongoing, and recording clinical trial results, with new reporting obligations on sponsors.
There are now more than 320 trials recorded in the system, and this is starting to make a reality of that noble aspiration of creating greater transparency over clinical research. But this is very much work in progress—and not just at EU level. A German survey released yesterday reveals striking gaps in transparency of national academic trials, adding to other recent findings of uneven levels of compliance with sponsors' and authorities' duties—prompting criticisms that research is going to waste.
German universities often do not make their clinical trial results public in any form, suggests a team at the BIH-QUEST Center for Responsible Research at the Charité medical university in Berlin. A dashboard it has developed displays the performance of university medical centers in Germany on established registration and reporting practices for clinical trial transparency. It shows that 35 German universities are neglecting reporting on interventional clinical trials they have conducted.
Across Europe, clinical trials fall into three distinct regulatory categories: investigative drug trials, medical device trials, and all other trials—on surgery or radiation therapy, for instance, or other treatment modalities. Drug trials are now subject to legal requirement to make results public—a duty reinforced by the clinical trials regulation, and with which compliance rates are high. For device trials, legal requirements are in principle in force, even if the database envisioned—EUDAMED—is not yet operational. But for other clinical trials, there is at present no legal obligation at EU level to make results public—although the World Health Organization recommends that all trial results should be published on registries within a year of completion, and the UK recently introduced a national monitoring and reporting system covering all trials.
The German dashboard focuses on the non-drug “other” trials that make up around half of all studies run in Germany, or around 1,000 trials per year, and for which German law imposes no monitoring by any agency. No results have ever been made public for many of these clinical trials, either through publication in journals or summary results posted on registries, and when results have been provided, they often appear up with long delays—as much as two years after trial completion.
A Hannover Medical School trial launched in 2002 recruited patients who had received a lung transplant to explore whether a structured exercise program would help to improve their quality of life. The registry record was last updated in 2008 and the study was scheduled to be completed by September 2009, but no further updates to the registry record were made, and the results were never made public. The school has recently acknowledged that there is a problem. It blames staffing problems dating back to the early 2000s, and says it is "creating solutions" with a new in-house center for clinical studies and a central study registry.
Deutsche Forschungsgemeinschaft (DFG), a major funder of German research, is now conducting an audit of the clinical trials it has supported in the past, after admitting at the end of 2022 that it could not answer questions about trials completed between 2009 and 2017. It is "currently preparing an evaluation of its clinical trials program," it said, adding that "the outcomes of trials supported by DFG is of high interest including for DFG itself."
Health campaigners and academics have repeatedly pointed out that failure to report results amounts to costly waste of research and resources that leaves gaps in the medical evidence base, serving neither science nor patients—as well as being ethically questionable.In response, public funders worldwide are stepping up their efforts to curb research waste.Recent funder initiatives include auditing trial portfolios, strengthening policies, publishing monitoring reports, and actively chasing up missing trial results with grantee institutions. And—often under pressure—national authorities in some European countries have also been more diligent in chasing non-reporting of drug trials, particularly in the non-commercial sector, where the record has been very uneven.
At the start of 2023, a German conference focused on the national solution to the challenge that the UK has established, and explored how far the experience could improve the situation at home. Since 2018, the UK Health Research Authority registers new clinical trials on the global ISRCTN registry, and one year after trial completion checks on whether theresults were made public. It also archives centrally all ethics approval documentation. A parallel move in Germany would depend, it was suggested, on building a national alliance of all stakeholders and generating sufficient political will. But one participant at the conference went further, urging EU-level action to tighten up on reporting of all trials right across Europe.