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The reporting of one man in Europe is changing accountability with compliance.
A new and highly effective form of reporting pressure has been brought to bear on clinical trial sponsors in Europe over the last five years—much of it attributable to just one man: Till Bruckner, the founder of TranspariMED. Almost single-handedly, Bruckner, a self-confessed “transparency and accountability nerd,” has campaigned to tighten up compliance with trial reporting requirements by drug firms and research institutions.
Laxity and non-compliance in this area has been an issue for years in Europe, resulting in 2019 in a European Medicines Agency reminder to all sponsors of their obligations to report on all trials, and more recently in the stringent rules on reporting introduced by the new EU clinical trial regulation that came finally into effect in January. Bruckner, based in Bristol, UK, says his motivation springs from his conviction that the “ongoing public health crisis” of failure to register and fully report clinical trials results in harm to patients, waste of taxpayers' money, and unjustified obstacles to the development of new treatments, vaccines and cures.
In a crowded international field of healthcare campaigning, the demonstrable impact of his own engagement has been largely due to his innovative use of social media, publicly and very visibly naming and shaming failings by individual sponsors, commercial and non-commercial, and by the national authorities responsible for enforcement. Successive studies—often in cooperation with larger and more established organizations he has induced to add their weight—have provided the evidence for Bruckner’s exposés: Transparency International, major consumer defense bodies and health-related civil society bodies like Cochrane, Health Action International and Universities Allied for Essential Medicines are among the allies he has recruited.
He also pays tribute to the EU Trials Tracker and the FDAA Trials Tracker—two online tools kept updated by Nicholas DeVito at Oxford University that he says make possible TranspariMED’s ratings of academic institutions in Europe and the United States. Without these trackers, he says, it would be impossibly time-consuming for a small campaign to compile ratings manually, or to compare national regulators' performance across Europe.
His work has, he says, convinced 23 of the 26 top medical research institutions in Europe to make trial results public. And most major non-commercial sponsors in Europe and the United States have become aware of their legal obligation to report their trial results, with some choosing to “get ahead of the curve and routinely report the results of all their clinical trials on registries. ”He is pleased to see the tighter reporting rules that the clinical trials regulation will impose on sponsors in Europe, claiming some small part in the lobbying that contributed to this outcome. His inquiries into national regulators’ performance in enforcing compliance are also starting to generate some valuable responses, he says. His work has also highlighted the risks of fragmented research efforts, and he is gratified to see the UK now asking research funders and sponsors to wind down clinical trials that have little chance of being completed, so as to free up resources for more promising research projects.
Bruckner explains his involvement in clinical trial reporting—an unusual focus for a PhD in politics and international relations with a professional background as an aid worker in Afghanistan and the Caucasus—as the consequence of an opportunity to pursue research in something of a neglected field. A chance engagement with AllTrials as a researcher on clinical trial transparency sparked his interest, and he set up TranspariMED in 2017 to fill what he saw as a gap in studies in the sector. He suggests that his rather different background has led him to employ unconventional approaches both to prosecuting his work and to drawing attention to the results.
One of his most recent tweets announced, “Great news from the last @FDAAAtracker update on clinical trial reporting in the US: Nearly all top pharma companies and universities now have a reporting rate of >90%.” He adds: “Sad exceptions,” naming four institutions: MGH Medicine, Icahn Mount Sinai, Brigham Womens, and the University of Virginia. In another recent tweet—one of his favored communication techniques for its efficiency and access—he congratulates Charite Berlin, Germany's largest medical university, because it has “hit a clinical trial reporting rate of 92%.” Equally impressive, he notes, are the Medical University of Vienna and KU Leuven, and he highlights others who are “now catching up.” But his interventions have also repeatedly excoriated backsliders and urged them by name to improve their performance.
Bruckner’s identified ‘”targets” are policy makers, regulators, research funders and research institutions, using his chosen tools of reports, blogs, submissions of evidence, FOI requests, media coverage, and direct lobbying. And he has won a profile both within the clinical research community and across European media.
But he remains modest, both about his resources and his current ambitions. His output is produced without external funding, and he receives only a monthly partnership stipend from a UK-based nonprofit, augmented by his own consultancy earnings (“no pharma or medical device clients”), he insists.
For the present, he still sees plenty to do in his chosen field and admits to no wider intentions in relation to broader health-campaigning agendas such as the issues around the actual conduct of trials, or questions over medicine pricing. Declining to offer any broader views on EU or US health policy, he says, with the characteristic restraint of a researcher, “I like to go in deep rather than spread myself thinly.”