Reporting rates for clinical trials are showing promising improvements, driven by increased regulatory scrutiny and growing awareness of the importance of transparency in research. However, significant gaps persist, particularly in publicly funded trials across various countries.
Increased Reporting Rates in the EU and US
After nearly a decade of effort, recent data indicates a positive trend in clinical trial reporting. The EU Trials Tracker reports that 83.4% of trials due to report have published their results. Similarly, in the United States, FDA data shows that 77.4% of trials registered on clinicaltrials.gov have published their results.
Nick DeVito, a data researcher at the University of Oxford, notes substantial improvements in Europe since 2018, attributing this to the UK's progress and advocacy efforts, especially in Germany. "This could be due to a couple of reasons, mainly the UK getting its act together and advocacy work on the continent, especially in Germany. It comes down to institutions educating their principal investigators."
Compliance Disparities Across Countries
Despite overall improvements, compliance rates vary significantly between countries. A 2022 report highlighted that Italy, the Netherlands, Spain, and France accounted for two-thirds of the nearly 5,500 clinical trials without reported results. As of August, approximately 3,500 trials registered on the EUCTR are still missing results.
Italy, in particular, has the lowest reporting rate, with 76% of its completed trials on EUCTR awaiting publication in 2022. In contrast, Germany has shown marked improvement, increasing its reporting rate from 44% in 2020 to 66% as of July 2022.
Till Bruckner, founder of TranspariMED, credits media attention and pressure on national regulators for Germany's progress. "Medical researchers were saying we should act ethically; we owe it to patients to have all our results made public."
Challenges and Future Directions
While reporting rates are improving, challenges remain in ensuring complete and accurate reporting. Kelly Cobey, a public-health scientist at the University of Ottawa, notes that Canada's efforts are hindered by a lack of researcher education, reliance on manual input, and limited resources.
Susanne Teupen of Germany’s Federal Joint Committee advocates for making more information mandatory to improve transparency on funding, failed drugs, and non-pharmaceutical interventions. "Patients are getting wiser, and many will only participate in trials that will publicize all results. There is a moral reason that should motivate all scientists: not knowing is always bad."
Experts also emphasize the need to move beyond binary reporting metrics and focus on the quality and completeness of reported information. As DeVito notes, "While we are getting results out there, how useful these results are is another matter."
Institutional Efforts and Enforcement
Several UK universities, including the University of Oxford and Imperial College London, report 100% of their trial results. The University of Edinburgh has achieved a 97.7% reporting rate by actively tracking down unreported trials and training principal investigators on the importance of publication.
While the FDA has the authority to impose fines for late publication, it remains unclear whether any fines have been issued. Bruckner suggests that enforcement may be challenging due to vague laws and lengthy legal processes.
