How Cochrane Germany is advocating for clinical trial transparency through collaboration
Authors: Mariam Salman1, Valérie Labonté2, Lea Gorenflo2
1. Cochrane
2. Cochrane Germany and the Institute of Evidence in Medicine, Medical Center - University of Freiburg, Germany
Introduction
Clinical trials provide the basis for patient-oriented, effective, and efficient medicine that is based on scientific research. However, many clinical trial results are never published, leaving gaps in our knowledge and blurring our understanding of what is or isn’t true.
Why we should care about unpublished clinical trials
Evidence-based health care requires knowledge of and access to scientific research. This is only possible if the results of all clinical studies are published promptly, comprehensively, and are made available to everyone.
Clinical trials that are never published can lead to ill-informed health care decisions and policies, which can ultimately have negative effects on the health and well-being patients. The trust of people who have participated in unpublished clinical trials is also undermined. Many people who participate in clinical trials do so with the expectation that the risk associated with the interventions being studied are for the betterment of human health, and they are let down when their efforts are in vain.
Where are we at right now?
A study has found that a third of clinical trials conducted at university hospitals in Germany between 2014 and 2017 have never been published. Researchers state that this is because scientific journals lack interest in results that are seen as “negative” and so they are not incentivized to take further action.
However, there are other avenues for publication. For example, a summary can be submitted to the study register; this is already a legally mandatory requirement for drug and medical devices studies; therefore, this process is already familiar to many researchers. Not only is it essential to know about "negative" results, but it is also valuable to know more about trials that were not completed so that we can plan better studies in the future.
This situation is not unique to Germany – across the globe, we have instances of clinical trial studies remaining unpublished due to negative test results. Cochrane Denmark, Cochrane Norway, and Cochrane Sweden, along with the AllTrials campaign, the Dam Foundation, Melanomföreningen, and TranspariMED, jointly published a report which found that 475 clinical trials involving 83,903 patients completed during 2016-19 in the associated countries never made their results public in any form. There has since been widespread media coverage of the matter, leading to demands to action the findings of this report.
Although we have made progress, such as with the WHA75.8 resolution which aims to strengthen clinical trials, there is still much to be done in Germany and across the globe.
Coming together to improve clinical trial transparency
Earlier this year, we published a position paper that looked at clinical trial transparency in Germany. This paper focused on the ways in which unpublished trial results can harm ongoing and future research and why it is paramount that we change the way things are done.
Through our many years of working in advocacy around clinical trial transparency, we know that change is rarely won by working in silos. Cochrane Germany had been working with different partners across the country and collectively decided that to be as impactful as possible, they needed to share their collective expertise, knowledge, and connections. By working in tandem with the German Network for Evidence-Based Medicine, HTA.de and the BIH Quest Center, the Alliance for Transparency in Health Research was formed.
Working in collaboration, the Alliance urged the Federal Ministry of Health and the Federal Ministry of Education and Research to establish an appropriate framework for complete clinical trial registration and publication of results in Germany, and propose a legal regulation. It was recommended that all prospective interventional clinical studies be registered in a WHO-accredited study registry and that the results be published within 12 months of the end of the study. This would align with Articles 35 and 36 of the Declaration of Helsinki and the WHO recommendations.
However, influencing and informing government policy often encounters obstacles; it requires navigating through a labyrinth of bureaucracy and building relationships with various parliamentarians and minsters.
To ensure that the findings of this publication reached the relevant decision-makers, the Alliance decided to collaborate on a position paper that addressed a more generalized audience, with the hope that it would gain enough traction and make its way to those in the relevant positions of power.
We used a two-pronged approach where we (1) focused on getting media attention and generating public interest in the topic of clinical trial transparency and, (2) pushed the subject matter directly with parliamentarians by presenting a comment on the legislation process for them to consider.
Overall, we managed to secure excellent media coverage and public interest in the topic, with many national newspaper picking up the story, including Der Tagesspiegel, which is a publication this is read by parliamentarians in Germany.
Key messages and lessons learned
Change takes time as well as the collective knowledge, action, and effort of multiple partners. Policy and legislation can’t be re-written overnight but that doesn’t mean that we should be discouraged and stop trying.
There is strength in numbers. By facilitating dialogue and intersectoral collaboration, Cochrane Germany’s work with the Alliance for Transparency in Health Research has re-started the conversation on clinical trial transparency and moved a step in the right direction toward evidence-based decision-making in health care and policy.
References
Riedel, N., Wieschowski, S., Bruckner, T., Holst, M. R., Kahrass, H., Nury, E., Meerpohl, J. J., Salholz-Hillel, M., & Strech, D. (2022). Results dissemination from completed clinical trials conducted at German university medical centers remained delayed and incomplete. The 2014 -2017 cohort. Journal of clinical epidemiology, 144, 1–7. https://doi.org/10.1016/j.jclinepi.2021.12.012
Hamilton, D. G., Everitt, S., Page, M. J., Vazire, S., & Fidler, F. (2024). Attitudes of people living with cancer towards trial non-publication and research participation. BMJ evidence-based medicine, 29(1), 64–66. https://doi.org/10.1136/bmjebm-2023-112456
Scherer, R. W., Ugarte-Gil, C., Schmucker, C., & Meerpohl, J. J. (2015). Authors report lack of time as main reason for unpublished research presented at biomedical conferences: a systematic review. Journal of clinical epidemiology, 68(7), 803–810. https://doi.org/10.1016/j.jclinepi.2015.01.027
Cochrane Germany, The German Network for Evidence-Based Medicine, HTA.de and the BIH Quest Center. (2024). Unpublished study results endanger evidence-based health care. https://www.cochrane.de/positionspapier-buendnis-transparenz
Cochrane Denmark, Cochrane Norway, and Cochrane Sweden, AllTrials, the Dam Foundation, Melanomföreningen, TranspariMED. (2024). Unreported clinical trials in Denmark, Iceland, Finland, Norway and Sweden. https://www.transparimed.org/single-post/nordic-trials
To link to this article - DOI: https://doi.org/10.70253/XKNA5134
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