Student groups across Europe are preparing to challenge their universities on clinical trial transparency by assessing their performance and calling on them to ensure that all their trials conform to World Health Organization guidelines.
The groups are part of Universities Allied for Essential Medicines (UAEM), a global network of university students that advocate for the maximal public health impact of health products, by promoting access to essential medicines. UAEM is running a global transparency campaign throughout 2018, covering transparency of drug pricing in addition to clinical trial transparency.
Over the coming weeks and months, UAEM chapters within individual European universities will search trial registries and document instances in which their own university has failed to post the summary results of clinical trials onto registries.
UAEM student groups will use this evidence to call on their universities to:
Upload missing old trial results
Ensure that future trials are registered and their outcomes are posted on trial registries within the 12 month timeline set out by the World Health Organisation, and
Sign up to the WHO Joint Statement on trial disclosure
TranspariMED supported UAEM’s campaign by delivering two workshops and a hands-on training session in Maastricht during their April 2018 European Conference.
Around 100 students from around Europe participated in transparency workshops; a further 20 got hands-on coaching in searching the European and American clinical trial registries.
Comment by a German student looking at his university’s gap-filled registry records for the first time: “Das ist echt traurig” – “This is really sad”
TranspariMED will continue to provide direct assistance to individual UAEM university chapters over the coming months as they dig through trial registries.
In addition, TranspariMED will provide technical support to UAEM-UK’s efforts to conduct a broader assessment of clinical trial policies and performance across top British universities and integrate this data into its flagship Global Health Ranking publication. This work is already in progress; we welcome feedback from universities on the proposed assessment criteria.
At present, around half of all clinical trials never publish their results, generating an estimated $85 billion in research waste, leading to severe distortions in the evidence base underlying modern medicine, and slowing down the discovery of new treatments and cures. Research consistently shows that universities perform worse than industry at publishing trial results.
According the Declaration of Helsinki, which sets the ethical rules for medical research worldwide, failure to register clinical trials and/or report trial results is unethical.
USEFUL RESOURCES FOR UAEM STUDENT GROUPS
Power Point presentation on clinical trial transparency
Outlines the problem, and explains what UAEM chapters can do to solve it.
Rapid External Audit of Aberdeen University Trials
This is a practical example of what an assessment of one university’s trial registry entries could look like. (Note that the methodology could be further simplified.) The good news: In response to this study, the university has improved its policies and started uploading missing clinical trial results, making it a front-runner among European universities.
Clinical Trial Transparency: A Guide for Policy Makers
Study that summarizes the literature, explains laws and regulations, and flags relevant global standards and best practices.
Universities and Clinical Trials: Common Myths Debunked
Many universities do not understand the laws, regulations and best practices surrounding clinical trials. This one-pager looks at some common misunderstandings.
Faced with public pressure, research institutions step up reporting of clinical trial results
Excellent article by STAT News explaining how many US universities successfully improved their clinical trial reporting performance. Type the name of your own university into the search window to see whether any of its trials currently violate US transparency laws. (You should consider sharing this article with the research governance team at your university.)
A Push By Funders for Transparency in Medical Research
You've been warned: Universities that fail to post the summary results of trials onto registries may soon no longer be able to get research funding from key funders.