How many Swiss clinical trials have become research waste?
Major Swiss universities and hospitals may have failed to make public the results of around a quarter of their clinical trials, a new report by TranspariMED and Universities Allied for Essential Medicines Switzerland shows. On the positive side, several leading institutions in the country have already launched significant efforts to fix the problem.
The report includes a breakdown of trial reporting by five institutions, and a detailed analysis of the Swiss legal and regulatory framework for registering and reporting clinical trials.
TranspariMED contacted all five institutions covered by the report. At least four major Swiss institutions are already actively working to curb research waste.
Lausanne University Hospital
“Our academic hospital is currently working on the improvement of clinical research transparency, setting-up a sponsor’s office to centralise and overview ongoing clinical research. We are progressively implementing the Inquire quality frame through the training and advising role of our CTU to investigators. The Basel-led Inquire initiative provides a quality frame attempting to reduce waste in parallel of improving quality in clinical research, efficiency. Inquire is actively promoted through the Swiss Clinical Trial Organization (SCTO) of which our institution is an active member and our CTU an affiliate.”
University of Zurich (UZH)
“The University of Zurich is committed to ensuring that all its study results are internationally accessible and easy to find. In its training and continuing education programs for doctors, the Faculty of Medicine highlights the importance of consistent international reporting, as well as giving workshops and advice on the topic. It is also on the agenda at the recently established UZH Center for Reproducible Science…
The University of Zurich wants further measures to be instigated at federal level. One possibility would be a rule whereby the final reports of all authorized clinical trials at Swiss universities would only be accepted provided that the results are published on the international platforms.”
University of Basel and University Hospital Basel (USB)
“In 2018, the USB introduced a registration requirement for clinical research projects. This requires all prospective clinical research projects (interventional and observational) at the USB to be recorded in a public register. Since then, the hospital has been funding two specialists who support researchers in planning, registering and publishing their studies. In this way, it was possible to double the number of registrations at USB and to get a reliable view of the initial situation… In a next step, it is planned to track the publication and to support researchers in publishing the results.”
Bern (Insel Gruppe)
“Transparency in research including publication of results is of great importance to Insel Gruppe. We are currently obtaining an overview of the situation and will take measures to support re-searchers in increasing transparency, ideally in consultation with other university hospitals and universities. Insel Gruppe supports and welcomes the planned changes in the Human Research Act regarding registration and publication of results.”
Geneva University Hospitals (HUG) did not provide a statement.
Globally, an estimated $85 billion in medical research funding is wasted every year because the results of studies are not made public. In the past, hidden clinical trial results have left doctors unaware of dangerous side effects of some medicines they were prescribing, leading to countless patient deaths.
Studies consistently show that academic and non-profit trial sponsors tend to perform significantly worse at trial reporting than pharma companies do. However, many of the top institutions in Europe and the United States are now tackling the problem, partly because research funders are increasingly demanding rapid results publication and monitoring grantee compliance.
Thus, both the suboptimal past performance of Swiss institutions and their current efforts to curb research waste are in line with broader global trends.
Till Bruckner, founder of TranspariMED, said:
“It is extremely encouraging that leading Swiss institutions are putting into place mechanisms to improve clinical trial registration and reporting. Their commitment to curb research waste will benefit taxpayers, patients and scientists in Switzerland and beyond.
Looking forward, all Swiss patients who volunteer to participate in clinical trials should be able to have complete confidence that their efforts will make a contribution to medical progress, irrespective of which institution is sponsoring their trial. In order to achieve that goal, the Swiss federal government should follow the example of other jurisdictions, legally mandate the registration and reporting of all clinical trials, and actively monitor and enforce compliance.”
Tristan Kaufmann, Vice-president of Universities Allied for Essential Medicines Switzerland, said:
“The harmful effects of publication bias have been known for a long time. Meta-analyses combining the outcomes of multiple clinical trials are essential to evidence-based medicine because they show whether treatments and procedures are effective, useless or even harmful. Heads of hospitals services, public health workers and doctors use meta-analyses for decision-making, so they have a huge impact on patients from all over the world.
But how can we trust those meta-analyses if a substantial share of trial results cannot be included in them? Swiss universities have a duty to ensure that all the results of their medical research are made public.”
Swiss trial sponsors - including smaller sponsors not named in the report - are encouraged to contact TranspariMED for a copy of the dataset, which can help them to identify completely unreported trials.
TranspariMED’s collection of transparency tools contains useful resources for institutions that wish to improve their clinical trial registration and reporting.
The full report by TranspariMED and UAEM Switzerland can be accessed here:
Note on report methodology and limitations:
WARNING: Swiss institutions named in the report may have retrospectively made some of their missing trial results public since the data was originally collected in early 2019. Therefore, institutional performance data presented in the report may not accurately reflect their current performance. Due to this and other limitations, TranspariMED has deliberately chosen not to share this report with Swiss media.
The report’s scope and methodology differs from TranspariMED’s standard approach:
The dataset underlying the report covers all interventional clinical trials completed during 2007-2016 that are listed on three internationally recognised trial registries: EudraCT, ClinicalTrials.gov, and the German DRKS. (Other TranspariMED reports usually only include trials that are listed on a single registry and that are subject to disclosure laws.)
Trials were counted as ‘reported’ if they had made their results public either on a trial registry or in an academic journal. (Other TranspariMED reports usually mirror regulatory requirements by focusing exclusively on results uploaded to trial registries.)
The dataset underlying the report is based on registry and literature searches conducted by Swiss journalists in January 2019. Their searches may have missed or misidentified some publications, and any more recent publications will not have been captured. TranspariMED did not independently double-check the data. Two institutions have challenged the accuracy of the data: one cited a higher figure, another cited a lower figure; neither provided a list of trials. Please see the full report for further details.
Despite these limitations, the headline finding – that around a quarter of all trials listed on registries sponsored by the five Swiss institutions have never made their results public in any form – is credible and in line with the findings of a similar study of German university trials.