A new study has found that 62 clinical trials involving over 13,000 patients run by Polish academic medical centres have never made their results public.
CORRECTION 30 January 2020:
The original version of this blog incorrectly stated that the universities had acted as the sponsors of the trials. In fact, the universities had acted as research sites for the trials, which were sponsored by external parties. In some cases, several universities had equally participated as research sites for the same trial; this was not accurately reflected in a ranking of universities by number of unreported trials included in the original blog, which has now been removed. Please see the corrected spreadsheet of trials for a detailed breakdown of trials by university. TranspariMED apologises for these mistakes, which have now been corrected in the blog below.
In total, just over 20% of all trials in which these Polish institutions participated have become research waste.
Failure to publish clinical trial results is unethical, scientifically unsound, and harms patients and public health. It also wastes money, often from public sources, because unreported trials make no contribution to the development of new treatments.
The study – the first of its kind in Poland – looked at trials run by nine medical universities, three universities with a medical college, and one center of postgraduate medical education. All of these 13 Polish institutions were affiliated with at least one teaching hospital.
The 13 Polish academic medical centres vary strongly in their performance, as the chart below shows.
The results of all trials in which the University of Warmia and Mazury in Olsztyn and the Centre of Postgraduate Medical Education participated reported results. At the botttom of the list, 28% of the trials conducted at the Medical University of Silesia were left unreported.
In total, the institutions had participated in 305 trials listed on Clinicaltrials.gov that were completed between 2009 and 2013. Between them, the trials aimed to enrol 119,490 participants. The data include trials conducted at those institutions, rather than trials directly sponsored by those institutions.
The study team checked for each trial whether its results were available on the trial registry or had published its outcomes in an academic journal. Trials listed on other registries such as EudraCT were not included in the study.
Polish universities can download this spreadsheet of unreported trials compiled by the study's lead author, Karolina Strzebonska, to identify which of the trials they ran are missing results, and follow up to ensure that their results are made public.
TranspariMED’s collection of Transparency Tools provides useful guidance to universities in Poland and beyond that wish to improve their clinical trial reporting.
The study team also looked at the speed of results sharing. Less than half of trial results were available within two years of study completion.
If the trials' sponsors had adhered to WHO best practices, which require all clinical trial results to be uploaded onto a trial registry within 12 months of trial completion, they would have significantly accelerated medical progress as well as avoiding research waste. To this day, over half of the trials examined are missing results on the trial registry, Clinicaltrials.gov.
The researchers noted that while the performance of Polish academic medical centres is disappointing, they nonetheless outperform their peers in Germany and the United States.
In response to the study, Cochrane Poland called on universities to make the results of all their trials public:
"Timely dissemination of studies’ results is a crucial ethical requirement, and not meeting it may negatively influence on decisions in healthcare and is unfair to their participants and the wider community."
"[W]e urge Polish academic medical centres to set a good example in making the results of 100% of their studies publicly available in a timely manner."
[Full Cochrane statement below.]
Rachel Cooper, director of the Transparency International Health Initiative, said:
“This data shows a massive, unnecessary waste of scientific and trial participant time, resource and effort. There is no reason why Polish universities should not make the rapid progress that other countries have demonstrated is possible in this area. They need to commit to do so.”
Till Bruckner, founder of TranspariMED, said:
"Many Polish academic medical centres have violated the trust of patients who volunteered to participate in their clinical trials. This is completely unethical. These institutions should act immediately to ensure that the results of all trials they participated in are reported before they are lost forever. Going forward, Polish universities should adopt policies aligned with WHO best practices, and ensure that trial sponsors they work with adhere to WHO standards, to ensure that this does not happen again."
According to the Standing Committee of European Doctors (CPME), which represents national medical associations across Europe:
"Transparency of clinical trial data and results is essential to the good conduct of medical research, to the development of new medicines and medical treatments, to expand scientific knowledge on those medicines and treatments and for patient safety. CPME insists that all results of clinical trials, whether they are positive, negative or inconclusive, should be made publicly available."
Full text of Cochrane Poland's statement
An article recently published by BMJ Open showed that unacceptably high rate of interventional clinical trials registered by Polish academic medical centres in Clinicaltrials.gov do not have their results disseminated in a timely manner (WHO defined timeframes: within 12 months from study completion to posting in the results section of the registry and within 24 months to publication in a peer reviewed journal).
Though about 80% of trial results were finally disseminated, as the authors highlight, some of them were difficult to find or not clearly linked with the identifier number. Only 1% of the trials met both timeframes, 43% of them met either of the timeframes.
Timely dissemination of studies’ results is a crucial ethical requirement, and not meeting it may negatively influence on decisions in healthcare and is unfair to their participants and the wider community.
For the work of Cochrane timely access to the complete evidence is essential. Cochrane's systematic reviews aim to gather and assess all evidence answering a specific research question. This aim can only be achieved with timely dissemination of clinical trials results.
We would like to highlight that failure to disseminate results of studies contributes to the risk of publication bias that may lead to incomplete/biased conclusions of systematic reviews.
Therefore we urge Polish academic medical centres to set a good example in making the results of 100% of their studies publicly available in a timely manner.
Malgorzata Bala, MD, PhD