What is the best way to improve clinical trial reporting? Set up a helpline, researchers say
A new study highlights the European Medicine Agency’s shortcomings in supporting compliance with its own transparency rules.
A survey of university and hospital staff shows that the lack of helpline support provided to users of the cumbersome European clinical trial registry is a leading cause for low reporting rates.
At present, over 5,500 clinical trials listed on the European registry are missing results in violation of European Union guidelines. Nearly 40% of due trials there are verifiably missing results. (The true proportion of missing results is far higher as many completed trials are falsely listed as ‘ongoing’.)
This means that a large amount of evidence on the effectiveness and safety of medicines remains invisible to patients, doctors and public health agencies, generating costly research waste and undermining public health.
Two researchers, Sandra Fedders and Charlotte Kjær, recently surveyed 39 university and hospital staff in Denmark to understand the reasons behind low trial reporting rates.
They found that the top barrier to uploading results onto EudraCT, the European clinical trial registry, is that the process is too complicated and time consuming. Out of 17 respondents who had started uploading results, 3 never managed to complete the process because of the platform's lack of user-friendliness.
Researchers were also asked to identify ways in which trial reporting rates could be increased.
Two thirds of respondents said that a helpline would help to boost reporting rates.
Email reminders that results are due, the creation of central units at institutions to support trial reporting, and providing guidance on how to report results were also widely cited as effective ways to increase reporting rates.
The findings of the survey are in line with what experienced trial registry managers have been telling TranspariMED for a long time.
A report by Health Action International and TranspariMED published earlier this year warned that the EudraCT registry is – in the words of one user – “a nightmare” to navigate.
The report recommended that the European Medicines Agency, which manages the registry, should make EudraCT more user-friendly, send out email reminders when trial results become due, and set up a functioning helpdesk. (Registry users consistently describe the existing European helpdesk as being completely dysfunctional, in stark contrast to its excellent American counterpart.)
To its credit, the European Medicines Agency has been listening.
Following the release of the report, the Agency made minor changes to the platform, and added more guidance for registry users. Last month, an Agency representative attended a clinical trial reporting workshop organised by the BIH QUEST Center in Berlin to gain a better understanding of the challenges medical universities face.
However, the European Medicines Agency remains resistant to investing the limited resources required to significantly improve trial reporting rates.
The Agency still does not send out email reminders when trial results become due, despite the World Health Organisation explicitly encouraging it to do so.
IMPORTANT UPDATE
Shortly after publication of this blog, a senior EMA official emailed TranspariMED with the following message:
"The EMA has been contacting sponsors on a regular basis since the beginning of the year. We contacted commercial and non-commercial sponsors that had trials set as 'completed' in EudraCT and with results that were overdue (if not provided within 6 months from the end of trial date for paediatric trials and within one year for adults trials). We could notice improvements in reporting results especially for non-commercial Sponsors."
TranspariMED will provide more details about the scope and impact of these email notifications as soon as EMA has made them publicly available.
Meanwhile, EMA's existing helpdesk remains as dysfunctional as ever.
Founder of TranspariMED Till Bruckner said:
“With every passing month, more data on drug safety and effectiveness is being irretrievably lost, resulting in evidence gaps that undermine public health. The investment required to stem this ongoing haemorrhage of medical research waste is marginal compared to the financial – and human – cost of continuing to do nothing. The European Medicines Agency urgently needs to up its game, and start actively promoting and supporting compliance with its own rules.”
This Thursday in Brussels, Health Action International and TranspariMED will bring together parliamentarians, the medical research community and the European Medicines Agency for a public debate on how to increase transparency and curb research waste in clinical trials. Click below to sign up and join us at the European Parliament.
Note: The Danish study was performed in collaboration with the GCP unit at Aalborg and Aarhus University Hospitals. Click here to read the full study. TranspariMED would like to thank its authors, Sandra Fedders and Charlotte Kjær, for their permission to make it publicly available.
Universities and hospitals that want to improve their clinical trial reporting can find a collection of transparency tools, tips and tricks on the TranspariMED website.