Norway: Medicines regulator drags feet while top sponsors embrace transparency
Norway’s top medical research institutions have promised to upload missing clinical trial results onto the European trial registry even as the country’s medicines regulator continues to drag its feet.
LARGE GAPS IN TRIAL REPORTING
The pledges were obtained by Dam Foundation in the run-up of today’s release of a report showing that the 13 largest trial sponsors in Norway have failed to make public the results of an estimated 96 trials on the EudraCT trial registry, in violation of European Union transparency rules. Only 6 of their trials currently have results available.
Oslo University Hospital, by far the largest sponsor in Norway, alone accounts for an estimated 44 missing results. None of the major Norwegian sponsors are currently fully compliant with European transparency rules.
NORWEGIAN MEDICINES AGENCY DISAPPOINTS
The Norwegian Medicines Agency continues to refuse to take action:
“Due to the implementation of the clinical trial regulation in January 2022, we find it justifiable not to introduce a new system for a follow up of the sponsor’s responsibility, but rather wait for the opportunities in the new EU-portal and database.”
Jan-Ole Hesselberg, program manager at the Dam Foundation, said:
"The situation is unsustainable. The losers are the patients who receive worse treatment than they could have received."
While Norway is not a member of the European Union, it has joined the regulatory umbrella of the European Medicines Agency and is therefore bound to adhere to its transparency rules.
Last month Cochrane, Transparency International and 16 other health and patient groups called on national medicines regulators across Europe to proactively contact trial sponsors that have left trial results unreported and remind them of their obligations.
SPONSORS PROMISE TO TAKE ACTION
Oslo University Hospital has announced that it will get its trials fully reported by taking the following steps:
“The routines and procedures will be revised and the requirements for summary reports will be further specified and highlighted, as well as the departments responsibility to follow-up.
Researchers and heads of departments will be informed and motivated for fulfilment of all the requirements through courses and annual reviews, and there will be special calls for submitting the reports that currently are missing.
OUH will strive for better use of existing or new systems and software to support reporting and reuse of data across different platforms.
OUH will try to secure funding for better local support and guidance from the regional CTU.”
Other major sponsors have also pledged to fix the problem:
Akershus University Hospital announced that it “will include the details about registering and reporting clinical trials in the EU Clinical Trial Register in our procedures at the hospital level. We will also build competence to guide research teams on how to correctly report clinical trials.”
University of Norway will review and update the procedures in its quality system for medical and health research.
Haukeland University Hospital will contact researchers who led currently unreported studies and “inform them about the importance of reporting.”
In a joint statement, St. Olavs University Hospital and the Norwegian University of Science and Technology (NTNU) made no commitment to fix the problem.
RESEARCH COUNCIL OF NORWAY PLANS TO MONITOR TRIAL REPORTING
The Research Council of Norway announced that in future it will compile and publish monitoring reports that track whether its grantees are following transparency rules.
The Council also noted that it already “endorses [the] WHO Joint Statement on public disclosure of results from clinical trials and has implemented requirements and guidelines according to this statement for projects resulting from calls in 2020 and forward”.
By signing up to the WHO Joint Statement, the Council committed to ensuring that the results of all clinical trials (not just drug trials) that it funds are made public on trial registries within 12 months of trial completion.
Ida Svege, head of program development at Stiftelsen Dam said:
"This can give researchers, clinicians and patients access to fresh information about which treatment works and does not work, reduce the amount of wasted research, and provide increased recruitment for ongoing clinical studies. We hope that the situation will improve quickly."
WHO IS PUTTING PATIENTS FIRST?
Till Bruckner, founder of TranspariMED, said:
"Making the results of clinical trials public on registries can substantially accelerate medical progress. Norwegian taxpayers and patients will benefit from today's commitment by leading institutions to follow global best practices in the reporting of drug trials. Hopefully, these efforts will soon be extended to all trials, including trials of medical devices, which are less tightly regulated but equally important to patients."
“Against this positive backdrop, it is deeply disappointing that the Norwegian Medicines Agency refuses to even contact institutions that are breaking transparency rules. The incoming European regulation will not magically solve the problem of older unreported trials. If Legemiddelverket continues to drag its feet, valuable medical insights will be lost forever.”
Major institutions in Sweden and Finland are currently also working to improve their trial reporting. Cochrane Sweden will run a free webinar on clinical trial reporting on 16 June; Norwegian institutions are welcome to sign up.
Dam Foundation and TranspariMED will produce a follow-up report later this year to track Norwegian trial sponsors’ progress in uploading missing results onto the EudraCT registry.
The report with the full statements of Norwegian stakeholders can be downloaded below: