What's next for clinical trials reporting? A roadmap for reform
With the conclusion of 72nd World Health Assembly (WHA), governments reiterated their support for transparency in medicines research and development.
Indirectly, at centre stage of the assembly, was clinical trials where governments debated the “transparency clause”. This would mean that companies would have to disclose the actual costs of researching and manufacturing of medicines. Clinical trials are at the heart of that process. Whilst knowing the costs or research is a great next step forward in clinical trials reporting, it is not far enough.
To ensure stronger clinical trials reporting, here are three further needed reforms:
1. Strengthening of accountability mechanisms and active enforcement of current legislation.
Currently, all trails are required to report their findings within a year of their completion, as required by the Food and Drugs Administration Amendment Act (FDAAA) in America and in Europe. Failure to do so would result in a fine. Yet according to the FDAAA trial tracker (at the time of writing) only 67% of completed trails have been reported.
The estimated fines that the US government should impose amounts to $3,960,496,753. And yes, you read that correctly.
Europe has an even lower rate of 57.2% of reported trials. Universities are often the worst offenders with certain institutions such as The Medical University of Vienna with a reporting rate of just 7.4%.
Even leading universities in America struggle to report their trails, for a variety of unknown reasons. A researcher at the university of Harvard’s affiliated Baim institute said: “We have been on the forefront of academic publications over the past two decades, and strive for the transparency of publishing all clinical trial results”. Whilst Harvard University was a key driver behind the 2007 FDAAA legislation, it has not enforced its promise with its affiliated institutions. The Brigham and Women’s Hospital has only reported on 5 of its 9 trials. [Note: figures updated from original blog to reflect more recent tracker data, 18 August 2019].
If the legislation is to be taken seriously then accountability measures need to be enforced.
2. Sponsors and trialists must take responsibility to maintain their registry entries of trials and keep them up to date.
Trials are completed, but the results aren’t published, registers don’t show the progress of the trial or records simply aren’t completed. The implications of this are colossal, from replicated experiments to slowing down patients’ access to information for them to find treatments.
Researchers have a scientific commitment to share their results in a timely manner, and this principle forms the basis of the World Health Organisations (WHO) statement on Public disclosure of Clinical Trials Results. Also, neglected records make it harder for potential trial participants to find active recruiting trails, and vice versa, for trialists to find participants. This slows the whole research process and stifles medical innovation.
3. Adopt and enshrine the CONSORT standards.
Often when clinical trials are published they have inconsistent data or are badly reported, reducing the readability and benefit or the trial. A solution would be to adopt the Consolidated Standards of Reporting Trials, the results of the trials, both positive and negative, are accessible and importantly understandable.
Sloppy writing and reporting mean that research is duplicated, which wastes resources and hides the validity of trial findings. CONSORT provides methodological guidance on the majority of methods used in clinical trials.
Strong rigour and methodology should be something that comes naturally in R&D, however, it would appear that this is not the case.
The 72nd WHA made a brave step to introducing transparency into medical drug research and pricing. However, it should have gone further, calling for: increased strengthening of accountability mechanisms and the enforcement of the current legislation, maintaining trial registers by sponsors and clinical trialists and finally, adoption of the CONSORT standards for clinical trial publishing.
“Chalking it up to a win” doesn’t cut it in an age and industry that relies on facts and accuracy.
Josselin Canevet works with the Transparency International Health Initiative. He can be contacted via Twitter. This blog was originally published on the TI Health website and is reproduced here with minor edits, with permission of the author and TI.