No need to redact clinical trial data, medical journals tell regulators
Medical journals have announced that they will publish clinical trial data that were previously disclosed in regulatory or health technology assessment reports, removing a little-known but important barrier to greater transparency in medicine.
For example, the UK’s National Institute for Health and Care Excellence (NICE), which decides whether treatments should be offered by the National Health Service, frequently redacts the results of unpublished clinical trials in its reports.
This prevents patients and doctors from seeing the full evidence on the benefits and harms of treatments. A 2021 study concluded that NICE redactions were “alarming in volume and context,” but the UK government has so far declined to discuss the issue.
Medical journals traditionally refuse to publish trial data already disclosed elsewhere, and academic researchers running trials rely on journal publication to further their careers. Hence, the so-called ‘academic in confidence’ redactions made by NICE were intended to safeguard researchers’ interests.
New medical journal policy
Now, the International Committee of Medical Journal Editors (ICMJE) has clarified that journals will publish trial data even if they were first disclosed in official assessment reports.
In May 2022, the ICMJE added the following sentence to its policies:
“The ICMJE does not consider results or data contained in assessment reports published by health technology assessment agencies, medical regulators, medical device regulators, or other regulatory agencies to be duplicate publication.”
The ICJME’s statement removes the rationale behind all ‘academic in confidence’ redactions worldwide, and thereby opens the door to the more rapid public disclosure of trial results as well as economic evaluation and indirect comparison data.
The ICJME’s move comes in response to an open letter that was coordinated by the London-based non-profit Consilium Scientific. Five other groups co-signed the letter: Cochrane, Health Action International, the International Society of Drug Bulletins, Transparency International Global Health, and TranspariMED.
Till Bruckner, founder of TranspariMED, said:
“We are grateful to ICMJE for removing this barrier to clinical trial transparency."
"Hopefully, NICE and other health technology assessment agencies and medicines regulators worldwide will take note and immediately stop redacting clinical trial data in their public reports.”