06.06.2022

Academic-in-Confidence data redaction must stop

ICMJE publishes new recommendations

Medical journals have announced that they will publish data that were previously disclosed in regulatory or health technology assessment reports, removing a little-known but important barrier to greater transparency in medicine.

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 data as Commercial-in-Confidence or Academic-in-Confidence. 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 data already disclosed elsewhere, and academic researchers running trials rely on journal publication to further their careers. Hence, the Academic-in-Confidence redactions allowed by NICE were intended to safeguard interests of industry and sometimes academics representing Evidence Review Groups.

Now, the International Committee of Medical Journal Editors (ICMJE) has clarified that journals will publish data even if they were first disclosed in official assessment reports. In May 2022, the ICMJE added the following statement 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 ICMJE’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 analyses.

The ICMJE’s move comes in response to an open letter that was coordinated by the London-based non-profit organisation 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.

Leeza Osipenko, founder of Consilium Scientific, said:

“This very important decision by ICMJE is the key step towards improving transparency in clinical data, however actually stopping data redaction is yet to be achieved. Consilium Scientific, in collaboration with partners, will continue to work towards transparency until practices such as academic-in-confidence data redaction become obsolete.”