Six health groups including TranspariMED today call on medical journals to help patients, doctors and scientists to rapidly access data from recently completed clinical trials.
In a joint open letter, they ask the International Committee of Medical Journal Editors (ICMJE) to issue a statement clarifying that any trial data contained in official documents can later also be published in scientific journals.
Data from recently completed clinical trials is often rapidly assessed by governmental bodies, while publication of the same data in medical journals can take several years. Government bodies often redact such data in public assessment reports, leading to long delays in data availability.
This seemingly obscure issue has recently been identified as a barrier to clinical trial transparency.
As the letter explains:
“A research article published in BMJ Open in 2021 showed that over 80% of appraisals by NICE contain redacted data, including data on clinical trial outcomes that are of importance to patients, clinicians and researchers. Health Technology Assessment (HTA) agencies in other countries also routinely redact data.”
“A significant portion of these data are redacted as being “academic in confidence” (as opposed to “commercially confidential information”) based on widespread concern among researchers that disclosure of data in a public HTA report could prevent them from later publishing the outcomes of the trial in a peer-reviewed journal.”
“We are currently advocating with HTAs to discontinue their “academic in confidence” redactions so that patients, clinicians, and researchers can access all relevant elements of HTA reports.”
The letter asks the Committee to issue the following statement:
"The ICMJE will not consider results data contained in assessment reports published by HTAs, medicines regulators, medical device regulators, or other regulatory agencies to be prior publication.”
One Committee member, the BMJ, already takes this approach, but many government agencies and medical researchers are not aware of this.
The Committee has traditionally been very supportive of trial transparency, benefiting patients worldwide. In 2005, it issued a statement that led to a dramatic increase in clinical trial registrations.
Today’s open letter was coordinated by Consilium Scientific and is supported by five other groups:
Health Action International
International Society of Drug Bulletins
Transparency International Global Health
The full letter can be downloaded below: