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Very few clinical trial results are reported

These are the findings of a new report on clinical trial transparency in Norway. The consequences? Patients are harmed. Public health agencies cannot make informed decisions. Public health funds are wasted. Medical progress is slowed down.

The report, published 1 June, was given by TranspariMED and Stiftelsen Dam. It is based on EU Trials Tracker data on the 13 Norwegian clinical trial sponsors that had launched at least five drug trials as of 28 February 2021. 

The report covers 204 registred clinical trials of investigative medicinal products. It finds that:

"Only 25 drug trials – an implausibly low number – are marked as having been completed more than a year ago, and thus should have results available. Results are only available on the registry for 6 of those verifiably due trials (24 %). Results are missing for the other 19 verifiably due trials (76 %).

Reporting rates in Norway are far lower than in other European countries, including Austria, Denmark, Germany, Ireland, and the UK. "

"The situation is unsustainable. The losers here are patients who receive poorer treatment than they could have, says program manager at the Dam Foundation, Jan-Ole Hesselberg in a press release.

Lack of knowledge and central coordination

Prior to publication of the report, national medicines regulator Legemiddelverket and the six largest trial sponsors in Norway were presented with a draft copy and asked to share their perspectives.

In general, they recognize the need for registration and explain the results with a lack of knowledge, of notification and central coordination, among other things.

Recommend santions

Several respondents indicate plans to improve the situation, such as Ahus:

"As a continuation, we 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. As partners in the Norwegian Clinical Infrastructure Network, we will continue to work on sharing best practice
nationwide for maintaining clinical trial transparency as a sponsor."

The report also includes recommendations for the different stakeholders, such as: 

"Norwegian trial sponsors should establish central oversight over their clinical trial registry data, adopt policies that reflect WHO best practices, audit existing registry records, and upload missing clinical trial results as rapidly as possible."

It also suggests the national medicines regulator Legemiddelverket should monitor compliance, and develop a mechanism for imposing sanctions after the EU Clinical Trials Regulation comes into force in late 2021. Here, the report refers to Denmark, where a fine or imprisonment of up to four months is the ultimate punishment if the results from clinical trials of medicines are not published. 

Read the report here: https://dam.no/content/uploads/2021/06/Clinical-Trial-Transparency-In-Norway-2021.pdf