Thursday, January 14, 2021 11:54:28 AM
3. Company looking for acceptance and as high as possible priority of a publication in a prestigious medical journal, which take a long time taking into account revisions, corrections, experts peer reviews, etc. that can only start after staticians work is finished. In order to be successful, the most important goal for a pharmaceutical company finishing a Phase III trial is to spread the message to the medical community and in a professional way and not to just give information to investors and general public. All recognized journals have restrictions about the use of media and press releases. If the company just publishes TLD as soon as possible without any strategy, publication may be not approved or not prioritized by a prestigious journal.
I also strongly believe that trial outcome is positive, because otherwise the company would not be so interested in getting the journal publication and they would be at risk of having legal consequences for not reporting earlier if results were bad.
Below are some extracts of the document Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (updated December 2019) published by the International Committee of Medical Journal Editors (ICMJE) that support what I'm mentioning. Take a look at the whole document if you like, to these extracts, or to what is in bold, specially red bold.
Link to the document mentioned: http://www.icmje.org/icmje-recommendations.pdf
Also take a look at the amount and prestigious names (NEJM and the Lancet among much others) of journals that follow ICMJE. They provide a list. Link to ICMJE webpage: http://www.icmje.org/
I also think that juornal publication is the reason for not having new end point information updated with the FDA (clinicaltrials,gov information is updated by the company) and having it updated in the UK and Germany (information is not updated by the company, but by the regulatory entities). Look at the extracts of the document where it mentions government agencies.
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