NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

DOES THE NEJM ONLINE VERSION CYCLE WEEKLY ON WEDNESDAYS, OR ANOTHER DAY?





Tuesday, 01/12/21 12:49:07 PM
Re: None 0
Post #
346837
of 346883
I want to share what I found in the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals document (updated December 2019) published by the International Committee of Medical Journal Editors (ICMJE).

I strongly believe that the reason for the delay in the press release with TLD is clear and is related to the journal publication approval restrictions and prioritization. I think that it also is the reason for not having clinicaltrials,gov updated with the new end points, where information is updated by the company, and having it updated in UK and Germany, where it is not updated by the company, but by the regulatory entities. 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 have legal consequences for not reporting earlier.


Link to ICMJE webpage: http://www.icmje.org/

Link to the document: http://www.icmje.org/icmje-recommendations.pdf


Below are some extracts of this document, where I highlighted the statements that support what I'm mentioning:


Quote:
2. Duplicate and Prior Publication

Duplicate publication is publication of a paper that overlaps substantially with one already published, without clear, visible reference to the previous publication. Prior publication may include release of information in the public domain.

Readers of medical journals deserve to be able to trust that what they are reading is original unless there is a clear statement that the author and editor are intentionally republishing an article (which might be considered for historic or landmark papers, for example). The bases of this position are international copyright laws, ethical conduct, and cost-effective use of resources. Duplicate publication of original research is particularly problematic because it can result in inadvertent double-counting of data or inappropriate weighting of the results of a single study, which distorts the available evidence.

When authors submit a manuscript reporting work that has already been reported in large part in a published article or is contained in or closely related to another paper that has been submitted or accepted for publication elsewhere, the letter of submission should clearly say so and the authors should provide copies of the related material to help the editor decide how to handle the submission. See also Section IV.B.

This recommendation does not prevent a journal from considering a complete report that follows publication of a preliminary report, such as a letter to the editor, a preprint, or an abstract or poster displayed at a scientific meeting. It also does not prevent journals from considering a paper that has been presented at a scientific meeting but was not published in full, or that is being considered for publication in proceedings or similar format. Press reports of scheduled meetings are not usually regarded as breaches of this rule, but they may be if additional data tables or figures enrich such reports. Authors should also consider how dissemination of their findings outside of scientific presentations at meetings may diminish the priority journal editors assign to their work.

Authors who choose to post their work on a preprint server should choose one that clearly identifies preprints as not peer-reviewed work and includes disclosures of authors’ relationships and activities. It is the author’s responsibility to inform a journal if the work has been previously posted on a preprint server. In addition, it is the author’s (and not the journal editors’) responsibility to ensure that preprints are amended to point readers to subsequent versions, including the final published article.

In the event of a public health emergency (as defined by public health officials), information with immediate implications for public health should be disseminated without concern that this will preclude subsequent consideration for publication in a journal. We encourage editors to give priority to authors who have made crucial data publicly available (e.g., in a gene bank) without delay.

Sharing with public media, government agencies, or manufacturers the scientific information described in a paper or a letter to the editor that has been accepted but not yet published violates the policies of many journals. Such reporting may be warranted when the paper or letter describes major therapeutic advances; reportable diseases; or public health hazards, such as serious adverse effects of drugs, vaccines, other biological products, medical devices. This reporting, whether in print or online, should not jeopardize publication, but should be discussed with and agreed upon by the editor in advance when possible.

The ICMJE will not consider as prior publication the posting of trial results in any registry that meets the criteria noted in Section III.L. if results are limited to a brief (500 word) structured abstract or tables (to include participants enrolled, key outcomes, and adverse events). The ICMJE encourages authors to include a statement with the registration that indicates that the results have not yet been published in a peer-reviewed journal, and to update the results registry with the full journal citation when the results are published.

Editors of different journals may together decide to simultaneously or jointly publish an article if they believe that doing so would be in the best interest of public health. However, the National Library of Medicine (NLM) indexes all such simultaneously published joint publications separately, so editors should include a statement making the simultaneous publication clear to readers.

Authors who attempt duplicate publication without such notification should expect at least prompt rejection of the submitted manuscript. If the editor was not aware of the violations and the article has already been published, then the article might warrant retraction with or without the author’s explanation or approval.

See COPE flowcharts for further guidance on handling duplicate publication.


Quote:
K. Journals and the Media

Journals’ interactions with media should balance competing priorities. The general public has a legitimate interest in all journal content and is entitled to important information within a reasonable amount of time, and editors have a responsibility to facilitate that. However media reports of scientific research before it has been peer-reviewed and fully vetted may lead to dissemination of inaccurate or premature conclusions, and doctors in practice need to have research reports available in full detail before they can advise patients about the reports’ conclusions.

An embargo system has been established in some countries and by some journals to assist this balance, and to prevent publication of stories in the general media before publication of the original research in the journal. For the media, the embargo creates a “level playing field,” which most reporters and writers appreciate since it minimizes the pressure on them to publish stories before competitors when they have not had time to prepare carefully. Consistency in the timing of public release of biomedical information is also important in minimizing economic chaos, since some articles contain information that has potential to influence financial markets. The ICMJE acknowledges criticisms of embargo systems as being selfserving of journals’ interests and an impediment to rapid dissemination of scientific information, but believe the benefits of the systems outweigh their harms.

The following principles apply equally to print and electronic publishing and may be useful to editors as they seek to establish policies on interactions with the media:

• Editors can foster the orderly transmission of medical information from researchers, through peer-reviewed journals, to the public. This can be accomplished by an agreement with authors that they will not publicize their work while their manuscript is under consideration or awaiting publication and an agreement with the media that they will not release stories before publication of the original research in the journal, in return for which the journal will cooperate with them in preparing accurate stories by issuing, for example, a press release.

• Editors need to keep in mind that an embargo system works on the honor system—no formal enforcement or policing mechanism exists. The decision of a significant number of media outlets or biomedical journals not to respect the embargo system would lead to its rapid dissolution.

• Notwithstanding authors’ belief in their work, very little medical research has such clear and urgently important clinical implications for the public’s health that the news must be released before full publication in a journal. When such exceptional circumstances occur, the appropriate authorities responsible for public health should decide whether to disseminate information to physicians and the media in advance and should be responsible for this decision. If the author and the appropriate authorities wish to have a manuscript considered by a particular journal, the editor should be consulted before any public release. If editors acknowledge the need for immediate release, they should waive their policies limiting prepublication publicity.

• Policies designed to limit prepublication publicity should not apply to accounts in the media of presentations at scientific meetings or to the abstracts from these meetings (see Duplicate Publication). Researchers who present their work at a scientific meeting should feel free to discuss their presentations with reporters but should be discouraged from offering more detail about their study than was presented in the talk, or should consider how giving such detail might diminish the priority journal editors assign to their work (see Duplicate Publication).

• When an article is close to being published, editors or journal staff should help the media prepare accurate reports by providing news releases, answering questions, supplying advance copies of the article, or referring reporters to appropriate experts. This assistance should be contingent on the media’s cooperation in timing the release of a story to coincide with publication of the article.




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