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Saturday, May 16, 2015 10:07:28 AM
The ASCO late-breaking data policy allows for the submission of late-breaking data only for randomized phase II and III trials for which no preliminary data are available at the time of the abstract submission deadline (February 3, 2015), but for which a preplanned analysis of the primary endpoint is scheduled after that date but before April 1, 2015 (the deadline for the final, updated late-breaking data). During abstract submission, you will be required to provide the primary clinical endpoint for analysis, type of analysis, date of planned analysis, and planned statistical methods for analysis. The policy is not a mechanism to allow for updated data to be submitted later when preliminary data are available by the abstract submission deadline.
Was the OS analysis pre-planned? More:
For a study to be eligible for acceptance into an ASCO Meeting, information contained in the abstract, as well as additional data and information to be presented about the study at the ASCO Meeting, must not be disclosed before the findings have been publicly released in conjunction with the ASCO Meeting. If information from the abstract or additional study data are disclosed in advance of public release in conjunction with an ASCO Meeting, the abstract will be subject to rejection or removal unless an official Confidentiality Policy Exception applies (see below).
Furthermore, the contents and conclusions of the abstract must not be presented at any scientific, medical or educational meeting of 500 registrants or more or be published in a scientific, medical or educational publication (in any medium), in whole or in part, before the ASCO Meeting. ASCO co-sponsored meetings represent an exception to this restriction on prior presentation and publication. Studies submitted to the Gastrointestinal Cancers Symposium, Genitourinary Cancers Symposium, Breast Cancer Symposium, Quality Care Symposium, or Palliative Care in Oncology Symposium, and other ASCO co-sponsored meetings where ASCO is the lead sponsor are eligible for acceptance even if previously presented or published in the scientific, medical or educational arena. Abstracts presented at these particular ASCO meetings may also be submitted for presentation at any other ASCO meeting. Authors are strongly encouraged to provide updated data in the abstract, as the novelty of the data will be taken into account during the abstract selection process.No new or updated data may be added to an abstract after it has been formally submitted unless it was formally submitted as a placeholder for a Late Breaking Data Submission abstract.
So, it is clear that the old data is not at all sufficient to qualify for a poster, much less an oral presentation. But the OS data could have been from a Feb analysis. It seems likely they would have that for their meeting with the FDA.. It could still go either way, IMO.
On a slightly different topic, I wonder who will present the SWOG data - and when. ASCO 2016?
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