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Re: flipper44 post# 4311

Tuesday, 02/11/2014 8:41:29 AM

Tuesday, February 11, 2014 8:41:29 AM

Post# of 700544
Here is why I said, but for Linda Power's "glimpse" that they are "encouraged" by what they see in the phase I Direct trial, the ASCO submission would otherwise have little significance for me.


About ASCO

"What is the abstract selection process for submitted Trials in Progress abstracts?

Abstracts will be reviewed by the ASCO Scientific Program Committee. Abstracts will be evaluated on

Strength of the science underlying the trial
Novelty of the study design and/or correlatives
Potential for collaboration
Overall interest to the ASCO community

What is acceptable in a Trials in Progress abstract and poster?

Scientific background/rationale for the trial. Preclinical and/or earlier-phase clinical data that has already been publically presented or published may be included with references. The Trials in Progress session should not be used to present preclinical or earlier-phase clinical data for the first time.
Trial design and statistical methods, highlighting any novel aspects of the design
Treatment or intervention planned
Major eligibility criteria, highlighting unusual aspects
Correlative studies of particular interest
Current enrollment without providing results or endpoints
Enrollment must have already begun or have been completed with no data analysis available by the February 4th deadline.
Phase I studies may say, "Cohorts 1 and 2 have been completed without DLT. Enrollment to cohort 3 began in January 2014."
Phase II studies may report, "8 of planned 32 patients have been enrolled" or "Prespecified activity goal for the first stage of accrual was met; second stage accrual began in January 2014."
Phase III trials may report, "The DMC last reviewed the trial in December 2013 and suggested that the trial continue as planned."
Clinical trial registry number (required)

What is not acceptable in a Trials in Progress abstract?

Any preliminary data including toxicity, response rate, pharmacokinetic, or correlative analyses. NOTE: Abstracts including results or preliminary data will be rejected without further review.

Proprietary drug names"

--- http://am.asco.org/submission-guidelines-5
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