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Post# of 72440

(Total Views: 653)

Posted On: 05/28/2017 11:28:51 AM

Posted By: someconcerns

SLC parrying an insinuation by loanranger that the recruiting in the OM trial is taking too long:

Quote:
slcimmuno Member Level Sunday, 05/28/17 08:41:35 AM
Re: loanranger post# 183470
Post # of 183478

Lots of reasons why trials can take longer than anticipated -- ~80% of all trials fail to meet enrollment timelines.

https://www.clinipace.com/wp-content/uploads/...raphic.pdf

As for the CTIX OM trial, competing studies at sites was cited I recall, as well as wanting to further establish Brilacidin's topical application before going all-in:

"In recent months, the number of study sites in the OM trial has been increased and enrollment is accelerating. Cellceutix has moved through this trial methodically, waiting to increase trial sites to conserve capital until research provided additional support to the potential of the anti-inflammatory and immunomodulatory properties of the drug candidate. As we saw signs of patient benefits in our open label UP/UPS trial, we started increasing the number of sites in the OM trial to hasten progression. Now that supportive data have been collected, efforts to expedite enrollment even faster are being implemented. In 2015, Cellceutix’s Brilacidin was granted FDA Fast-Track designation for the OM indication. Should the study conclude with similar results to those of the preliminary interim, we intend to seek FDA Breakthrough Therapy designation. Cellceutix expects the OM trial to be completed in 2017."

http://www.cellceutix.com/press-release/2017/...el-disease

More reading / context

//

EXAMINATION OF CLINICAL TRIAL COSTS AND BARRIERS FOR DRUG DEVELOPMENT
07/25/2014
https://aspe.hhs.gov/report/examination-clini...evelopment

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https://antidote.me/blog/2012/03/05/clinical-...ticipants/

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https://www.forbes.com/sites/emilymullin/2015...drugs/amp/

Excluding trials that closed because of toxicity or interim results, the researchers found that 145 trials–or 18%–closed with low enrollment or were accruing at less than 50% of their target enrollment three years or more after the clinical trial began.

"Predicting Low Accrual in the National Cancer Institute’s Cooperative Group Clinical Trials"
https://academic.oup.com/jnci/article/108/2/d...nal-Cancer

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http://jme.bmj.com/content/medethics/early/20...0.full.pdf