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Re: intexp post# 19096

Thursday, 03/03/2016 10:17:22 AM

Thursday, March 03, 2016 10:17:22 AM

Post# of 36919
As usual Rob is not telling the truth. He said:

That is correct. Per FDA regulation only updates that can posted are new trial locations prior to trial completion.



Here is an example of changes made in another study. This is typical of most studies:
Start with this study:
Addition of Carboplatin to Neoadjuvant Therapy for Triple-negative and HER2-positive Early Breast Cancer (GeparSixto)
ClinicalTrials.gov Identifier:
NCT01426880
Here's the link:
https://clinicaltrials.gov/ct2/show?cond=%22Breast+Neoplasms%22&rank=9

Notice that the study has been completed. Click on "History of changes" That will bring you to this screen:
https://clinicaltrials.gov/ct2/archive/NCT01426880

When you get to that screen click on "ClinicalTrials.gov Archive Site"

That will bring you to this screen:
https://clinicaltrials.gov/archive/NCT01426880
This screen is the actual history of changes. Notice the label recruitment status in the "type of info changed" column
go to the line 2013_05_22 and click on ChangesThis will bring you to this screen:
https://clinicaltrials.gov/archive/NCT01426880/2013_05_22/changes

On this screen you will see a side by side of changes made from one version to the next. Under the before column you will see the word "recruiting" with a line through it. In the after column you will see the words Active, not recruiting. This means they have finished recruiting and started the study.

On that same screen hit the right pointing blue arrow in the right hand corner which will take you to the next change in the study:
https://clinicaltrials.gov/archive/NCT01426880/2013_11_18/changes
On this screen you will see a side by side of changes made from one version to the next. Under the before column you will see the word "Active, not recruiting" with a line through it. In the after column you will see the words "Completed".

So in other words You can document whether the ongoing study is in the recruiting phase or the active phase. Apparently the El Camino study is only in the recruiting phase and they are not active yet after 7 months! I know that some will say that since they plan on doing studies at the James that they are still recruiting but this study does not list the James Cancer Center anywhere in the protocols. That would be a seperate study all together or at least an expansion of this study which would require a change. So in other words either the El Camino study has not even started or Cyrcadia Health has not documented the change from "Recruiting" to "Active"

Go through any random study in the clinical.gov archives and you will see the history of changes that I have outlined. I suspect that Rob Royea is not being perfectly honest with us as usual. I believe that the El Camino study that was supposed to have completed it's data in DEC 2015 hasn't even started yet.

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