JohnnySeville
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Due to some of the questions posted concerning the number of participants in the Phase III trial being lower than the norm of 1000-3000 as required by the FDA, I decided to give them a call and follow up.
First guy I spoke to must have been a former CIA agent. Every question I asked was responded with " its proprietary information". So I decided to call back and hopefully get someone a little more accomodating. Next guys I spoke to explained to me that since the drug being tested had already been approved safe for another indication, and the method of delivery was the same, then it is possible they would allow GSK to use a lesser number of men in the test, but could not elaborate on this since he did not have access to the file.
Since the listing on clinicaltrials.gov was put up by the NIH, I called them next. I asked if perhaps there had been a error in the number of men in the trial, maybe instead of 150 there were actually 1500. The woman told me it was possible but GSK usually was good about relaying the information. She told me she would email the person from GSK that issued the info to verify what she termed "target accrual", asked for my email address so that the drug company could email me directly. About 30 min later I get an email from this guy at GSK asking for a clarification of my concern. I emailed him back and waited. This was Monday. I emailed him again yesterday, but still no response.
You can make of it what you wish, it just seems highly suspicious that no one is getting back to me anymore. Was this a questionable move by the drug company or what?
First guy I spoke to must have been a former CIA agent. Every question I asked was responded with " its proprietary information". So I decided to call back and hopefully get someone a little more accomodating. Next guys I spoke to explained to me that since the drug being tested had already been approved safe for another indication, and the method of delivery was the same, then it is possible they would allow GSK to use a lesser number of men in the test, but could not elaborate on this since he did not have access to the file.
Since the listing on clinicaltrials.gov was put up by the NIH, I called them next. I asked if perhaps there had been a error in the number of men in the trial, maybe instead of 150 there were actually 1500. The woman told me it was possible but GSK usually was good about relaying the information. She told me she would email the person from GSK that issued the info to verify what she termed "target accrual", asked for my email address so that the drug company could email me directly. About 30 min later I get an email from this guy at GSK asking for a clarification of my concern. I emailed him back and waited. This was Monday. I emailed him again yesterday, but still no response.
You can make of it what you wish, it just seems highly suspicious that no one is getting back to me anymore. Was this a questionable move by the drug company or what?
