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Quote from Guest on February 21, 2023, 6:53 amQuote from Guest on February 21, 2023, 2:18 amQuote from Guest on February 20, 2023, 5:55 pmIt has been brought up numerous times by all levels that we need to slow enrollment for many studies because we're not able to do quality work. There have been enrollment mistakes, documentation mistakes, icf mistakes, lab mistakes, and thats not only on pfizer. The concerns are swept aside by the owners because to them it didn't matter as long as we were meeting numbers, we could just clean up the mistakes later. Now that this has happened they are taking our concerns more seriously but it's too little too late. The CEO is trying to blame pfizer saying they have no basis to do this and presenting theories as to why this happened instead of taking ownership.
I hope this serves as a wake up call to take your employees concerns more seriously in the future. It's not only about meeting numbers it's about quality and safety of everyone involved.
Who says Pfizer isn’t the one to blame? They’ve not only bailed but abandoned participants. They could have made an effort to keep them enrolled. Unless the issue was something along the lines of poor blinding etc. why give up 3500 participants - just transfer them to another CRO or private clinics etc.
There is likely plenty of blame to go around here. CA is willing to submit data to the FDA and IRB. Pfizer should come forth with their reasoning as well.
Both sides are to blame…but make no mistake, CA submitting data to the FDA is most likely due to an audit, so they aren’t doing it out of their own goodwill.
CA had an obligation to think of every operational aspect of the study. Some of the things they are accused are doing are due to inexperience and poor planning. there’s no excuse to mishandle patient samples and source data. Pfizer should have also monitored the situation earlier on. This isn’t their first foray into DCT and im not surprised they didnt manage this vendor well.
Quote from Guest on February 21, 2023, 2:18 amQuote from Guest on February 20, 2023, 5:55 pmIt has been brought up numerous times by all levels that we need to slow enrollment for many studies because we're not able to do quality work. There have been enrollment mistakes, documentation mistakes, icf mistakes, lab mistakes, and thats not only on pfizer. The concerns are swept aside by the owners because to them it didn't matter as long as we were meeting numbers, we could just clean up the mistakes later. Now that this has happened they are taking our concerns more seriously but it's too little too late. The CEO is trying to blame pfizer saying they have no basis to do this and presenting theories as to why this happened instead of taking ownership.
I hope this serves as a wake up call to take your employees concerns more seriously in the future. It's not only about meeting numbers it's about quality and safety of everyone involved.
Who says Pfizer isn’t the one to blame? They’ve not only bailed but abandoned participants. They could have made an effort to keep them enrolled. Unless the issue was something along the lines of poor blinding etc. why give up 3500 participants - just transfer them to another CRO or private clinics etc.
There is likely plenty of blame to go around here. CA is willing to submit data to the FDA and IRB. Pfizer should come forth with their reasoning as well.
Both sides are to blame…but make no mistake, CA submitting data to the FDA is most likely due to an audit, so they aren’t doing it out of their own goodwill.
CA had an obligation to think of every operational aspect of the study. Some of the things they are accused are doing are due to inexperience and poor planning. there’s no excuse to mishandle patient samples and source data. Pfizer should have also monitored the situation earlier on. This isn’t their first foray into DCT and im not surprised they didnt manage this vendor well.
Quote from Guest on February 21, 2023, 3:52 pmQuote from Guest on February 21, 2023, 6:53 amQuote from Guest on February 21, 2023, 2:18 amQuote from Guest on February 20, 2023, 5:55 pmIt has been brought up numerous times by all levels that we need to slow enrollment for many studies because we're not able to do quality work. There have been enrollment mistakes, documentation mistakes, icf mistakes, lab mistakes, and thats not only on pfizer. The concerns are swept aside by the owners because to them it didn't matter as long as we were meeting numbers, we could just clean up the mistakes later. Now that this has happened they are taking our concerns more seriously but it's too little too late. The CEO is trying to blame pfizer saying they have no basis to do this and presenting theories as to why this happened instead of taking ownership.
I hope this serves as a wake up call to take your employees concerns more seriously in the future. It's not only about meeting numbers it's about quality and safety of everyone involved.
Who says Pfizer isn’t the one to blame? They’ve not only bailed but abandoned participants. They could have made an effort to keep them enrolled. Unless the issue was something along the lines of poor blinding etc. why give up 3500 participants - just transfer them to another CRO or private clinics etc.
There is likely plenty of blame to go around here. CA is willing to submit data to the FDA and IRB. Pfizer should come forth with their reasoning as well.
Both sides are to blame…but make no mistake, CA submitting data to the FDA is most likely due to an audit, so they aren’t doing it out of their own goodwill.
CA had an obligation to think of every operational aspect of the study. Some of the things they are accused are doing are due to inexperience and poor planning. there’s no excuse to mishandle patient samples and source data. Pfizer should have also monitored the situation earlier on. This isn’t their first foray into DCT and im not surprised they didnt manage this vendor well.
It’s not just submitting it for the purpose of an audit. That may very well be the case, but they’ve clearly stated they disagree with Pfizer’s assessment.
Quote from Guest on February 21, 2023, 6:53 amQuote from Guest on February 21, 2023, 2:18 amQuote from Guest on February 20, 2023, 5:55 pmIt has been brought up numerous times by all levels that we need to slow enrollment for many studies because we're not able to do quality work. There have been enrollment mistakes, documentation mistakes, icf mistakes, lab mistakes, and thats not only on pfizer. The concerns are swept aside by the owners because to them it didn't matter as long as we were meeting numbers, we could just clean up the mistakes later. Now that this has happened they are taking our concerns more seriously but it's too little too late. The CEO is trying to blame pfizer saying they have no basis to do this and presenting theories as to why this happened instead of taking ownership.
I hope this serves as a wake up call to take your employees concerns more seriously in the future. It's not only about meeting numbers it's about quality and safety of everyone involved.
Who says Pfizer isn’t the one to blame? They’ve not only bailed but abandoned participants. They could have made an effort to keep them enrolled. Unless the issue was something along the lines of poor blinding etc. why give up 3500 participants - just transfer them to another CRO or private clinics etc.
There is likely plenty of blame to go around here. CA is willing to submit data to the FDA and IRB. Pfizer should come forth with their reasoning as well.
Both sides are to blame…but make no mistake, CA submitting data to the FDA is most likely due to an audit, so they aren’t doing it out of their own goodwill.
CA had an obligation to think of every operational aspect of the study. Some of the things they are accused are doing are due to inexperience and poor planning. there’s no excuse to mishandle patient samples and source data. Pfizer should have also monitored the situation earlier on. This isn’t their first foray into DCT and im not surprised they didnt manage this vendor well.
It’s not just submitting it for the purpose of an audit. That may very well be the case, but they’ve clearly stated they disagree with Pfizer’s assessment.
Quote from brad on February 21, 2023, 3:55 pmQuote from Guest on February 21, 2023, 3:52 pmQuote from Guest on February 21, 2023, 6:53 amQuote from Guest on February 21, 2023, 2:18 amQuote from Guest on February 20, 2023, 5:55 pmIt has been brought up numerous times by all levels that we need to slow enrollment for many studies because we're not able to do quality work. There have been enrollment mistakes, documentation mistakes, icf mistakes, lab mistakes, and thats not only on pfizer. The concerns are swept aside by the owners because to them it didn't matter as long as we were meeting numbers, we could just clean up the mistakes later. Now that this has happened they are taking our concerns more seriously but it's too little too late. The CEO is trying to blame pfizer saying they have no basis to do this and presenting theories as to why this happened instead of taking ownership.
I hope this serves as a wake up call to take your employees concerns more seriously in the future. It's not only about meeting numbers it's about quality and safety of everyone involved.
Who says Pfizer isn’t the one to blame? They’ve not only bailed but abandoned participants. They could have made an effort to keep them enrolled. Unless the issue was something along the lines of poor blinding etc. why give up 3500 participants - just transfer them to another CRO or private clinics etc.
There is likely plenty of blame to go around here. CA is willing to submit data to the FDA and IRB. Pfizer should come forth with their reasoning as well.
Both sides are to blame…but make no mistake, CA submitting data to the FDA is most likely due to an audit, so they aren’t doing it out of their own goodwill.
CA had an obligation to think of every operational aspect of the study. Some of the things they are accused are doing are due to inexperience and poor planning. there’s no excuse to mishandle patient samples and source data. Pfizer should have also monitored the situation earlier on. This isn’t their first foray into DCT and im not surprised they didnt manage this vendor well.
It’s not just submitting it for the purpose of an audit. That may very well be the case, but they’ve clearly stated they disagree with Pfizer’s assessment.
I'm honestly really surprised that they came out and said something so quickly. The whole thing has my head spinning for sure.
Quote from Guest on February 21, 2023, 3:52 pmQuote from Guest on February 21, 2023, 6:53 amQuote from Guest on February 21, 2023, 2:18 amQuote from Guest on February 20, 2023, 5:55 pmIt has been brought up numerous times by all levels that we need to slow enrollment for many studies because we're not able to do quality work. There have been enrollment mistakes, documentation mistakes, icf mistakes, lab mistakes, and thats not only on pfizer. The concerns are swept aside by the owners because to them it didn't matter as long as we were meeting numbers, we could just clean up the mistakes later. Now that this has happened they are taking our concerns more seriously but it's too little too late. The CEO is trying to blame pfizer saying they have no basis to do this and presenting theories as to why this happened instead of taking ownership.
I hope this serves as a wake up call to take your employees concerns more seriously in the future. It's not only about meeting numbers it's about quality and safety of everyone involved.
Who says Pfizer isn’t the one to blame? They’ve not only bailed but abandoned participants. They could have made an effort to keep them enrolled. Unless the issue was something along the lines of poor blinding etc. why give up 3500 participants - just transfer them to another CRO or private clinics etc.
There is likely plenty of blame to go around here. CA is willing to submit data to the FDA and IRB. Pfizer should come forth with their reasoning as well.
Both sides are to blame…but make no mistake, CA submitting data to the FDA is most likely due to an audit, so they aren’t doing it out of their own goodwill.
CA had an obligation to think of every operational aspect of the study. Some of the things they are accused are doing are due to inexperience and poor planning. there’s no excuse to mishandle patient samples and source data. Pfizer should have also monitored the situation earlier on. This isn’t their first foray into DCT and im not surprised they didnt manage this vendor well.
It’s not just submitting it for the purpose of an audit. That may very well be the case, but they’ve clearly stated they disagree with Pfizer’s assessment.
I'm honestly really surprised that they came out and said something so quickly. The whole thing has my head spinning for sure.
Quote from Guest on February 24, 2023, 6:49 pmQuote from Guest on February 19, 2023, 4:39 pmInteresting but little unclear here as to how GCP protocols were violated so far. Taking lab samples to a hotel room in a mobile environment is…not ok? Is ok? In a decentralized environment things are presumably going to operate a little differently.
the issues around getting paid - employees not getting paid? Hipocratic oath? - important things in general but what do they specifically have to do with GCP with respect to how participants in a trial are managed?
Pfizer needs to shed some light here on what exactly went wrong. Otherwise trial participants are basically being left in the dark. Gut says this has little to do with GCP - but it will be used as a scapegoat (sure, don’t take samples to hotel rooms if that really happened) - and has more to do with pure business and $$$.Is the hotel room on the 1572? Clinical trial data needs to be collected systematically to ensure quality, storing samples in a hotel room doesn't scream systematic to me and therefore I'd question the quality of the sample and data collected from it. That's not fair to the participant who donated the blood with the expectation it would be used for the study.
Quote from Guest on February 19, 2023, 4:39 pmInteresting but little unclear here as to how GCP protocols were violated so far. Taking lab samples to a hotel room in a mobile environment is…not ok? Is ok? In a decentralized environment things are presumably going to operate a little differently.
the issues around getting paid - employees not getting paid? Hipocratic oath? - important things in general but what do they specifically have to do with GCP with respect to how participants in a trial are managed?
Pfizer needs to shed some light here on what exactly went wrong. Otherwise trial participants are basically being left in the dark. Gut says this has little to do with GCP - but it will be used as a scapegoat (sure, don’t take samples to hotel rooms if that really happened) - and has more to do with pure business and $$$.
Is the hotel room on the 1572? Clinical trial data needs to be collected systematically to ensure quality, storing samples in a hotel room doesn't scream systematic to me and therefore I'd question the quality of the sample and data collected from it. That's not fair to the participant who donated the blood with the expectation it would be used for the study.
Quote from Guest on February 27, 2023, 2:18 amQuote from Guest on February 24, 2023, 6:49 pmQuote from Guest on February 19, 2023, 4:39 pmInteresting but little unclear here as to how GCP protocols were violated so far. Taking lab samples to a hotel room in a mobile environment is…not ok? Is ok? In a decentralized environment things are presumably going to operate a little differently.
the issues around getting paid - employees not getting paid? Hipocratic oath? - important things in general but what do they specifically have to do with GCP with respect to how participants in a trial are managed?
Pfizer needs to shed some light here on what exactly went wrong. Otherwise trial participants are basically being left in the dark. Gut says this has little to do with GCP - but it will be used as a scapegoat (sure, don’t take samples to hotel rooms if that really happened) - and has more to do with pure business and $$$.Is the hotel room on the 1572? Clinical trial data needs to be collected systematically to ensure quality, storing samples in a hotel room doesn't scream systematic to me and therefore I'd question the quality of the sample and data collected from it. That's not fair to the participant who donated the blood with the expectation it would be used for the study.
But it’s not clear that this is what happened, or that this was their concern. It’s all rumors at this point. Furthermore, it’s not clear that even if this happened, that Pfizer wasn’t previously aware of it already.
Quote from Guest on February 24, 2023, 6:49 pmQuote from Guest on February 19, 2023, 4:39 pmInteresting but little unclear here as to how GCP protocols were violated so far. Taking lab samples to a hotel room in a mobile environment is…not ok? Is ok? In a decentralized environment things are presumably going to operate a little differently.
the issues around getting paid - employees not getting paid? Hipocratic oath? - important things in general but what do they specifically have to do with GCP with respect to how participants in a trial are managed?
Pfizer needs to shed some light here on what exactly went wrong. Otherwise trial participants are basically being left in the dark. Gut says this has little to do with GCP - but it will be used as a scapegoat (sure, don’t take samples to hotel rooms if that really happened) - and has more to do with pure business and $$$.Is the hotel room on the 1572? Clinical trial data needs to be collected systematically to ensure quality, storing samples in a hotel room doesn't scream systematic to me and therefore I'd question the quality of the sample and data collected from it. That's not fair to the participant who donated the blood with the expectation it would be used for the study.
But it’s not clear that this is what happened, or that this was their concern. It’s all rumors at this point. Furthermore, it’s not clear that even if this happened, that Pfizer wasn’t previously aware of it already.
Quote from Guest on February 27, 2023, 4:12 pmThe problem with forums like these are that they are all speculation and rumor. Period. It probably would have served Brad better to wait until the situation plays out before inciting opinions from everyone and their grandmother. But, what fun is that? Seems like certain people thrive off of this stuff...
The problem with forums like these are that they are all speculation and rumor. Period. It probably would have served Brad better to wait until the situation plays out before inciting opinions from everyone and their grandmother. But, what fun is that? Seems like certain people thrive off of this stuff...
Quote from brad on February 27, 2023, 4:46 pmI originally only set out to collect any info I could find about this debacle as I expect neither Pfizer nor Care Access to say anything of any actual value on the subject.
This is not a news site. This is a place to share thoughts and opinions. I do not want to contribute to misinformation but have tried my best to find what info I can in an industry that is far too opaque.
Perhaps I can strike a better balance in the future but I'm willing to bet no one will willingly be disclosing the full extent of what went on here.
I originally only set out to collect any info I could find about this debacle as I expect neither Pfizer nor Care Access to say anything of any actual value on the subject.
This is not a news site. This is a place to share thoughts and opinions. I do not want to contribute to misinformation but have tried my best to find what info I can in an industry that is far too opaque.
Perhaps I can strike a better balance in the future but I'm willing to bet no one will willingly be disclosing the full extent of what went on here.
Quote from Guest on February 27, 2023, 8:42 pmQuote from Guest on February 27, 2023, 4:12 pmThe problem with forums like these are that they are all speculation and rumor. Period. It probably would have served Brad better to wait until the situation plays out before inciting opinions from everyone and their grandmother. But, what fun is that? Seems like certain people thrive off of this stuff...
How do I 👍🏽 this. Seems like on brad can like comments on here.
Quote from Guest on February 27, 2023, 4:12 pmThe problem with forums like these are that they are all speculation and rumor. Period. It probably would have served Brad better to wait until the situation plays out before inciting opinions from everyone and their grandmother. But, what fun is that? Seems like certain people thrive off of this stuff...
How do I 👍🏽 this. Seems like on brad can like comments on here.
Quote from brad on February 27, 2023, 8:58 pmQuote from Guest on February 27, 2023, 8:42 pmQuote from Guest on February 27, 2023, 4:12 pmThe problem with forums like these are that they are all speculation and rumor. Period. It probably would have served Brad better to wait until the situation plays out before inciting opinions from everyone and their grandmother. But, what fun is that? Seems like certain people thrive off of this stuff...
How do I
this. Seems like on brad can like comments on here.
You might have to be logged in to use the thumbs up/down feature. I'll look at the settings. Either way, point taken.
Quote from Guest on February 27, 2023, 8:42 pmQuote from Guest on February 27, 2023, 4:12 pmThe problem with forums like these are that they are all speculation and rumor. Period. It probably would have served Brad better to wait until the situation plays out before inciting opinions from everyone and their grandmother. But, what fun is that? Seems like certain people thrive off of this stuff...
How do I
You might have to be logged in to use the thumbs up/down feature. I'll look at the settings. Either way, point taken.
Quote from Guest on February 28, 2023, 5:10 amQuote from Guest on February 27, 2023, 4:12 pmThe problem with forums like these are that they are all speculation and rumor. Period. It probably would have served Brad better to wait until the situation plays out before inciting opinions from everyone and their grandmother. But, what fun is that? Seems like certain people thrive off of this stuff...
i wouldn't go so far to say it's "all speculation and rumor." some people actually are in the know a bit more than others as we are involved in discussions that require some knowledge of what transpired. Obviously, we can't divulge everything, but i would say a good amount of what's been posted out there have been rooted in some truths. of course, as time goes by, these stories become more and more overblown...like a game of telephone. but i wouldn't exonerate care access completely
Quote from Guest on February 27, 2023, 4:12 pmThe problem with forums like these are that they are all speculation and rumor. Period. It probably would have served Brad better to wait until the situation plays out before inciting opinions from everyone and their grandmother. But, what fun is that? Seems like certain people thrive off of this stuff...
i wouldn't go so far to say it's "all speculation and rumor." some people actually are in the know a bit more than others as we are involved in discussions that require some knowledge of what transpired. Obviously, we can't divulge everything, but i would say a good amount of what's been posted out there have been rooted in some truths. of course, as time goes by, these stories become more and more overblown...like a game of telephone. but i wouldn't exonerate care access completely
