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Quote from brad on February 19, 2023, 5:04 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 $$$.This was honestly my first assumption as well. But since then I've heard so much from former employees it's really hard to ignore. Time will tell. I'm just trying to compile what I see
Quote from Guest on February 19, 2023, 4:39 pmInteresting but little unclear here as to how GCP protocols were violated so far. Taking lab samples to a hotel room in a mobile environment is…not ok? Is ok? In a decentralized environment things are presumably going to operate a little differently.
the issues around getting paid - employees not getting paid? Hipocratic oath? - important things in general but what do they specifically have to do with GCP with respect to how participants in a trial are managed?
Pfizer needs to shed some light here on what exactly went wrong. Otherwise trial participants are basically being left in the dark. Gut says this has little to do with GCP - but it will be used as a scapegoat (sure, don’t take samples to hotel rooms if that really happened) - and has more to do with pure business and $$$.
This was honestly my first assumption as well. But since then I've heard so much from former employees it's really hard to ignore. Time will tell. I'm just trying to compile what I see
Quote from Guest on February 19, 2023, 5:25 pmSorry but I think your gut is way off the mark on this one. This is likely to cost Pfizer a lot more money to get this product thru phase 3 and on to the FDA. This protocol was revised from an enrollment target of 18,000 down to 6,000 because CA was going to provide access to subjects in super high lyme endemic parts of the country (like Nantucket and Block islands)(btw CT.gov does not reflect that change). The reason is they need tick bites is to prove efficacy. Now they will likely have to increase that enrollment goal to get those events which is going to cost a whole lot more money. In addition since Pfizer got smacked after their Covid issues in Texas I have seen a significant ratchet up in their demands and vigilance in the conduct of their trials. If anything their response to this situation is being driven by that recent past experience and a commitment to the FDA not to let it happen again. My guess, in this case, is that they ran with a model that was not prepared to deal with enrollment in areas with insufficient infrastructure which led to these alleged GCP violations.
Sorry but I think your gut is way off the mark on this one. This is likely to cost Pfizer a lot more money to get this product thru phase 3 and on to the FDA. This protocol was revised from an enrollment target of 18,000 down to 6,000 because CA was going to provide access to subjects in super high lyme endemic parts of the country (like Nantucket and Block islands)(btw CT.gov does not reflect that change). The reason is they need tick bites is to prove efficacy. Now they will likely have to increase that enrollment goal to get those events which is going to cost a whole lot more money. In addition since Pfizer got smacked after their Covid issues in Texas I have seen a significant ratchet up in their demands and vigilance in the conduct of their trials. If anything their response to this situation is being driven by that recent past experience and a commitment to the FDA not to let it happen again. My guess, in this case, is that they ran with a model that was not prepared to deal with enrollment in areas with insufficient infrastructure which led to these alleged GCP violations.
Quote from Guest on February 19, 2023, 11:12 pmIsn’t the purpose of using a decentralized model specifically to target these areas though? Hence the use of mobile units, jump teams etc. they even brought in reps from their Brazil unit to reach out to the Portuguese speaking community in Martha’s Vineyard.
All of this costs more than having people walk in to a private practice ambulatory setting. They’ve likely done that cost benefit analysis, and realize this is the Lyme vaccine - not the COVID vaccine - and is gonna serve a fairly limited population at the end of the day. I know I won’t be taking it whenever it comes out.anyhow, more will come out I’m sure. If current employees have something to share anonymously, they absolutely should - from CA or Pfizer. And participants who are being eliminated from the trial should be either allowed to participate in whatever matter Pfizer is able to set up for them (fly them out somewhere if have to - oh, sorry, that might cost too much) or at least receive follow up medical care and monitoring for adverse effects.
Isn’t the purpose of using a decentralized model specifically to target these areas though? Hence the use of mobile units, jump teams etc. they even brought in reps from their Brazil unit to reach out to the Portuguese speaking community in Martha’s Vineyard.
All of this costs more than having people walk in to a private practice ambulatory setting. They’ve likely done that cost benefit analysis, and realize this is the Lyme vaccine - not the COVID vaccine - and is gonna serve a fairly limited population at the end of the day. I know I won’t be taking it whenever it comes out.
anyhow, more will come out I’m sure. If current employees have something to share anonymously, they absolutely should - from CA or Pfizer. And participants who are being eliminated from the trial should be either allowed to participate in whatever matter Pfizer is able to set up for them (fly them out somewhere if have to - oh, sorry, that might cost too much) or at least receive follow up medical care and monitoring for adverse effects.
Quote from Guest on February 20, 2023, 5:37 pmi guarantee CA isn't the first DCT company to conduct these practices....the others just haven't been exposed quite yet. most things i've read about what happened are shocking, but not new. The idea is great, there just aren't enough people out there who are willing to put in the effort to make DCT work for the patient. They just prefer to be "thought leaders" and attend fancy conferences
i guarantee CA isn't the first DCT company to conduct these practices....the others just haven't been exposed quite yet. most things i've read about what happened are shocking, but not new. The idea is great, there just aren't enough people out there who are willing to put in the effort to make DCT work for the patient. They just prefer to be "thought leaders" and attend fancy conferences
Quote from Guest on February 20, 2023, 5:50 pmQuote from Guest on February 20, 2023, 5:37 pmi guarantee CA isn't the first DCT company to conduct these practices....the others just haven't been exposed quite yet. most things i've read about what happened are shocking, but not new. The idea is great, there just aren't enough people out there who are willing to put in the effort to make DCT work for the patient. They just prefer to be "thought leaders" and attend fancy conferences
I've definitely heard rumblings from more companies in the space. It just feels like these many of these companies are trying the "fake it till you make it" and getting out way over their skis. I'd be willing to guess we hear more as time goes on. Interesting times.
Quote from Guest on February 20, 2023, 5:37 pmi guarantee CA isn't the first DCT company to conduct these practices....the others just haven't been exposed quite yet. most things i've read about what happened are shocking, but not new. The idea is great, there just aren't enough people out there who are willing to put in the effort to make DCT work for the patient. They just prefer to be "thought leaders" and attend fancy conferences
I've definitely heard rumblings from more companies in the space. It just feels like these many of these companies are trying the "fake it till you make it" and getting out way over their skis. I'd be willing to guess we hear more as time goes on. Interesting times.
Quote 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.
It 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.
Quote from Guest on February 20, 2023, 6:40 pmQuote 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.
i would say it's not just to slow enrollment, but seeing it from the other side, these CEOs are also making empty promises and signing a bunch of deals before their ops teams have fully built out the capabilities yet. Usually, these deals have zero input from the clinical operations team because they're usually seen as the downers and realists...not something the CEO wants to hear. So what happens? C suite signs on a bunch of studies, overworking the coordinators and PMs....so they have to hire more people, but don't have the ability find those qualified people quickly.
Who gets the blame then? the clinops team. it's the same theme at every one of these start-up companies.
Quote 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.
i would say it's not just to slow enrollment, but seeing it from the other side, these CEOs are also making empty promises and signing a bunch of deals before their ops teams have fully built out the capabilities yet. Usually, these deals have zero input from the clinical operations team because they're usually seen as the downers and realists...not something the CEO wants to hear. So what happens? C suite signs on a bunch of studies, overworking the coordinators and PMs....so they have to hire more people, but don't have the ability find those qualified people quickly.
Who gets the blame then? the clinops team. it's the same theme at every one of these start-up companies.
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.
Quote 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.
Quote from brad on February 21, 2023, 2:26 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.
I think it's safe to say Pfizer fucked up in their own way, no doubt. But I'm guessing the reason they needed mobile clinics in the first place is the same reason there aren't sites for these patients to go to.
Either way, it initially struck me as pretty fishy for Pfizer to throw CA under the bus so quickly. Either way, I hope we learn more.
Also I'm not so sure CA has a choice - of course they're "willing" to submit to the FDA and IRB.
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.
I think it's safe to say Pfizer fucked up in their own way, no doubt. But I'm guessing the reason they needed mobile clinics in the first place is the same reason there aren't sites for these patients to go to.
Either way, it initially struck me as pretty fishy for Pfizer to throw CA under the bus so quickly. Either way, I hope we learn more.
Also I'm not so sure CA has a choice - of course they're "willing" to submit to the FDA and IRB.
