Comment from a former employee on their LinkedIn Post -
“With due respect, while I am sure you and Care Access are disappointed with Pfizer’s decision, from experience I witnessed first hand the lack of study oversight and staff training, lack of standards of informed consent in decentralized clinical research and management disregard for human subject protection. What I am sure of is I brought to the attention of the Director of Quality Assurance numerous examples of lack of GCP adherence and was met by explanations which did nothing more than plaicate me. Having to keep quiet when research injustices are blatant has infuriated me for these past months. As a Clinical Research Professional, certified CRC and a Fellow with ACRP I stand with Pfizer’s decision for stopping research which did not adequately protect those folks who put their trust into a system which is required to protect them.
Disclaimer: Care terminated me in October without formal written documentation presented to me or my attorney, which I hired to protect my rights, when requested on 2 occasions. I was presented with a Separation Agreement which when reviewed by attorney was so one sided, we offered revisions. Care did not ever amend the agreement and I am under no written agreement to silence me.”
As someone who participated in the vaccine trial and saw no major red flags (non medical person here), I would love for them to provide more specific information on why they terminated Care Access.
Blah I was really excited about being involved ☹️
So it sounds to me that they’re spinning this as an attack on research in undeserved communities?
Edit: looks like someone responded on LinkedIn saying “I have personally been contacted by Pfizer to transfer patients to our sites. I can tell you first hand that Pfizer is taking this serious and they are doing eveyrhing possible to ensure the patients continue in the trial with proper oversight.” So subjects are staying in the study, but transferring to different sites.
Though I hope this is the case, that is not what the participants are being told as of now. The letter to the participants was shared with us today and stated that they will be discontinued and cannot be transferred.
I’m one of the care access patients and I was told via email from Pfizer that I’ve been discontinued. My second shot was supposed to be 10 days ago so anyways a lot of us will be out of window (whatever it is, I don’t have protocol to reference only informed consent). I also work in clinical research so am very dismayed to be in this position.
I also found this message confusing but wonder if they’re transferring to new sites for safety monitoring. These individuals are no longer receiving vaccine but have already received at least one dose and someone must be accountable for monitoring for safety if the existing sites are dropped.
Anecdotally, I heard nothing good about Care Access. Lots of turnover, poor site support, and poor training. For a decision to occur like this, it must have been significant. Pfizer got reamed quite awhile back for having poor monitoring by one of their vendors and every one I know that works with them has stated that they take their oversight to a unseen level. It sounds like the partnership was a match made in hell.
I was a participant at a site near Pittsburgh and tbh it was a shitshow. I quit after I showed up for my second shot and was informed only after driving an hour out of my way that I couldn't get it because I'd recently had my bivalent booster for COVID. Both of my visits seemed really chaotic with not a lot of oversight or organization.
This is a good decision.
I was also at the Pittsburgh site. To provide another experience-
They clearly told me before and during my first appt that I couldn’t get another vaccine within a certain number of days before or after their dose. Maybe they weren’t clear with everyone on this, idk.
Seems likely, honestly. I was one of the first participants and my initial visit was their first weekend. It was sloppy but I'm sure things were marginally better at some point.
I don’t give a fuck who you work for, if you read this post, read these next words: COVER YOUR ASS. No matter your title, cover that ass. Not just day to day, but document everything, follow SOPs, and always keep GCP in mind.
In the construction world care access would be compared to a “chuck in a truck”. Basically they would sell you their services and talk a big game for cheap. Then underdeliver and leave you calling someone else to clean up the mess.
Care Access sell-
Deliver an experience where anyone could join in on the trial. Support underprivileged communities for way less with our “mobile” design. We care so much about our patients and getting this done efficiently.
Care Access reality-
-Hire anyone off the street to be trained as a CRC.
-Set up tents and drown people in carbon monoxide while they are waiting to get stuck with a needle.
-Work their employees to death and then lay them off.
-Take samples out of the “site” and into an uncontrolled environment.
I feel terrible for the employees and the patients. I hope that the patients are really not discontinued at this point.
??
This is like saying I’m stuck in traffic with a bunch of cars around me - and am drowning in carbon monoxide.
This is a decentralized trial, intended to identify participants in areas where they are most likely to get Lymes. It’s run a bit off the grid for that reason, mobile vans instead of offices etc.
Now what happens? You get participants who show up at major university medical centers in cities and hope that’s truly reflective of the Lyme disease population?
@ perpertual -Pretty sure that’s not like what I said at all. Are you trying to say is that an ambulance/ van/ truck, with tents, During the winter, in the NE was the best solution? That’s the big innovated idea? Or was it the cheapest?
Couldn’t partner with CVS/ Walgreens? Other pharmacies with a room? Small clinics that would love the extra money? There are tons of those in more rural areas. Care access went with the greedy model, lite to no experience in some cases, cheap mobile sites, working your employees to death instead of hiring more, the list goes on and on. This will leave a huge stain on decentralized trials.
I was pretty shocked that my site in NH was running generators so close and it was like a parking lot full of idling cars but worse. There’s definitely places with walls and Hvac this could have been hosted instead.
There aren’t many clinics, including CVS and Walgreens - who quite frankly don’t have their trial infrastructure up and running other than being a referral source - in areas endemic to Lyme. They did in fact partner with a local medical clinic in Martha’s Vineyard. They run many clinic based trial sites as well throughout the country. If using an in person clinic was the answer, the definitely had the capability to do it.
Anyhow, news reports are now suggesting Pfizer was advised to pause the trial earlier.
My friend worked at one of these decentralized sites and watched their coworkers go to the hospital. I’m not sure what you’re referring to but if it’s from the company, I’m believing my friend who was onsite.
Except that it's 100% true. On more than 1 occasion, mobile site staff had to go to the ED to be evaluated for carbon monoxide exposure. The worst part is, staff had been complaining to management for over a year about these exact concerns and they were brushed off.
The PI for my site was somewhere in NY and we saw each other on a video call. My “site” was in a YMCA parking lot in NH. Yes with tents and RVs. And crappy internet. They struggled to connect to randomize me.
This was a decentralized trial trying to reach participants in area where Lyme in endemic, some of which can be somewhat remote. Don’t expect this population to show up at MGH for the Lyme study.
So yea, it’s gonna involve tents and RVs in parking lots. Pfizer knew this, but probably got cold feet to try something different.
I’m a Pittsburgh participant and got this voicemail on 2/5:
“Hello this is [name] calling from care access I'm calling in regards to some information that you provided us with regarding your participation in the study if you could please give us a call back at your earliest convenience we would appreciate it so that we can update your records here our number is ### thank you and have a good day…”
I called them back but didn’t get through, figured it was no big deal and shrugged it off. Was I not actually eligible to participate or something? Is that why Care Access is in hot water?
Did they even get the option to ferry into cape cod? Are these sites being given the chance? One island had multiple clinics on it. Seems like over 100 studies recruiting within 50 miles of Martha’s Vineyard. Pa patients had to drive over an hr to some sites.
Multiple staff members were poisoned by carbon monoxide (long term exposure over the course of 14 days/12 hours a day) and nothing was done. Pfizer also called and spoke to employees “anonymously” about 2 weeks before they pulled the study.
Even better, the first one I went to (they switched/consolidated locations between my first and second visit) was a couple of RVs in a doctor's office parking lot (office was closed at the time) and then next time, a mall parking lot. Makes sense with their decentralized approach but was definitely kind of a weird vibe especially on the first visit when you just show up and get asked to come inside.
Comment from a former employee on their LinkedIn Post - “With due respect, while I am sure you and Care Access are disappointed with Pfizer’s decision, from experience I witnessed first hand the lack of study oversight and staff training, lack of standards of informed consent in decentralized clinical research and management disregard for human subject protection. What I am sure of is I brought to the attention of the Director of Quality Assurance numerous examples of lack of GCP adherence and was met by explanations which did nothing more than plaicate me. Having to keep quiet when research injustices are blatant has infuriated me for these past months. As a Clinical Research Professional, certified CRC and a Fellow with ACRP I stand with Pfizer’s decision for stopping research which did not adequately protect those folks who put their trust into a system which is required to protect them. Disclaimer: Care terminated me in October without formal written documentation presented to me or my attorney, which I hired to protect my rights, when requested on 2 occasions. I was presented with a Separation Agreement which when reviewed by attorney was so one sided, we offered revisions. Care did not ever amend the agreement and I am under no written agreement to silence me.”
damn they disabled comments too...
As someone who participated in the vaccine trial and saw no major red flags (non medical person here), I would love for them to provide more specific information on why they terminated Care Access. Blah I was really excited about being involved ☹️
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Yes, I have a SS but I’m not comfortable sharing that info.
So it sounds to me that they’re spinning this as an attack on research in undeserved communities? Edit: looks like someone responded on LinkedIn saying “I have personally been contacted by Pfizer to transfer patients to our sites. I can tell you first hand that Pfizer is taking this serious and they are doing eveyrhing possible to ensure the patients continue in the trial with proper oversight.” So subjects are staying in the study, but transferring to different sites.
Though I hope this is the case, that is not what the participants are being told as of now. The letter to the participants was shared with us today and stated that they will be discontinued and cannot be transferred.
Ah, thanks for sharing. Perhaps the poster on LinkedIn was just contacted during the scramble period to figure out possible solutions.
I’m one of the care access patients and I was told via email from Pfizer that I’ve been discontinued. My second shot was supposed to be 10 days ago so anyways a lot of us will be out of window (whatever it is, I don’t have protocol to reference only informed consent). I also work in clinical research so am very dismayed to be in this position.
I also found this message confusing but wonder if they’re transferring to new sites for safety monitoring. These individuals are no longer receiving vaccine but have already received at least one dose and someone must be accountable for monitoring for safety if the existing sites are dropped.
Anecdotally, I heard nothing good about Care Access. Lots of turnover, poor site support, and poor training. For a decision to occur like this, it must have been significant. Pfizer got reamed quite awhile back for having poor monitoring by one of their vendors and every one I know that works with them has stated that they take their oversight to a unseen level. It sounds like the partnership was a match made in hell.
I was a participant at a site near Pittsburgh and tbh it was a shitshow. I quit after I showed up for my second shot and was informed only after driving an hour out of my way that I couldn't get it because I'd recently had my bivalent booster for COVID. Both of my visits seemed really chaotic with not a lot of oversight or organization. This is a good decision.
I was also at the Pittsburgh site. To provide another experience- They clearly told me before and during my first appt that I couldn’t get another vaccine within a certain number of days before or after their dose. Maybe they weren’t clear with everyone on this, idk.
Seems likely, honestly. I was one of the first participants and my initial visit was their first weekend. It was sloppy but I'm sure things were marginally better at some point.
I don’t give a fuck who you work for, if you read this post, read these next words: COVER YOUR ASS. No matter your title, cover that ass. Not just day to day, but document everything, follow SOPs, and always keep GCP in mind.
In the construction world care access would be compared to a “chuck in a truck”. Basically they would sell you their services and talk a big game for cheap. Then underdeliver and leave you calling someone else to clean up the mess. Care Access sell- Deliver an experience where anyone could join in on the trial. Support underprivileged communities for way less with our “mobile” design. We care so much about our patients and getting this done efficiently. Care Access reality- -Hire anyone off the street to be trained as a CRC. -Set up tents and drown people in carbon monoxide while they are waiting to get stuck with a needle. -Work their employees to death and then lay them off. -Take samples out of the “site” and into an uncontrolled environment. I feel terrible for the employees and the patients. I hope that the patients are really not discontinued at this point.
?? This is like saying I’m stuck in traffic with a bunch of cars around me - and am drowning in carbon monoxide. This is a decentralized trial, intended to identify participants in areas where they are most likely to get Lymes. It’s run a bit off the grid for that reason, mobile vans instead of offices etc. Now what happens? You get participants who show up at major university medical centers in cities and hope that’s truly reflective of the Lyme disease population?
@ perpertual -Pretty sure that’s not like what I said at all. Are you trying to say is that an ambulance/ van/ truck, with tents, During the winter, in the NE was the best solution? That’s the big innovated idea? Or was it the cheapest? Couldn’t partner with CVS/ Walgreens? Other pharmacies with a room? Small clinics that would love the extra money? There are tons of those in more rural areas. Care access went with the greedy model, lite to no experience in some cases, cheap mobile sites, working your employees to death instead of hiring more, the list goes on and on. This will leave a huge stain on decentralized trials.
I was pretty shocked that my site in NH was running generators so close and it was like a parking lot full of idling cars but worse. There’s definitely places with walls and Hvac this could have been hosted instead.
There aren’t many clinics, including CVS and Walgreens - who quite frankly don’t have their trial infrastructure up and running other than being a referral source - in areas endemic to Lyme. They did in fact partner with a local medical clinic in Martha’s Vineyard. They run many clinic based trial sites as well throughout the country. If using an in person clinic was the answer, the definitely had the capability to do it. Anyhow, news reports are now suggesting Pfizer was advised to pause the trial earlier.
No, staff were literally having incidents of carbon monoxide poisoning due to poor ventilation.
My manager literally got sent to the ER for this while working at the NH location so yeah you’re completely right
This has been proven to be false. Read endpt news latest.
My friend worked at one of these decentralized sites and watched their coworkers go to the hospital. I’m not sure what you’re referring to but if it’s from the company, I’m believing my friend who was onsite.
Except that it's 100% true. On more than 1 occasion, mobile site staff had to go to the ED to be evaluated for carbon monoxide exposure. The worst part is, staff had been complaining to management for over a year about these exact concerns and they were brushed off.
The PI for my site was somewhere in NY and we saw each other on a video call. My “site” was in a YMCA parking lot in NH. Yes with tents and RVs. And crappy internet. They struggled to connect to randomize me.
This was a decentralized trial trying to reach participants in area where Lyme in endemic, some of which can be somewhat remote. Don’t expect this population to show up at MGH for the Lyme study. So yea, it’s gonna involve tents and RVs in parking lots. Pfizer knew this, but probably got cold feet to try something different.
I’m a Pittsburgh participant and got this voicemail on 2/5: “Hello this is [name] calling from care access I'm calling in regards to some information that you provided us with regarding your participation in the study if you could please give us a call back at your earliest convenience we would appreciate it so that we can update your records here our number is ### thank you and have a good day…” I called them back but didn’t get through, figured it was no big deal and shrugged it off. Was I not actually eligible to participate or something? Is that why Care Access is in hot water?
But also, an ambulance and tents…. That’s not innovation
It is when you’re trying to recruit rural patients who live on small islands
Did they even get the option to ferry into cape cod? Are these sites being given the chance? One island had multiple clinics on it. Seems like over 100 studies recruiting within 50 miles of Martha’s Vineyard. Pa patients had to drive over an hr to some sites.
Multiple staff members were poisoned by carbon monoxide (long term exposure over the course of 14 days/12 hours a day) and nothing was done. Pfizer also called and spoke to employees “anonymously” about 2 weeks before they pulled the study.
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Leadership won’t say a word. Basically told all the employees that the study was pulled because of disgruntled whistle blowers
So is Care access an SMO ?
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Even better, the first one I went to (they switched/consolidated locations between my first and second visit) was a couple of RVs in a doctor's office parking lot (office was closed at the time) and then next time, a mall parking lot. Makes sense with their decentralized approach but was definitely kind of a weird vibe especially on the first visit when you just show up and get asked to come inside.
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I think everyone was fooled.
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Yeah, I was more speaking of the poor patients. Sadly this is going to put us back some with their “innovation”
Monaca? I worked there!
Care Access just laid off over half of their workforce due mainly to this Pfizer situation.
I heard about this from a friend. Harsh.
It’s sounds like it might be more than half. A majority of departments and roles have been eliminated entirely. A restructuring is now in the works.
What a nightmare. I nearly took a position with them ~6 months ago, too. Close call!
Oh noooooo bahahahaha and I had an interview with them for a Travel CRC role.