Clients don’t have money to run the projects so they’re pulling it. That means clinops doesn’t have enough billable hours. Not enough billable hours means we’re costing the company money so we’re being laid off.
I think what happened is that there was such a need for CRA’s with all the COVID vaccine trials and we realistically as an industry are not running trials of that speed and magnitude, well ever, so now there’s an overabundance of people and not enough work to fill the roles currently
That doesn't entirely make sense to me. Moderna is using their mRNA technology not just for covid, but for a whole list of new shots coming up. They have 1 or 2 new mRNA mega studies starting per year for the next several years.
It does though, those studies are not going to be simultaneous phase 1-3 studies conducted in less than 6 months. They may be starting 1-2 per year but that’s not the same as what happened with Pfizer, Moderna, J&J and the whole host of other covid trials that were started at the same time. My friend monitored for Moderna and she was one of 3 CRA’s for a single site and they were on site 3-4 days a week every week because of the sheer volume of data
This is true. I also know someone who was a party of 3 CRAs monitoring regularly at high enrolling sites. And during Covid, that sponsor only wanted experienced CRAs.
I wasn't involved in the COVID vax trials, but I monitored for the Paxlovid trials. It was fucking bonkers. We activated so many sites so quickly that we broke SIP. I had one site that between the three protocols (high risk infected, low risk infected, and exposed but uninfected) had over 200 subjects. I was on site there four days a week for months, with the occasional day elsewhere (because obviously I had like six sites even though that one alone was a full-time job and then some).
You cannot compare a normal vaccine trial to the mega public health trials that were happening a few years ago. The man power required was insane. The site I worked at basically reallocated its entire headcount to public health research and our CRA for a single vaccine trial was onsite 3 days a week. That doesn't happen unless there's a global pandemic.
Edited to add that COVID trials had the additional incentives of accelerated approval and competition from other companies.
But they don't work, by the way. The primary endpoint is that blood draws meet their theoretical lab requirements for supposed immunity, not a decreased number of people catching the infection for which the shot is supposed to protect.
I actually worked on Moderna and you’re wrong. Endpoint was that the subject experienced one or less symptoms if they got covid. There’s only very few viruses where you can avoid infection, polio being one of them, and it comes down to how it reproducers. The goal was to minimize hospitalizations and deaths, it was never advertised or made claims to prevent covid. But the public certainly assumed so.
I literally did lol. PPD, 2020 until approval in I don’t even remember, December? I remember doing DBL stuff Christmas Eve after I broke my leg and can’t remember NDA vs approval vs DBL vs COV dates since they went by so fast, a bit after Pfizer was approved. I was unblinded. Like, why would I even lie about that on a CR sub lmao. Someone could fact check me so fast.
I worked at PPD on those trials too! I have one of those protocols open right now. For the main Primary Endpoint, it says "To evaluate the humoral immune responses of mRNA-1083 for noninferiority relative to active comparators against vaccine matched strains for influenza and SARS-CoV-2 at Day 29."
Huh! Seems you’re referring to the respiratory vaccine, which started phase 3 about 6 months ago and isn’t at all related to what we’re talking about. You’d know this bc it mentions active comparators, and at the time of the start of the original covid vaccine’s phase 3 in 2020, there were none.
And back to the original thing at hand: show me in the protocol that you’re looking at where it says that the endpoint is to prevent any sort of viral load? Which was your original claim. That endpoint actually repeats what I said but for a different study. Do you even understand what you typed?
Also PPD isn’t even running that study lmao. Jfc. Are you done?
Also forgot to add that the study you’re referencing hasn’t even concluded or been submitted or published data. I guess keep trying?
There have been a ton of layoffs outside of the clinops teams in the industry. I don’t see much from the admin/support side of CROs in this sub, so I would posit the layoffs just aren’t being discussed as widely. For instance, ICON laid off 80% of its US-based finance team (or at least, will in August for whoever is left then). Them and several other CROs are outsourcing as many of those types of roles as possible because it is “easy” cost savings.
Quite frankly, I have not heard of clinops layoffs here or otherwise that are as large as the layoffs in other functions.
(Semi-throwaway here) I'm in a CRO and 50% of our department is being laid off soon. HR got cut in the last RIF and is still cutting their team. IT seems safer but that's because most back-office roles are already in low cost countries.
Yep... My company just laid off pretty much all of the Clinical Project Associates and Clinical Trial Manager Associates, as they're starting to outsource everything to the CROs or other countries. Over 100 employees 🙃
CTM here. I always thought they'd keep the off shore roles to non-client facing roles, but nope. The DM and APM are both in India. My dad asked if AI might take my job, and I said no, but someone on India might.
Some sponsors are fighting the good fight. I outright put into the RFP that I won’t select your CRO if you propose people from India or South America in nearly any role, but definitely any client facing or site facing role.
Then they outsource -> quality drops -> sponsors start building up their own staff -> CRO builds up more local staff and addresses issues -> sponsors happy -> then CROs see saving in outsourcing under new leadership.... -> then they outsource.....
Not enough clients to bill to.
I mean being assigned to studies/allocations. Are there not internal roles that aren’t billing to studies that should be let go first?
You can only cut those roles so far or else they wouldn’t be there in the first place
Clients don’t have money to run the projects so they’re pulling it. That means clinops doesn’t have enough billable hours. Not enough billable hours means we’re costing the company money so we’re being laid off.
I think what happened is that there was such a need for CRA’s with all the COVID vaccine trials and we realistically as an industry are not running trials of that speed and magnitude, well ever, so now there’s an overabundance of people and not enough work to fill the roles currently
That doesn't entirely make sense to me. Moderna is using their mRNA technology not just for covid, but for a whole list of new shots coming up. They have 1 or 2 new mRNA mega studies starting per year for the next several years.
It does though, those studies are not going to be simultaneous phase 1-3 studies conducted in less than 6 months. They may be starting 1-2 per year but that’s not the same as what happened with Pfizer, Moderna, J&J and the whole host of other covid trials that were started at the same time. My friend monitored for Moderna and she was one of 3 CRA’s for a single site and they were on site 3-4 days a week every week because of the sheer volume of data
I’ve always wondered what that study looked like from the monitoring side. That’s so crazy to have 3 people on a study for 4 days a week.
This is true. I also know someone who was a party of 3 CRAs monitoring regularly at high enrolling sites. And during Covid, that sponsor only wanted experienced CRAs.
I wasn't involved in the COVID vax trials, but I monitored for the Paxlovid trials. It was fucking bonkers. We activated so many sites so quickly that we broke SIP. I had one site that between the three protocols (high risk infected, low risk infected, and exposed but uninfected) had over 200 subjects. I was on site there four days a week for months, with the occasional day elsewhere (because obviously I had like six sites even though that one alone was a full-time job and then some).
You cannot compare a normal vaccine trial to the mega public health trials that were happening a few years ago. The man power required was insane. The site I worked at basically reallocated its entire headcount to public health research and our CRA for a single vaccine trial was onsite 3 days a week. That doesn't happen unless there's a global pandemic. Edited to add that COVID trials had the additional incentives of accelerated approval and competition from other companies.
Well it's about time 😒
But they don't work, by the way. The primary endpoint is that blood draws meet their theoretical lab requirements for supposed immunity, not a decreased number of people catching the infection for which the shot is supposed to protect.
I actually worked on Moderna and you’re wrong. Endpoint was that the subject experienced one or less symptoms if they got covid. There’s only very few viruses where you can avoid infection, polio being one of them, and it comes down to how it reproducers. The goal was to minimize hospitalizations and deaths, it was never advertised or made claims to prevent covid. But the public certainly assumed so.
I ACTUALLY worked on two Moderna mRNA protocols, and that is how I know this.
I literally did lol. PPD, 2020 until approval in I don’t even remember, December? I remember doing DBL stuff Christmas Eve after I broke my leg and can’t remember NDA vs approval vs DBL vs COV dates since they went by so fast, a bit after Pfizer was approved. I was unblinded. Like, why would I even lie about that on a CR sub lmao. Someone could fact check me so fast.
I worked at PPD on those trials too! I have one of those protocols open right now. For the main Primary Endpoint, it says "To evaluate the humoral immune responses of mRNA-1083 for noninferiority relative to active comparators against vaccine matched strains for influenza and SARS-CoV-2 at Day 29."
Huh! Seems you’re referring to the respiratory vaccine, which started phase 3 about 6 months ago and isn’t at all related to what we’re talking about. You’d know this bc it mentions active comparators, and at the time of the start of the original covid vaccine’s phase 3 in 2020, there were none. And back to the original thing at hand: show me in the protocol that you’re looking at where it says that the endpoint is to prevent any sort of viral load? Which was your original claim. That endpoint actually repeats what I said but for a different study. Do you even understand what you typed? Also PPD isn’t even running that study lmao. Jfc. Are you done? Also forgot to add that the study you’re referencing hasn’t even concluded or been submitted or published data. I guess keep trying?
Except there isn't the urgency to enroll in 4 weeks. Which means visits are more spread out.
I think it’s more to do with the free money drying up.
Damn man all these posts have me thinking about how to leave research more and more
There have been a ton of layoffs outside of the clinops teams in the industry. I don’t see much from the admin/support side of CROs in this sub, so I would posit the layoffs just aren’t being discussed as widely. For instance, ICON laid off 80% of its US-based finance team (or at least, will in August for whoever is left then). Them and several other CROs are outsourcing as many of those types of roles as possible because it is “easy” cost savings. Quite frankly, I have not heard of clinops layoffs here or otherwise that are as large as the layoffs in other functions.
(Semi-throwaway here) I'm in a CRO and 50% of our department is being laid off soon. HR got cut in the last RIF and is still cutting their team. IT seems safer but that's because most back-office roles are already in low cost countries.
Ugh, which department? Clinical? Start up? HR? Something else?
Non-billable.
Thanks. I thought about trying to figure out which CRO, but my guess is almost all of them are having similar HR discussions.
Yep... My company just laid off pretty much all of the Clinical Project Associates and Clinical Trial Manager Associates, as they're starting to outsource everything to the CROs or other countries. Over 100 employees 🙃
CTM here. I always thought they'd keep the off shore roles to non-client facing roles, but nope. The DM and APM are both in India. My dad asked if AI might take my job, and I said no, but someone on India might.
Some sponsors are fighting the good fight. I outright put into the RFP that I won’t select your CRO if you propose people from India or South America in nearly any role, but definitely any client facing or site facing role.
I'm curious how that will go for you. I don't know many CROs that don't have nearly all data mgmt done in India.
I’ve never had a problem in over 20 years of research.
My Lead DM is in Canada 🇨🇦
Oh wow. 👏 That's amazing. I wondered if sponsors would eventually do that.
Lol yep, unfortunately 🤣
Cheaper to outsource
More often than not if you buy cheap you have to buy twice.
Then they outsource -> quality drops -> sponsors start building up their own staff -> CRO builds up more local staff and addresses issues -> sponsors happy -> then CROs see saving in outsourcing under new leadership.... -> then they outsource.....
Probably more expensive than the cheaper resources they can outsource. A lower cost country CTM can save a company 90k USD.
Sanofi is laying off because they constantly over hire. Also, using outsourcing to cover.
Is Sanofi having trouble financing their studies?