Verified Clinical Trials, LLC

[martin]

I have a few questions--and doubts--about August's blog entry.

justanotherlabrat.blogspot.com/

My first question: this is a blog entry? It's clearly not: it's an advertisement.

I've tried to figure out exactly who/what this company is. Apparently, it's owned by a urologist named Mitchell Efros. He has this very amusing informercial on YouTube.

www.youtube.com/watch?v=-j38uI7Qet4

The informercial contains footage "Courtesy of: Council for Research Subject Safety and Data Integry." Who exactly is that?

Why, it's a little organization headed by... Dr Efros!

www.councilforclinicalresearch.com/leadership.aspx

Compare the "leadership" of this "council" with that of the company Efros' heads:

www.accumedresearch.com/about-us.php

My first scent of B.S. came from the "blog" entry, which is plainly a paid advertisement. My second, from the comments on the YouTube video. Read them. They're obviously the work of sock puppets. Click on those (all very similar) YouTube account names, too. How many of them even have any "Favorites"? What other comments have they made?

Anyone else have any thoughts on this, or about this website's evidently total lack of integrity?

[caligula]

Celerion has started using VCT and I recently screened for a study there and had to sign a consent allowing consent for VCT. I feel this new VCT company leaves leaves alot of room for error because I am dependent on the previous CRU to correctly input information and to be appropriately matched with existing info within VCT network. I wonder how much lobbying and marketing Dr. Efros has to do for the Pharma companies to utilize his service. I agree martin, smells like alot of b.s.

[antecubital]

Looks like Effros is doing a heavy marketing job. He's got SNBL on board now. There's another company called clinicalRSVP that Spaulding Clinical is using.

Interesting that Celerion asked your consent. I suppose they would have to do that by law, HIPAA-wise.

I looked up VCT's website today, and they claim there is a way for us to correct misinformation.

Check out my own postings on this topic here on this site. There are some useful links.

[antecubital]

Caligula, could you share some information with us? Did Celerion take your fingerprint? Do they share your entire study history with VCT? If you get referred to your own physician due to a clinically significant screening result, does it get reported to VCT? Did the consent state whether you were giving permission for Celerion to share your information about that study only, or about all studies? And if they check the database and see that you are ineligible, would there be any punitive action taken against you, like suspending you or banning you?

Just wondering.

[antecubital]

It occurs to me that this might be part of the industry-wide push in health care to convert to electronic record keeping. One could foresee a day when a person has a permanent medical record on file with some central agency or other, and in to get treatment from a physician, has to give that doctor consent to look up his/her medical e-records and report any treatments and diagnoses thereto. Now, with Verified Clinical Trials, &c., coming online, how much of a stretch would it be to imagine that research units would demand consent to access that file, both to read it and report to it, as a condition of enrolling in a study? You won't be able to run, you won't be able to hide.

As a side note, in scanning an advertisement-article (soing that looks like a real news article, but is really paid-for propaganda) in the Jan-Feb 2012 Atlantic Monthly, tech company Fujitsu touts its ability to facilitate electronic record keeping in the health care industry. In one paragraph, they state that the federal government itself is behind the push to convert medical records from isolated paper files to shared computer networks:

"As for the government's part, it has developed an incentive program designed to offset the cost of implementing electronic health records and the systems needed to make this change. However, there are some strings attached. Providers must meet a 'meaningful use' standard to receive the federal funding. That's because the goal is not merely to get technology in place and scan in existing health records, but to have useful data points that are well organized and can be shared across secure networks."

So obviously there's a lucrative little niche to be carved here by these up-and-coming subject verification registries. Things look to get very interesting...

[respect]

You are definitely on to soing. This appears as pilot program that set these verification companies up for an electronic file sharing advantage. Essentially at the clinical stage they are using us as lab rats for their larger agenda.

Here is the difference though. When your doctor request permission to release your information its done without coercion or inducement which is clearly supported by HIPAA rule. The same can not be said about these cerification protocol. If you wish not to seed your HIPAA rights you are not allowed to do the study. That in itself to me suggest coercive force and warrants scrutiny under HIPAA. The inducement is if you give up your HIPAA rights even though you dont want to the inducement is the payment receive from participating in the study.

Because of the larger implications these verification process deserve the more scrutiny of the public and the courts because of evolving consequence if these programs are allowed to move forward.

To make another point these programs may jeopardize individuals participating in stages II,III and IV. Some of you have been in CROs where individuals with life threatening illnesses are participating in clinical research. If these patients are aware of the existence of these databases they may be less likely to enroll in these CROs further undermining scientific advancement. The economic viability of such clinics may be undermined as such individual shift to CROs that are mindful of their concerns. That inturn undermine abilities of CRO with these veri programs to ue to perform phase 1 because funding for the other phase trials have been jeopardized.

In my best opinion these programs should be suspended and until further input from all the stake holders and until definitive opinion is handed down from the courts.

[antecubital]

Soing else that hasn't come up here is the so-called "stimulus" from 2009. Did you know there were billions in grants handed out specifically for providers (and researchers) to switch over from paper records to electronic ones?

[respect]

I guess the CROs are now becoming lab rats for the bigger prize-the millions in funding for bragging rights of having a head start in electronic data management in the health field. This comes with serious downside for the CROs, a potential stampede of law suits for HIPAA infringements.
Its just a matter of time before other entities realize the potential damage these verified programs may have on privacy concerns of the larger population and collaborative effort to protect individuals privacy gain moment. I think we are going to see this interest being litigated in 2013.

[idoitforthepong]

FYI, spaulding was on Clinical RSVP but is now on VCT...that's what screening nurse told me at consent anyway

[dangermouse]

Lifetree in Mount Laurel, NJ is now starting to use VCT, though not systematically, I don't think. They're doing this on a study by study basis, and only require it if the sponsor does.

Recently, when I screened for a study with them, I was told by a staff member that VCT has been leading a very aggressive campaign to get CRU's on board.

So, east coast places that use VCT:

- Celerion
- Clinilabs
- Lifetree
- SNBL

[respect]

The profiteers who own these database dont care whether we debate who own their companies or if their ads are poorly made. They have nothing to lose unless we legally challenge their infringements under HIPAA.
They have proceeded with little regard because of their eption of lab rats as class B citizens not worthy of the protection of HIPAA. This class B citizenship conferred on subjects by clinical research units eminates from society at large.

We are well aware that many research subjects are minorities. This further impacts how you are treated in these units and yes the liberty they take with your privacy under HIPAA simple because you are eived of not worthy of those privileges or not intelligent enough to challenge your assigned class B status.
What you are encouraged to do is discuss the issues with members of your community. A family, a friend, a teacher, a pastor, your account, your lawyer and see if they would be comfortable being herded into a database.
We need investigate the application of these database where research unit participants over all are mostly white. The results may surprise you.

[mike]

Hunh? Minorities? What in the world does the eived ethnicity or race of any particular study participant(s) have to do with the VCT issue?

[yhwhzson]

dangermouse,
You say that when you went to CRI they informed you that they were implementing VCT?
What day did you go?

[travelingrat]

Apr 28, 2013 1:44:17 GMT -5 mike said:

Hunh? Minorities? What in the world does the eived ethnicity or race of any particular study participant(s) have to do with the VCT issue?

i wondered about this also. i do believe that whatever ethnicity we are, we are basically expendable bodies with only two rights: the right not to sign up for a study and the right to quit. i think the IRB's are basically worthless if a labrat has questions or problems. i have emailed many with questions and received only form responses ... very disheartening to me.

but some of the post seems to be only connected to the VCT issue by a thin thread of lack of rights and respect in general for labrats.

still, i found the post interesting in that i applaud any of us who stands up for any of our rights (privacy rights and VCT or whatever) re clinical trials. it takes guts. i have a close friend who complained to the management about celerion NJ a few years back and was subsequently thrown out in the middle of a study.

and this is off-topic too ... jsut want to add that if one wants to complain, best way to do it is with others if you possibly can. it is much harder for a clinic to ignore or oust a group of rats!

[mike]

Definitely, labrats of all colors need to band together, but also we need to have the gumption to stand up to some clinics or clinic employees even if we think we are by ourself in our protest. I have done this before and suddenly found that many of the other people in the study were irritated by what was going on also.

I have never even tried to use the IRB's, I guess they always struck me as a pretty useless position created to give the appearance of an independent monitor. But people should still file an official complaint with them if it falls under their purview as even useless bureaucrats eventually have to actually do soing if they are given enough prodding and especially if they feel like they are becoming liable from the information they are given.