Drugmakers Tap Hospital Data For Clinical Trials
 

Drugmakers Tap Hospital Data For Clinical Trials

Finding patients for clinical trials is not so easy in the US, but a new test project ... hopes to speed the process and lower costs. Called the Partnership to Advance Clinical Electronic Research, or PACeR, the effort is a collaboration between five large drugmakers, 13 hospitals across New York, clinical research organizations, health information technology companies and regulators.

The idea is to cull data from hospital records that can be used to identify patients who may be appropriate for specific clinical trials. Along the way, the drugmakers hope to save money and hospitals are forecast to make up to $75 million a year. “This is going to be a game changer, making medicine more of a science and less of an art,” says John Murphy, senior director of clinical analytics for Quintiles Transnational, tells Bloomberg News.
How will it work? The drugmakers - those involved are Bayer, Roche, Johnson & Johnson and Pfizer - would pay PACeR up to $200,000 to sift through the records of the hospitals to find patients whose profile would fit the criteria for a trial, according to Bloomberg, which notes the project is designed to comply with federal law that prevents hospitals, as well as doctors and insurers, from disclosing such info (read more on the PACeR site here).

From there, a hospital would contact a patient’s physician, but not before receiving approval from an ethics board, but no personal data can be accessed without patient consent...

http://www.pharmalot.com/2011/11/dru...inical-trials/

(wonder why the guy quoted is from a clinical research organization? And why this whole enterprise makes me very very anxious...madelyn)

scary
 

I don't like this at all. I'm all for "getting the word out there" about trials, as I do think some folks' doctors aren't as well informed about trials as they could be. But to cull through hospital records? Who knows what else they might glean, and how it will be used, and to whom it might be sold, er, I mean shared? "safeguards"..."ethics boards"..."controls" my #@!

I wonder if there is a way of "opting out" of this, short of never going to a hospital, sort of like the "do not call" list for phone solicitation. Because that's what this really is, another way to solicit, but in a much more dangerous way.

Why don't the drug companies just advertise the trial on TV or in magazines, just like they do for drugs, and if folk are interested they can contact their doctor? Would drug companies be allowed to cull through hospital records to see if a particular drug might go with a particular patient? No way, so why is this different? Oh, silly me, it's not , it's just cheaper for the drug companies.

With the internet, facebook, twitter, youtube, etc., you can find out more than ever about what is going on in your area of interest. I don't really think lack of awareness is the main reason there are not enough people, as they claim, to participate in trials. I think some docs aren't that convinced a trial drug/procedure is worth it (we've had a couple of neuros poo-poo things we wanted to go after), and/or a lot of folks have done the research and drawn that conclusion themselves. We were invited to participate in a gene therapy trial, but did some research and declined. And the kicker as well: some people have seen what the longer-term side effects can be once a drug's approved and don't want to take the risk (lipitor, etc.).

HIPPA might as well not exist if they are going to let this go through. I'm not sure even the other doctor-patient confidentiality laws would help that much in this situation either. Would a doctor be obligated to talk to a patient that was identified as being a potential participant in an upcoming trial? If he were, would patients then view their doctor mentioning the trial to them as an endorsement of it, and something they should do? Would doctors, heaven forbid, get a small incentive to "strongly suggest" that a particular patient participate in a trial....kinda like how some docs currently get "incentives" to write scripts? I can't believe this is on the table.

additional coverage...
 

Thirteen hospitals in New York could see major investments in electronic patient records pay off in spades. Pfizer ($PFE) and four other large drug companies aim to pay the hospitals $50,000 to $200,000 every time the hospitals mine their databases and come back with a list of qualified patients for the drugmakers' clinical trials, Bloomberg BusinessWeek reported.

As pharma groups search for ways to make trials recruitment more efficient, the Partnership to Advance Electronic Patient Research (PACeR) has a pilot project in New York to improve the usability of electronic patient data for clinical researchers. Oracle ($ORCL) and Quintiles Transnational ($QTRN) are two firms helping to build the system required for the project, and large drug companies such as Pfizer, Roche, Merck ($MRK), Johnson & Johnson ($JNJ) and Bayer are backing the endeavor. The patient-recruitment effort, which could generate $75 million per year, gets started this month, according to the Bloomberg article....

http://www.fiercebiotechit.com/story...ource=internal

Landmine for doctors
 

Other concerns:

What effect will this have on physicians? Will they face an ethical issue of having to decide whether or not to tell a patient of an upcoming trial if they are contacted and advised that their patient "fits" the criteria? Will they get sued if they dont' mention the trial to that patient, or sued because they mention it, the patient participates, and something goes wrong?

It gets stickier and stickier, as they say.

What a nightmare for docs, I wonder if individual physicians support this whole concept?