Drugmakers Tap Hospital Data For Clinical Trials

Drugmakers Tap Hospital Data For Clinical Trials

November 7th, 2011 // 1:26 pm @ jmpickett

Finding patients for clinical trials is not so easy in the US, but a new test project beginning this month 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. “There is no central database,” David Krusch, head of PACeR’s leadership team and director of medical informatics at the University of Rochester Medical Center, tells Bloomberg. “We’re not dumping big buckets of de-identified data anyplace. Pfizer will not have a network connection, say, to the University of Rochester, or to any other participant in the network.”

Of course, privacy concerns are going to remain, despite any patient benefits. Karen Maschke of the Hastings Center, a bioethics group that did consulting work on PACeR, tells the news service that she supports the effort, but adds that “I’m also a skeptic. There probably should be conversations at the national level about best practices for these endeavors to guard confidentiality.”

For drugmakers, the project could be a bonanza, given that estimates suggest that delays in late-stage trials can cost more than $1 million a day. “If pharmaceutical companies can make this happen faster and more cheaply, they’re big winners,” C. William Schroth, a former consultant for the New York State Health Department, tells Bloomberg.

Source: Pharmalot