"The industry has bottomed out and is on its way up," says Norman Goldfarb, chairman of the Model Agreement Group Initiative (MAGI), a volunteer organization dedicated to streamlining clinical research.

Twice a year, on the east and west coasts respectively, Goldfarb helps to plan the MAGI conference. For 2010, the eastern conference is scheduled for the last week of May in Boston. Goldfarb says the attendees are the people who do the bulk of work at clinical sites and contract research organizations (CROs).

"It's the hands-on people that are the primary audience," Goldfarb says. He's also the managing partner of First Clinical Research, which publishes the Journal of Clinical Research Best Practices. Going back a few years, he helped to found Calgene, an early biotech that Monsanto purchased in 1997.

'Cleansing Process'

Goldfarb has his ear to the ground. One theme of this year's meeting will be embryonic, not-yet-draft guidances, regulations and enforcement actions. Some of it can be traced not so much to President Barack Obama's new team as to escalating FDA budgets, he says, which allow the agency to respond to historic problems. "We're seeing a more proactive FDA," he says. "We're going to be seeing more guidances and regulations," potentially clarifying the responsibilities of institutional review boards (IRBs) and clinical sites.

One potential future guidance would require sponsors to report individuals and sites that are deliberately falsifying clinical trial data. That could be a significant new federal push to ensure more integrity in the corporate scientific realm. The reporting responsibility would rest entirely with sponsors.

"The idea is that if a sponsor sees a site is falsifying data, according to the new rule, they would be required to report that to the FDA," Goldfarb says. On Feb. 19, 2010, FDA asked for public comment on such a rule in the Federal Register. "A sponsor would be required to report this information to the appropriate FDA center promptly, but no later than 45 calendar days after the sponsor becomes aware of the information," the agency said.

Goldfarb muses that the new requirement could be an outgrowth of the Ketek scandal, in which an Alabama site's egregious falsifications were silently tolerated for years by a major U.S. contract research organization, a French sponsor and the FDA itself.

Goldfarb's views can be baldly phrased. He would welcome consolidation among U.S. research sites. Investigators who find few patients and limp along, he notes, are hardly serving science or doing themselves any favors.

"There are too many investigators in the U.S., of which many are not committed to clinical research," Goldfarb says. "The ones who are not committed should leave the industry. There should be a cleansing process in which the good sites get more attention and build stronger relationships with sponsors and do better financially because they do good work—anywhere in the world."

Discontented Scientists

Having said that, he's hearing something a bit more worrisome. Some of the scientists leaving the industry are not the low performers but the most experienced investigators. The reasons: money and bureaucracy. "The people you'd like to keep are getting out of the business. It's too much hassle. It's not profitable," he says.

Another factor in sites' discontent may be technology. Some independent surveys suggest that sites are relatively happy with electronic data capture systems. But that is not what's on the grape vine, he reports. "The anecdotal stories I hear express high levels of discontent with EDC," Goldfarb says.

Payment Particulars

The 2010 conference will have six tracks, two of which relate to contracts and budgets. The pharmaceutical industry continues to take its time paying clinical sites, he says. Some investigators, making most of their income with other activities, can afford to wait 140 days to be paid for industry-sponsored research. Other sites are getting more sophisticated about contracts and payments and getting their money a bit earlier.

Goldfarb says the relative scarcity of traditional invoices in clinical research can lend a curious quality to the industry. Investigators may receive a check in the mail, and be left to search their records to determine which study or activities it might relate to.

Goldfarb is not claiming comprehensive knowledge of all sponsor activity on the investigator relationship management (IRM) front, but says he is aware of two sponsors that are attempting to do a bit more: Pfizer and sanofi. Top contract research organization Quintiles is also trying to deliver more than sugary rhetoric about sites as valued partners. Says Goldfarb: "A sponsor that wants to build strong relationships with sites needs to do more than what the average sponsor is doing."

Quality Gap

At the same time, Goldfarb says, sites have been incongruously excused from worrying too much about the quality of their research. Few sites categorize queries or examine the origin of the problem underneath the query. Few sites collect metrics to show sponsors hard numerical indications of their performance. Goldfarb compares the situation of sponsors cleaning clinical data for sites to parents excessively helping children with homework. "The message that the sponsors are sending is 'Don't worry about quality,' " he says.

Goldfarb suspects that a few sponsors are starting to selectively, and belatedly, award bigger budgets to sites that generate higher quality data. But doling out those rewards is somewhat random. He'd rather see clear contractual incentives for cleaner data, and does not anticipate ethical issues around such clauses.

Another perennial topic is the degree to which some sites bill insurers for services that are rendered to patients, and not otherwise reimbursed by industry for research-related reasons. At this year's conference, Goldfarb reports, "there is going to be a whole workshop on it. The big research sites are really scrambling to get systems in place. There are several different [federal] laws the government can use to go after a site. You do not want the Office of the Inspector General (OIG) after you."

Compliance Issues

There have been perhaps half a dozen settlements between research-oriented sites and the OIG and the Centers for Medicare and Medicaid Services (CMS), he says. This is a report on OIG activity.

A key question for most sites is what good-faith methods are being used to keep track of which procedures. The goal is to have some sort of process to sort out which procedures should be billed to a research-oriented drug company—and which to a federal payor or commercial insurance program. Some sites use a billing code like "ZZ." Others elect to establish a nonexistent, fictitious insurance company which helps the sites to stay organized.

Says Goldfarb: "No matter how good your system is, you're going to make mistakes. Medicare understands that. They're looking for people to set up systems to make a good effort to comply. If you make a sincere effort, you'll be in the middle of the herd. You're not going to get eaten by a lion."

Here's the agenda for this year's meeting in Boston and the companion conference in San Francisco in October.

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