Science Weekly: Nobel prizewinner Andre Geim, and Steve Jones on incest

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2010 Nobel prizewinner Andre Geim speaks to the pod, Brian Cox takes us around Cern, and we investigate the science of incest

Ending Mindless Monitoring

The following article in it’s completeness was published this past week in, October 4, 2010, by Mark D. Uehling

“Some contract research organizations (CRO) had to be dragged into using technology. They presented at conferences, pooh-poohing software. They doubted, delayed, complained. They did not necessarily advocate fountain pens and carrier pigeons. But they could quote a price on ink and birdseed.

“And then there are people like Jules Mitchel, president of Target Health. He delights in the power of technology as much as any software vendor, except that his day job is running a mid-sized New York City CRO with 45 employees. Mitchel and his team represent 30 sponsors at the FDA, with perhaps 40 projects under way at any given time. The company’s clients have won three product approvals during the 2010 calendar year: one in Canada and two in the U.S. In aggregate, over the existence of the company, Target Health has helped clients bring 27 products to the market. Nineteen of those products included trials that relied on Target Health’s proprietary electronic data capture (EDC) solution. Mitchel’s stuff works.

Sleepy CTTI

“When we checked in with him recently, he assured us that the work of the Clinical Trial Transformation Initiative (CTTI) was not … ahem … moribund. (Note to self: hold off publishing that CTTI obituary.)

“As readers may recall, some very smart people at Duke Clinical Research are trying to corral a diverse group of high-level industry, academia and FDA representatives into experimenting on a few truly revolutionary projects. Those efforts are ongoing. If codified into regulation some day, they could push the modern clinical trial abruptly into the 1990s, when other industries discovered the Internet.

“Mitchel’s company is on the steering committee of the CTTI. He says the group is making steady progress. He can’t speak for the organization. But he can opine that its work has already shown that automatic monitoring of all records at all clinical sites according to some rigid, preset schedule is not necessary from a regulatory perspective. Or cost-effective.

Uncommon Sense

“In other words, mindless monitoring of everything is not mandated by U.S. law or Good Clinical Practice guidelines. Says Mitchel: “There was no scientific rationale for monitoring plans in clinical trials. It was mostly based on peoples’ previous experiences and what they were taught.”

“Mitchel thinks that the FDA might eventually clarify what the agency has long said at conferences: that its rules never demanded routine, rote, automatic monitoring of every data point under the clinical sun.

“What might make more sense? A risk-based approach, Mitchel speculates. That might involve doing source document verification on 100 percent of all initial case report forms (CRF). Using that inspection of the data, a sponsor or CRO might identify a few critical scientific variables and verify only those. The concept is to confirm the protocol is indeed being followed, and then check the most important data. “It’s 100 percent unnecessary,” he says about 100 percent source document verification.

“Instead, Mitchel says, an assessment of the protocol and the sites themselves should drive a more limited, selective examination of the data. Some of that examination could happen remotely, using technology. Says Mitchel: “We need to show evidence-based monitoring works. We have to prove it. That’s what CTTI is all about – not showing it theoretically.”

“Target Health is about to start two trials in which there are no paper source documents. One is a Phase II project, the other is a pivotal Phase III. Mitchel foresees no regulatory issues on those projects. Regulatory officials are aware of the paperless aspects, he says. Mitchel anticipates 50 percent cost savings in the data monitoring budgets. Such savings could be appealing to sponsors feeling economic pressures. Sometimes, it seems, the future arrives before even forward-looking companies expect it.”d9A2t49mkex

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