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24 April 2006

The following was published in the 14 April 2006 edition of eCliniqua,  The scientific editor of eCliniqua is Mark Uehling. For information about Bio-IT World, and how to subscribe to eCliniqua, please visit their website http://www.bio-itworld.com/.

Expo Highlights: EDC and Clinical Trial Design at InfaCare  -  Mark Uehling

InfaCare Pharmaceutical, a four-year-old small pharma out of Philadelphia, is working on a drug for neonatal hyperbilirubinemia. InfaCare estimates that one newborn in twelve is at high risk of the condition, and one in four is at moderate risk. Ben Levinson, consulting pharmaceutical physician for InfaCare, noted the company was on a limited budget, but still wanted to use electronic data capture (EDC). InfaCare used just half a dozen investigators, finding 800 neonatal patients.

To handle the data, Infacare selected Target Health, a technologically adroit clinical research organization (CRO) in New York City. InfaCare's three trials (one still under way) have used paper source documents, but in general the whole operation has been Internet-based. And it has gone smoothly. "We had one final interim report five weeks after the database was closed," Levinson said. He was especially glad that Target Health involved programmers and data managers upstream of data collection earlier than some in the industry, even as the trial protocols were being designed. Levinson insisted that those data architects start thinking about the structure of the database early, while there was still time to optimize it. Elsewhere in the industry, he notes, that expertise is sought only after the trial is completed. Levinson was also glad to see data from two different laboratories (an analytical lab and the usual hospital lab) automatically populate the same database. That facilitated trend analysis and patient-by-patient data review. "We had it all on one electronic case report form (eCRF)," Levinson said of the lab data.

As many readers know, there are differing approaches to compare paper trial documents to electronic data-a process called "source document verification" (SDV). Large pharmas tend to do SDV on all data, but cost-conscious companies tend to view such an approach as extravagant. InfaCare has been doing 100 percent SDV, but in the future may take a different tack. Target Health's software could allow it to pick and choose mission-critical fields. Said Levinson: "With paper, you have to do 100 percent source data verification because there are no electronic edit checks up front."

Using the same database, Target Health also supplied an email newsletter for investigators participating in the trial. That publication served up milestones and metrics, listed by a number assigned to each site. But the investigators knew each other. And the recruitment numbers encouraged a measure of friendly jostling among investigators. "They almost started to get in a little competition about how to keep up," Levinson noted about patient recruitment metrics. The newsletter was also a communication tool to track adverse events and serious adverse events. "Everybody could stay up to speed with something we found," said Levinson. Levinson believes that the up-front work before the start of a study can significantly affect the quality of the data, and it's fair to say he's happy with the services provided by Target Health. He believes that smart CROs can figure out ways to optimize site productivity and the scientific insights expected from a trial.  

In previous articles about Target Health, this newsletter has noted how the company blurs the line between a CRO and a technology supplier. There's another wrinkle here. We'd love feedback from readers on this. But it's clear that for small sponsors across the industry, the right services partner and the right technology provider can result in a far more effective database design and clinical trial workflow. We're sure that's happening with many vendor-sponsor pairings. Still, the InfaCare-Target story in Boston was quite compelling.

After the show, we checked in with Jules Mitchel, Target Health's president. He related that InfaCare had signed up for a typical package of services. What, exactly, has Target Health done for InfaCare? "We have done web trials, biostatistics, data management, protocol writing, and regulatory affairs consulting," Mitchel said. "We have also assisted with their European partner. We provided guidance to InfaCare when they were on clinical hold, and interacted with one of their key investigators, a professor of pediatrics at Stanford University. As a result of that interaction, we are now collaborating with Stanford, under a government grant, to evaluate jaundice in newborns." The combination of CRO and technology vendor and trial design assistance was new to us, we must confess. Not to Target Health. "The full drug development team must now collaborate prior to study start," Mitchel said. "Because the database, data management plan, and data entry screens need to be up and running before the study starts, there is an increased chance that the study will be well designed."

TARGET HEALTH INC.
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New York, NY 10016
Phone: (212) 681-2100; Fax (212) 681-2105
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Dr. Jules T. Mitchel, President
Ms Joyce Hays, CEO
©2006 Target Health Inc. All rights reserved