FDA’s First New Drug Application Approval Based on PDA Patient Diary

invivodata Collects Primary Endpoint Data for FDA’s First New Drug Application Approval Based on PDA Patient Diary Data

Proves Model for Collection of Valid, Reliable and Sensitive Patient Self-Report Data on a Handheld Computer

PITTSBURGH — June 16, 2003 — invivodata inc., the industry leader in PDA patient self-report solutions for clinical research, today announced that the U.S. Food and Drug Administration (FDA) has approved the first drug for which the primary efficacy data in Phase III pivotal trials were collected using a handheld computer based patient diary. Allergan Inc. received the approval for its pharmaceutical ACULAR LS (ketorolac tromethamine ophthalmic solution) 0.4%, an ophthalmic non-steroidal anti-inflammatory drug.

“Collecting the patient self-report data needed for a New Drug Application (NDA) can be challenging,” said Elizabeth Bancroft, senior director of regulatory affairs at Allergan. “As primary endpoint data for this drug, it was critical that submitted data were collected using a proven methodology that would meet FDA 21 CFR part 11 requirements. This approval validates our confidence in the self-report data collected with the invivodata PDA based eDiary system.”

invivodata's PDA Patient Diary System was used to capture real-time data both immediately after corneal refractive surgery and for several days afterward. Patients were asked to make repeated real-time entries on the eDiary, which delivered more than 7,200 reports to help distinguish the results of the drug vs. placebo.

“We have been working closely with Allergan and the FDA to ensure that the patient self-report data collected met their high standards,” said Doug Engfer, president and CEO of invivodata. “It is exciting to see our electronic patient diary system playing a central role in NDAs.”

About invivodata inc.

invivodata combines behavioral science, information technology and clinical expertise to capture clinical trial data of the highest integrity directly from patients. invivodata’s electronic patient self-report system delivers high-quality patient self-reported data by driving patient compliance with the protocol and eliminating recall biases that plague self-report studies. The invivodata solution also provides real-time access to study data, giving researchers and sponsors visibility into study progress and improving trial efficiencies. The invivodata eDiary system has been used in more than 60 trials involving tens of thousands of patients. It has also collected more than 5 million patient-initiated records, far more than any other electronic diary solution. invivodata inc. is a privately held company with headquarters in Pittsburgh; its primary development center is in Scotts Valley, Calif.


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