invivodata Collects Primary Endpoint Data for
FDAs First New Drug Application Approval Based on PDA Patient
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
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
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. invivodatas 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.