PHT LogPad Improves DURECT's Ability to Measure Treatment Benefit More Accurately in Post-Herpetic Neuralgia Clinical Trial
Electronic patient diary minimizes statistical noise in data, enables trial success
CHARLESTOWN, MA – April 23, 2007 – How do you measure pain in a clinical trial? Certain objective outcomes, such as cholesterol and blood sugar levels, are easily assessed with accurate devices and tests. The only dependable way to determine pain level, however, is to ask the patients directly – and the excess noise found when using paper diaries to accomplish this has led to the failure of many clinical trials. PHT’s LogPad® System is the market-leading electronic patient reported outcome (ePRO) system, used in over 280 clinical trials worldwide by forward-thinking study sponsors, such as DURECT Corporation, in order to improve data quality and reliability.
DURECT selected PHT’s LogPad System to collect symptom and quality of life data from 50 patients in a Phase II post-herpetic neuralgia (PHN) study. People suffering from PHN experience episodic pain and usually take prescriptions to manage their pain.
“An adequate understanding of the effects that new medications have on pain levels and the quality of life that patients are experiencing is crucial to developing new and better treatments,” said Peter Langecker, Chief Medical Officer at DURECT. “ePRO data, collected in real time from patients using PHT’s handheld devices, is our approach to solving this challenge.”
“In the past, I have been involved with numerous pain research trials using paper diaries,” said Dr. Nacer Dean Abrouk, Vice President of Biostatistics at DURECT. “The potential problems resulting from paper-based data were the excessive variability and biases due in part to relying on patients’ recall of information. The researcher was also limited in the ability to ensure and verify the timing of the data collection and the actual time the paper case report forms were filled out by the patient. For example, it was impossible to verify when patients took any rescue medication (opiates) to relieve their pain in relation to the pain score recording. Opiates are powerful drugs with significant side effects, and reliable knowledge of medication timing and compliance is critical. Traditional paper data collection tools seem to contribute to larger than necessary clinical trials sizes, and may diminish our ability to conduct successful studies, especially in the pain therapeutic area.”
PHT’s LogPad System enables clinical researchers to increase the reliability of patient reported outcomes by reducing time-based recall biases and by increasing diary compliance. This improves the accuracy, timeliness and validity of the patient data, thereby enhancing the credibility of the findings.
“The LogPad’s time-stamped data alone gives our trial a much higher scientific validity from a regulatory standpoint,” said Dr. Abrouk. “In addition, narrow time response windows allow us to reduce variance considerably. Paper diaries lack such controls. In fact, we estimate that actual patient compliance with paper diaries, in terms of patients completing records when they claimed to, was approximately 50%. With the LogPad, we’ve gone from much noise in the data to minimal, which is important from the viewpoint of the regulatory authorities rendering a verdict on our trial.”
“PHT is excited to help DURECT collect reliable ePRO data from patients in this important study investigating a new therapy for a painful condition,” said Phil Lee, PHT President and CEO. “No one would argue that paper data is error prone, and we are pleased that DURECT is taking advantage of the LogPad’s proven ability to minimize excessive data variability and biases, and to run a faster, more economical clinical trial.”
About DURECT Corporation
DURECT Corporation is an emerging specialty pharmaceutical company developing pharmaceutical systems based on its proprietary drug delivery platform technologies. The Company currently has a number of late-stage pharmaceutical products in development addressing large markets in pain management, with a number of research programs underway targeting chronic disease and other therapeutic areas. For more information, please visit www.durect.com.
About PHT Corporation
PHT is the market-leading provider of electronic patient reported outcome (ePRO) solutions used in more than 280 clinical trials around the world. Our proven LogPad® and StudyPad® Systems deliver the voice of the patient – directly and without distortion – with reliable and timely self-reported data. Patient experiences captured firsthand by PHT’s ePRO Product Suite have been used successfully in at least eight NDA submissions, with five known approvals, to date. To learn more about how study sponsors worldwide are using ePRO to improve data quality, conduct smaller trials, and manage patient safety, enrollment and compliance in real time, visit the new www.phtcorp.com.
PHT, LogPad and StudyPad are among the trademarks and registered trademarks belonging to PHT Corporation.
© 2007 PHT Corporation
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