|By Business Wire||
|December 2, 2013 08:01 AM EST||
The PHT Corporation LogPad® System was used by Gilead Sciences, Inc. (NASDAQ: GILD) on the Phase 4 TERISA trial which measured the antianginal effect of Ranolazine in T2DM patients in the therapeutic areas of cardiology and endocrinology. PHT Corporation is the leading provider of technologies used to collect patient-driven eData for clinical research. The LogPad System, which has been used on more than 650 clinical trials, eliminates data quality concerns created by a paper diary.
Eight million people in the U.S. alone suffer from chronic stable angina, yet many patients remain undertreated. Gilead Sciences successfully completed their TERISA trial and collected the needed FDA regulatory-compliant patient-reported outcomes (PROs) primary endpoint data with the LogPad System. The LogPad System was customized to fit the trial’s needs to provide accurate and verified data.
- A clinical trial to support Gilead Sciences’ work to benefit angina sufferers
- Confirmation that eDiaries are an effective and economical way to capture angina endpoints such as episodes and dyspnea in angina patients vs. treadmill or paper diaries
- Evidence that global patients, including elderly patients, demonstrate high and stable compliance with diary completion at 98%
Download the complete case study here: http://bit.ly/PHTCaseStudies
Patrick Yue MD, Director of Cardiovascular Clinical Research at Gilead Sciences, explained, “Gilead Sciences chose the PHT LogPad System because it eliminated poor quality paper diary data and logistics concerns. Observing the patient-reported number of angina episodes and sublingual nitroglycerin use over a period of time follows the increasing regulatory emphasis on PROs. It also provides a significantly more cost-effective trial design. With the PHT LogPad System, an ePRO diary could be designed and customized to fit the exact TERISA trial needs.”
Watch Dr. Yue talk about his experience working with PHT on the TERISA trial: http://bit.ly/GileadVideo
The LogPad System was advantageous vs. other ePRO providers because PHT has significant experience in the angina indication, having run previous global Phase 3 angina studies in similar regions around the world. Additionally, PHT enabled Gilead to integrate data from the LogPad System directly into an Electronic Data Capture System, Medidata Rave, to streamline data management. PHT’s international logistics expertise allowed for seamless device delivery, trial integration and translation into local languages in 14 countries including Russia.
PHT President and CEO Philip Lee said, “PHT was proud to work with Gilead on this important study. It is another proof point that PHT eCOA Systems are an extremely effective method for collecting compliant PROs that enable sponsors to speed the delivery of new drugs and treatments to patients who need them.”
To hear other case studies, innovations and best practices about PROs and eCOA Strategy and Systems, register for the 2014 PRO & eCOA Congress at bit.ly/16EYVSg. PHT invites all Congress alumni to join the exclusive PRO & eCOA Congress LinkedIn Community to exchange information, ideas and experiences throughout the year.
About Gilead Sciences, Inc.
Gilead Sciences (NASDAQ: GILD) is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.
About PHT Corporation
PHT Corporation helps pharmaceutical companies and CROs conduct clinical trial programs with greater confidence, ease and accuracy. Proven PHT electronic clinical outcome assessment (eCOA) Systems collect patient-driven eData via smartphones, tablets and the web. This data, available via StudyWorks™ online reporting portal, provides sponsors and clinicians with a real time window into how patients feel and function. PHT has helped trial sponsors collect patient-driven eData in 650+ global trials resulting in 16+ regulatory approvals. PHT Clinical Science and Consulting offers the scientific, regulatory, and technological expertise today’s eCOA market demands and patients deserve. Visit phtcorp.com for more information on PHT. Follow PHT on LinkedIn, Twitter, Google+ and YouTube.