SYS-CON MEDIA Authors: Carmen Gonzalez, Sean Houghton, Glenn Rossman, Ignacio M. Llorente, Xenia von Wedel

News Feed Item

Gilead Sciences, Inc. Uses the PHT Corporation LogPad® System for 1st Antianginal Drug to Treat Type 2 Diabetes

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.

The result:

  • 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.

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
In her General Session at 15th Cloud Expo, Anne Plese, Senior Consultant, Cloud Product Marketing, at Verizon Enterprise, focused on finding the right mix of renting vs. buying Oracle capacity to scale to meet business demands, and offer validated Oracle database TCO models for Oracle development and testing environments. Anne Plese is a marketing and technology enthusiast/realist with over 19+ years in high tech. At Verizon Enterprise, she focuses on driving growth for the Verizon Cloud platfo...
The Internet of Things will greatly expand the opportunities for data collection and new business models driven off of that data. In her session at @ThingsExpo, Esmeralda Swartz, CMO of MetraTech, discussed how for this to be effective you not only need to have infrastructure and operational models capable of utilizing this new phenomenon, but increasingly service providers will need to convince a skeptical public to participate. Get ready to show them the money!
"Matrix is an ambitious open standard and implementation that's set up to break down the fragmentation problems that exist in IP messaging and VoIP communication," explained John Woolf, Technical Evangelist at Matrix, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
P2P RTC will impact the landscape of communications, shifting from traditional telephony style communications models to OTT (Over-The-Top) cloud assisted & PaaS (Platform as a Service) communication services. The P2P shift will impact many areas of our lives, from mobile communication, human interactive web services, RTC and telephony infrastructure, user federation, security and privacy implications, business costs, and scalability. In his session at @ThingsExpo, Robin Raymond, Chief Architect...
What do a firewall and a fortress have in common? They are no longer strong enough to protect the valuables housed inside. Like the walls of an old fortress, the cracks in the firewall are allowing the bad guys to slip in - unannounced and unnoticed. By the time these thieves get in, the damage is already done and the network is already compromised. Intellectual property is easily slipped out the back door leaving no trace of forced entry. If we want to reign in on these cybercriminals, it's hig...
We are reaching the end of the beginning with WebRTC, and real systems using this technology have begun to appear. One challenge that faces every WebRTC deployment (in some form or another) is identity management. For example, if you have an existing service – possibly built on a variety of different PaaS/SaaS offerings – and you want to add real-time communications you are faced with a challenge relating to user management, authentication, authorization, and validation. Service providers will w...
"ElasticBox is an enterprise company that makes it very easy for developers and IT ops to collaborate to develop, build and deploy applications on any cloud - private, public or hybrid," stated Monish Sharma, VP of Customer Success at ElasticBox, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
The term culture has had a polarizing effect among DevOps supporters. Some propose that culture change is critical for success with DevOps, but are remiss to define culture. Some talk about a DevOps culture but then reference activities that could lead to culture change and there are those that talk about culture change as a set of behaviors that need to be adopted by those in IT. There is no question that businesses successful in adopting a DevOps mindset have seen departmental culture change, ...
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at Internet of @ThingsExpo, James Kirkland, Chief Ar...
WebRTC defines no default signaling protocol, causing fragmentation between WebRTC silos. SIP and XMPP provide possibilities, but come with considerable complexity and are not designed for use in a web environment. In his session at @ThingsExpo, Matthew Hodgson, technical co-founder of the Matrix.org, discussed how Matrix is a new non-profit Open Source Project that defines both a new HTTP-based standard for VoIP & IM signaling and provides reference implementations.
The 4th International DevOps Summit, co-located with16th International Cloud Expo – being held June 9-11, 2015, at the Javits Center in New York City, NY – announces that its Call for Papers is now open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's large...
DevOps Summit 2015 New York, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is obsolete...
The definition of IoT is not new, in fact it’s been around for over a decade. What has changed is the public's awareness that the technology we use on a daily basis has caught up on the vision of an always on, always connected world. If you look into the details of what comprises the IoT, you’ll see that it includes everything from cloud computing, Big Data analytics, “Things,” Web communication, applications, network, storage, etc. It is essentially including everything connected online from ha...
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation of details. It's the vision of a world in which continuous Internet connectivity and addressability is embedded into a growing range of human artifacts, into the natural world, and even into our smartphones, appliances, a...
Connected devices and the Internet of Things are getting significant momentum in 2014. In his session at Internet of @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, examined three key elements that together will drive mass adoption of the IoT before the end of 2015. The first element is the recent advent of robust open source protocols (like AllJoyn and WebRTC) that facilitate M2M communication. The second is broad availability of flexible, cost-effective ...