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Case Studies

Leading pharmaceutical companies share success stories on the use of the PHT eCOA system.

PHT Client Success Stories:

In the demanding world of clinical research, it is helpful to learn from the innovative use cases of sponsors who have used PHT's ePRO/eCOA systems to achieve their research goals effectively and efficiently.

Merck Research Laboratories: Insomnia Study 

Merck Research Laboratories: Insomnia Study

Presented by Merck’s Dr. Jay Pearson, Senior Director, Epidemiology Dept., and PHT Chief Scientific Officer, Dr. Steve Raymond at DIA 2004 and ISOQOL annual meeting, June 2004
What if you could reduce your sample size by half? When you collect better data, you can do more with fewer patients - thereby saving significant cost and shortening your trial. An insomnia study performed by Merck was the first randomized trial to compare the relative abilities of paper and eDiaries to show efficacy. The study found that PRO data collected by the LogPad exhibited a 35% lower standard deviation than paper diary data.

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Asthma Invervention Research 2(AIR2) Trial – Phase III 

Asthma Invervention Research 2(AIR2) Trial – Phase III

How sites really feel about using ePRO.

The AIR2 Trial, a pivotal Phase III study sponsored by Asthmatx, investigates the safety and effectiveness of Bronchial Thermoplasty™, the first non-drug treatment for asthma, using the Alair® System. 300 patients at 35 global sites use the LogPad to record and transmit daily symptomatic data on their experiences following treatment. Two principal investigators took to time to tell PHT about the benefits and challenges of using ePRO in a trial.

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Temple University: COPD Disease Management Study 

Temple University: COPD Disease Management Study

Can a call center and a LogPad reduce hospitalizationsand improve QoL?

Published: 2006

Temple's unique disease management study uses the LogPad to investigate the impact of a pulmonary call center on COPD patient hospitalizations, deaths, lung function and quality of life. The LogPad uses automatic graded scoring and real-time alerts at the site to identify warning signs of exacerbations, and notifies patients when they need to contact the call center based on these scores. Early results have reduced hospitalizations significantly - but don't take our word for it. To learn more, read the case study or watch the news report, which features patient and study coordinator interviews.

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ePRO in Action for Phase II 

ePRO in Action for Phase II

Author: Shelia Rocchio
Published: March 2010
Source: Applied Clinical Trials On-line

Sanofi Pasteur had used electronic patient reported outcome (ePRO) solutions provider PHT Corporation in previous trials. "eDiaries motivate subjects to complete their daily questionnaires. In addition, it is much more efficacious to ask subjects how they feel at a precise moment and get an immediate, accurate answer," said Vicki Tyler, Clinical Trial Manager at Sanofi Pasteur's Massachusetts facility, who oversees the Clostridium difficile study

Read the Complete Case Study information at appliedclinicaltrialsonline.com

 
Tackling Allergy Studies with an eDiary ‘Paper vs. Electronic’ 

Tackling Allergy Studies with an eDiary ‘Paper vs. Electronic’

Published: Oct 2, 2008
Source: Applied Clinical Trials Online

Patti Hall, RN, CCRC, director of clinical research at Family Allergy, explained, the immediate information they receive as a subject completes a questionnaire enables her team of nine coordinators and investigators to know in real time if a subject is being compliant and answering the questionnaire. "It gives us the opportunity to keep an eye on patient safety and also to make sure they complete every question and enter data correctly," she said. "The questionnaire is designed so the patient has to answer each question appropriately before proceeding to the next one."

Read the Complete Case Study information at appliedclinicaltrialsonline.com

 
ALK-Abello 

ALK-Abello

Author: Valdo Arnera, MD
Published: October 2010
Source: Applied Clinical Trials Online
ALK is currently developing a house dust mite (HDM) immunotherapy tablet. In the latest HDM clinical trial, ALK used an ePRO system from PHT to enable subjects to record their experiences in the trial. ePRO is the electronic capture of patient reported outcomes (PRO) data from study subjects. This was the seventh trial in which ALK used ePRO solutions from PHT.

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