SOURCE: PHT Corporation

November 11, 2008 09:00 ET

PHT Corporation and Clinvest Partner on Landmark Migraine Cognitive Processing Program Using ePRO

Clinical Study With 500 Patients Is the First Major Study to Measure Cognitive Processing Efficiency During Migraine Attacks

BOSTON, MA--(Marketwire - November 11, 2008) - PHT Corporation, the market-leading provider of electronic patient reported outcome (ePRO) solutions used in more than 360 clinical trials worldwide, is providing its innovative LogPad® System to help headache experts at Clinvest Clinical Research measure cognitive deficits during migraine attacks in a sponsored clinical trial. This is the first time cognitive processing time has been tested in a major migraine research study.

Forward-thinking technology providers such as Clinvest and PHT enable scientific researchers to ask new and exciting questions in clinical research. In prior research with a U.S. military computerized testing system, Clinvest founder Roger K. Cady, MD, realized his migraine patients did not have the same cognitive processing speed as non-sufferers. Dr. Cady believed the changes in migraine patients resulted from dysfunction in the speed of the brain's ability to process information, i.e., cognitive processing efficiency. This resulted in the first objective handheld cognitive processing system, called the Mental Efficiency and Workload Test (MEWT), in June 1997. Since then, Clinvest has conducted more than 200 Phase II-IV clinical research trials at its state-of the-art facility in Springfield, Missouri.

Recently, one of the world's leading pharmaceutical companies asked Clinvest to create and manage a MEWT for 500 subjects in a migraine trial occurring in 50 sites across the United States. The groundbreaking protocol planned to use these results as primary efficacy data (as opposed to number of headache-free days, for example). Because subjects are required to complete a battery of cognitive assessments at home, in conjunction with a daily diary, the client suggested Clinvest work with PHT Corporation to implement the study with minimal respondent burden by using the industry's leading electronic patient diary.

The trial examines the effect of barbiturates on pain, mental alertness, cognitive efficiency, and fine motor function for six months. As patients use PHT's LogPad to report on migraine occurrence, duration and severity, they are given electronic tests to measure their ability to perform simple calculations and react appropriately to stimuli. They also assess their quality of sleep.

"We didn't have to reinvent the wheel for this program," said Dennis L. Reeves, Ph.D., and Vice President at Clinvest. "We partnered with PHT to integrate our highly sensitive cognitive processing test system into the LogPad. The test results are seamlessly transferred into the PHT database and we can access it for the data analysis from almost anywhere. It's perfect. We provide the objective assessment and PHT has surveys they include in the testing system. Because the LogPad automatically uploads the data to the database, the Clinvest analysis team can remotely review, download analyze and report on the cognitive data in real time."

Dr. Reeves, and his associate Dr. Elsmore, pointed out those electronic diaries hold several advantages over paper.

"There's no question that the 'old school' paper diaries are usually filled in after-the-fact by memory," said Dr. Reeves. "For example, a subject may complete two weeks of diaries just prior to a clinic visit. When we are talking about assessments that need to be accurate to a tenth of a second, data from recall is totally unacceptable. Conversely, with the eDiary and MEWT, we know exactly when the test is taken because we record time and date, and we store test results immediately. In terms of data analysis, the eDiary is a phenomenal advantage."

Dr. Reeves continued, "We've enjoyed working with PHT. They consider human factors when engineering the LogPad to avoid information overload or giving the patient too much work. The design keeps the patient motivated to fill out the electronic questionnaire."

"ePRO is more than digitized paper diaries," explained PHT President and CEO Phil Lee. "Assessing a treatment's ability to enhance or prohibit reduction of cognitive processing efficiency is a rapidly emerging center of study in the pharmaceutical industry. Other studies have taken advantage of cognitive assessments on the LogPad to capture data which may serve as a competitive differentiator, such as a pain drug which is proven not to impair concentration or cause drowsiness. We are privileged to be working with Clinvest on this novel program and look forward to providing ePRO technology that helps clinical trial sponsors worldwide optimize data quality, program efficiency, and patient safety."

About PHT Corporation

Trust your patient and questionnaire data again. PHT is the market-leading provider of electronic patient reported outcome (ePRO) solutions used in more than 360 clinical trials by 90 biopharmaceutical clients. The proven LogPad® System and revolutionary SitePad™ Tablet deliver the voice of the patient, in 80 languages, from homes and sites in 60 countries around the world. By capturing high-quality and time stamped assessments with minimal respondent burden, transmitted over reliable analog and wireless global technologies, sponsors are able to run smaller and more conclusive clinical research programs. Real-time study management through PHT StudyWorks™ features eClinical data integration, standard and custom data summaries for compliance and enrollment, SafetyPRO™ email alerts, and the industry's premier study archive. Patient experiences captured firsthand by PHT's ePRO Product Suite have been used successfully in at least 11 NDA submissions and seven approvals to date. For more information, review interactive product demonstrations at the award-winning www.phtcorp.com.

About Clinvest

Clinvest is a research organization dedicated to the advancement of medicine and health management through clinical research and education. The Research Management Department conducts and manages multi-center medical research with primary care providers throughout the United States. Phase III and Phase IV trials, marketing surveys and practice-related outcome questionnaires are sponsored by pharmaceutical companies, clinical research organizations, and local and federal government agencies including National Institutes of Health (NIH). Investigative sites are selected from the Clinvest Research Network. The Clinical Research Department conducts FDA Phase II-IV research at our centrally-located, state of the art facility. Our dedicated team of Research Professionals is committed to excellence, making us one of the leaders in the field of Clinical Research. More than 200 clinical trials sponsored by leading pharmaceutical companies have included: headache, hypertension, diabetes, osteoarthritis, GI disorders, Alzheimer's disease, fibromyalgia, herpes simplex, asthma, low back pain, inflammatory bio-markers, and high cholesterol. For more information, visit www.clinvest.com.

PHT, LogPad and SitePad are among the registered trademarks and trademarks of PHT Corporation.

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