PHT Corporation Hosts Upcoming Adult Oncology Webinar ‘Clinical Outcome Assessments (COAs) and Patient Reported Outcomes (PROs)’

Webinar highlights scientific literature based best practices and Regulatory Guidance for researchers incorporating Patient Reported Outcomes and Instruments in adult oncology trials

BOSTON & GENEVA--(BUSINESS WIRE)--Join Dr. Susan M. Dallabrida, Senior Scientific Advisor, Department of Technical Operations and Consulting Services, PHT Corporation, for a webinar, “Adult Oncology: Clinical Outcome Assessments (COAs) & Patient Reported Outcomes (PROs)” February 27, 10:00-11:00am EST. PHT is the leading provider of innovative technology systems used to collect patient-driven eData for clinical research.

“Adult Oncology: Clinical Outcome Assessments (COAs) & Patient Reported Outcomes (PROs)”

Patient-reported outcome (PRO) and electronic PRO (ePRO) measures are standard tools for directly eliciting the patient experience for Clinical Outcome Assessments (COAs). The 2009 FDA Guidance for Industry Patient Reported Outcome Measures: Use in Medical Product Development to Support Label Claims highlights the importance of PROs and other Clinical Outcome Assessment (COAs) in clinical research. Increasingly, oncology therapies have been leveraging COAs and electronic COAs to demonstrate treatment benefit for patients.

This one-hour webinar is designed for professionals in clinical trials, data management, eClinical, health outcomes, medical affairs, oncology, and regulatory affairs. Dr. Dallabrida will review:

• Published papers comparing electronic to paper data collection in oncology;
• The completion of PRO/ePRO assessments by prostate patients to determine variables that might affect compliance; and
• Various instruments including QoL and the PRO-CTAE system which has been developed to provide the cancer research community with an electronic platform to improve the quality and efficiency of administering, completing, managing, and analyzing symptom questionnaires used for patient reporting.

At the conclusion of the webinar, participants should be able to:

1. Understand measures and instruments being used for COAs in oncology;
2. Describe how to incorporate COAs and PROs into the design of clinical trials in adult oncology; and,
3. Explain what the Center for Medical Technology Policy (CMTP) sets as minimum best practices to ensure that data collection allows for examination of patients’ directly reported experiences.

The session leader, Dr. Susan Dallabrida, has more than 20 years of experience in clinical trial design, strategy, and R&D in therapeutic areas including cancer, cardiovascular disease, hemophilia, vascular disorders, obesity, and aging. She has led multiple cross-functional oncology drug discovery and product development teams and collaborations. Dr. Dallabrida has 20 peer-reviewed articles, 14 grants, 3 patents, 15 abstracts and 29 conference presentations. Her 17 awards include the Harvard Catalyst Pilot Award and David Bray Scholars in Medicine from Harvard Medical School, Young Investigator’s Awards, NIH grants, biotechnology/pharmaceutical sponsored funding (Genentech, Amgen, Astrazeneca), and foundational grants (American Heart Association, Heart and Stroke Foundation, Plastic Surgery Education Foundation, Leet/Guthrie Patterson Trust Foundation). Dr. Dallabrida received a B.A. in Chemistry and a B.S. in Biology, both cum laude, from Bloomsburg University and a Ph.D. in Biochemistry and Molecular Biology from Pennsylvania State University.

The PHT Consulting Services Team has more than 100 years of collective experience in ePROs and COAs. The Team guides pharmaceutical researchers and clinicians in implementing optimal ePRO/COA trial design strategies to ensure the success of drug development programs. PHT consults on all aspects of collecting COAs, with scientific, regulatory, data management and health outcome expertise.

Register at: http://bit.ly/WDcPPt

About PHT Corporation

PHT Corporation helps pharmaceutical companies and CROs conduct clinical trial programs with greater confidence, ease and accuracy. Proven PHT eCOA (electronic Clinical Outcome Assessment) Systems collect patient-driven eData via smartphones, tablets and the web. This data, available via the PHT StudyWorks® online 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 600+ global trials resulting in 16 regulatory approvals. PHT offers the regulatory, technological, and scientific expertise today’s market demands and patients deserve. Visit www.phtcorp.com for more information on PHT. Follow PHT on LinkedIn, Twitter and YouTube.