[December 05, 2012]

PHT Corporation to Present at DIA Webinar, "Adult Oncology: Clinical Outcome Assessments (COAs) & Patient-Reported Outcomes (PROs)"

PHT Corporation will moderate and present a new DIA Webinar, "Adult Oncology: Clinical Outcome Assessments (COAs) & Patient-Reported Outcomes (PROs)" to educate clinical research professionals on how to incorporate Clinical Outcome Assessments (COAs) and patient reported outcomes (PROs) into the design of clinical trials in adult oncology.

PHT is the leading provider of innovative technology systems used to collect patient-driven eData for clinical research.

• When: December 11, 2012, 11:00am-12:30pm EST
• Register: http://www.goo.gl/yjbUp
• Who should attend: Professionals involved in clinical trials, data management, eClinical, health outcomes, medical affairs, oncology, and regulatory affairs

PRO and ePRO measures are standard tools for directly capturing patient experience data in clinical research. 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 in therapeutic areas including oncology.

Event moderator Sheila Rocchio, MBA, Vice President of Marketing and Product Management at PHT, said, "Attendees of the webinar will leave with a better understanding of the benefits COAs provide in oncology research and best practices for incorporating patient-driven outcomes in clinical trials."

The DIA Webinar addresses COAs within oncology in two parts:

1) Part l will review the current use of clinical trial outcome assessments in oncology. It will examine various instruments including QoL and the PRO-CTCAE electronic system deigned to improve the qualty and efficiency of developing, administering, completing, managing, and analyzing symptom questionnaires used for patient reporting in adult oncology.

2) Part II will focus on recommendations made within the Effectiveness Guidance Document (EGD) by the Center for Medical Technology Policy (CMTP) for incorporating PROs into the design of comparative effectiveness studies in adult oncology. This presentation will review what CMPT sets as minimum best practices for data collection, and review components of the EGD including the specific 15 Guidance Recommendations and 12 symptoms for consideration across studies in populations with advanced or metastatic cancers.

Presenters

Susan Dallabrida, PhD, Senior Scientific Advisor, PHT Corporation - Dr. Dallabrida has more than 10 years of experience as a Senior Scientist and Project Director in R&D, clinical trial design and strategy, and product development. She has led cross-functional drug discovery and product development teams and collaborations in a wide range of therapeutic areas including oncology, cardiovascular disease, hemophilia, dermatology, obesity, and vascular disorders.

Ethan Basch, MD,MSc, Director, Cancer Outcomes Research Program; Associate Professor of Medicine and Public Health, University of North Carolina at Chapel Hill - Dr. Basch is a medical oncologist and health services researcher. His clinical expertise is prostate cancer, and his research expertise includes patient reported outcomes, drug regulatory policy, and comparative effectiveness research. He is a member of the PCORI Methodology Committee, a member of the Board of Scientific Advisors of the National Cancer Institute, Co-Chair of Health Outcomes for the Alliance Cooperative Group, and a Board member of the International Society for Quality of Life Research.

About DIA

DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related medical products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; and Beijing, China. Visit www.diahome.org for more information on DIA. Follow DIA on Facebook, Twitter, LinkedIn, and YouTube.

About PHT Corporation

PHT Corporation helps pharmaceutical companies and CROs conduct clinical studies with greater confidence, ease and accuracy. PHT enables clients to gain insights, through measuring how patients feel and function, that help speed new therapies to market and improve lives. From its 600 global trial experiences including 16+ regulatory approvals, PHT offers the breadth, history and scientific expertise today's market demands. Proven PHT eCOA 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 to patients between visits for improved protocol compliance and safety monitoring. For more information on patient-driven eData, review the interactive content and demonstrations at phtcorp.com. Follow PHT on Twitter and Linked In.

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