PHT Corporation to Present at DIA Webinar, “Adult Oncology: Clinical Outcome
Assessments (COAs) & Patient-Reported Outcomes (PROs)”
BOSTON & GENEVA -- December 05, 2012
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
*Who should attend: Professionals involved in clinical trials, data
management, eClinical, health outcomes, medical affairs, oncology, and
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 quality 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.
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.
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.
for PHT Corporation
Brenda Nashawaty, 617-688-3253
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