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
eData for clinical research.
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
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
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
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,
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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