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

Overview

Patient-reported outcome (PRO) and electronic PRO (ePRO) measures are standard tools for directly eliciting the patient experience for Clinical Outcome Assessments (COAs). Ever since regulators approved Quality of Life (QoL) data sufficient to prove efficacy, oncology trials have been leveraging COAs and electronic COAs (eCOAs) for submissions. The first part of this Webinar will review the current use of clinical trial outcome assessments in oncology including a review of published papers that compare electronic to paper data collection in oncology; and an examination of various instruments including QoL and the PRO-CTAE. The PRO-CTCAE system has been developed to provide the cancer research community with an electronic platform to improve the quality and efficiency of developing, administering, completing, managing, and analyzing symptom questionnaires used for patient reporting.

The second part of this Webinar 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. Patient-centered outcome data are essential towards informed decision-making by multiple stakeholders, but there are no widely accepted standards for developing or implementing PRO measures in oncology CER. Learn what CMPT sets as minimum best practices to ensure that data collection allows for examination of patients’ directly reported experiences in this context. Various components of the EGD will be reviewed, including the specific 15 Guidance Recommendations and 12 symptoms for consideration across studies in populations with advanced or metastatic cancers. The relationship to PCORI’s more broad patient-centeredness methodological standards will also be reviewed.

Who Should Attend

Professionals involved in:

Clinical trials
Data management
eClinical
Health outcomes
Medical affairs
Oncology
Regulatory affairs

Learning Objectives

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

Describe what measures and instruments are being used for COAs in oncology
Describe how to incorporate COAs and PROs into the design of clinical trials in adult oncology
Discuss what CMPT sets as minimum best practices to ensure that data collection allows for examination of patients’ directly reported experiences

Contact Information

Agenda and Event Details
Colleen Braun, Content Lead
Phone +1.215.442.6160
Fax +1.215.442.6199
Colleen.Braun@diahome.org

Technical Requirements

Click here for minimum system requirements.

Presenter(s)

Previous Next

Sheila Rocchio, MBA

Vice President, Marketing
PHT Corporation, United States

Susan Dallabrida, PhD

Senior Scientific Advisor
PHT Corporation, United States

Ethan Basch, MD,MSc

Director, Cancer Outcomes Research Program; Associate Professor of Medicine
University of North Carolina At Chapel Hill, United States

Continuing Education

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The Drug Information Association designates this educational activity for up to 1.5 contact hours or .15 CEUs.
0286-0000-12-101-L04-P; Type of Activity: Knowledge

ACPE CREDIT REQUEST UPDATE
DIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor system. All ACPE-certified activity credit requests need to be submitted through DIA’s My Transcript within 45-days post activity. Pharmacists will need to provide their National Association of Boards of Pharmacy (NABP) e-Profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly. If you need to obtain your NABP e-Profile, please visit www.cpemonitor.net.

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102.

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer.2 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

Name	Credit Type	Max Credits	CEU
Adult Oncology: COAs & PROs	ACPE	1.50	0.150
Adult Oncology: COAs & PROs	IACET	1.50	0.200

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

If you would like to receive a statement of credit, you must participate in the live webinar, & complete the online credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” & you will be prompted for your user ID & password. Select “My Transcript” (left side bar) & “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Wednesday, December 26, 2012.

Registration Fees

Other Fees

Government (Full Time) Individual: $125.00
Charitable Nonprofit/Academia Individual: $175.00
Group Site: $799.00
Group Plus: $995.00

Member

Member Individual: $250.00

Non-Member

NonMember Individual: $295.00

Group Discounts

There is no Group Discount available for this event.

CANCELLATIONS
No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.

Participants with Disabilities
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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