Strategies for Coding Oncology Trial Data in Today’s World

2 part webinar
60-minute presentation followed by 30-minute Q&A

 

Presenter

Sandra Oyola, clinical research scientist at Inovio Biomedical, is a board-certified medical technologist and has been an associate member of the American Society of Clinical Pathologists since 1993. Sandra has worked in for-profit and nonprofit environments, sponsor and CRO, and in drug, device and IVDD trials for the past 11 years. She is a member of the WHODrug Working Group for Standardized Drug Queries (SDQs) and has created an SDQ for Antineoplastics. SDQs will be implemented in March 2010.

 

Overview
A working knowledge of MedDRA and WHO Drug are essential to coding oncology trial data. Strategies will be discussed to overcome the challenges of coding unique concepts found within oncology data. Implementation of the CTCAE Version 4.0 will help facilitate coding and reporting of adverse events. A frequent challenge for medication coding is combination chemotherapies, which are not included in the WHO Drug dictionary to date. Utilization of the MedDRA and WHO Drug browsers provide essential tools for coding processes. Standardized MedDRA queries and standardized drug queries can be utilized for signal detection. Discussions related to future strategies to address these issues will also be presented.

Session 1
Coding for Oncology Studies

Part 1 - CTCAE v4.0 and MedDRA
The purpose of the NCI Common Terminology Criteria for Adverse Events (CTCAE) is to standardize AE reporting and grading in clinical trials. The CTCAE v4.0 integration with MedDRA has been recommended for use in oncology trials as of October, 2009. The recently released version of the CTCAE is mapped to the current version of MedDRA (12.1). Each AE term is represented in CTCAE as a unique MedDRA term and definition.

Discussion includes an overview of the CTCAE v4.0, MedDRA terminology, and the MedDRA Browsers.

Part 2 - Coding Chemotherapies
WHODrug, the World Health Organization Drug Dictionary, is used for coding medications. Over 180,000 unique names are available in the WHODrug B-2 Format, and the C Format contains over 1 million medications.

Discussions include an overview of the WHODrug Dictionaries, the online browser and strategies to code chemotherapy regimens which will be implemented in future releases of the WHODrug Dictionaries.


Session 2
Searching for Data: Standardized MedDRA Queries (SMQs) and Standardized Drug Queries (SDQs)

SMQs and SDQ are groupings of MedDRA or WHODrug terms, related to a defined area of interest, intended to aid in the identification and retrieval of potentially relevant individual case safety reports or signal detection for prohibited medications. In July 2008, the work of developing the Standardized Drug Queries started. A working group of coding experts was formed and the result of the work within the group is presented as the pilot release of the SDQs. The first SDQs released in the pilot version aim mainly to test the format of the files.

The session will include an overview of SMQs, the newly released pilot version of the SDQs, and strategies to use these two tools for mining data.


Level
Intermediate

Outcomes

  • Explain the implementation of CTCAE Version 4.0 toxicity reporting
  • Discuss of the challenges and strategies for coding chemotherapy regimens
  • Explain the value of the MedDRA and WHODrug browsers
  • Describe Standardized MedDRA Queries (SMQs) and Standardized Drug Queries (SDQs)

Attendees Who Will Benefit From This Webinar Include:

  • Coding Coordinators
  • Medical Monitors
  • Drug Safety Associates
  • Programmers
  • Statisticians

Continuing Education Credit Opportunity

Attendees are eligible for CEUs upon attendance and successful completion of assessment questions.  Each part of this 2 part webinar carries 0.2 CEUs.
SCDM is authorized by IACET to offer .2 CEUs for this program.

 

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