1. Outcome Measures WG October 16, 2008

2. Agenda Brief introductions Meeting Mechanics Methodology/Process Meeting Schedule Definitions Discussion: Scope & Issues CRF Review: COH2649 Adjourn

3. WELCOME !! Brief introductions Ami Biggi (AmyBiggi@westat.com)AmyBiggi@westat.com Andrea Hwang (ychwang@uci.edu)ychwang@uci.edu Anne Ryan (ryana@mail.nih.gov)ryana@mail.nih.gov Betty O'Meara (eomeara@phila.acr.org)eomeara@phila.acr.org Bev Meadows (meadowsb@mail.nih.gov)meadowsb@mail.nih.gov Charlotte Furey (cfurey@exelixis.com)cfurey@exelixis.com David W Hillman (Hillman.David@mayo.edu)Hillman.David@mayo.edu Eric Lickerman (elickerman@daedalussoftware.com)elickerman@daedalussoftware.com Deb Grant (dgrant@phila.acr.org)dgrant@phila.acr.org Diane Paul (Funnylady93@earthlink.net)Funnylady93@earthlink.net Dianne Reeves (reevesd@mail.nih.gov)reevesd@mail.nih.gov

4. Brief introductions (continued) Donald P Connelly MD, PhD (don@umn.edu)don@umn.edu –Outcome Measures WG Lead (612 624-4689) Mary Cooper (MARY.J.COOPER@saic.com) Pamela Harvey (pharvey@phila.acr.org)pharvey@phila.acr.org Paul Courtney (courtney_paul@bah.com)courtney_paul@bah.com Rebecca Hills (hillsr@u.washington.edu)hillsr@u.washington.edu Rhonda Facile (rfacile@cdisc.org)rfacile@cdisc.org Riki Ohira (ohira_riki@bah.com)ohira_riki@bah.com –Point of Contact, CRF Project Stephen Dorian (Sdorian@phila.acr.org)Sdorian@phila.acr.org Tim Peters (TPeters@childrensoncologygroup.org)TPeters@childrensoncologygroup.org Wendy Bergantz (wbergantz@phila.acr.org)

5. Meeting Mechanics Teleconference information (number and pass code) and Centra information (url and event id) will be sent with the email announcements and listed in the Agenda. This group is working primarily through email, teleconference meetings (using Gforge to store files). –GForge Page: https://gforge.nci.nih.gov/projects/ctmscrfwghttps://gforge.nci.nih.gov/projects/ctmscrfwg –Select “Docs” tab –Select “Outcome Measures” –No Listserv, so either Reply-All to a previous email or create your own local email list / group for this WG. Zip file caution. –More and more institutions are blocking emails that have.zip files attached...as they consider them too great a risk for viruses. So, keep in mind, if you send a zip – several folks may not get it. –Notify us if the file is too big to email otherwise and we’ll work something out.

6. Meeting Mechanics Using Centra To ask a Question Attendees To answer Yes or No When “nature” calls…don’t forget to Mute your phone. Functions – click once to select, again to deselect To express yourself!

7. CRF Standardization - Methodology Review Vision and Scope of CRF Standardization: –https://cabig.nci.nih.gov/workspaces/CTMS/ARCHIVED_CTWG_Implementation/crf-standardization- sig/CRF_Documents/index_htmlhttps://cabig.nci.nih.gov/workspaces/CTMS/ARCHIVED_CTWG_Implementation/crf-standardization- sig/CRF_Documents/index_html Goals & Methodology 1.Assemble a representative sample of forms – PLEASE SUBMIT SAMPLES!! 2.Agreement on core questions/data associated with an agents-related CRFs Determine question intent Partition into: Mandatory, Conditional, Optional or Non-harmonized 3.Detailed analysis: work with caDSR curator (NCI’s Cancer Data Standards Repository) to map these to CDEs in the caDSR More info on caDSR: http://ncicb.nci.nih.gov/NCICB/infrastructure/cacore_overview/cadsrhttp://ncicb.nci.nih.gov/NCICB/infrastructure/cacore_overview/cadsr 4.End Product: a set of well-described questions (CRF), derived through consensus, that are mapped to common data elements (CDEs) in the caDSR Build off of CDASH effort with a focus on cancer. –More info on CDASH: http://www.cdisc.org/standards/cdash/index.htmlhttp://www.cdisc.org/standards/cdash/index.html Caveat: We should not be creating new questions that have not been asked before on an existing CRF.

8. CRF Standardization - Methodology Partition Categories Mandatory: –A data collection variable that must be on the CRF (e.g., a regulatory requirement (if applicable)). Must be used. Conditional: –A data collection variable that must be collected on the CRF for specific cases that may be dictated by local or sponsor defined business rules. Optional: –A data collection variable that is available for use if needed. Usually collected due to the design of the protocol, like in instances where marital status or educational level are important indicators in a study. Non-harmonized: –A data collection variable that is, by consensus, to primarily belong to a different CRF module or is not belonging to any defined module.

9. CRF Standardization - Methodology Map to CDEs / Detailed Analysis Work with caDSR Curator to assemble questions into spreadsheet and Start mapping to CDEs in the caDSR Workgroup needs to harmonize on: –Question meaning –Question text –Valid values (where applicable)

10. Meeting Schedule 1st and 3rd Thursday of each month 11:30 AM – 1:00 PM ET –Dial-in: 1-866-819-8739 –Passcode: 9035127 –Centra http://ncicb.centra.com ID: outcomeshttp://ncicb.centra.com –October 16, 2008 –November 6, 2008 –November 20, 2008 –December 4, 2008 –December 18, 2008 –January 15, 2009 –January 29, 2009*

11. Some definitions From Hiatt RA et al, 2004, JNCI Monograph In cancer, –final endpoints (outcomes) include such traditional and important biomedical outcomes as survival and disease-free survival, but also health-related quality of life (HRQOL), perceptions of and satisfaction with health care, and economic burden. Final outcomes are distinguished from –“intermediate” outcomes (e.g. whether the individual was screened for cancer, or quit smoking, or received appropriate adjuvant therapy following cancer surgery) and –“clinical” outcomes (e.g., whether the patient’s tumor shrank or disappeared, or whether the tumor recurred). Definitions from NCI Dictionary of Cancer Terms –endpoint In clinical trials, an event or outcome that can be measured objectively to determine whether the intervention being studied is beneficial. The endpoints of a clinical trial are usually included in the study objectives. Some examples of endpoints are survival, improvements in quality of life, relief of symptoms, and disappearance of the tumor. –outcome A specific result or effect that can be measured. Examples of outcomes include decreased pain, reduced tumor size, and improvement of disease.

12. Discussion: Scope & Issues

13. CRF Review: COH2649 Got to GForge –https://gforge.nci.nih.gov/projects/ctmscrfwg/https://gforge.nci.nih.gov/projects/ctmscrfwg/ Select “Docs” tab Select “Outcome Measures” Select “Sample CRFs Inventory” Select “COH Outcome Measure CRFs” Select “COH2649_prostate response.pdf”

14. Adjourn Thank you Next Meeting: –November 6, 2008, 11:30 EDT