# Presentation: 506909

## CTMS Steering CommitteePanel Discussion

***caBIGTM Clinical Trials Management Systems Workspace Face-to-Face Meeting***
***May 30 – 31, 2007***
***Portland, Oregon***

## Panel

**Bob Annechiarico (Duke University)**
**Sharon Elcombe (Mayo Clinic)**
**Meg Gronvall (Booz Allen Hamilton, General Contractor)**
**Charles Hurmiz (St. Jude’s)**
**Kim Johnson (Cancer and Leukemia Group B)**
**Warren Kibbe, Ph.D. (Northwestern University)**
**Sorena Nadaf (Vanderbilt University)**
**Peter Schad, Ph.D. (Federal Observer, NCI Division of Cancer Control and Population Sciences)**
***Moderator: John Speakman (Federal Observer, NCI Center for Biomedical Informatics and Information Technology)***

## Questions

**Who’s on the Steering Committee?**

## The CTMS Steering Committee - Composition

**15 “Trialists”**
- PIs from Phase III Therapeutic, Phase I/II Therapeutic, Prevention/Behavioral, Imaging/Radiology, CCOP, SPORE
- Statisticians, Data managers, RNs
- Pharmaceutical company PIs
**13 “Informaticists”**
- Cancer Center informaticists, Cooperative Group informaticists
- Clinical trials registry expert, terminology expert, database/systems development expert, electronic medical records integration expert, clinical trials operations expert, biospecimen repository expert, one standards organization representative, one pharmaceutical/IT industry representative
**Two Patient Advocates**
**14 Federal Observers (13 NCI, one FDA)**

**Notes:**
Be sure to mention that these members represent the breadth of organizations involved in cancer research including:
Cancer Centers
CoOp Groups
CCOP
Pharma

## The CTMS Steering Committee – “Trialists”

**James Atkins, M.D. (Wake Forest)**
**Powel Brown, M.D. (Baylor)**
**Jan Buckner, M.D. (Mayo)**
**Walt Cronin (NSABP)**
**Howard Fingert, M.D. (Pfizer, Inc.)**
**David Gandara, M.D. (UC Davis)**
**Bob Gray, Ph.D. (Dana-Farber)**
**Collette Houston (Memorial Sloan-Kettering)**
**David Johnson, M.D. (Vanderbilt)**
**Philip Kantoff, M.D. (Dana-Farber)**
**Kristin Padavic, R.N. (Fox Chase)**
**Electra Paskett, M.D. (Ohio State)**
**Nick Petrelli, M.D. (Delaware CCOP)**
**Mitch Schnall, M.D. (UPenn)**
**Donald Trump, M.D. (Roswell Park)**

**Notes:**
Be sure to mention that these members represent the breadth of organizations involved in cancer research including:
Cancer Centers
CoOp Groups
CCOP
Pharma

## The CTMS Steering Committee – “Informaticists”

**Bob Annechiarico (Duke)**
**Chris Chute, Ph.D. (Mayo)**
**Hugh Donovan (Siemens)**
**Sharon Elcombe (Mayo)**
**Charles Hurmiz (St. Jude’s)**
**Chuck Jaffe, M.D. (Intel)**
**Kim Johnson (CALGB)**
**Warren Kibbe, Ph.D. (Northwestern)**
**Rebecca Kush, Ph.D. (CDISC)**
**Sorena Nadaf (Vanderbilt)**
**Ida Sim, M.D., Ph.D. (UCSF)**
**Mark Watson, M.D., Ph.D. (Wash U.)**
**Brenda Young (American College of Radiology)**

**Notes:**
Be sure to mention that these members represent the breadth of organizations involved in cancer research including:
Cancer Centers
CoOp Groups
CCOP
Pharma

## The CTMS Steering Committee – Patient Advocates and Federal Observers

**Diane Paul (Patient Advocate)**
**Kevin Lewis (Patient Advocate)**
**Jeff Abrams, M.D. (NCI CTEP)**
**Frank Balis, M.D. (NCI CCR)**
**Ken Buetow, Ph.D. (NCICB)**
**Jim Doroshow, M.D. (NCI DCTD)**
**Leslie Ford, M.D. (NCI DCP)**
**Lakshmi Grama (NCI OCE)**
**Ernie Hawk, M.D. (NCI OTCR)**
**Carl Jaffe, M.D. (NCI DCTD)**
**Randy Levin, M.D. (FDA)**
**Sheila Prindiville, M.D. (NCI CCCT)**
**Peter Schad, Ph.D. (NCI DCCPS)**
**John Speakman (NCICB)**
**Peggy Tucker, M.D. (NCI DCEG)**

**Notes:**
Be sure to mention that these members represent the breadth of organizations involved in cancer research including:
Cancer Centers
CoOp Groups
CCOP
Pharma

## Questions

**How were they selected?**

## Questions

**What’s the Steering Committee’s broad remit?**

## Questions

**How does the Steering Committee make decisions? Can they be overridden by the Government?**

## Questions

**What’s the role of Federal Observers?**

## Questions

**How will CTMS Workspace activities be prioritized?**

## Questions

**Do Steering Committee members get paid? **

## Questions

**What was the Agenda for the Steering Committee kickoff meeting on March 7?**

## Questions

**What decisions were made in the following areas?**
- (1)   Library of Standard Case Report Forms (Conduct)
- (2)   Clinical Trials Database (Reporting and Sharing)
- (3)   System Interoperability and Harmonization 			     (Interoperability)
- (4)   Investigator and Site Credential Repository (Planning 		     and Monitoring)

## Questions

**Will minutes be published?  Are there other ways to find out what was discussed, what decisions were made and what if any action will be taken as a result?**

## Questions

**Who is the Steering Committee Chair?**

## Questions

**Will the Steering Committee members focus/align with specific TF/SIGs, or will everyone discuss everything?**

## Questions

**Does the SC only focus on the CTWG initiatives?**

## Questions

**When is the SC reconvening?**