ABA – Multicenter Trials Group Meeting
ABA 39th Annual Meeting
San Diego, CA
March 21, 2007

Welcome (Jeffrey Saffle)

Steering Committee update (Jeffrey Saffle)

• The steering committee members were introduced
• Jeffrey Saffle (Chair)
• Tina Palmieri (Vice-Chair)
• Linda Edelman (Secretary)
• Steve Wolf (Treasurer)
• Dan Caruso
• Mike Peck
• Karen Richey
• Recent Steering Committee activities
• Organizational structure has been established (see by-laws)
• MCTG research has two directions
•  Funded clinical trials
• Seeking funding for infrastructure
• Investigator initiated research

• Any ABA member can participate in the MCTG

• A formal relationship with the ABA has been established

• Bylaws have been presented to and approved by the ABA Board of Trustees

Discussion of Bylaws

• Dave Greenhalgh, ABA President, welcomed MCTG members and stated that the group has the support of the MCTG
• John Kirchbaum, ABA Executive Director, discussed why the Board of Trustees approved the Bylaws

• Provides formal structure
• Will help diffuse problems as they arise

• Questions were raised as to whether this puts the ABA at risk?

• The Bylaws provides a system of checks and balances for potential risks (HIPAA etc.)
• Must practice due diligence
• The group has much to gain by being associated with the ABA

Discussion of where the MCTG is going

• The SOS and Dr. Greenhalgh’s consensus conferences were big leaps
• Several concerns were raised

• How do we translate our small scale successes into large scale trials with a data monitoring center (DMC)?
• There are a number of committees in the MCTG structure. Do we have the expertise within the MCTG to fill these committees?
• Do we also need a formal relationship with the American College of Surgeons? NIH sponsorship?

• Jeffrey Saffle responded:

• We could easily limit ourselves to retrospective studies but there is a dearth of evidence for many basic issues in burn care
• These studies need to be conducted appropriately
• The best model is to have experts in burn care involved in managing a DMC
• The NIH is still not funding many clinical trials

• Mike Peck responded:

• In addition, the ABA has a track record of finding appropriate resources for performing specialty functions, such as quality control and safety monitoring.  For example, the ABA contracts with a professional lobbytist, Mr. Dan Crane, and also with a private, independent data management company (DI) for operation of the National Burn Registry.

Potential funding mechanisms

• Department of Defense (Tina Palmieri)

• The ABA and Dan Crane (lobbyist) presented the need for a DMC to Senator Barbara Boxer

• Impressed upon her the importance of having organizational structure (such as PECARN) when conducting large clinical trials
• There is precedence for this model in other organization (Cystic Fibrosis, etc.)

• Senator Boxers office is preparing a proposal for infrastructure funding for the MCTG

• Funding would provide support for future funding
• Must be prepared to move forward
• Dan Crane and Dr. Peck will meet with aides to Congressmen on the Hill, as well as aides on Senate and House Armed Services Committee next week to lobby for this appropriation
• Other possible funding sources (Steve Wolf)
• Congressional support
• Just need to ask
• Takes an act of Congress but “Congress does act”!
• The political culture is changing and this is a great opportunity for us to capitalize on current events

MCTG Website (Kitty Vineyard)

• The website has not been active
• It has been moved under the ABA website
• Everything will be public except for the Steering Committee section
• Please contact Linda Edelman (Linda.edelman@hsc.utah.edu) if you would like to post anything on the website

Proposed studies (please see attached slide shows for more details on individual studies)

• Glutamine (Alexis Armour for Dominique Garrels)
• Fungal Infections (Lee Cancio)
• The need for a DNA repository as a component of the DMC (Bob Barber)
• ICECI injury reporting (Mike Peck)
• Cross-state lines reimbursement (Mike Peck)
• Percutaneous abdominal decompression (Barbara Latenser)

Submitted by Linda S. Edelman 4/3/07