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SWOG Update
April 2010

Contents  
Welcome to the April 2010 SWOG Update.

For all members and friends of the Southwest Oncology Group, the SWOG Update will keep you informed of what's happening with the Group. News to report? Send it to communications@swog.org.

View a one-page version for printing.
 
Study Updates  
S0941: TKIs against biliary cancers
bile ducts illustration Just launched, S0941 tests combined erlotinib and sorafenib on patients with unresectable or metastasized gallbladder carcinoma or cholangiocarcinoma. [more]
 
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Administrata

Speeding the protocol and contract development process

-- by Nathan Eriksen, SWOG chief of administration

Nathan Eriksen, SWOG chief of administration
Photo: SWOG
We recently submitted a proposal to the National Cancer Institute in response to their RaPID grant request for applications. The RaPID program is meant to support cooperative group efforts to speed the process of protocol and contract development and implementation in line with the NCI Operational Efficiency Working Group's (OEWG's) recommendations.

The need for a shorter timeline for protocol development is one SWOG has understood, and has been addressing, for some time. Our SWAT process, which applies additional resources to ushering through high priority protocols on an accelerated development schedule, was rolled out initially in 2008.


Our competitive renewal process has just come to fruition, and when it was submitted a year ago we outlined our plan for many of the steps detailed below. When it comes to improving efficiency, our Group Chair, Dr. Baker, has been driving us toward change for some time. The OEWG recommendations and the RaPID program provide us additional input from the NCI to add to our own evaluations, give us a chance to align our tactics with those of the Institute, and (we hope) will bring us some badly needed funding to help implement our initiatives.

Our RaPID proposal outlines the steps we plan to take, including the following elements:
  • Hire a contracting specialist
    A new contracting specialist will help ensure that protocols and contracts move through the many review cycles in the development process according to an ambitious timeline.

    Study coordinators and protocol coordinators oversee all aspects of protocol development. The contracting specialist will focus on two aspects: timeline and contracting.

  • Upgrade existing protocol development tracking tool
    For several years, the protocol development team in the Operations Office has used an online tracking tool to track the process. We will enhance this tool in several ways, including adding a function that will automatically send reminder e-mails to reviewers when a deadline is approaching or has passed. We will also add Web-based tracking reports for those involved in the process.

  • Add a contract development tracking tool
    We're developing a module that will integrate the tracking of the contracts and protocol related grant applications along with the protocol itself.

  • Consultant to help improve adoption of the CIRB
    Garnering protocol approval by local Institutional Review Boards (IRBs) can be a lengthy undertaking, delaying initial activation of a trial at many sites, not to mention interrupting ongoing trial accrual as protocol amendments await approval.

    The National Cancer Institute's Central IRB (CIRB) was established to speed this process, replacing numerous individual reviews with one central review that could allow many sites to expedite their review. To date, though, most SWOG sites don't take advantage of the CIRB, still relying instead on review by their local IRB.

    Our RaPID proposal will bring in a consultant to help us better understand why many of SWOG's high-accruing institutions haven't switched to CIRB review and help encourage and facilitate that switch. Reducing the time to activation benefits individual sites as well as the Group as a whole. We need to do a better job of helping sites recognize these benefits.

Our RaPID proposal embraces the recommendations of the OEWG and lays out a plan that will, along with the dedicated effort of many individuals within the Group, allow us to meet their aggressive timelines.

When it comes to reducing the time between protocol concept and trial activation, we are focused on and dedicated to continuing improvement.

Administrata is an occasional column by Nathan Eriksen, chief of administration for the Southwest Oncology Group.

protocol and contract development timeline


Got news to tell? Send it to communications@swog.org.