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The Front Line
The Front Line: Charles D. Blanke, MD, SWOG Chair

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Quality is Word One

June 6, 2014 - Assuring quality in all we do is vital to successful scientific and other achievement. SWOG of course has had a long-standing commitment to monitor and improve the quality of every aspect of our work. This commitment was intensified under our previous Chair, Dr. Larry Baker, who specifically brought on Executive Officer Dr. Manuel Valdivieso to lead a still ongoing Quality Initiative (and to direct our International Initiative, which will be the subject of a future Front Line column). Working closely with SWOG Quality Assurance Manager Elaine Armstrong, who has guided the Group's efforts on that front since 1995, Dr. Valdivieso convened a Quality Initiative (QI) Subcommittee, which has now evaluated our clinical trials process across the continuum of patient eligibility, registration, pathology reports, performance status, consent forms and related regulatory processes, treatment administration, treatment side effects, quality of submitted data, response to queries, publications, and of course audit reports.

The QI Subcommittee has three current priorities. First, although there is a standard SWOG policy for defining and measuring disease progression when it is used as an endpoint in a study, protocols have not always spelled this out, and a review of audits over a number of years has found variability in how progression is assessed. The Subcommittee is working to remedy this and ensure consistency.

Second, as SWOG expands our global efforts, we find ourselves working with sites that do not always have the same trial approval process, procedures for shipping specimens, availability of study drugs, or other infrastructure resources we've come to expect as standard. The QI Subcommittee sees a need for a more active mechanism to monitor and assist international sites, and for a well defined policy to govern their participation in SWOG and NCI clinical trials.

Third, as the QI Subcommittee has formalized their procedures for assessing and improving quality within SWOG studies, they have also recently approached the National Cancer Institute leadership and proposed developing a similar program on an NCTN-wide basis to prospectively evaluate quality metrics across the network. NCI leadership has expressed interest and wants to revisit the question once the NCTN has hit its stride.

SWOG rises or falls on the quality of its research and the reliability of its data and conclusions. The QI team is there to help ensure the bar remains high, and I am happy to have them. Anyone interested in knowing more or even helping out is welcome to contact me or Dr. Valdivieso.


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