CRO Communique - Oct -Nov, 2009

CRO Communiqué

Keeping you informed about CRO progress

October & November, 2009

Top Enrolling Physicians for Grant Year - (6/1/09 – 5/31/10)

With half of our grant fiscal year behind us, our enrollments are lagging behind NCI expectations.  We currently have 44.3 treatment credits and the NCI projection for this time period is 65.  Cancer Control credits are 13.5 with NCI expectation projections at 45 for this period.  We appreciate all efforts to put patients on a clinical trial.

Enrollment Efforts

As we continue to struggle with low enrollments, we have worked hard at promoting “N08C7- Phase III, Randomized, Placebo-controlled, Double-Blind Trial of Flaxseed for the Treatment of Hot Flashes”.  Steps we have taken include:

-Requested and received early approval of the study from both Cox and St. John’s IRB

- Promoted it at Cox’s Pink Ribbon Rally at Battlefield Mall on Saturday October 24^th

- Dr. Carolla and Dr. Holden sent a letter along with the flyer to all OB Gyn and family
               practice physicians at both institutions 

- Spoke with oncology nurse practioners at both OHA and CHC regarding the trial

- Placed flyers up in elevators, in waiting rooms, in physician offices, and at the breast
               centers of both institutions

- Promoted in St. John’s weekly co-worker announcements and in the “In Touch”
               employee newsletter

- Cox promoted the trial on their internal website.    

- Cox and St. John’s sent out a joint press release regarding the study

This is a great study and women do not have to have cancer to qualify.  Every woman wishes to avoid estrogen due to the perceived risk of breast cancer. The trial is of short duration - only 7 weeks.  Women are randomized to receive a flaxseed bar or to receive a placebo bar once a day for six weeks. At this time we have 5 women enrolled to the study. Others are reviewing the consent and our phone has been ringing from those interested. 

Community Outreach

A board of administrators and physicians from Cox and St. John’s explored the possibility of setting up a community IRB for CRO during the past six months.  The group decided not to pursue the establishment of an additional IRB specifically for CRO.  Instead they agreed to expand the opportunity for clinical trials to outlying communities by exploring the interest of oncologists in Branson, Bolivar, Rolla and West Plains.  Both CoxHealth and St. John’s IRB have agreed to provide regulatory or IRB coverage for these smaller communities.  At this time we are continuing to explore this opportunity.