Rachel Vojvodic and Shelly Sayre are the project managers for the Cardiovascular Cell Therapy Research Network.  Presently, they coordinate all of the activity associated with two approved phase II clinical trial protocols and another phase II protocol which is currently pending FDA approval.  The study, which has received funding for five years from the National Heart, Lung, and Blood Institute (NHLBI) is investigating autologous bone marrow derived adult stem cells for treating cardiovascular disease.

Because the study is using these adult stem cells, Rachel and Shelly anticipate that some patients will have questions regarding
stem cell therapy and the differentiation between embryonic and (Shelly Sayer and Rachel Vojvodic)
adult autologous stem cells.  They have been working on a public
portion of their forthcoming website which includes educational information about the difference between these two types of stem cells and how they will derive and prepare the adult stem cells for the trials. (See www.cctrn.org)  While they are not yet recruiting for the two approved trials, they hope to do so within the next two months.

The UT School of Public Health is one of five clinical centers involved in the Network (the others being Texas Heart Institute, Minneapolis Heart Institute Foundation, Cleveland Clinic, University of Florida, and Vanderbilt University).  The UTSPH Coordinating Center for Clinical Trials serves in the role of the Coordinating Center for the entire network.  The fact that this is a multi-center site poses a great challenge for Ms. Vojvodic and Ms. Sayre.  The concept of Network-sponsored projects is still somewhat new.  The Network (comprised of research teams at five clinical centers, the Coordinating Center, the Steering Committee Chair, and the NHLBI Project Office) proposes ideas for studies; develops, agrees on, and carries out the protocols; and publishes the findings together.

“It has been a daunting task to coordinate the budgets and determine a reimbursement strategy that would satisfy multiple PIs and administrations in different states”, says Sayre.  “The plot thickens when you add in multiple cell processing and reference laboratories, six core laboratories, a new web-based eCRF system for data collection and research in a relatively new field.”

The challenge becomes more difficult because the Network originally set a goal to initiate three trials simultaneously, multiplying the complex process mentioned above times three.

When asked what advice would Sayre and Vojvodic give to other study coordinators and research nurses on coordinating a multi-site study, they stressed the importance of involving the nurse coordinators at the clinical centers every step of the way; their input is invaluable to the success of the trial.  Also, identify and maintain good relations with seasoned veterans at the sites to respond to budget information requests.  Lastly, establish a timeline that allows for a sound foundation to be created while providing flexibility for the unanticipated.