Congress Abstracts 2005

221

TAKING IT TO THE STREETS: OPENING CLINICAL TRIALS SITES IN THE COMMUNITY. Patricia Green, MSN, MHSA, Audria Crowder, BS, and Norma Sheridan-Leos, RN, MSN, AOCN^®, CPHQ, Curtis and Elizabeth Anderson Cancer Institute, Savannah, GA.

All of the new anti-cancer agents are developed through clinical trials. Unfortunately, not all patients are aware of or participate in clinical trials. This hinders the introduction of new agents to patients that need them. Taking clinical trials to community oncologists’ offices may significantly increase recruitment and participation for both patient and physician.

This poster will describe the work of a nurse-led research team to open two community clinical trials sites in Southeast Georgia. Details will be provided for replication purposes.

In April of 2004, a medical oncologist expressed an interest in participating in clinical trials at his community office, but did not have the resources to manage this process. A nurse-led clinical trials team from a local cancer center devised and implemented the process for effective recruitment and data management. Specific interventions included: (1) Cost benefit analysis of implementing a clinical trials site in the office, (2) Review of the potential number of study subjects, (3) Education of the community office staff in clinical trials processes, (4) Development of standardized recruitment processes, (5) Quality Control system for data submission from the community office to the sponsors, and (6) Provisions for regulatory compliance.

This project is ongoing. Within forty-five days, the office was ready to recruit subjects. Due to the success of this endeavor, a second oncologist approached the nurse-led team to assist in opening a clinical trials site at his office.

Clinical trials are vital to advancing cancer care. Nurses are able to lead teams that are effective in bringing clinical trials to settings that are closer to the patient’s residence. Having a convenient clinical trials locations results in:

1. Increased patient/physician awareness of clinical trials;
2. Improved recruitment efforts;
3. The elimination of transportation issues; and
4. Better support for patients during the clinical trials process, which results in study completion.