Cancer Center Model For Early Phase Clinical Trials

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DESCRIPTION (provided by applicant) This proposal is to develop a community (network) model for conducting and enhancing patient participation in early phase clinical trials. In our model, the academic cancer center remains the focal point for these studies, which will be made available at selected community sites. To accomplish this goal, a number of barriers will need to be clearly elucidated and overcome. Since the vast majority of early phase clinical trials are currently conducted at academic medical centers under the direction of academic faculty, faculty attitudes and concerns about extending their trials to community sites will need to be explored and barriers overcome. For our clinical faculty, i.e. community-based oncologists/hematologists, who choose to participate in early phase clinical trials, this will be a new effort. Despite having experience in cooperative group and phase II/III pharmaceutical trials, these physicians and their staffs have not participated in early phase clinical trials. Their attitudes and concerns about participating in these trials will need to be defined and are likely to include perceptions about faculty-clinical faculty interactions, their own lack of time, training, and resources. In addition, patient barriers that exist in the community setting that up to this time has prevented wider participation in early phase clinical trials will be investigated. Based on our assessments to date, community-based oncologists perceive that patient barriers to increased participation include age, co-morbidities, poor understanding of the clinical trials process, and the fear and expense of leaving the community to travel to the academic center. Procedures will be developed to measure attitudes and changes in attitudes, develop the needed infrastructure to provide closer links between the academic center and community-site, the necessary on-site resources to conduct safely and completely these trials, and to develop outreach programs within the community sites to increase the awareness, understanding and availability of early phase clinical trials.