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Breast cancer investigators must contend with the critical issue of how to fund their trials, including what costs should be included in the budget for a trial. We have divided this chapter into 2 sections: first, a discussion of the various components associated with clinical trials that require funding, and, second, potential funding sources to fund the proposed trial costs.

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The costs of a clinical trial include both central costs, related to protocol development and management, as well as the institutional costs, related to the regulatory review and the actual conduct of the trial at participating sites. If a clinical trial is to be conducted at only one location, then all these costs will be incurred at that site. If the trial will take place in multiple locations, then the central and institutional costs will be incurred at different locations.

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Protocol Design and Development

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The guiding text for a trial is the protocol document and associated appendices. Drafting a functional protocol document requires input from a variety of disciplines, including all those treatment modalities used in the trial, as well as biostatistics, nursing, pharmacy, and ancillary clinical disciplines such as pathology and radiology. Wherever possible, investigators should use an appropriate template to streamline the task of developing a new protocol. Model templates are available at the National Cancer Institute's Cancer Therapy Evaluation Program (NCI CTEP) Web site, as well as through the NCI-sponsored Clinical Trials Cooperative Groups.1 In general, a face-to-face meeting involving representatives of the appropriate disciplines is required to initiate protocol development. Follow-up work may be conducted via e-mail, telephone, and conference calls. The trial budget should include, therefore, the costs of face-to-face meetings, as well as the time of key investigators, biostatisticians, and protocol coordinators.

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Before the trial begins, the investigators must also develop case report forms and a system for data collection. This process requires time and potentially money. The requirement for time and money can be lessened by the use of existing case report forms and a data collection system that is already in place. For multi-institutional trials, remote data capture via a secure Web site may prove less time consuming and expensive than the traditional paper-based system in which forms are mailed or faxed to a central location. We also recommend that all case report forms use the standard Common Data Elements, which the NCI and the Clinical Trials Cooperative Groups jointly developed.2 We also encourage the collection of clinical trial data through electronic means using consistent definitions and formats across trials. Compliance with data collection standards and electronic data reporting standards, as developed by 2 international groups, the Clinical Data Standards Interchange Consortium (CDISC) and Health Level 7 (HL7), can further increase clinical trials efficiency and speed up regulatory review.3,4

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CDISC and HL7 are the 2 principal groups that have taken on the task of creating clinical-research reporting standards. ...

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