PROJECT SUMMARY/ABSTRACT The Trial Design and Biostatistical Support Core provides a broad array of statistical services in support of the three Projects and other three Cores. The Core will provide regular advice on experimental design, such as selection of end points, sample size and power, and optimal use of animals. The Core is responsible for trial design and all clinical data management as it relates to the proposed phase I and early phase II trials in Projects 1 and 3. Prospective collection of clinical data is maintained in the Blood and Marrow Transplant and Cell Therapies Program Database in a secure central location. The Core will perform expert statistical analyses in a format consistent between Projects using techniques that are state of the art in practice. The Core will also facilitate data sharing with the Program as well as the general scientific community. The Core is staffed by experienced biostatisticians who have daily working relationships with the Project investigators. The Core biostatisticians have been an integral part in the development of the Program and have participated in this P01 for its entire history. The Core has access to all needed software. This dedicated Trial Design and Biostatistics Core has easy access to Program investigators with each of the biostatisticians specializing in the specific Project areas, gaining working knowledge in the field and helping provide the tailored biostatistical support.