Biostatistics Core

核心D：生物统计核心的工作人员将负责向 这一方案的研究。生物统计学核心由蒂莫西·D·约翰逊博士监督 密歇根大学公共卫生学院生物统计学系。核心提供帮助 在设计、分析和解释临床前和临床实验的方案项目。堆芯 人员将与项目调查人员互动，以确保适当的设计和分析方法 都被使用过。设计问题涉及剂量的选择、随机化、测量的时间、数量 动物或病人。对于数据分析，核心将确保使用有效的方法。标准 将采用图表、分组比较和相关分析的方法进行初步调查 实验数据。混合模型方法将用于以下实验中的数据的有效利用 反复采取措施。核心人员在动物和临床的设计和分析方面都有经验。 数据。这将确保从磁共振测量(项目1-3)、肿瘤组织学(项目)获得的所有数据 1-2)，与治疗相关的细胞杀伤和生长变化(项目1-2)和患者结局(项目3)将 得到有效的收集和适当的分析。 酒吧。健康：总体而言，这项研究工作将为启动临床试验提供理论依据 分子靶向治疗恶性脑肿瘤的联合疗法。此外, 将识别和验证用于早期评估治疗反应的成像生物标记物，这将 导致患者治疗的个体化。 密歇根大学 安阿伯，密歇根州 小灵通398(09/04版)第“*&>第三季度表格第2页 首席研究员/项目主任(最后、第一、中间)：Ross，Brian D. 关键人员。请参阅说明。根据需要使用续页，以如下所示的格式提供所需信息。 从首席调查员开始。按字母顺序列出所有其他关键人员，姓氏在前。 名称时代共享用户名项目上的组织角色 约翰逊，密歇根大学蒂莫西·D核心主任 泰勒，密歇根大学杰里米大学联合研究员 其他重要贡献者 命名项目中的组织角色 李，密歇根大学朱莉娅 人类胚胎干细胞^否|~~|是 如果建议的项目涉及人类胚胎干细胞，请从下面的列表中列出特定细胞系(S)的注册号： Http://stemcells.nih.aov/reqistrv/index.asp.根据需要使用二次评估页面。 如果此时不能引用特定的行，则包括一条将使用注册表中的行的声明。 细胞系 披露许可声明。仅适用于SBIR/STTR。请参阅SBIR/STTR说明。[~]是L~1否 小灵通398(09/04版)J^表第2页-续 从头到尾连续地给下面的页面编号 应用程序。不要使用诸如4a、4b之类的后缀。 首席研究员/项目主任(最后、第一、中间)：Ross，Brian D. 从头到尾 初步预算期明细预算 直接成本仅为核心/约翰逊2006年12月1日2007年11月30日 人员(仅限申请组织)请求的美元金额(省略美分) 键入Effort Inst. 角色在 阿普特。关于基本工资和福利 项目名称(月)项目。薪资申请福利合计 堆芯 蒂莫西导演12 25%98,808$24,702$7,411$32,113 共同-- 泰勒，杰里米调查员95%$136,500$6,825$2,048$8,873 共同-- 泰勒，杰里米调查员25%$30,333$1,517$455$1,972 12 10%$75,020$7,502$2,251$9,753 GSRA GSRA(待定)12 100%$23,422$23,422$7,027$30,449 ？ 分期付款A 10^ 63,968元19,192元83,160元 顾问费 设备(分项) 用品(按类别分项列出) 研究经费300美元 电脑2500美元 2,800美元 旅行 每年参加1-2次科学会议1,000美元 住院病人护理费用 门诊病人 改建和翻新(按类别分列) 其他费用(按类别分项列出) GSRA学费14,772美元(秋季和冬季学费) 电脑维护费900美元 电脑维护费100美元 软件许可证$1,000$16,772 联合体/合同成本直接成本 初步预算PEF(项目7a，FacePage)的直接费用小计i*103.732！ 财团/合同费用、设施和行政费用 1 初始预算期的总直接成本 *103,732人 仅限SBIR/STTR：需要收费 小灵通398(09/04版)页面格式第4页

CORE D: The staff of the Biostastics Core will be responsible for providing biostatistical support to the research of this program. The Biostatistical Core is under the supervision of Dr. Timothy D. Johnson of the Biostatistics Department in the University of Michigan School of Public Health. The core provides assistance in the design, analysis and interpretation of preclinical and clinical experiments of the program project. Core personnel will interact with project investigators to ensure that appropriate designs and methods of analysis are used. Design issues involve selection of dose, randomization, timing of measurements, number of animals or patients. For analysis of data, the core will ensure that efficient methods are used. Standard graphical, group comparison and correlation methods of analysis will be used for initial investigation of the experimental data. Mixed model methods will be used for efficient use of the data in experiments involving repeated measures. Core personnel are experienced in the design and analysis of both animal and clinical data. This will ensure that all data obtained from MR measurements (Projects 1-3), tumor histology (Projects 1-2), cell kill and growth changes associated with therapy (Projects 1-2) and patient outcome (Project 3) will be collected efficiently and analyzed appropriately. Pub. Health: Overall, this research effort willprovide therationale for initiation of clinical trials with combinations of molecularly targeted therapies for the treatment of malignant brain tumors. In addition, imaging biomarkers for early assessment of treatment response will be identified and validated which will lead to individualization of patient treatment. University of Michigan Ann Arbor, Michigan PHS 398 (Rev. 09/04) Page "*>3Q Form Page 2 Principal Investigator/Program Director (Last, First, Middle): ROSS, Brian D. KEY PERSONNEL. See instructions. Use continuation pages as needed to provide the required information in the format shown below. Start with Principal Investigator. List all other key personnel in alphabetical order, last name first. Name eRA Commons User Name Organization Role on Project Johnson, Timothy D. University of Michigan Core Director Taylor, Jeremy University of Michigan Co-Investigator OTHER SIGNIFICANT CONTRIBUTORS Name Organization Role on Project Lee, Julia University of Michigan Human Embryonic Stem Cells ^ No |~~| Yes If the proposed project involves human embryonic stem cells, list below the registration number of the specific cell line(s) from the following list: http://stemcells.nih.aov/reqistrv/index.asp. Usecontinuation pages as needed. If a specific line cannot be referencedat this time, include a statementthat one from the Registrywill be used. Cell Line Disclosure Permission Statement. Applicable to SBIR/STTR Only. SeeSBIR/STTR instructions. [~] Yes l~1 No PHS 398(Rev. 09/04) Page J^ Form Page 2-continued Number the following pages consecutively throughout the application. Do not use suffixes such as 4a, 4b. Principal Investigator/Program Director (Last, first, middle): Ross, Brian D. FROM THROUGH DETAILED BUDGET FOR INITIAL BUDGET PERIOD DIRECT COSTS ONLY CoreD/johnson 12/1/2006 11/30/2007 PERSONNEL (Applicant organization only) DOLLAR AMOUNT REQUESTED (omit cents) TYPE EFFORT INST. ROLE ON APPT. ON BASE SALARY FRINGE NAME PROJECT (months) PROJ. SALARY REQUESTED BENEFITS TOTALS Core Johnson, Timothy Director 12 25% $98,808 $24,702 $7,411 $32,113 Co- Taylor, Jeremy Investigator 9 5% $136,500 $6,825 $2,048 $8,873 Co- Taylor, Jeremy Investigator 2 5% $30,333 $1,517 $455 $1,972 Lee, Julia Biostatistician 12 10% $75,020 $7,502 $2,251 $9,753 GSRA GSRA (TBN) 12 100% $23,422 $23,422 $7,027 $30,449 ¿ SUBTOT A 10 ^ $63,968 $19,192 $83,160 I CONSULTANT COSTS EQUIPMENT (Itemize) SUPPLIES (Itemize by category) Research Supplies $300 Computer $2,500 $2,800 TRAVEL Attendance to 1-2 Scientific Meetings per Year $1,000 PATIENT CARE COSTS INPATIENT OUTPATIENT ALTERATIONS AND RENOVATIONS (Itemize bycategory) OTHER EXPENSES (Itemize bycategory) GSRA Tuition $14,772 (Fall & Winter tuition) Computer Maintenance $900 Computer Maintenance $100 Software Licenses $1,000 $16,772 CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS SUBTOTAL DIRECT COSTS FOR INITIAL BUDGET PEF (Item 7a, FacePage) I * 103.732! CONSORTIUM/CONTRACTUAL COSTS FACILITIES AND ADMINISTRATION COSTS 1 TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD * 103,732| SBIR/STTR Only: FEE REQUESTED PHS 398 (Rev.09/04) Page Form Page 4