Biostatistics

生物统计学

• 批准号: 8000110
• 负责人: PETER F THALL
• 金额: $ 15.39万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-01 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8000110
• 关键词: Accounting; Address; Aggressive-Phase Myeloid Leukemia; Biological; Biometry; Biostatistics Core; Blast Phase; Cancer Center Support Grant; Cessation of life; Characteristics; Clinical; Clinical Investigator; Clinical Trials; Clinical Trials Design; Collaborations; Consult; Consultations; Data; Data Analyses; Development; Diagnosis; Disease remission; Dose; Drug Formulations; Ensure; Ethics; Funding; Goals; Grant; Heterogeneity; Homologous Transplantation; Hybrids; Instruction; Laboratories; Laboratory Scientists; Laboratory Study; Lymphocyte; Methods; Modeling; Molecular; Monitor; Outcome; Patients; Peer Review; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Regimen; Reporting; Research; Research Personnel; Resources; Statistical Methods; Statistical Models; Stem cells; Stratification; Time; Toxic effect; Treatment Efficacy; University of Texas M D Anderson Cancer Center; base; computer program; design; graft vs host disease; improved; innovation; meetings; molecular marker; novel; outcome forecast; prognostic; programs; randomized trial; research study; response

PROJECT SUMMARY (See instructions): The purpose of the Biostatistics Core is to support the dinical and laboratory-based projects of this program project so that research studies are efficiently designed, conducted, monitored, and analyzed. To ensure that scientifically valid conclusions can be drawn from these experiments, this includes statistical modeling, hypothesis formalization, design of laboratory experiments, clinical trial design, and data analysis. These activities in tum may require development of innovative statistical methods as needed to address new statistical problems as they arise, and accompanying development of appropriate new computer programs to implement these methods. All of these activities are carried out in collaboration with the laboratory and clinical investigators. The specific objectives are: Aim 1 To provide biostatistical consultation and collaboration in the planning, conduct, analysis and reporting of clinical trials in CML, including phase I trials to determine safe dose combinations, phase II trials to assess therapeutic efficacy, randomized trials to compare competing treatments, and hybrid trials having multiple goals. Trials involving biologic agents or specific types of lymphocytes or stem cells are especially relevant. These statistical designs accommodate multiple patient outcomes, including toxicity, regimen-related death, complete remission (CR), graft-versus-host disease (GVHD) in allogeneic transplantation (allotx) trials, and times to disease remission, progression, onset of CML accelerated phase, blast crisis, and death. Many of the designs accommodate patient heterogeneity by stratification or regression models.that account for patient prognostic characteristics, to help develop individualized treatments when treat-prognosis interactions exist. Aim 2. To consult and collaborate with researchers evaluating the cellular and molecular basis of response. Aim 3.T0 develop novel statistical methods for clinical trial design and data analysis as required to address special goals and needs of the projects. Aim 4. To evaluate prognostic significance of innovative treatments and possible synergistic effects with specific biological and molecular markers. This includes regression, data analysis, and hypothesis formulation.

项目摘要（请参阅说明）： 生物统计学核心的目的是支持该计划的基于二十个和实验室的项目 预测研究经过有效设计，进行，监测和分析。确保 可以从这些实验中得出科学有效的结论，这包括统计建模， 假设形式化，实验室实验的设计，临床试验设计和数据分析。这些 TUM中的活动可能需要根据需要开发创新的统计方法来解决新的 出现的统计问题，并随附适当的新计算机程序来开发 实施这些方法。所有这些活动都是与实验室合作进行的 临床研究人员。 具体目标是： 目标1在计划，进行，分析和报告中提供生物统计学咨询和协作 CML中的临床试验，包括确定安全剂量组合的I期试验，II期试验以评估 治疗功效，比较竞争治疗的随机试验以及具有多个多次的混合试验 目标。涉及生物学剂或特定类型的淋巴细胞或干细胞的试验特别相关。 这些统计设计可容纳多种患者结果，包括毒性，与方案相关的死亡， 完全缓解（CR），同种异体移植（AlloTX）试验中的移植物抗宿主病（GVHD）和 疾病缓解，进展，CML加速阶段的发作，爆炸危机和死亡的时间。许多 设计通过分层或回归模型适应患者的异质性。 患者预后特征，以帮助开发个性化治疗时治疗治疗 存在相互作用。 目的2。与评估反应的细胞和分子基础的研究人员进行咨询和合作。 AIM 3.T0开发用于解决临床试验设计和数据分析的新型统计方法以解决 项目的特殊目标和需求。 目的4。评估创新治疗的预后意义和可能的协同作用 特定的生物学和分子标记物。这包括回归，数据分析和假设 配方。