Clinical Trial Informatics and Biostatistics Core

Beckman Research Institute/City Of Hope, Duarte CA

Investigators

Linked publications & trials

Abstract

The Clinical Trials Informatics and Biostatistics Core (CTIBC) serves as a centralized resource to the[unreadable] investigators of the Hematopoietic Cell Transplantation (HCT) for Hematologic Malignancies Program Project[unreadable] Grant (PPG), providing biostatistical expertise, clinical research management and informatics resources to all[unreadable] projects. The CTIBC includes 2 Core Co-Directors, 2 Senior Biostatisticians, 2 Masters Biostatisticians, a[unreadable] Clinical Trials Administrator, 5 Clinical Research Associates (CRAs), Quality Assurance (QA) and Data[unreadable] Operation Sections, data entry, and the Phoenix BMT Coordinator. The CTIBC provides study design, sample[unreadable] size projections, analytic planning, statistical programming, analysis of study results, and collaboration in[unreadable] writing abstracts and peer-review publications. Statistical analyses are performed using the SAS and S-PLUS[unreadable] software packages, and specialty software. The CTIBC provides coordination of multi-centered studies,[unreadable] including documentation of site IRB approval, common Case Report Forms (CRFs), staff training, verification[unreadable] of subject eligibility, central patient registration, data collection, expectation and quality checking, and[unreadable] centralized data analyses. A centralized clinical trials database system (BITS) was developed in-house and[unreadable] has been in continual use for the past 15 years. BITS contains data on all bone marrow transplant recipients to[unreadable] date, including the data collected by the Long Term Follow-up Core (Core C). The CTIBC has developed[unreadable] customized data collection instruments specific to the patient populations under study, using a modular forms[unreadable] design approach and implemented via scannable forms. The CRAs provide protocol management and data[unreadable] collection for the clinical studies, and the QA team conducts training, review of data, and audits of in-house[unreadable] protocols. Additional support is provided to the PPG by members of the Division of Information Sciences (DIS)[unreadable] within which the CTIBC is housed, including expertise from the Department of Biomedical Informatics, at no[unreadable] additional cost to the grant. This support includes resources and expertise in the creation and maintenance of[unreadable] information systems and tools, such as integration of electronic medical record data (demographics, lab results,[unreadable] HLA, vital status) with the BITS database, and automation of CTC grading, in collaboration with PPG[unreadable] investigators (see Core A). During the last funding period CTIBC members were co-authors of 45 publications[unreadable] and over 50 abstracts. The CTIBC has been involved in study design for each specific aims of the current[unreadable] proposal, and will continue to be a critical component to successful conduct of the PPG.