The Biostatistics and Bioinformatics Core (BBC) provides expert biostatistical, bioinformatics, and data management guidance in the design, conduct and analysis of research projects conducted by ACC members, and offers training in all aspects of design and analysis. Core personnel apply existing design and analysis methodologies, and also adapt or develop new methods to address novel design and analysis issues arising in cancer studies. A major BBC responsibility is to support the design and conduct of clinical trials. As such, the BBC plays a key role in the Protocol Review and Monitoring System, particularly through the Clinical Trials Scientific Review and Monitoring Committee. Qi Long, PhD, Professor of Biostatistics, has served as BBC Director since 2016 and leads an accomplished and highly collaborative team primarily drawn from the faculty of the Department of Biostatistics, Epidemiology and Informatics in the Perelman School of Medicine.
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Major Services
The Biostatistics and Bioinformatics Core (BBC) supports the mission of the Abramson Cancer Center (ACC) by providing statistical, bioinformatics, and data management support to the full range of research studies and community outreach and engagement (COE) activities, with the following services:
- Support research projects and grant applications through the provision of expertise in the design, conduct, and analysis of basic, translational, clinical, and population science studies.
- Provide consultation on the design, conduct and analysis of cancer studies, including the preparation of statistical and bioinformatics sections of research protocols.
- Review clinical trial protocols submitted to the ACC Protocol Review and Monitoring System.
- Support design and implementation of data management systems that ensure timely data capture, high quality data, and efficient analysis of cancer clinical and observational studies.
- Provide training to cancer investigators in the fundamentals of data management, statistical design and analysis, and bioinformatics analysis.
- Adapt existing statistical and bioinformatics methods and develop new methods to address issues in the design and analysis of cancer research studies.
- Provide consultation to ACC leadership concerning the catchment area and support COE activities.
Biostatistical and Bioinformatics Support
The BBC offers sophisticated statistical and bioinformatics support in a centralized and cost-effective manner. Collaborations emphasize establishing valid and testable hypotheses, identifying appropriate outcome measures, determining and applying optimal study designs, and examining power and sample size. Study planning considers feasibility, subject availability, data collection, and quality assurance. BBC members perform analyses across the full range of cancer research using the best available statistical and bioinformatics methods. To address problems with no standard approach, they adapt existing methods or develop new methods.
Protocol Review
BBC members are active participants on the Clinical Trials Scientific Review and Monitoring Committee (CTSRMC). Before each CTSRMC meeting, the staff member(s) in charge (Dr. Qi Long for adult studies, Dr. Yimei Li for pediatric studies) designates a statistical reviewer for each protocol on the agenda, based on research background, avoiding conflicts of interest. The assigned member writes a detailed report addressing all major facets of the trial: definition of goals and endpoints, validity of design (including sample size) and analysis plans, and adequacy of statistical support. The reviewers attend the CTSRMC meeting and contribute to the discussion. BBC members also perform off-line reviews of fast-tracked studies. In their reviews, BBC members present issues related to study design in an objective and constructive manner. When a multi-center study sponsored by a pharmaceutical company is judged to have statistical defects, it may not be possible to effect the needed changes; if the problems are sufficiently serious, the trial will be disapproved on the statistician's recommendation. When a review identifies concerns in an ACC investigator-initiated trial, a BBC member will work with the PI to address issues so that it can ultimately attain approval. The aim of the biostatistical review is to ensure that all clinical protocols efficiently, rigorously, and ethically achieve their clinical and translational objectives.
Data Management
With the growing emphasis on reproducible research, a planned and comprehensive approach to data management is recognized as an essential component of any substantial research activity. The BBC seeks to help ACC investigators ensure data integrity and study efficiency by providing a range of data-centered services, including data resource needs assessment; evaluation, selection, and deployment of software tools; development of specialized software systems; support for data collection, management, and integration; guidance on computing hardware support; and education and training.
Technologies and Equipment
BBC members have offices in Blockley Hall, centrally located on the Penn campus. The Penn Medicine Academic Computing Services (PMACS) provides a robust, heterogeneous computing environment for the BBC, including high-performance computing. Each Core member has a desktop computer with access to a grid computing system, the internet, and many statistical, graphical and data management programs such as SAS, R, and PASS. PMACS provides desktop support, file backup, and software installation and maintenance.