Biostatistics and Qualitative Research Shared Resource (BQSR)


Jingqin Rosy Luo, PhD


Siteman Cancer Center Biostatistics and Qualitative Research Shared Resource

The Siteman Cancer Center (SCC) Biostatistics and Qualitative Research Shared Resource (BQSR) fulfills a critical function by providing methodologic and analytic support for the development and conduct of scientifically sound, innovative cancer research at SCC. Advances in biotechnologies and computing systems/software increasingly require specialized expertise and tools for sophisticated statistical methodologies. Qualitative research requires sound methods and approaches that support rigor and best practice. The overarching goal of the BQSR is to provide a comprehensive, centralized, and accessible biostatistics and qualitative support infrastructure for all phases of cancer research; from study development and design to data collection, ongoing monitoring and final analysis. BQSR aims for this project period include:

Aim 1a: Provide statistical collaboration, consultation, data management, and quantitative resources to clinical, pre-clinical, behavioral, and preventive research at SCC. The BQSR designates a team of faculty and analysts to each SCC research program and disease area. Members of the team respond to researchers’ in-person and online requests for biostatistics services and collaborate with investigators on internal and external cancer-related grant applications. BQSR faculty and analysts provide statistical support through the life cycle of a research project including: proposing/developing sound statistical designs (sample size calculations, research proposals, protocol development); supporting ongoing studies (randomization, interim analyses, safety and data monitoring, data management); devising and executing final data analyses (tables, statistical graphics); and preparing manuscript for publications.

Aim 1b.  Provide methodologic collaboration, consultation, coaching, and support for qualitative and mixed method research at SCC.  The BQSR has qualitative faculty and specialists to support the lifecycle of a research project including development of approaches (including methods for data collection and interview/focus group guides), supporting ongoing studies, and guiding sound analysis and dissemination. They function as study team members, or through coaching, consultation, and training of research teams.

Aim 2: Outreach to educate SCC researchers on the fundamentals of biostatistics, data management, and research rigor and reproducibility by enforcing statistical operating standards in research protocol reviews at SCC. BQSR faculty are actively involved in training and mentoring students, residents, fellows, and junior faculty in statistical concepts through roles as course-masters or co-instructors in programs awarding formal degrees (e.g., MS, PhD, MD). BQSR faculty apply statistical and rigor/reproducibility standards to SCC research to protect the scientific integrity of research and patient safety. This is accomplished at a study-specific level through their role on independent Data Safety and Monitoring Committees for SCC investigator-initiated, multi-site clinical trials. At an institutional level, BQSR faculty apply these standards as reviewers on SCC’s Protocol Review and Monitoring Committee (PRMC), Siteman Investment Program (SIP) scientific study section, and the SCC Quality Assurance and Safety Monitoring Committee (QASMC). Key components of BQSR’s protocol review include evaluation of study design, statistical power/sample size calculations, and futility/efficacy/toxicity monitoring rules. Statistical analysts follow standard operating procedures to ensure reproducibility.

Aim 3: Develop cutting-edge statistical methodologies tailored for specific collaborative research at SCC. Motivated by challenges that arise in clinical and translational research, BQSR faculty members will develop novel statistical approaches to facilitate SCC members’ ability to effectively answer innovative and impactful scientific questions. In the next funding period, BQSR expects further growth in capacity related to innovative study design and statistical methodology research. The BQSR plans to add new expertise such as spatiotemporal statistical analysis and stepped wedge design (SWD), both of which are useful tools for community-based studies. The BQSR has successfully recruited new faculty biostatisticians with expertise on biomarker analysis and electric health records (EHR). This will enhance statistical support for immunotherapeutic studies and also meet SCC members’ increasing needs in the area of EHR-based comparative effectiveness research.

LOCATION: 600 S. Taylor Avenue Building, Suite 2400

PRICING: Please access the website above for pricing information.

TO ACCESS: Please access the website above and complete the service request form.

Washington University Co-Authorships Guidelines apply.

NIH PUBLIC ACCESS POLICY: As of April 7, 2008, the NIH requires investigators with a publication using Siteman (or other NIH-funded) shared resources to submit (or have submitted for them) their final, peer reviewed manuscripts to PubMed Central(PMC) upon acceptance of publication, to be made publicly available within 12 months of publication. Many journals automatically submit these for authors, but Washington University also has assistance available through the Becker Medical Library. Please see,upon%20acceptance%20of%20the%20publication for more information.

PUBLICATION ACKNOWLEDGEMENT: If research supported by the Siteman Biostatistics Shared Resource results in publication, please acknowledge this support by including the following in your publication(s):

We thank the Alvin J. Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis, MO., for the use of the Siteman Biostatistics and Qualitative Research Shared Resource, which provided __________ service. The Siteman Cancer Center is supported in part by an NCI Cancer Center Support Grant #P30 CA091842.