Guidance and collaboration in developing grant applications

Core faculty collaborate on proposal development, addressing hypothesis formulation, study design, power and sample size calculations and data analyses.  Priority is given to junior faculty and those submitting developmental grants.  With the exception of developmental grants and some awards with limited funding, it is expected that Core faculty and staff effort will be budgeted prospectively in the grant application.

Collaboration on study design, conduct, and statistical analyses

Core faculty work closely with investigators on the following activities

• Create detailed study design and analysis plans that include clearly defined aims and hypotheses, outcome variables, independent variables, covariates, and statistical methods. Identifying appropriate hypotheses, study design, and analysis plan
• Apply a range of methods, from standard well-established approaches to advanced innovative methods depending on the setting.
• Collaborate with investigators in the review the results of all statistical analyses as well as the interpretation and presentation of the findings for abstracts, manuscripts, and presentations.

Statistical training and mentoring

Core faculty provide statistical training and mentoring at multiple levels.  This includes

• Working closely with junior investigators and providing statistical guidance in the development of new grants, abstracts, manuscripts, and conference presentations
• Conducting didactic workshops on topics such as study design and data analysis
• Contributing to capacity building at partner institutions in low- and middle-income countries
• Mentoring junior faculty in biostatistics and data science fields to promote their career development

Facilitate linkages to potential collaborators

The core will make referrals to other members of the biostatistics, epidemiology or informatics faculty where appropriate, or to relevant resources.

Provide guidance and support for accessing EMR data

In collaboration with the BioBehavioral Sciences Core, the Core will provide guidance and support for accessing and analyzing electronic health records (EHR) data from Brown and BU-affiliated hospitals as well as for statistical issues related to analysis of EHR data.

Facilitate access to HIV databases from other centers/programs

The core can facilitate access to data from well-characterized cohorts with substance use and HIV in Russia and Uganda and HIV/TB co-infected cohorts in Brazil, China and South Africa.  Core members are available to assist investigators in preparing formal data requests and analysis plans in order to access these databases.

Develop novel statistical and epidemiologic methods for HIV research

Core members develop, implement, and disseminate novel statistical and epidemiologic methods for HIV research, typically as needed in the context of specific collaborations.

Due to the high demand placed on the Biostatistics Core during preparation of developmental grants (DG), the CFAR has implemented a process for collaboration and consultation.  The process has two objectives:

• To ensure that core faculty has sufficient time to learn about the goals of the DG proposal, provide meaningful feedback, and schedule meetings as needed.
• To ensure that applicants have sufficient opportunity to develop a design and analysis plan that is specific to their proposal and is suitable for meeting project goals

Submit an email request for consultation. 

All requests, whether from Brown or Boston University faculty, should be sent to Corinne Wahlberg.

The request should contain a concept page that includes the following:

• PI name, title and affiliation
• Working title of DG proposal
• Current version of specific aims
• Clear statement of hypotheses to be tested
• Detailed description of data available or to be collected
• Anticipated statistical analysis.  

The CFAR Symposium on Statistics and Data Science in HIV is designed to bring together statistical and data science researchers either working directly in the area of HIV or whose work has direct relevance to problems and data structures encountered in HIV research. The Biostatistics core is particularly interested in engaging data science researchers in fields such as computer science, engineering, and applied mathematics, whose work in related areas might lead to innovative new approaches.

In partnership with the Population Health Data Science Program the Biostatistics Core promotes the development and quality of health data science research.

In addition to the CFAR Clinical Research Database (CCRD), the availability of REDCap (Research Electronic Data Capture) portals are open to all CFAR faculty and trainees.  REDCap is a secure web-based application for building and managing online surveys and databases for research. Using REDCap’s streamlined process for rapidly developing projects, users can create and design projects applying:

• the online method from your web browser via the Online Designer; and/or
• the offline method by constructing a “data dictionary” template file in Microsoft Excel, which can be later uploaded into REDCap

Both surveys and databases (or a mixture of the two) can be built using these methods. REDCap provides audit trails for tracking data manipulation and user activity, as well as automated export procedures for seamless data downloads to Excel, PDF, and common statistical packages (SPSS, SAS, Stata and R). Also included are a built-in scheduling module and project calendar, ad hoc reporting tools, and advanced features, such as branching logic, file uploading, and calculated fields.

In addition to access to portals at Lifespan, Boston University and Tufts University, google groups are available and serve as a communication forum for usage questions, troubleshooting and brainstorming.

CFAR researchers within Brown University and Lifespan affiliated hospitals can set-up new accounts and access the Lifespan portal through the Lifespan Biostats Core.  Lifespan REDCap Users Group

CFAR researchers within Boston University and Boston Medical Center can set-up new accounts and access the Boston University portal free-of-charge through the Boston University Clinical & Translational Sciences Institute by completing an on-line request.

CFAR researchers within Tufts University and Tufts Medical Center can set-up new accounts and access the Tufts University portal through the Tufts University Clinical & Translational Sciences Institute.

Drop in sessions are available at the various sites to obtain additional information.