Biostatistics, Epidemiology, & Research Design Core

Overview

The Biostatistics, Epidemiology & Research Design Core (BERD) provides expert knowledge and support in research design and statistical analysis to clinical investigators at all levels, including young investigators. BERD has recruited and established collaborations with experts with specialized knowledge from Alliance and other institutions.

Availability of BERD expertise and provision of individual consultations to Alliance researchers throughout the entire research process as part of a centralized resource will increase investigators’ access to quality methodological advice and statistical support. This, in turn, will improve the quality of conducted research, and will help advance their research careers.

Goal & Objectives

Our Core goal is to improve the overall quality of clinical and translational research studies and the impact on the community in Puerto Rico. The primary role of the BERD Core is the provision of infrastructure and resources to support and enhance the ability of investigators to develop competitive clinical and translational research proposals with solid research design methods, as well as high-quality scientific publications with the potential to improve the health of Hispanic populations.

As part of the Alliance, BERD aims to address the demand for epidemiology and biostatistics services (individual consulting and training), and with added expertise in qualitative and mixed methods, will serve as a comprehensive, centralized resource for clinical and translational researchers.

Core Aims

Specific Aim 1. Provide epidemiological and biostatistical expertise and support for design, implementation, and analysis of clinical and translational research projects focused on health conditions prevalent in Hispanic communities in Puerto Rico and across the United States.
Specific Aim 2. Develop and implement training programs to increase knowledge and skills in research design, data management, and statistical methods, for Alliance investigators, BERD staff, and community leaders and members.
Specific Aim 3. Establish and strengthen working relationships of BERD with other IDeA institutions, Clinical and Translational Research Centers, and other external consultants.

Main Activities

Consultation to the researchers in the study design stage
Consultation to the researchers in the study implementation and analysis stage
Tracking and Monitoring Progress
Trainings for the investigators and BERD Core staff
Training and educational materials (videos/pods, flyers) for specific communities and study participants
Development of epidemiological and statistical tools and methods in areas that will maximize the quality and productivity of research projects.
Promotion of use of pre-existing large databases
Collaboration with leading epidemiology and biostatistics experts with existing ties to the core.
Collaborations with the BERD cores from other IDeA institutions and other research centers and individual collaborators outside the IDeA network.

BERD activities improve the quality of generated knowledge about the diseases and conditions prevalent in Hispanic populations in Puerto Rico and in the United States mainland.

Core Accomplishments

From 2010 to 2019 our team, functioning as the Research Design and Biostatistics Core (RDB) of Puerto Rico Clinical and Translational Research Consortium (PRCTRC), provided research design and/or statistical analysis support for 292 projects and 163 principal investigators. This support resulted in 34 grants awarded and over $13,282,346 of funding obtained.

Our core successfully collaborated with statistical components from several institutions, such as: DCC-RTRN, UNC Chapel Hill, the Biostatistics, Epidemiology and Bioinformatics’ Core (BEBIC) of the U54 UPR/MD Anderson Partnership for Excellence in Cancer Research, the NCMHD Endowment Program “Hispanics in Research Capability: SoHP and SoM Partnership”, and the Endowed Health Services Research Center (EHSRC). These collaborations resulted in publication of manuscripts, abstracts, presentations, grant submissions and/or trainings.

As part of the Alliance, we will continue offering services, drawing on the expertise and individual strengths of core staff and consultants, as needed.

Capabilities

The Biostatistics, Epidemiology, & Research Design Core has ample local and external resources and expertise for both current and future needs. BERD has co-leaders in each of the ALLIANCE participating institutions, who provide oversight of the core’s overall functions. In addition, co-leaders actively participate in monitoring and evaluating statistical analyses, and the writing of progress reports and scientific publications. The core’s coordinator serves as a liaison between BERD’s leadership members, investigators, Epidemiologists, and Biostatisticians. Furthermore, the selection of doctoral-level experts, as well as the analysts for a particular research project is done according to the required expertise

Standard Operating Procedures

Our Services

Services

The Biostatistics, Epidemiology, & Research Design Core services are among the most requested and essential services for clinical researchers. BERD is the hub for expertise to address the epidemiology and biostatistics needs of Alliance researchers, especially for unfunded, investigator-initiated projects and those with relatively short submission deadlines. Our Core provides consulting and support services, as well as research methods trainings. With the expertise in qualitative and mixed methods, BERD serve as a comprehensive, centralized resource for clinical and translational researchers, in study design and analysis methods to better serve the new emphasis on community-oriented research.

BERD services are provided to investigators from any of the following institutions: University of Puerto Rico Medical Sciences Campus, Universidad Central del Caribe in Bayamon, and Ponce Health Sciences University. Investigators from these institutions can be from any of the following levels:

Junior investigators (5 year or less since last degree)
New investigators or established investigators entering a new area of research (changing from basic to clinical may qualify as a new area)
Clinicians (MDs, PhDs, DMDs, DMVs, etc.) or basic scientists (PhDs, DrSc, etc.)

A request for one or more BERD services begins with the completion of Application Form. There are different application forms that are tailored for each category of service. Each application should be submitted with enough time (at least 3 weeks) prior to the project’s deadline since the evaluation of each application can take 2-4 days to process. To request services regarding a proposal/grant preparation, database design or data analysis you can click here.

Assisting with proposal development

Development of research objectives and hypothesis.
Selection of appropriate study design and statistical plan.
Sample size and/or power calculation.
Determining optimal sampling technique.
Advice on strategies for minimizing potential study bias.
Development of randomization and stratification schemes.
Assessment of validity, precision, and accuracy of the study measurements.

To see the list of funded proposals that received RDB Research Design Services, click here.

Database design, data management & quality control

Data collection instrument design and validation.
Advice on data safety and reporting to the Data Safety Monitoring Board.
Database creation (in REDCap, Epi-Info, Stata, Access and other programs)
Data management services.
Data entry services (only for pilots projects funded by the Alliance).

Data Processing, Analysis and Interpretation

Data analysis according to study aims, using Statistical Software (STATA, SAS, SPSS, and others)
Interpretation of results
Support in preparation of abstracts and manuscripts, including creation of tables and figures, write-up of the methods and results section

To see the list of Select Peer-reviewed Publications by year resulted from the PRCTRC and The Alliance click here.

To request services regarding how to initiate an application form, you can write to the following email: hispanicalliance.rcm@upr.edu.

Trainings

On average, at least once a month, BERD core provides workshops and conferences to all researchers, coordinators and staff from projects approved by the Alliance as well as to faculty and graduate students from any of the three institutions that we serve. The purpose of the trainings is to increase investigators’ research capacity in the area of research design, statistical methods, data management, and research ethics. These include, but are not limited to, lectures, workshops, and webinars.

Conferences and workshops cover basic, intermediate and advanced topics in biostatistics and research design. Access some of our conferences here. For a list of RDB and BERD Trainings click here.

During the months of January, July, and/or December trainings are not provided due to institutions recess periods.

In addition to training researchers, BERD experts are available for trainings for the community members, in topics related to study design and interpretation of results. These trainings will be organized at the request of the primary investigators for community-based research projects, and will be tied to the specific research study.