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Research Design and Biostatistics

The Research Design and Biostatistics (RDB) Core of the Puerto Rico Clinical and Translational Research Consortium (PRCTRC) provides centralized support and capacity building for appropriate and rigorous research design, biostatistics, data management and research ethics necessary to translate basic and clinical research focused on minority health and/or health disparities into practice and policy.

Our overall goal is to enhance and consolidate the existing research infrastructure to increase research productivity, particularly in the areas of health disparities and to facilitate intra-institutional and multi- or inter-disciplinary collaborations. This goal directly serves the mission and vision of the PRCTRC to address health disparities in Hispanic populations and support the development of minority researchers in clinical and translational research.

The RDB Core actively contributes to help accomplish the aims of the PRCTRC by:

Providing support to clinical and translational research projects initiated by investigators for all aspects of research from the pre-application conceptual phase, the planning phase, the implementation phase to the analysis and publication phase, to address existing health disparities in Hispanics. To request our services visit (please re-direct to the page of Request Service and hyperlink the word visit).

Training in research design, statistical methods, data management and research ethics to assist junior, mid-level and senior investigators in developing clinical and translational research. To view our calendar of activities visit (please re-direct to the section of training calendar and hyperlink the word visit).

Promoting multi- or inter-disciplinary translational research by linking researchers from diverse disciplines conducting related research on health disparities in order to foster collaborations to pursue potential funding opportunities.


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RDB Overall Goal

The overall goal of the RDB core is to enhance and consolidate the existing research infrastructure to increase research productivity, particularly in the areas of health disparities in Hispanic populations and to facilitate intra-institutional and multi- or inter-disciplinary collaborations.

RDB Specific Aims

  • Promote the use of surveillance databases and epidemiological markers for Hispanic population to identify health disparities in Hispanic populations and provide relevant data/statistical services for the secondary data to improve academic productivity.
  • Develop and implement programs to increase Consortium investigators’ research capacities in the area of research design, statistical methods, data management and research ethics.
  • Maintain/reinforce working relationship with external consultants and RTRN biostatistical core to expand expertise of RDB in specialized areas of research methodology to support PRCTRC investigators and ensure sustainability of research support.

RDB Main Activities

  • Provide consultations of clinical and translational design, analysis, and ethics consultations among PRCTRC investigators.
  • Monitor RDB consultation services.
  • Explore opportunities to increase the expertise and research capacity of the RDB team, focusing on the specialized areas of increasing service demand.
  • In collaboration with PDC, organize and promote training activities that address the needs of junior, mid-career and senior-level researchers throughout the PRCTRC.
  • Identify and study health disparities among Puerto Rico’s Hispanic populations through existing surveillance databases.
  • Evaluate PRCTRC pilot project applications submitted in terms of study design and analysis.


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 Capabilities

 

Our core has ample local and external resources and expertise for both current and future needs. The RDB consists of a coordinator who serve as a point of contact to initiate and streamline services. In addition, the RDB internal team of Epidemiologists and Biostatisticians includes Dr. Ana P. Ortiz (Ph.D. in Epidemiology), Dr. Erick Suarez (Ph.D. in Biostatistics), Dr. Diana M. Fernandez (M.Sc. in Epidemiology and Ed.D. in Education) and Dr. Sona Rivas-Tumanyan (Dr.P.H. in Epidemiology), who advise PRCTRC researchers on the development of the research design and statistical approach for the research proposals, as well as data analysis of already funded projects. The internal team works directly with our group of Master’s level trained Epidemiologists/Biostatisticians, who implement data management and analysis procedures to assure quality control of databases. Our unit also includes an external consultant team of faculty from members-institutions of the PRCTRC (University of Puerto Rico-Medical Sciences Campus, Universidad Central del Caribe in Bayamon, and Ponce Health Sciences University) as well as faculty members from other institutions in the United States.

Our RDB Core staff has assisted multiple investigators in these main areas:

 

The RDB provides support to researchers in preparation of abstracts and manuscripts by conducting data analyses, creating tables and figures, providing results interpretations, and write-up of the methods and results section.

  1. Our core has been involved in developing more than 40 scientific manuscripts and 55 abstracts for last 4 years.
  2. More than 85% of all manuscript submissions and 89% of all abstract submissions has been accepted for publications and to be presented in local, national and international conferences, respectively.

The RDB has provided assistance to more than 25 proposals (IRB or grants submissions) for last 4 years by advising on appropriate research design and methodology, on various aspects of clinical research ethics, and/or giving guidance on sampling and statistical power.

  1. Two of the projects assisted by our core received an R21-NIH funding and a total of 13 pilot projects have been funded.

A. The RDB offers expertise on information systems for the development of electronic and hard-copy data collection forms as well as electronic databases.

  1. Data collection forms are created before researchers started collecting data; format of collection forms will depend on variables definitions.
  2. Electronic databases are created in REDCap, Epi-Info, Stata, Access and other programs.

B. Statistical quality control activities are conducted by applying high level statistical methods to the accumulating data.
C. Data management services are provided to all projects requesting this service and/or projects that once reviewed by the RDB core requires this service in order to be able to analyse the data according to their study aims.
D. Data entry services are provided to pilot projects funded by PRCTRC.

Our Services

 

The Research, Design, and Biostatistics core (RDB) assist investigators with services related to research design, database validation, and statistical analysis among others. The RDB 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.)

The services that are provided by the RDB core to all he investigators includes:

 

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.

 

Database design, data management and quality control

 

  • Data collection instrument design and validation.
  • Advice on data safety and reporting to the Data Safety Monitoring Board.

 

Data processing and analyses by means of statistical computer software (Stata, SAS, SPSS and others)

 

  • Data analysis according to study aims.
  • Interpretation of results

 

Consultation of research ethics aspects

 

  • Recruitment in vulnerable populations.
  • Storage of tissue samples.
  • Data Storage.
  • Use of data without consent.
  • Confidentiality

A request for one or more of these 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 prior to the projects’ 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 (please re-direct to the page of Request Service where the Application Form document is and hyperlink the word here).

To request a meeting regarding how to initiate an application form you can write to the following email address: prctrc.rcm@upr.edu.

Trainings

 

On average, at least once a month the RDB core provides workshops and conferences to all researchers, coordinators and staff from projects approved by PRCTRC 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 (please provide the direct link to the materials of the conferences and hyperlink the word here.

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


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Core Members and Contact Information

  • Robert F. Hunter-Mellado, MD, FACP, MS
  • RDB Program Director
    robert.hunter@uccaribe.edu
  • Sona Rivas-Tumanyan, DMD, DrPH RDB
  • Core Leader
  • sona.tumanyan@upr.edu
  • Diana M. Morales-Ortiz, PhD, MPH
  • RDB PHSU Co-Leader
    dmorales@psm.edu
  • Diana M. Fernández-Santos, EdD, MS
  • RDB UCC Co-Leader
    diana.fernandez@uccaribe.edu
  • Ángel M. Mayor-Becerra, MD, MS
  • Epidemiologist
  • amayorb@gmail.com
  • Lorena González-Sepúlveda, MS
  • RDB Core Coordinator
    lorena.gonzalez2@upr.edu
  • Eduardo J. Santiago-Rodríguez, MPH
  • Biostatistician
    eduardo.santiago@uccaribe.edu
  • Raúl O. Ramón, MS
  • Quality Control and Data Management Coordinator
    raul.ramon@uccaribe.edu
  • Naydi Pérez-Ríos, MS
  • Epidemiologist/Biostatistician
    naydi.perez@upr.edu

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