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.

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.

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.

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.

  • 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.
  • 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.
  • From 2010 to 2018 RDB has provided support in research design and/or statistical analysis for 264 projects and 151 principal investigators from the consortium institutions.

 

YearStudies SupportedInvestigators SupportedPeer-Reviewed PublicationsGrants Applications SubmittedGrants Funded
2010-20112620665
2011-201267485204
2012-2013775224164
2013-201471471282
2014-201589601882
2015-2016856220113
2016-2017856132114
2017-2018977026204

 

  • 28 grants have been awarded to RDB-supported projects, resulting in over $6,427,015 of funding obtained. Four projects proposals that received RDB support in research design stage obtained NIH funding through competitive mechanisms (R01, R21, SC3, and RCMI/NIH pilot). In addition, 14 of the projects funded by the PRCTRC/NIH pilot program since 2010 received RDB research design support prior to their proposal submission.
  • Three investigators have been awarded with PRCTRC/HiREC small grants to leverage analysis of pre-existing large databases in Health Disparities among Hispanics. Two abstracts (RCMI Translational Science 2017; and 2017 NAACCR Conference) and one manuscript (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5870969/) have resulted from these projects.

 

Year of AwardPITitle of the Project
2016-2017Karen Ortiz-Ortiz, DrPHA Feasibility Study to Evaluate the Use of Adjuvant Chemotherapy in Patients with Stage III Colon Cancer
2018-2019Dagmar F. Hernández-Suárez, MDRacial/Ethnic Disparities in Patients Undergoing Transcatheter Aortic Valve Replacement: Insights of the Healthcare Cost and Utilization Project’s National Inpatient Sample
2018-2019Angel M. Mayor, MDCancer Incidence Trends in a Hispanic Cohort of Persons Living with the HIV in the cART era

 

 

  • 143 publications have resulted from RDB support on research design and/or statistical analysis since 2010. Articles have been published on high impact-factor journals, such as: Annals of Internal Medicine, Clinical Infectious Disease, and American Journal of Human Genetics.
  • Over 130 abstracts have been accepted at local, national and/or international conferences.
  • Over 70 training opportunities (seminars, workshops, symposium, among others) in the area of research design, statistical methods, data management and research ethics have been offered in Consortium institutions. In addition, numerous trainings resources are available online through our Partners and other Clinical and Translational Research Centers.
  • RDB 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 have resulted in publication of manuscripts, abstracts, presentations, grant submissions and/or trainings.
  • RDB Fee-for-service program was established to provide services for projects with external funding.

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 (PhD in Epidemiology), Dr. Erick Suarez (PhD 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:

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:

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

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

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.

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

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.
  1. The RDB offers expertise on information systems for the development of electronic and hard-copy data collection forms as well as electronic databases.
  2. Data collection forms are created before researchers started collecting data; format of collection forms will depend on variables definitions.
  3. Electronic databases are created in REDCap, Epi-Info, Stata, Access and other programs.
  4. Statistical quality control activities are conducted by applying high level statistical methods to the accumulating data.
  5. 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.
  6. Data entry services are provided to pilot projects funded by PRCTRC.

To request services regarding a proposal/grant preparation, database design or data analysis you can press the following button.

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. Fernández-Santos, EdD, MS

RDB UCC Co-Leader

diana.fernandez@uccaribe.edu

 

Erick Suárez, PhD

Senior Statistical Consultant

erick.suarez@upr.edu

 

Ana Patricia Ortiz, PhD

Epidemiology Consultant

ana.ortiz7@upr.edu

 

Lorena González-Sepúlveda, MS

RDB Coordinator

lorena.gonzalez2@upr.edu

 

Naydi Pérez-Ríos, MS

RDB Epidemiologist/Biostatistician

naydi.perez@upr.edu

 

Angel Mayor-Becerra, MD, MS

RDB UCC Epidemiologist

amayorb@hotmail.com

 

Gerónimo Maldonado, MPH

RDB UCC Biostatistician

geronimo.maldonado@uccaribe.edu

 

Wanda I Marin

Data Entry

wanda.marin@uccaribe.edu