OVERVIEW

The Puerto Rico Clinical and Translational Research Consortium (PRCTRC) was established on September 2010 with the idea of implementing productive collaborations among local institutions and have a broader impact across all levels of research in health disparities in Puerto Rico. We are a centralized clinical and translational research program focused on health problems prevalent in our community.

The PRCTRC leverages the intellectual and physical resources of three major medical and health science centers on the Island: The University of Puerto Rico Medical Sciences Campus (UPR-MSC), the Universidad Central del Caribe (UCC), and the Ponce Health Sciences University (PHSU) to address and reduce health disparities that most impact Hispanic populations.

Through its inclusive and integrated structure, the PRCTRC has fostered a synergistic environment that supports research across the clinical and translational research continuum in our four primary clinical foci: HIV/AIDS, neuroscience, cardiovascular and metabolic disease, and cancer. These four disease states represent some of the greatest threats to the health of our population.

To serve as a vital and catalytic element in the efforts to understand, define, and address health disparities in Hispanic populations.

To create, develop and support an integrated, island-wide program dedicated to the conduct of clinical and translational research for reducing health disparities in Hispanic populations.

STRATEGIC GOALS

a. Facilitate the generation and translation of knowledge from the bench into the community by establishing a centralized program focused on reducing health disparities among Hispanic populations.

b. Enhance and support existing training and mentoring programs to increase the number of new minority investigators in Clinical and Translational Research.

c. Encourage collaborations among basic, clinical, and social scientists and community networks and health programs.

d. Enhance and integrate existing infrastructure for clinical and translational research across Puerto Rico to support and expand Clinical and Translational Research in health disparities.

GOVERNANCE

MARCIA CRUZ-CORREA

MD, PhD

PROGRAM INVESTIGATOR AND CONTENT PI

Dr. Marcia Cruz-Correa completed her B.S. in Biology at the University of Puerto Rico (UPR), and her medical degree at the UPR Medical School. Dr. Cruz-Correa continued her training in Internal Medicine at the University of Puerto Rico Hospital, and subsequently a fellowship in Gastroenterology & Hepatology at Johns Hopkins University in Maryland. Dr. Cruz-Correa completed a doctorate degree in Clinical Investigation and Genetic Epidemiology at the Johns Hopkins Bloomberg School of Public Health.

Dr. Cruz-Correa is an Associate Professor of Medicine & Biochemistry at the University of Puerto Rico, Visiting Assistant Professor of Medicine at Johns Hopkins University and Adjunct Associate Professor of Surgical Oncology at the MD Anderson Cancer Center. Her research focuses in gastrointestinal oncology, including the study of epigenetics and genetics in gastrointestinal cancer, hereditary GI cancers, and chemoprevention of gastrointestinal neoplasia.

Dr. Cruz-Correa leads a Gastrointestinal Oncology Program at the UPR Cancer Center, which is integrated by a multidisciplinary team of clinicians, basic and clinical scientists, and epidemiologists with an expertise in gastrointestinal cancer. The main focus of the Program is to elucidate genetic and epigenetic pathways for colorectal carcinogenesis among Hispanic patients. Evaluation of environmental and nutritional factors as effect-modifiers and gene-environmental interactions is an active investigative priority. Dr. Cruz-Correa and her team developed the first population-based familial colorectal cancer registry in Puerto Rico that currently has over 500 colorectal cancer patients with detailed epidemiological and environmental information (http://purificar.rcm.upr.edu). A second research area is chemoprevention, and Dr. Cruz-Correa leads an NCI sponsored clinical trial evaluating the role of bioflavinoids (curcumin) as a chemopreventive agent in adult patients with Familial Adenomatous polyposis (FAP) and is a co-investigator evaluating the use of celecoxib in pediatric patients with FAP. In addition, her group is a member of the Polyp Prevention Study Group (11-site national consortia, lead by Dr. John Baron, Dartmouth University) participating in several clinical trials aimed at evaluating different compounds for chemoprevention of sporadic colorectal adenomas. Dr. Cruz-Correa’s research is sponsored by the National Cancer Institute and other private foundations including Doris Duke Charitable Foundation and the Cancer Research Prevention Foundation.

Dr. Cruz-Correa has published over 50 original publications, is a reviewer of several NCI special review panels, and reviewer for numerous medical journals including Gastroenterology, Cancer Research, and GUT. She is actively involved as a Chair or committee member in several national gastroenterology societies, including the American Gastroenterology Association and the American Society for Gastrointestinal Endoscopy and is President of the Puerto Rico Gastroenterology Association.

CARLOS A. LUCIANO-ROMÁN

MD, MS

PRINCIPAL INVESTIGATOR

Dr. Carlos Luciano received his M.D. from the UPR School of Medicine and completed his residency in neurology at the Boston City Hospital. He completed subspecialty training in Electromyography and Clinical Neurophysiology and in Neuromuscular Medicine at the National Institutes of Health where he also served as Acting Chief of the electromyography section from 1991 through 1996. He was recruited from the National Institutes of Health in 1998 to contribute to the clinical research efforts at the UPR-MSC where he joined the RCMI-Clinical Research Center. He is a fellow member of the American Academy of Neurology and the American Association of Neuromuscular Medicine and Electrodiagnosis and is a recognized expert in electromyography and clinical research in neuromuscular medicine. He maintains a research laboratory funded by NIH through the Specialized Neuroscience Research Program and has been actively involved in translational research applying confocal microscopy and multilabelling techniques to the study of cutaneous innervation in healthy children and adults, as well as patients with HIV and diabetic neuropathy. He has also participated in various multicenter clinical trials and is a member of the North Eastern ALS consortium, a consortium organized to perform clinical trials in ALS, and the Cooperative International Neuromuscular Research Group (CINRG), a consortium of researchers studying treatment modalities for the muscular dystrophies.

IVETTE MOLINA-RIVERA

MHSA

ADMINISTRATIVE DIRECTOR

Ivette Molina Rivera, MHSA, serves as the Administrator for the Puerto Rico Clinical and Translational Research Center. Mrs. Molina completed her B.S. in Biology at the Río Piedras Campus, University of Puerto Rico, and her master degree in Health Services Administration at the School of Public Health of the Medical Sciences Campus, University of Puerto Rico.

She has extensive experience in the management of large health care institutions having served as the Health Services Administrator for the Bayamón Correctional Center and Associate Administrator for the Doctors’ Center Hospital in Manati, Puerto Rico. Prior to joining the Clinical Research Center at the University of Puerto Rico Medical Sciences Campus, Mrs. Molina was the Executive Director of the State Psychiatric Hospital Dr. Ramón Fernández.

In 2001, she joined the University of Puerto Rico Medical Sciences Campus as the Program Administrator for the RCMI – Clinical Research Center (RCMI-CRC), overseeing and providing administrative guidance to a complex organization with a mission to develop the necessary infrastructure and support services to conduct clinical research activities and to stimulate the clinical research potential of faculty.

Mrs. Molina assists the Principal Investigator, Program Directors and Key Functions Leaders with administrative guidance as well as the faculty and investigators from the three Consortium-member institutions: the University of Puerto Rico Medical Sciences Campus, the Ponce School of Medicine and Health Sciences, and the Universidad de Central Caribe.

Robert Hunter

ROBERT HUNTER-MELLADO

MD, FACP

PROGRAM DIRECTOR

Dr. Robert Hunter Mellado is Professor of Internal Medicine at the Universidad Central del Caribe in Bayamon. Dr. Hunter completed medical school at the UPR-MSC in 1978 followed by completing Internal Medicine training at the VAH in San Juan in 1981. He completed Hematology and Medical oncology training at Duke University in Durham in 1984. During his tenure as Assistant Professor at the University of Tennessee in Memphis he continued his studies in the basic pathogenesis of Aplastic Anemia and was leader in the clinical trial development in Lung Cancer. He was appointment Chairman and Program Director of the residency training program of the Department of Medicine at the Universidad Central del Caribe in 1989, a position he held until 2002. He is director and Principal investigator of the Retrovirus Research Center at the UCC since 1992, Director of the Cancer Research Unit of the RRC since 2010 and director of the Clinical Research Center of the UCC since 2009. He has served as Invited editor of the Boletín de la Asociación Medica de Puerto Rico and is Editorial consultant of the Puerto Rico Health Sciences Journal. He is a member of the NASBP and ECOG cancer cooperative groups and is Fellow of the American College of Physicians.

His research interests include the study of the natural history of HIV infection in Puerto Rico and are active in the study of platelet activation in several inflammatory conditions. He is also active in the recruitment of Hispanic cancer patients to NCI sponsored clinical trials. He has more than 60 scientific publications in peer-reviewed journals. In 2007, Dr. Hunter completed a Masters degree in Bioethics, becoming one of the few clinicians and researchers in the Island to have formal advanced training in the Bioethics. This training has been effectively used to mentor researchers in the area of the ethical conduct of research, as overseer of various DSMB programs and by providing patients with the highest standards of research ethics. His role in the PRCTRC is as co-program director with the task as a facilitator in the areas of regulatory, bioinformatics, Epidemiology, Biostatistics and clinical ethics.

Jose Torres

JOSÉ TORRES-RUIZ

PhD

PROGRAM DIRECTOR

Dr. Jose A. Torres-Ruiz received his Ph.D. and post-doctoral training at the Department of Biochemistry and Biophysics at Washington State University in Pullman, WA. He joined the faculty at the Ponce School of Medicine and Health Sciences (PSM&HS) in 1987 as an Assistant Professor of Biochemistry. Currently, he serves as the Chairman of the Department of Biochemistry and holds the academic rank of Full Professor. Dr. Torres-Ruiz research interests fall in the areas of cellular stress and protein folding under pathological conditions. Through his tenure at PSM&HS Dr. Torres-Ruiz has occupied several administrative positions including; the Director of the Doctoral Program in the Biomedical Sciences, Director of the Office for Sponsored Programs and Projects, and the Associate Dean for Research and Graduate Studies. Further, he have served as the Principal Investigator/Program Director of numerous federal as well as non-federal research and training initiatives; MBRS Program (NIGMS), RCMI Program NCRR), the PSM/Moffitt Partnership Award (U56) sponsored by NCI, the TRIGR Program for Diabetes Type I (NIDDK and several foundations), the STEP-UP Program for High School Students (NIDDK), etc. More recently, he has been named as one of the four PDs for the Puerto Rico Clinical and Translational Research Consortium (PRCTRC) which is supported by NCRR. Dr. Torres-Ruiz actively participates as a grant reviewer for various agencies and foundations including; NIH (NCI, NIGMS, NCRR, NICHHD, and NIMHHD), NSF, Department of Defense, and the Howard-Hughes-Medical Institute. Dr. Torres-Ruiz has served as a member in national and international scientific and other professional organizations; Society for Research Administrators, Association of Chairs of Departments of Biochemistry, GRAND and GREAT Groups-AAMC, National Board of Medical Examiners Item Development Group in Biochemistry and Cell Biology, etc.

Marizaida

MARIZAIDA SÁNCHEZ-CESÁREO

PhD

PROGRAM DIRECTOR

In the proposed project I will serve as the Program Director of Collaboration and Partnership Core and Community Based Research Cores. I have extensive expertise in program development, program evaluation, capacity building, technical assistance, community based research and evidence based interventions, which have prepared me to direct these cores. Of most relevance is the completion of a community trial with an experimental design conducted to elevate a positive parenting intervention to evidence based. My team has served as the internal/external evaluators of several university based training initiatives in Puerto Rico funded by the National Institutes of Health and the National Science Foundation. Among these initiatives are the Neuroscience Research Opportunities to Increase Diversity (NeuroID), Puerto Rico Alliance for the Advancement of Biomedical Research Excellence (PR-AABRE), Minority Access to Research Careers (MARC U*STAR), Research Infrastructure in Minority Institution (RIMI) Program, and the Partnership for Research and Educational Materials (PREM). These initiatives focus on the development of students (graduate and undergraduate), faculty (investigators) and research infrastructure of the sponsoring universities. Additionally, I have expertise replication and adaptation of evidence based interventions in various areas of prevention and in working with youth in various settings including school based populations. I have worked in several capacity building initiatives focused on: HIV/AIDS, youth violence prevention, positive youth development, substance abuse prevention and homelessness. Some of those initiatives include: Chicago HIV Prevention Evaluation Demonstration Project-AIDS Foundation of Chicago; Evaluation Resource Institute Training & Coaching Services, Illinois Violence Prevention Authority/Illinois Center for Violence Prevention; Diffusion of Effective Behavioral Interventions Project-Centers for Disease Control/American Psychological Association; Connect To Protect Project, Adolescent Trials Network-NICHD; Illinois SPF-SIG-Division of Community Health & Prevention, Illinois Department of Human Services and Puerto Rico SPF-SIG-Mental Health & Substance Abuse Services Administration. In summary, I have a demonstrated a record of successful and productive research projects in an area of high relevance for prevention program with young populations.

HEALTH DISPARITY FOCUS

ETHICS AND VALUES

In the context of scientific investigations, ethical conduct is the expression of a behavior that is coherent with the development of new knowledge, knowledge that is gained through veracity, teamwork and transparency. Our society relies and places clear responsibility on investigators to expand human knowledge; it also places accountability to the scientific community to uphold the highest ethical standards. Thus our commitment to a code of ethics is ultimately a commitment to the needs of our society.

The work of an investigator seeks the truth of a physical reality. This by itself imposes the obligation to maintain a high standard of veracity on each and every one of the phases of the research endeavors from the generation of hypothesis to the communication of the results.  The expression of an ethical code needs to have a place in our hearts. The code of Ethics presented below represents the norms of conduct that we, as individuals and scientists, will uphold in representation of the PR-CTRC.

As members of the PR-CTRC we understand and value the following principles:

Fundamental Tenets of Ethical Research:

A. Freedom, only truth determines science:

  1. Autonomy in the methodological process.
  2. Neutrality in the problem proposition
  3. Neutrality in the interpretation of data
  4. Objectivity in the scientific process
  5. Constructive criticism of valid knowledge

B. With freedom there is responsibility in:

  1. The process of conducting and applying research findings
  2. Communicating findings
  3. Admitting error
  4. Expressing reservations on particular issues
  5. Ensuring the veracity of information vi. Understanding the basic tenets of research misconduct (defined below)

Professional Attitude:

A. Adhere to the goals and objectives of the Consortium:

  1. Understand the mission and the multiple initiatives the Consortium is sponsoring
  2. Understand our Roles and Responsibilities within the Consortium as a whole and with each project we are working with.
  3. Contribute to the positive image of the Consortium and the Academic Institutions
  4. Display an attitude of Respectfulness, Honesty and Trust between our internal/external collaborators and workers.

B. Responsibility:

  1. Express discipline in our work and self learning habits
  2. To optimize the fiscal resources available to us
  3. To fulfill the obligations entrusted to us
  4. To work for the common good

Teamwork Initiative:

  1. To contribute, create, innovate, improve and support the activities and the processes which are intrinsic to established projects and those that are in development.
  2. To contribute towards an atmosphere of harmony within the Consortium fomenting positive interpersonal relations
  3. To contribute towards developing a culture of dialogue and conflict resolution
  4. To be proactive in the team work
  5. To generate constructive criticisms in an atmosphere of rational thinking

Norms for the Conduct of Investigation:

  1. Understand our role as investigators in the context of human beings as subjects.
  2. Take a course of Human Rights Protection during research offered by Citi program
  3. Comply with the full process of informed Consent for study participants
  4. Follow the guidelines of authorship and data sharing as established by the Consortium

 

Professional Development Core (PDC)

Estela Estapé Garrastazu, PhD (UPR-MSC)
Wanda Vélez Torres, PhD (UCC)
Gladys Pereles Vélez, EdD (PHSU)

Clinical Research Resources and Facilities (CRF)

Julio Benabe Rivera, MD (UPR-MSC)
Robert Hunter Mellado, MD (UCC)

Collaborations and Partnerships Core (CPC)

Margarita Irizarry Ramírez, PhD (UPR-MSC)
Zilka Ríos Orraca, MS (UCC)
Kenira Tompson García, PhD (PHSU)

Community Based Research (CBR)

Hector Colón Jordán, PhD (UPR-MSC)
Edna Acosta Pérez, PhD (UPR-MSC)

Biomedical Informatics Core (BIC)

Mary Helen Mays Serpan, PhD (UPR-MSC)

Research Design and Biostatistics Core (RDB)

Sona Rivas Tumanyan, DrPH (UPR-MSC)
Diana Fernández Santos, EdD (UCC)
Diana Morales Ortiz, PhD (PHSU)

Regulatory Knowledge and Support Core (RKS)

Wanda Figueroa Cosme, MD (UCC)

Evaluation Core (EC)

Carlamarie Noboa Ramos, MS, PhDc (UPR-MSC)

Clinical and Translational Pilot Project Program (PPP)

Valerie Wojna Muñíz, MD (UPR-MSC)

Technology and Resources for Core Laboratories

José Rodríguez Medina, PhD (UPR-MSC)
Eddy Ríos Olivares, PhD (UCC)
Richard J. Noel Jr., PhD (PHSU)

Internal Advisory
Emma Fernandez

Emma Fernández, PhD, UPR-MSC

Enid Garcia

Enid García, MD, UPR-MSC

Angel Lopez

Angel López Candales, MD, UPR-MSC

Barbara Segarra

Bárbara Segarra, DHS, UPR-MSC

Juan Negrón

Juan Negrón, PhD,UCC

Misty Eaton

Misty Eaton, PhD,UCC

Pedro Santiago

Pedro Santiago, PhD, PHSU

Elizabeth Rivera

Elizabeth Rivera, EdD, PHSU

External Advisory
Antonio Anzueto

Antonio Anzueto, MD

University of Texas Health Science Center at San Antonio

Walter Frontera

Walter Frontera, MD, PhD

Vanderbilt University School of Medicine

Jesse Roman

Jesse Roman, MD

University of Louisville

Judith S. Kaur

Judith S. Kaur, MD

Mayo Clinic

Charles Flexner

Charles Flexner, MD

Johns Hopkins University

Jorge Juncos

Jorge Juncos, MD

Emory University

Elmer Bernstam

Elmer Bernstam, MD, MSE

University of Texas Health Sciences Center at Houston, Texas

CONTACT MEMBERS AND CONTACT INFORMATION

Marcia Cruz-Correa, MD, PhD- Principal Investigator and Content PI
marcia.cruz1@upr.edu

Carlos A. Luciano-Román, MD, MS- Principal Investigator
carlos.luciano1@upr.edu

Robert Hunter-Mellado, MD, FACP- Program Director
robert.hunter@uccaribe.edu

José Torres-Ruíz, PhD- Program Director
jtorres@psm.edu

Marizaida Sánchez-Cesáreo, PhD- Program Director
marizaida.sanchez@upr.edu

Ivette Molina – MHSA Administrative Director
ivette.molina@upr.edu
787-759-0306 Ext. 231

Joselyn Gandía – Coordinator
josely.gandia@upr.edu
787-759-0306 Ext. 228