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Rho Principal Investigators

Our Principal Investigators' passion for science makes us leaders in federally and commercially funded research

Rho Principal Investigators (PIs) must balance being leaders, researchers, authors, communicators, problem solvers, and mentors. It's these characteristics that make it possible for our partners in federally funded and commercial projects to trust that we will assist them in their research endeavors. The work of our Principal Investigators enhances the scientific reputation of our company.

Rho Principal Investigators have guided the work of statistical and data management coordinating centers (SDMCs) involved in more than 80 federally sponsored studies at over 600 sites with almost 50,000 trial participants. Every year, Rho Principal Investigators contribute to the greater scientific community by sharing the results of these studies in peer-reviewed publications and at industry events.

Our PIs continually drive the growth of our expert staff by mentoring future Principal Investigators. During the mentoring process, these future PIs serve for 2 to 3 years as co-Principal Investigators under their mentor. Through this process, Rho provides constant development and reinforces the highest degree of scientific integrity in its future work and staff.

Working in parallel with our Principal Investigators, Rho's teams get a greater level of exposure to science-driven federal research. This scientific immersion helps set Rho apart from other CROs. It provides our people with knowledge they can apply to commercial work and enhances their ability to become industry leaders in federal and commercial research.

Ron HelmsRonald W. Helms, Ph.D.

Chairman and Co-founder

Read Dr. Helms' CV here.pdf

More than 10 years before co-founding Rho, Ron Helms had already been working as a Principal Investigator for a National Institutes of Health (NIH)–funded study. In 2008, the Rho chairman concluded work on his 14th project as a PI. In leading these programs, Dr. Helms has explored a broad range of treatment areas including allergy, asthma, autoimmune disease, infectious diseases, lung injury, mental health, and sickle cell disease.

Over the course of his career, Dr. Helms' participation and achievements have made him one of the most respected voices in modern biostatistics. He's been a member of 10 professional societies and has held eight elected positions and nine appointed offices in professional statistical organizations. Ron has served on nine advisory committees for the federal government and other national organizations. In addition to being a faculty member since 1968, Dr. Helms has also participated in or directed numerous advisory, public health, and biostatistics committees for the University of North Carolina at Chapel Hill (UNC-CH).

He has shared his expertise in statistical analyses, data management, and computer systems with state and national organizations and less developed countries in Central and South America and Eastern Europe. Dr. Helms designed pioneering statistical analysis programs and data management systems that include some of the first interactive programs to receive widespread use by leading universities and industries across the United States. He has authored or co-authored more than 120 peer-reviewed papers and publications. His commitment to the clinical research industry reflects extraordinary contributions to the advancement of statistical and medical sciences.

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Herman MitchellHerman Mitchell, Ph.D.

Vice President, Federal Operations

Read Dr. Mitchell's CV here.pdf

Herman Mitchell has established his credentials as a Principal Investigator in coordinating some of the largest clinical research projects ever awarded by the NIH. Under Dr. Mitchell's leadership, Rho is serving as the statistical and data coordinating center for clinical and non-clinical research activities of the Immune Tolerance Network (ITN). This project includes the participation of 70 distinguished investigators from more than 50 institutions around the world. The ITN's objective is to accelerate the evaluation of promising approaches for the introduction and maintenance of immune tolerance.

For 26 years, Dr. Mitchell has been coordinating large, multicenter studies for the NIH in treatment areas including cardiovascular disease, HIV, and cognitive function for older adults. Today, Dr. Mitchell continues to coordinate groundbreaking research for the Inner-City Asthma Study (ICAS), an 18-year study on asthma and inner-city children. Physician and environmental interventions in the study have yielded positive results, such as reduced emergency department asthma visits and decreased reported symptoms. He has also worked with the National Cancer Institute to establish coordinating centers in Belarus and Ukraine for studies focusing on the human impact of the Chernobyl disaster.

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Samuel ArbesSamuel J. Arbes Jr., D.D.S., Ph.D.

Senior Research Scientist

Read Dr. Arbes' CV here.pdf

Samuel Arbes, a dentist and oral epidemiologist, has experience working not only in oral health research but in the field of allergy and asthma. Before joining Rho, Dr. Arbes was a scientist with the National Institutes of Environmental Health Sciences, where his work included the design implementation and management of observational and clinical studies involving indoor allergens and allergic diseases. Dr. Arbes joined Rho in 2007 to provide expertise in oral health and allergic disease for the company's federal and commercial projects. For several years, Dr. Arbes led the Clinical Research Operations and Management Support (CROMS) contract, which provides comprehensive clinical research operations support, management, and data coordinating services for clinical research sponsored by the National Institute of Dental and Craniofacial Research (NIDCR). Dr. Arbes currently serves as principal investigator for the Inner City Asthma Consortium (ICAC) Statistical and Data Coordinating Center (SACCC), a federal contract that provides research support in the field of allergy and asthma;  principal investigator for the SOPPRANO study, an NIDCR-sponsor investigation of treatment for temporomandibular disorder; and co-principal investigator for the Immune Tolerance Network SACCC (NIAID/NIH), a federal contract that provides research support in the field of allergy and asthma, organ transplantation, and autoimmune disease.

Dr. Arbes was a Clinical Research Fellow and Oral Epidemiology Fellow at the University of North Carolina at Chapel Hill (UNC-CH). He practiced dentistry for 10 years and is an adjunct associate professor at UNC-CH.

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Denise BabineauDenise Babineau Ph.D.

Statistical Scientist

Read Dr. Babineau's CV here.pdf

Denise Babineau holds a MS in Statistics from Simon Fraser University (Burnaby, British Columbia, Canada) and a B. Math and Ph.D. in Statistics from the University of Waterloo (Waterloo, Ontario, Canada). From 2005-2013, she was a collaborative biostatistician in academic medical centers in Cleveland, Ohio and participated on the design and analysis of observational studies and clinical trials in clinical research areas including (but not limited to) urology, biomedical engineering, pulmonary medicine, and infectious diseases. From 2009-2013, she was also the Co-Director of the Biostatistics, Epidemiology, and Research Design Core in the Cleveland Clinical and Translational Science Collaborative. This core provided data management and biostatistical support for clinical investigators in medicine, nursing and dentistry across the Cleveland area. She was also a Co-Investigator or lead statistician on several NIH funded research grants and has co-authored over 40 peer-reviewed publications. 

Dr. Babineau joined Rho in November, 2013 as a Statistical Scientist in the Statistical and Clinical Coordinating Center for the Inner City Asthma Consortium (ICAC) and the Statistical and Data Coordinating Center for the Atopic Dermatitis Research Network (ADRN). In this role, Dr. Babineau’s responsibilities will include protocol development and project management, with particular emphasis on the development of statistical analysis plans and performing and interpreting statistical analyses for inclusion in presentations and peer-review publications.

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Gloria DavidGloria David, Ph.D., M.H.Sc.

Senior Research Scientist

Read Dr. David's CV here.pdf

Gloria David is a talented, accomplished research scientist with an impressive resume of honors and awards such as the Intramural Research Training Award from the National Institute of Environmental Health Sciences (NIEHS) and the Fellows Award for Research Excellence from the NIH.  

Since joining Rho in 2004, Dr. David has served as co-PI of the Statistical and Clinical Coordinating Center (SACCC) for the National Institute of Allergy and Infectious Diseases (NIAID)-funded Inner City Asthma Consortium (2004-present) and as PI of the NIAID-funded Atopic Dermatitis Vaccinia Network (2008-2011) and the Atopic Dermatitis Research Network (ADRN)  (2010-present) Coordinating Centers. Dr. David also serves as Rho PI for the recently awarded Medical Countermeasures Clinical Studies Network (MCM-CSN) contract funded by the Office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical and Advanced Research Development Authority (BARDA).  Under this contract, Rho will provide clinical services to facilitate medical countermeasures product development toward licensure. Trials will evaluate chemical, biological, radiological, nuclear, pandemic influenza, and emerging infectious diseases countermeasures. 

Before coming to Rho, Dr. David completed two post-doctoral fellowships. At Johns Hopkins University Department of Oncology, she conducted drug resistance research in prostate and breast cancer. Later, she completed a fellowship at the National Institute of Environmental Health Sciences, examining genetic and environmental susceptibility to asthma and lung cancer. During her second fellowship, she completed the Duke University Clinical Research Training Program.

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Sharyne Donfield, Ph.D.

Senior Research Scientist

Read Dr. Donfield's CV here.pdf

Dr. Sharyne Donfield, an epidemiologist and an expert in the coordination of multicenter studies of coagulation disorders, has authored or co-authored more than 75 papers and publications. Her interests include factors that affect physical growth, development, and academic achievement in children and adolescents with hemophilia A and B, the use of prophylaxis to treat hemophilia and von Willebrand disease (VWD), and the development of inhibitory antibodies in response to clotting factor replacement therapies.

For 25 years, Dr. Donfield has directed data and statistical coordinating center activities for multicenter studies including the Hemophilia Growth and Development Study funded by the NIH, National Institute of Child Health and Human Development (NICHD). Currently, she heads the coordinating center for the international multicenter Hemophilia Inhibitor Genetics Study (HIGS), a collaborative effort of industry, government, and academic scientists to address genetic factors associated with the development of inhibitory antibodies to factor VIII, one of the most important complications of hemophilia A. She also directs the coordinating centers for the von Willebrand Disease Prophylaxis Network (VWD PN), an international study group investigating the role of prophylaxis in clinically severe VWD, and the Natural History Study of Factor IX Treatment and Complications (B-Natural).  She serves on the editorial board for the journal Haemophilia and, with colleague Alice Lail, prepared a chapter in the Textbook of Hemophilia, 3rd Edition.

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David HallDavid Hall, Ph.D.

Research Scientist, Bioinformatics

Read Dr. Hall's CV here.pdf

David Hall is a bioinformatician with an expertise in the development of algorithms, software tools, and data systems for the management and analysis of large biological data sets for biotechnology and biomedical research applications. He joined Rho in June, 2014 and is currently overseeing capabilities development in the areas of bioinformatics and big biomedical data. He holds a B.S. in Computer Science from Wake Forest University and a Ph.D. in Genetics with an emphasis in Computational Biology from the University of Georgia. From 2000–2008 he was a member of the Bioinformatics Group at RTI International where he served as Principal Investigator on several NIH studies including the NCI Breast and Colon Cancer Family Registries Informatics Support Center. After a short stint in the software industry, Dr. Hall worked at Syngenta Biotechnology from 2009-2014 where he served as Project Director on a number of large global informatics and “omics” projects and as the leader of the Genome Informatics group.

Dr. Hall has a wide and diverse set of skills including project and general management, information system design and implementation, and the analysis of high dimensional genomic and molecular profiling data sets. His training in both the information and life sciences enables him to significantly impact research studies from both perspectives and to serve as a bridge between scientific and informatics teams. He has extensive experience overseeing complex, global, multi-site research and development projects.

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David IkleDavid Ikle, Ph.D.

Senior Statistical Scientist

Read Dr. Ikle's CV here.pdf

David Iklé has more than 30 years of experience as a senior biostatistician in a variety of areas of application, including manufacturing research and development, statistical process control, clinical trial design and analysis, and bioinformatics. Prior to joining Rho, he was Director of Biostatistics and Academic Computing at National Jewish Health and a senior faculty member in Biostatistics at the University of Colorado Health Sciences Center in Denver, CO. He was also Director of Biostatistics at the City of Hope Comprehensive Cancer Center and senior faculty member in the Beckman Research Institute in Duarte, CA. He has served on numerous peer review committees of the NIH reviewing grant applications in allergy, asthma, oncology and organ transplantation and has co-authored more than 75 peer-reviewed publications in clinical and translational science. This varied background has made Dr. Iklé very well suited to assume senior leadership roles in NIH-funded consortia performing clinical, proteomic and genomic studies in immunologic disorders.

Since joining Rho in 2009, Dr. Iklé has become Co-PI of the Statistical and Data Coordinating Center (SDCC) for the Immune Tolerance Network (ITN), responsible for biostatistical leadership of its clinical trials in solid organ transplantation. In addition, he is PI of the Statistical and Clinical Coordinating Center (SACCC) for three consortia funded by the National Institute of Allergy and Infectious Diseases (NIAID): Clinical Trials in Organ Transplantation (CTOT), Clinical Trials in Organ Transplantation in Children (CTOT-C) and the Genomics in Transplantation Cooperative Research Program (GTCRP). He is also a Co-Investigator on two NIAID-funded grants responsible for developing biomarkers predictive of rejection in kidney transplant recipients and a central large-scale data archive for high dimension genomics data and high resolution biopsy pathology images and flow cytometry data. As a result, he is at the forefront of NIH-funded clinical and translational research in solid organ transplantation, providing biostatistical leadership for more than 30 clinical and observational studies designed to improve clinical outcomes from solid organ transplants, to reduce the burden on patients of immunosuppressive medications, and to develop genomic and proteomic biomarkers predictive of long term transplant survival.

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Karen KeslerKaren Kesler, Ph.D.

Senior Statistical Scientist

Read Dr. Kesler's CV here.pdf

Karen Kesler is a gifted statistician, adaptive design expert, and respected leader at Rho and in the clinical research industry. An adjunct professor of biostatistics at the University of North Carolina at Chapel Hill, Dr. Kesler has a passion for quality research and biostatistics. Her invaluable experience at Rho and 10-year history of sickle cell disease research serves her well as co-PI of the Statistical and Data Management Center for the Sickle Cell Basic and Translational Research Program. She also has experience working on oncology and cardiovascular studies.

Dr. Kesler has a passion for making studies more effective. Her expertise in study design informs an advanced insight that allows her to provide expert guidance to stakeholders. If a concept is limiting, she has an ability not only to identify it but also to help all stakeholders understand the inherent possibilities of another concept. Whether she's developing novel adaptive study designs, helping sponsors meet their specific research goals, or improving existing tools and developing new ones to facilitate project implementation, Dr. Kesler is always finding ways to enhance clinical research. She is also the co-PI for the Atopic Dermatitis and Vaccinia Immunization Network (ADVN) for which the primary goal is to advance clinical research in the development of safer smallpox vaccines for individuals with atopic dermatitis (AD).

Dr. Kesler is also the author of Rho's Adaptive Design blog, which covers topics such as FDA preferences, regulatory concerns, biostatistical considerations, and protocol implementation logistics for studies using Adaptive Designs.

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Lynette Keyes-Elstein, Dr.P.H.

Senior Statistical Scientist

Read Dr. Keyes-Elstein's CV here.pdf

Lynette Keyes-Elstein welcomes challenges and thrives on finding solutions for difficult problems. To conquer obstacles such as finding creative ways to analyze data and coordinating project activities across departments to rein in expenditures, she draws on both statistical expertise and exceptional management skills. Dr. Keyes-Elstein holds graduate degrees in both biostatistics and immunology and has published peer-reviewed articles as a biostatistician and as a bench scientist. Her background of scientific and biostatistical achievement enhances her ability to provide meaningful statistical consultation on design and analysis issues associated with studies of diseases and conditions with underlying immunologic mechanisms.

After serving as a co-PI of the Statistical and Clinical Coordinating Center for Autoimmune Disease Clinical Trials (SACCC-ADCT) for 6 years, Dr. Keyes-Elstein took over as Principal Investigator and head of Rho's department of infectious and autoimmune diseases in 2008. She is also a co-PI for Rho's Statistics and Data Coordinating Center for the ITN. As a reward for her efforts, Dr. Keyes-Elstein has won Rho's Presidential Award for Reaching Above and Beyond three times since 2005.

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James RochonJames Rochon, Ph.D.

Senior Statistical Scientist

Read Dr. Rochon's CV here.pdf

James Rochon received his Ph.D. in Biostatistics from the University of North Carolina at Chapel Hill in 1985. He is an experienced biomedical investigator, and over the years has gained considerable experience in a variety of medical studies leading to publications in the and elsewhere. From 1994 to 2002, he was an Associate Research Professor at the Biostatistics Center of the George Washington University. There, he collaborated on a number of large, multi-center clinical trials under the direction of senior investigators including Dr. John Lachin. From 2002 to 2010, he was a Research Professor in the Duke University Medical Center. He served as the PI for the Statistics and Data Coordinating Center (SDCC) in the Girls health Enrichment Multi-site Studies (GEMS) funded by the NHLBI, the Comprehensive Assessment of the Long-term Effects of Reducing Intake of Energy (CALERIE) funded by the NIA, and the Drug-Induced Liver Injury Network (DILIN) funded by the NIDDK. He also served as the PI for a methodological grant to develop statistical techniques for longitudinal studies. Dr. Rochon has authored and co-authored more than 71 peer-reviewed publications in biomedical and statistical journals including the New England Journal of Medicine, Journal of Immunology, Transplantation, Biometrics, Journal of the American Statistical Association, and Journal of the Royal Statistical Society.Dr. Rochon currently serves as a PI for the SDCC of the Immune Tolerance Network funded by the NIAID. The purpose of the network is to perform detailed investigations on how the immune system responds to outside pathogens with a view towards developing effective interventions to promote “tolerance” to these pathogens. There are currently more than 26 clinical trials either in development, enrolling and evaluating study participants or in analysis in the fields of allergy, asthma, autoimmune disease and solid organ transplantation. Under Dr. Rochon’s direction, RhoFED performs critical activities including statistical design and analysis, clinical data management, randomization, safety oversight, and clinical study web site development and maintenance.

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Michelle SeverMichelle Sever, Ph.D.

Research Scientist

Read Dr. Sever's CV here.pdf

Michelle L. Sever, PhD. is a Research Scientist who joined Rho in 2012. She is Co-Principal Investigator of both the Statistical and Data Coordinating Center for the Immune Tolerance Network and the Statistical and Clinical Coordinating Center for the Inner City Asthma Consortium, which are funded by the National Institute of Allergy and Infectious Disease/National Institutes of Health (NIH). She is also a Co-Investigator for the Community Healthcare for Asthma Management and Prevention of Symptoms study funded by the Merck Childhood Asthma Network. Dr. Sever provides general epidemiological expertise as well as scientific leadership in developing clinical trials to study allergen immunotherapy, asthma interventions and environmental exposures and their roles in allergy and asthma; translational research; community-based participatory research; interactions between community and individual-level factors in asthma and allergy and environmental dust sample collection and analysis.

Prior to joining Rho, Dr. Sever was an investigator in the Environmental Cardiopulmonary Diseases Group at the National Institute of Environmental Health Sciences (NIEHS)/NIH. From 2000 to 2012, she was involved in the design and implementation of numerous environmental intervention trials and epidemiologic surveys and oversaw the laboratory analysis of dust and blood samples from many of those studies. Dr. Sever assisted in the design and implementation of the Allergy Component of the 2005–2006 National Health and Nutrition Examination Survey. The multimillion-dollar component collected dust samples from 9000 subjects across the country, analyzed the samples for indoor allergens, and analyzed blood samples for antibodies to a panel of indoor and outdoor allergens.

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Meagan SpychalaMeagan E. Spychala, Dr.P.H.

Statistical Scientist

Read Dr. Spychala's CV here.pdf

Meagan E. Spychala holds a DrPH and MS in biostatistics from the University of North Carolina at Chapel Hill and a BS in mathematics from Washington and Lee University. She has worked at Rho since 2005. Dr. Spychala currently serves as the co-PI for the Medical Countermeasures Clinical Studies Network (MCM-CSN), a federal contract that provides support for clinical studies relevant to the Biomedical Advanced Research and Development Authority’s (BARDA) vision to create a nation with the capability to respond quickly and effectively to deliberate, natural and emerging threats by providing a range of clinical study services. For several years, Dr. Spychala served as the co-PI for the SACCC-Autoimmune Disease Clinical Trials (ADCT) consortium, providing scientific and technical oversight on the protocol development and implementation for a variety of autoimmune disease clinical trials. Dr. Spychala has supported Phase I-IV trials in ulcerative colitis, sclerosis-associated pulmonary arterial hypertension, systemic lupus erythematosus, multiple sclerosis, and rheumatoid arthritis. In addition to her federal experience, Dr. Spychala has worked on Phase I through Phase IV commercial trials; her roles have included consulting with protocol development and submission strategies, writing statistical analysis plans, supporting DSMB activities, designing and creating analysis datasets, performing planned and exploratory statistical analyses, and providing support for manuscripts and conference abstracts. Dr. Spychala has provided statistical support for the following therapeutic areas in commercial trials: acute and chronic pain, rheumatoid arthritis, autism, psoriasis, psoriatic arthritis, Parkinson's disease, renal transplantation, diabetic neuropathy, overactive bladder, cerebral palsy, and periodontal disease.

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Cindy VisnessCindy Visness, Ph.D., MPH

Research Scientist

Read Dr. Visness's CV here.pdf

Cynthia Visness is a Research Scientist at Rho and is currently servicing as the acting PI for the ICAC-SACCC. She has worked on inner-city asthma research at Rho since 1999. Since 2004, Dr. Visness has brought her expertise in reproductive epidemiology to the Urban Environment and Childhood Asthma (URECA) study, a longitudinal birth cohort study studying the development of asthma in high-risk children. She has also supervised three biomarker studies of cockroach allergen immunotherapy. Dr. Visness received her doctoral degree in epidemiology in 2008 from the University of North Carolina at Chapel Hill (UNC-CH) and has coauthored more than 43 manuscripts in peer-reviewed journals, 9 as first author. Before coming to Rho, Dr. Visness worked for 9 years at FHI 360 (formerly Family Health International), where she was involved in research on a wide variety of topics in contraceptive technology, family planning program evaluation, and STD transmission, including the infertility effects of breastfeeding and postnatal transmission of HIV infection. Dr. Visness is also an accomplished SAS programmer who has experience with many types of data analysis, including mixed models and survival analysis, and has worked with large and population-based datasets.

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Nancy YovetichNancy Yovetich, Ph.D.

Senior Research Scientist

Read Dr. Yovetich's CV here.pdf

Nancy Yovetich is the Principal Investigator of the Clinical Research Operations and Management Support (CROMS) services program:  a clinical research services contract with the National Institute of Dental and Craniofacial Research (NIDCR). Rho earned the initial contract in 2008 and won the renewal of this contract in September 2014.  Through the contract, Rho provides ongoing study services to NIDCR funded clinical studies and to the NIDCR Intramural and Extramural leaders and program officials in the following areas: protocol writing, materials development, clinical monitoring, data management, biostatistics, project management, safety reporting, regulatory support, quality management, website and other software development and support, scientific consultation, and tools and other infrastructure development. The large number of supported studies have a wide range of clinical indications such as dental and periodontal disease, Sjögren’s syndrome, severe refractory cancer pain, FGF-23 mediated hypophosphatemia, hypoparathyroidism, screening for acute myocardial infarction, oral cancer lesions, and oral health in diverse populations. Dr. Yovetich is also a project leader on commercial clinical trials; her current clinical trials responsibilities include a set of phase 3b studies in dermatology.  Dr. Yovetich has also served as the Principal Investigator of the Walk-PHaSST contract with the National Heart, Lung, and Blood (NHLBI) institute.  Walk-PHaSST was a multi-center, randomized, double-blind clinical trial studying the use of sildenafil to treat pulmonary hypertension in sickle cell disease. Rho's contract included protocol development, clinical monitoring, project and site management, data management, biostatistics, and medical writing.  Additionally, Dr. Yovetich led the statistics and data management center for an NHLBI-funded stroke prevention study: Stroke With Transfusions Changing to Hydroxyurea (SWiTCH). This was a safety and efficacy study comparing standard and alternative therapies for the prevention of secondary stroke and reduction of iron overload in pediatric subjects with sickle cell anemia. The SWiTCH study is closed, and the project is now in the manuscript writing phase.

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