Meet the Team

Picture of Donald Brambilla

Donald Brambilla, PhD – Principal Investigator, Senior Statistician

Dr. Brambilla has more than 27 years of experience collaborating with clinical investigators on the design and execution of multicenter clinical trials, including trials in various aspects of sickle cell anemia, reduction of inhibitors of Factor VIII in hemophilia, and treatments for thrombocytopenia (TTP, ITP). He knows the difficulties encountered in conducting trials in rare patient populations. In a recent trial in which he collaborated, fewer than 5,000 patients nationwide were eligible for the two trials of stroke prevention in children with sickle cell anemia. He helped develop strategies for screening, recruitment and retention, and proposed adjustments to sample sizes to compensate for losses and crossovers that resulted in successful completion of both trials. His collaborative work on multicenter trials and three clinical research networks taught him that many clinicians who have good ideas for improving the treatment of their patients lack the training, experience, or resources to design and complete trials to test their ideas. Dr. Brambilla has successfully collaborated with investigators to first outline the issues that needed to be addressed and work through them systematically and in a timely fashion such that trials in hemoglobinapathies were both well designed and successfully conducted and completed.
   
 

Picture of Diane Catelier

 

Diane Catellier, DrPH – Co-Investigator, Senior Statistician

As senior member of the clinical trials resource team, Dr. Catellier will provide support for finalization of clinical trial design, advice on database management and data security requirements, input on interim monitoring and statistical analysis plans, and site and subject recruitment strategies, and provide oversight of other services provided by RTI staff and consultants. Dr. Catellier has served as Coordinating Center PI for five NIH-sponsored Phase III clinical trials, and has first-hand knowledge of the process steps that are needed to launch a large clinical trial protocol and the barriers that exist in conducting trials. Dr. Catellier has contributed to a compendium of best practices for Coordinating Centers that support large clinical trials that will serve as a resource to National Heart, Lung, and Blood Institute Program Staff for crafting application and review criteria for RFAs/RFPs and when evaluating Coordinating Centers as part of a large clinical trial program. She is particularly interested in design and analytic approaches to increase the efficiency and reduce the cost of clinical trials.

   
 

Picture of Rick Williams

 

Rick Williams, PhD – Co-Investigator, Senior Statistician

Dr. Williams has more than 30 years of experience in public health and medical research as a statistician with skills in study design and management. He is a Fellow of the American Statistical Association. His recent statistical interests include the design and analysis of pharmacokinetic studies through his work on the Neonatal Research Network, the Obstetric-Fetal Pharmacology Research Units Network, and for commercial clients. He has also developed statistical methods which have been adopted by the U.S. Food and Drug Administration and the National Toxicology Program for the analysis of preclinical data. He frequently conducts workshops and training classes on the use of appropriate statistical analysis methods for cluster-correlated, longitudinal, or repeated measures data such as generalized estimating equations for marginal models, hierarchical linear and nonlinear mixed models, and multilevel models.

   
 

Picture of Sreelatha Meleth

 

Sreelatha Meleth, PhD – Co-Investigator, Senior Statistician

Dr. Meleth has more than 17 years of experience collaborating on public health research studies. Prior to joining RTI in 2011, she spent 11 years as a biostatistician in the University of Alabama at Birmingham’s Comprehensive Cancer Center Biostatistics & Bioinformatics Unit, including terms as the interim director and co-director. During this time, Dr. Meleth led several Biostatistics Cores for the Specialized Program for Research Excellence. In these roles, she was actively involved in supporting clinicians in developing and implementing multicenter Phase 1, Phase 2, and Phase 3 clinical trial protocols. She has provided statistical support and guidance for proposals that span the gamut of health research from proteomics and biomarkers to treatment of various disease conditions and the design and conduct of randomized clinical trials and mixed-study designs. Dr. Meleth’s experience also includes identifying optimal cut points for biomarkers and comparing the effects of statistical preprocessing and missing data. She is well versed in linear mixed models, generalized linear mixed models, survival analysis, Cox regression, time series analysis, and generalized additive models and meta-analytic techniques.

   
 

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Marie Gantz, PhD – Co-Investigator, Senior Statistician

Dr. Gantz has over a decade of experience providing statistical design and analysis support for randomized clinical trials. As the PI or Co-PI of the data coordinating centers for three NIH-funded multicenter research networks, she collaborates with clinicians to develop and implement protocols, provides oversight for the development of manuals of operations, case report forms, and data management systems, and manages study drug/placebo manufacturing in compliance with regulatory requirements. She has coauthored more than 30 manuscripts reporting on clinical trials and observational studies in women and children’s health in peer-reviewed journals including the New England Journal of Medicine and Journal of the American Medical Association. Her statistical interests include hierarchical models, survival analysis, and dirichlet multinomial mixture models.

   
 

Picture of Deborah McFadden

 

Deborah Whitehurst McFadden, MBA – Senior Study Manager

Ms. McFadden has been participating in multisite clinical and epidemiologic studies as a data coordinator, analyst, or project manager since 1974. One of her early experiences was as the coordinator for a Natural History Study of the Development of Factor VIII Inhibitors in Hemophilia. She has extensive experience in developing study documents such as protocols, manuals of operations, consent forms, data collection forms, randomization procedures, training manuals, and other supporting documentation and in training clinical staff on the implementation of study procedures. She is a member of an RTI Institutional Review Board and is a reviewer for RTI’s Office of Research Protections.

   
 

Picture of Julie Croxford

 

Julie Croxford, RN, MPH – Clinical Research Nurse

Ms. Croxford has more than 20 years of national and international research experience. She has been involved extensively in the development of study documents such as protocols, manuals of operations, data collection forms, and other supporting materials and has conducted data quality assessments internationally. In her role as study coordinator on clinical trials, she conducts training and monitoring and oversees many aspects of study planning and implementation, including safety reporting and data collection and management.

   
 

Picture of Kelly Roney

 

Kelly Roney, PhD, RAC – Regulatory Affairs Specialist

Dr. Roney is certified in regulatory affairs (RAC) and has experience in many areas of regulatory affairs and pharmaceutical development, including the writing and reviewing of regulatory, clinical, and scientific documents such as investigational new drug applications (INDs) and clinical study reports; clinical trial management; pharmaceutical development plans; and project management for phase I–III clinical trials of vaccines, allergy products, gastrointestinal cancer immunotherapies, antibiotics, devices, and neurology pharmaceuticals. Her graduate studies were focused in immunology, microbiology, and cell-cell interactions. Additional areas of scientific expertise include models of infectious disease, oncology, pelvic floor disorders, stem cell transplantation, obstetrics and pediatrics drug development, and the production and use of therapeutic biological agents.

   
 

Picture of Nigel Key

 

Nigel Key, MB ChB, FRCP (Consultant)

Dr. Key is an adult hematologist specializing in non-malignant hematologic disorders, particularly those affecting blood coagulation. He is the Harold R. Roberts Distinguished Professor, Chief of the Section of Hematology in the Division of Hematology/Oncology, and Director of the UNC Hemophilia and Thrombosis Center. He serves as a consultant for the Clinical Trials Development Resource for Hematologic Disorders. His clinical interests include the diagnosis and management of bleeding disorders including hemophilia and von Willebrand disease, as well as arterial and venous thromboembolic disorders. He has authored well over 150 peer-reviewed articles, approximately 25 book chapters, and is co-editor of a popular textbook on disorders of bleeding and clotting.

 

 

 


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