NIH-funded T32 Clinical Research Training Program

Message from the Leadership Team

Dr. Anna Lok
Anna S. F. Lok, MD, FRCP
Co-Director
Dr. Peter Higgins
Peter D. Higgins, MD, PhD, MS (CRDSA)
Co-Director
Dr. Sameer Saini
Sameer D. Saini, MD, MS, FAGA
Associate Director

 

 

 

 

 

 

 

 

Thank you for your interest in our NIH-funded T32 Clinical Research Training Program (DK062708).

The purpose of our Program is to train and develop future independent investigators and leaders in GI and hepatology clinical and health services research by providing selected fellows with:

  1. Core methodological skills in the design and execution of clinical research.
  2. A structured, mentored research experience under the guidance of our world-class Core Faculty.

With this training, our T32 fellows leave fellowship poised to compete for tenure-track faculty positions and secure external funding for further career development, ultimately leading to independent research careers. Since inception in 2003, 20 trainees have completed this program. Nearly 80% are faculty at academic medical centers, and two-thirds have successfully competed for career development awards. Our T32 has been successfully renewed three times since 2003, most recently in 2018.

How to Apply

Our Clinical T32 trainees are selected from the pool of GI fellowship applicants based on a competitive application process that includes a secondary application. If you are interested in applying for the T32 or if you have questions about our program, please contact the Associate Director, Dr. Sameer Saini, at sdsaini@med.umich.edu.

Goals of the T32 Clinical Research Training Program

The goals of our three-year Training Program are:

  1. Completion of a Master's degree in our renowned Institute for Healthcare Policy and Innovation (IHPI) Clinician Scholars Program, part of the National Clinician Scholars Program, which focuses on the design and execution of clinical research, including not only traditional clinical research, but also T2, T3, and practice-based research (Year 1).
  2. Completion of a focused GI clinical research seminar series (which includes presentation and discussion of ongoing research by GI fellows), a comprehensive clinical epidemiology/health care policy seminar series, and ongoing seminars and workshops (Years 1–3).
  3. Successful design, execution, and publication of multiple research projects under the guidance of a team of mentors (mentored research), including gastroenterologists, hepatologists, and methodologists performing clinical research (Years 1–3).
  4. Preparation of a career development award application or other research grant application. We believe that early grant applications are crucial to the success of early career faculty because these awards provide transitional funding to facilitate a successful career in clinical research (Year 3).

Each trainee focuses on a specific topic and completes 3 interrelated projects: (1) a meta-analysis; (2) a secondary dataset analysis; and, (3) design of a prospective study. These projects provide the foundation and preliminary data for a career development award application.

Our training program is greatly enhanced by the rich, collaborative environment of the University of Michigan, with its vast resources, centers, and research institutes, including:

  1. The CTSA-supported Michigan Institute of Clinical and Health Research (MICHR)
  2. The Institute for Healthcare Policy and Innovation (IHPI)
  3. The VA Center for Clinical Management Research (CCMR) (a VA HSR&D Center of Innovation).

Our multi-disciplinary Core Faculty includes expert biostatisticians, epidemiologists, behavioral economists, policy-makers, and translational, clinical, and outcomes researchers from not only the Division of Gastroenterology and Hepatology, but also the Division of General Internal Medicine and the School of Public Health. Most faculty are federally-funded for their ongoing research, and these faculty offer a broad spectrum of research expertise with multiple levels of established collaboration and many years of experience mentoring trainees.

Leadership Team

Dr. Anna S. F. Lok – Co-Director

Dr. Lok is the Alice Lohrman Andrews Research Professor in Hepatology and Director of Clinical Hepatology in the Department of Internal Medicine at the University of Michigan in Ann Arbor, Michigan. She also serves as Assistant Dean for Clinical Research in the University of Michigan Medical School (where she leads the clinical trials enterprise for the medical school), is the MICHR CTSA Clinical Trial Lead, and is the former President of the American Association for the Study of Liver Diseases (AASLD), the largest hepatology professional society in the world. 

Dr. Lok is an internationally recognized physician scientist, transplant hepatologist, leader, and mentor. She has published more than 550 articles and has an h-index > 100, reflecting the high impact of her work. She was recognized as one of the top 1% most cited scientists in the world during the period of 2002–2012. Her research has been supported by federal grants from the National Institutes of Health (NIH) and the Veterans Health Administration (VA). Currently, she is Chair of the Steering Committee on the Hepatitis B Clinical Research Network (U01DK082863), a disease in which she is arguably the world’s foremost expert. She is also Chair of the Steering Committee of the Translational Liver Cancer Network (U01CA230669). Dr. Lok’s research includes bedside clinical, T1, and T2 studies. She has also served as an author and working group member for AASLD and World Health Organization (WHO) guidelines on HBV and HCV.

Dr. Lok has trained more than 50 fellows and early career faculty over the course of her career, many of whom have gone on to become independent investigators and leaders in hepatology. In recognition of her accomplishments as a scientist, mentor, and leader, she has received numerous awards including the Distinguished Women Scientist Award from the American Gastroenterological Association (AGA) in 2008, the Distinguished Service Award from the AASLD in 2011, the Distinguished Mentor Award from MICHR in 2012, and an Inspirational Physician Award from the American Medical Association in 2014. In 2016, she was awarded the AGA’s William Beaumont Prize in Gastroenterology, which recognizes an individual who has made a unique, outstanding contribution of major importance to the field. In 2017, she received a Gold Medal from the Canadian Association for the Study of the Liver and an Honorary Doctor of Science degree from her alma mater – the University of Hong Kong. In 2018 she received an International Recognition Award from the European Association for the Study of the Liver. Dr. Lok served as an Associate Editor of Hepatology from 2001-2006, Co-Editor of Journal of Viral Hepatitis from 2007-2009, and Senior Associate Editor of Gastroenterology from 2011-2012. She has also served on various NIH and VA study sections.

Dr. Peter D. Higgins – Co-Director

Dr. Higgins, an internationally recognized leader in inflammatory bowel disease (IBD). Dr. Higgins is a Professor of Gastroenterology in the Department of Internal Medicine at the University of Michigan and Director of the Inflammatory Bowel Disease Program at the University of Michigan. He also previously served as Associate Director of the Training Program in GI Epidemiology and is himself a graduate of this Training Program.

Dr. Higgins’ research focuses on clinical trials in IBD, translational research in measuring intestinal fibrosis in Crohn’s disease, development of anti-fibrotic therapies, and the use of machine learning for predicting response to IBD therapies. He currently leads the Crohn’s and Colitis Foundation of America (CCFA) Clinical Research Alliance and the IBD Working Group at the University of Michigan. He has published over 170 research papers and has received multiple NIH grants and foundation awards for his research in IBD. His current funding portfolio includes two R01s (R01DK109032 and R01GM097117) and over 50 active clinical studies in IBD. Dr. Higgins has served as the Associate Editor for the American Journal of Gastroenterology and Inflammatory Bowel Diseases. His research has impacted policy related to IBD through his work on the AGA IBD Quality Measures Committee and the development of national guidelines for IBD. He has also received many honors and awards, including the AGA IBD Clinical Research Excellence Award.

Dr. Higgins has trained more than 20 fellows and early career faculty over the course of his career, several of whom have gone on to become independent investigators, including Dr. Akbar Waljee and Dr. Ryan Stidham. Notably, as an MD-PhD, he brings expertise in not only outcomes research, but also translational research and clinical trials.

Dr. Sameer D. Saini – Associate Director

Dr. Saini is an Associate Professor of Gastroenterology in the Department of Internal Medicine at the University of Michigan. He is a former graduate of this Training Program. He is also a Research Scientist at the VA Ann Arbor Center for Clinical Management Research. Additionally, he serves as Director of the Gastroenterology Junior Faculty Health Services Research Mentoring Program (JF2K) (which he founded in 2016) and Co-Director of the Mentoring Core at the VA Ann Arbor HSR&D Center for Clinical Management Research (where he also sits on the Investigator Leadership Team). Finally, he serves as Associate Director of the GI Fellowship Training Program.

Dr. Saini’s research focuses on appropriate use of resource-limited medical procedures, such as colonoscopy and upper endoscopy, development of “next generation” performance measures, and development and testing of multi-level interventions to reduce the use of low-value care. His research has been continuously federally funded since 2010. His funding as Principal Investigator has included a VA HSR&D Career Development Award (a 5-year K-level award that provides salary support for career development), a VA QUERI Rapid Response Proposal (an independent, operationally-focused implementation award), and multiple VA HSR&D Merit Awards (which are 4-year R-level investigator-initiated research awards). Dr. Saini’s mentees include Dr. Akbar Waljee (an independently-funded investigator who serves as Training Program Core Faculty) and several early career faculty who have successfully competed for NIH K-level awards. Dr. Saini currently serves on the American College of Physicians (ACP) Performance Measures Committee and is former Lead of the Colorectal Cancer Screening Workgroup for the AGA Quality Measures Committee. He also serves as Associate Editor of the American Journal of Gastroenterology and is a member of the American College of Gastroenterology (ACG) Research Committee, a study section for ACG research grants and career development awards.

Core Faculty

John I. Allen, MD, MBA, is a Clinical Professor of Medicine Medicine and the Chief Clinical Officer in the University of Michigan Medical Group. His career has spanned academic medicine, community practice, leadership, and healthcare policy. He brings a national reputation and expertise in the fields of quality measurement, quality improvement, medical group management, and health care policy. As former President of the AGA, he spearheaded AGA efforts to develop quality measures and worked with CMS and other payers to implement these measures into clinical practice. In 2012, he founded the “Practice Management: The Road Ahead” section of Clinical Gastroenterology and Hepatology, where he served as a Special Section Editor. His expertise in GI healthcare policy and leadership will be valuable to trainees with an interest in policy-oriented research, such as performance measure development and payment reform.

William D. Chey, MD, Professor of Medicine, is a renowned expert in functional gastrointestinal disorders (FGIDs) who has a long track record of research addressing the pathophysiology, diagnosis, and treatment of these highly prevalent and debilitating disorders. His work has been well-funded through multiple industry and foundation grants, including several that are currently active. He holds leadership positions at Michigan Medicine and in national organizations. He is a member of the Board of Trustees of the American College of Gastroenterology and the Council of the American Neurogastroenterology and Motility Society. He was an integral part of the Rome III and Rome IV processes, which were responsible for developing the diagnostic criteria for the FGIDs. He is co-inventor of the digital health platforms “My GI Health” and “My Nutrition Health”, as well as a glove-based manometry device called “Digital Manometry”. He was Co-Editor-In-Chief of the American Journal of Gastroenterologyfrom 2010-2015. Dr. Chey supervises a rapidly growing program of dietary and behavioral interventions for FGIDs at the University of Michigan. He is a member of the League of Research Excellence at the University of Michigan and has received the Distinguished Clinician Award from the American Gastroenterological Association. His expertise will be invaluable for trainees with clinical research projects related to FGIDs.

Raymond De Vries, PhD, is a Professor in the Department of Learning Health Sciences and the Department of Obstetrics and Gynecology, and Associate Director of the Center for Bioethics and Social Sciences in Medicine (CBSSM). He is a medical sociologist with broad experience in qualitative and deliberative methods. His NIH-funded work spans clinical domains but examines societal and ethical issues in medicine. He serves as a methodological expert for trainees who seek to utilize qualitative and mixed methods.

Robert J. Fontana, MD, Professor of Medicine and Medical Director of Liver Transplantation, is an internationally recognized expert in acute liver failure, drug-induced liver injury, and viral hepatitis. He has published over 250 papers on a variety of topics and has been a co-author of the AASLD Hepatitis C Guidance. He is the current co-chair of the U01-funded Drug-Induced Liver Injury (DILI) Network (U01DK065184) Steering Committee that was initiated in 2013. He has led analyses exploring the development of chronic liver injury from drugs, as well as genetic polymorphisms associated with individual drugs. As a national/international expert in DILI research, he has served as chair of the AASLD Hepatotoxicity Special Interest Group and has been a participant and co-chair of the AASLD-FDA-Pharma meeting on DILI for the past 15 years. He is also a co-PI on the US Acute Liver Failure Study Group, which has been working to improve our knowledge of the etiology, outcomes, and treatment of acute liver failure. Dr. Fontana also has served as the lead investigator on long-term outcomes in acute liver failure and has been the PI on various ancillary studies involving hepatitis A, hepatitis E, ischemia, and transplantation for acute liver failure. He has also participated in various clinical trials and is the current PI of the Methacetin Breath Test Study, which is attempting to identify a noninvasive predictor of outcomes in acute liver failure. Dr. Fontana is also a member of the Hepatitis B Research Network and serves as the Chief of the Publications Committee. Dr. Fontana is a current member of the AASLD’s Clinical Research Committee and has served on the AGA Research Committee. He has also been a grant reviewer for the NIH and FDA study sections for the past 20 years. He also has extensive experience using large datasets to evaluate outcomes related to liver transplantation. Dr. Fontana’s expertise will be invaluable to trainees with an interest in complications of liver disease and the use of large datasets to assess outcomes in liver disease patients.

Rodney Hayward, MD, Professor of Medicine in the Division of General Internal Medicine, is Director of the IHPI Clinician Scholars Program and former Director of the VA Ann Arbor Center for Clinical Management Research. His research focuses on quality improvement and application of practice guidelines to improve patient care. Dr. Hayward brings a wealth of experience in the organization and administration of training programs. He also brings significant leadership experience in mentoring and facilitating the performance of outcomes and health services research by post-doctoral trainees.

H. Myra Kim, ScD, is Adjunct Professor of Biostatistics in the School of Public Health, Research Scientist in the Center for Statistical Consulting & Research, and Core Faculty in the IHPI Clinician Scholars Program. Dr. Kim serves as consulting biostatistician for multiple faculty in the Department of Internal Medicine and the VA Center for Clinical Management Research. In this role, she collaborates on the statistical plan and data analysis for faculty research projects. She also mentors our trainees on statistical planning/data analysis for their research projects.

Laurence F. McMahon, Jr., MD, MPH, Professor of Medicine, is Chief of the Division of General Medicine. Other appointments include Professor, Health Management and Policy, School of Public Health, and Senior Associate Director of the IHPI Clinician Scholars Program. Dr. McMahon's research focuses on delivery of cancer screening services, health care administration, and payment models. He is currently Principal Investigator on an R01 studying the impact of disability and social determinants of health on value-based purchasing and new bundled payment models. Through his various roles, Dr. McMahon brings a wealth of experience in the organization and administration of training programs in clinical research and epidemiology, and he has served as advisor to literally dozens of post-doctoral epidemiology students, GI fellows, medical residents, and medical students.

Joel H. Rubenstein, MD, MSc, Associate Professor of Medicine, is the Director of the Barrett’s Esophageal Disorders Program at University of Michigan and a research scientist at the Ann Arbor Veterans Affairs Center for Clinical Management Research. Dr. Rubenstein’s primary research focus is on risk factors for Barrett’s esophagus and esophageal adenocarcinoma, and developing and testing efficient strategies for decreasing the burden of esophageal adenocarcinoma. To accomplish these goals, he utilizes epidemiologic, outcomes, and translational tools. He also has a focus on appropriate utilization of healthcare resources in gastroenterology. Dr. Rubenstein completed his Master’s Degree at the University of Michigan School of Public Health in Clinical Research Design and Statistical Analysis as a trainee in our Training Program. Dr. Rubenstein provides content and methodological expertise for trainees with an interest in esophageal diseases and cancer prevention. He also serves as a faculty member for the GI clinical research seminar series.

Sandeep Vijan, MD, MS, Professor of Medicine in the Division of General Internal Medicine, is a Research Scientist at the VA Ann Arbor Center for Clinical Management Research and Director of Quality Analytics at the University of Michigan. Dr. Vijan conducts health services and policy research on individualizing decisions around treatment of chronic diseases using statistical modeling methods, including econometrics and simulation methodology. He is a Core Faculty member of the IHPI Clinician Scholars Program (where our trainees receive their advanced clinical research training and earn their Master’s degree). His research has been funded by NIH and VA. His role in this research grant will be to mentor trainees in simulation modeling and economic analysis. Additionally, in his role as Director of Quality Analytics for the health system, he facilitates access to data from the University of Michigan Hospitals for secondary data analysis.

Akbar K. Waljee, MD, MSc, Associate Professor of Medicine, is an expert in IBD whose research focuses on the use of advanced data science techniques such as machine learning to predict clinical outcomes. He is a graduate of our Training Program. His current work is funded by VA, Department of Defense (DoD), and NIH. Dr. Waljee is the Associate Director of the IHPI Data and Methods Hub, which houses extensive data resources, including multiple large national datasets. He facilitates data access and provide methodological support related to advanced data science techniques.He also serves as a faculty member for the GI clinical research seminar series.

Brian Zikmund-Fisher, PhD, is an Associate Professor of Health Behavior and Health Education in the School of Public Health and a Research Associate Professor of Medicine. He is also Associate Director of the Center for Bioethics and Social Sciences in Medicine (CBSSM). Dr. Zikmund-Fisher uses his interdisciplinary background in decision psychology and behavioral economics to study factors that affect individual decision making about a variety of health and medical issues. His research in health communications focuses on making risk statistics and other types of quantitative health information meaningful and useful for decision making by patients and the public. An expert in survey design, Dr. Zikmund-Fisher leads the Internet Survey Lab at CBSSM and has assisted numerous trainees from our Training Program in survey design. He provides methodological guidance and support related to survey research, development of patient educational and risk communication materials, and medical decision-making.

Contact

For more information about this program, please email