Clinical Trials Academy

About the Academy

The Department of Internal Medicine’s Clinical Trials Academy offers early career faculty and new clinician investigators a combination of lectures and hands-on small groups sessions to teach the complex and changing landscape of clinical trials.

Launched in January 2018, this six-month program aims to help early career investigators from clinical departments at the University of Michigan formulate and finesse a clinical research protocol to submit for funding from NIH, pharma, or device.

Graduation from the Academy involves submitting the finalized proposals to the faculty group, who review and score based on NIH criteria. The overall scores and feedback on each proposal are then sent to the trainees, who have the opportunity to make changes to the proposal and prepare an oral defense of the project that concludes the  program in late summer. A formal graduation session combines the written critiques to each participant’s clinical trial provided by the faculty mentors in an NIH study section-like format and an oral defense outlining the overall trial design, response to critique, and grant submission timelines.

In 2019, the Clinical Trial Academy graduated 12 participants, all of whom successfully completed their clinical trial protocols and received seed funding.

The Academy is directed by Rodica Pop-Busui, MD, PhD, Larry D. Soderquist Professor, Professor of Internal Medicine, and Vice Chair for Clinical Research, and Anna Lok, MD, MSc, FAASLD, AGAF, Alice Lohrman Andrews Research Professor of Hepatology, Assistant Dean for Clinical Research, and Professor of Internal Medicine, and ran by Program Manager Claire Wolniewicz.

The steering committee includes co-directors Dr. Rodica Pop-Busui and Dr. Anna Lok, along with Steve Kunkel, PhD, Executive Vice Dean for Research, Peter A. Ward Distinguished University Professor of Pathology, and Endowed Professor in Pathology Research, and John Carethers, MD, C. Richard Boland Distinguished University Professor and John G. Searle Professor and Chair of Internal Medicine.


The academy is designed to teach the fundamentals of clinical trial design and to train the new generation of successful clinical investigators in all areas of human disease at Michigan Medicine.


  • To effectively help early career investigators to:
    • construct pertinent hypotheses and questions to catalyze innovation in drug/device/behavior discovery.
    • develop critical thinking on how to target cutting-edge basic research findings with direct relevance for human disease.
    • develop scientifically rigorous and practical clinical trial protocols.
    • understand the ever-changing landscape of clinical trials, from earlier phases to multicenter randomized and pragmatic population trials.
  • To teach practical tips for successful collaborations among investigators with complimentary expertise across divisions and departments, and academic institutions, and how to identify federal, foundations, and industry partners to address the therapeutic challenges of human diseases.
  • To increase investigator initiated industry and NIH funded clinical trials.
  • To facilitate leadership roles for Michigan Medicine investigators in landmark multicenter trials.


Program topics include:

  • Protocol Development
  • Trial Design
  • Statistical Considerations
  • Endpoints and Objectives
  • Study Design and Proposals
  • Behavioral Interventions
  • Trial Interventions and Population
  • Adverse Events and Adjudications
  • Ethical Considerations
  • CTSU
  • Manual of Operations
  • Sponsor and Monitoring

Class of 2022 Participants - Projects / Plans

  • Elizabeth Ames, MD, PhD (Pediatric Genetics) - Prospective Study of Biomarkers in Propionic Acidemia to Identify Decompensations (PAID)
  • Jeffrey Berinstein, MD, MSc (Gastroenterology & Hepatology) - Development of a Patient-Tailored Adaptive Treatment Strategy for Acute Severe Ulcerative Colitis
  • Salim Hayek, MD (Cardiovascular Medicine) - Extracorporeal suPAR Extraction to Prevent Cardiac Surgery-Associated Acute Kidney Injury: A Phase I Trial
  • Jacqueline Madison, MD (Rheumatology) - An Investigator-Initiated Phase 2, Open-Label Clinical Trial to Assess Mechanisms by Which Colchicine May Mitigate Thrombo-Inflammation in APS Patients
  • Karthik Ramani, MD (Nephrology) - Study will evaluate the effectiveness of a novel urinary tract silicone catheter balloon inflation fluid to effectively reduce CAUTIs by providing up to 7 days of bactericidal effectiveness via nitric oxide (NO) release
  • Charles Schuler, MD, MSc (Allergy & Clinical Immunology) - Developing Transepidermal Water Loss as a Novel Food Anaphylaxis Monitoring Tool
  • Udit Singhal, MD (Urology) - Prostatectomy with Pelvic Lymphadenectomy for Treatment of Prostate Cancer: A Multicenter, Randomized, Phase III Clinical Trial (PILOT)
  • Sara Till, MD, MPH (Obstetrics and Gynecology) - A Pilot Trial to Develop a Web-Based, Integrative Self-Management Program for Patients with CPP

Class of 2021 Participants - Projects / Plans

Projects and Plans

  • Owen Albin, MD (Infectious Diseases)
    • Diagnostic Evaluation of Ventilator-Associated Pneumonia in Low-Risk Patients
    • Received partial funding from Michigan Institute for Clinical & Health Research Catalyst Grant. Plans to submit for a R01 grant for the remaining
  • Khurshid Ghani, MBChB, MS, FRCS (Urology)
    • Stent Omission After Ureteroscopy and Lithotripsy
    • Submitted to PCORI in August 2021
  • Ingrid Ichesco, MD (Pediatric Adolescent Medicine)
    • Moving Towards Precision Medicine in Diagnosing and Treating Pediatric Chronic Pain
    • Received funding from P&F within a KL2 award
  • Allison Janda, MD (Anesthesiology)
    • PHEnylephrine versus NOrepinephrine in Major NONcardiac surgery (PHENOMENON) Pilot: A Pragmatic Randomized Clinical Trial Pilot Study
    • Plans to submit for a K award in October 2021
  • Mary McGrath, MD (Pediatric Hematology & Oncology)
    • Effectiveness of Tranexamic Acid and Aminocaproic Acid in Reducing Menstrual Blood Loss
    • Plans to submit to Foundation for Women & Girls with Blood Disorders Special Research Grant Award in March 2022
  • Rebecca Sripada, PhD (Psychiatry)
    • Using the Multiphase Optimization Strategy to Adapt Cognitive Processing Therapy
    • Received funding from VA Health Services Research and Development Service (HSR&D)
  • Adina Turcu, MD, MS (Metabolism, Endocrinology & Diabetes)
    • Primary Aldosteronism of Uncertain Subtype- Surgery vs. Medical Treatment - A Randomized Prospective Trial (PAUSSE Trial)
    • Will use discretionary funds
  • Beth Wallace, MD, MSc (Rheumatology)
    • Personalized Glucocorticoid Tapering for Patients with Rheumatoid Arthritis
    • Received funding from VA CAD Award

Class of 2020 Participants - Projects / Plans

Projects and Plans

  • Wassim Labaki, MD (Pulmonary)
    • Investigate the impact of reduction in hyperinflation via lung volume reduction surgery on the serum metabolome
    • K23 funded July 2020
  • Shijing Jia, MD (Pulmonary)
    • A population PK model of Envarsus XR adults with CF to ultimately provide monitoring and dosing recommendations in the CF patient population
    • No update
  • Jacob Kurlander, MD, MS (Gastroenterology)
    • An Effectiveness-Implementation Hybrid Trial of Gastroprotective Proton Pump Inhibitor Use in PCI Patients Treated in a Consortium of Cardiac Catheterization Laboratories
    • K Award was funded prior to starting the CTA
  • Prashant Singh, MBBS (Gastroenterology)
    • A pilot study to compare the effects of GFD with LFD in patients with IBS-D in a single center, parallel group, non-inferiority, randomized controlled trial
    • Submitted
  • Maria Woodward, MD, MS (Ophthalmology and Visual Sciences)
    • Automated Assessment of Microbial Keratitis Biomarkers for Prediction of Treatment Efficacy
    • Able to secure a highly competitive Research To Prevent Blindness Career Advancement award for this project
  • Wajd Al-Holou, MD (Neurosurgery)
    • Implantation of Carmustine-Impregnated Wafers after Surgical Resection of Brain Metastase
    • Not yet submitted
  • Farsad Afshinnia, MD, MS (Nephrology)
    • Effect of Polyunsaturated fatty acid enriched diet on plasma markers of β-oxidation
    • Awaiting transgenic mice before submitting
  • Alex Lin, MD (Metabolism, Endocrinology, and Diabetes)
    • Evaluating the Effectiveness of an Interactive Continuous Glucose Monitoring (CGM) Model in Improving Hypoglycemia Awareness, Endothelial Health, Cardiovascular Autonomic function
    • Obtained pilot funding from the Michigan Center for Diabetes Translational Research for development and feasibility evaluation of a mobile health program to improve hypoglycemia self-management
  • Sonja Schuetz, MD, MS (Neurology)
    • Objective is to better characterize OSA in patients with HFpEF, and to gain a better understanding of the relationship between sleep apnea and cardiac arrhythmias in patients with HFpEF
    • Not yet submitted
  • Elliot Tapper (Gastroenterology)
    • Home-delivered Meals to Improve the Outcomes of Patients with Ascites: The SALTY2 Multi-Center Randomized Controlled Trial
    • Submitted
  • Kelly Walkovich, MD (Pediatrics)
    • Clinical and Molecular Phenotyping of Patients 
    • Not yet submitted
  • Andrea Oliverio, MD (Nephrology)
    • Developing and testing a decision aid for reproductive health for women with chronic kidney disease
    • K-23 funded

Class of 2019 Participants - Projects / Plans

Projects and Plans

  • Vineet Chopra, MD, MSc (Hospital Medicine)
    • The Midline vs. PICC (MVP) Study
    • Submitted to AHRQ Health Services Research Projects (R01) in May 2019
  • Thomas Enzler, MD (Hematology and Oncology)
    • A Trial of Arginase Inhibitor INCB001158 in Combination with Gemcitabine/Nab-Paclitaxel and Nivolumab for the Treatment of Locally Advanced/Metastatic Pancreatic Adenocarcinoma
    • Submitted in August 2019
  • Erin Kirkham, MD (Otolaryngology)
    • Surgical Treatment Optimization for Pediatric Obstructive Sleep Apnea (STOP-OSA)
    • Plans to submit the to NIH NHLBI K23 Career Development Award in October 2019
  • Scott Lempka, PhD (Biomedical Engineering and Anesthesiology)
    • Randomized Clinical Trial Characterizing the Analgesic Effects of Spinal Cord Stimulation
    • Plans to submit to NIH in October 2019
  • Abhijit Naik, MBBS (Nephrology)
    • A Pilot Study to Assess the Safety, Feasibility, and Efficacy of Early Introduction of Angiotension II Blockade to Reduce Accelerated Podocyte Detachment After Kidney Transplantation
    • Plans to submit to NIDDK in October 2019
  • Paula Anne Newman-Casey, MD (Ophthalmology)
    • Support, Educated, Empower (SEE): Personalized Glaucome Coaching Trial
    • Submitted to the National Eye Institute in June 2019
  • Yannis Paulus, MD (Ophthalmology)
    • A Pilot Study to Assess the Feasibility and Safety of MB-102 in Ocular Angiogrpahy as Compared to Fluorescein Sodium
    • Submitted to MediBeacon Inc.
  • Matthew Pianko, MD (Hematology and Oncology)
    • A Phase Ib Study of Daratumumab Plus Anti-CD47 Antibody Hu5F9-G4 in Relapsed/Refractory Multiple Myeloma
    • Plans to submit to the Rogel Cancer Center
  • Brian Schmidt, DPM (Metabolism, Endocrinology & Diabetes)
    • Pro Diabetic Foot Ulcer (Pro-DFU) Healing
    • Submitted to the ADA in July 2019
  • Caitlin Schonewolf, MD (Radiation Oncology)
    • Utilizing Mobile Patient Monitoring with Surface Electromyography During Radiotherapy for Head and Neck Cancer to Improve Post-Treatment Dysphagia
    • Submitted to the Rogel Cancer Center and received funding in June 2019
  • Phillip Vlisides, MD (Anesthesiology) 
    • CAffeine, PAin, and CHange IN OutcomeS after Surgery (CAPACHINOS) Study
  • Justine Wu, MD, MPH (Family Medicine)
    • A Contraceptive Decision Tool for Patients with Medical Conditions: A Mixed Methods Pilot Study
    • Plans to submit to the National Institute of Child Health and Human Development in October 2019 

Class of 2018 Participants - Projects / Plans

Projects and Plans

  • Cagri Besirli (Ophthalmology)
    • Rapid, Automated, Precision Intravitreal Delivery Device (RAPIDD): A Multi-center, Prospective, Randomized, Masked Clinical Trial
  • Malika Gupta (Allergy & Clinical Immunology)
    • Pragmatic Clinical Trial to Assess the Role of a Psychological Intervention to Reduce Caretaker Anxiety in Food Allergy
    • Plans to submit for the American Academy of Allergy Asthma and Immunology 2019 Faculty Foundation Development Award in September 2018 3. Scott Hummel (DOIM, Cardiovascular Medicine) a. Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure-2 (GOURMET-HF 2) b. Submitted as an R01 Grant in April 2018 to NHLBI
  • Michelle Kim (Radiation Oncology)
    • A Phase II Study of Multiparametric MR-Guided High Dose Radiotherapy with Concurrent Temozolomide in Patients with Newly Diagnosed Glioblastoma
    • Plans to submit an R01 Grant in October 2018
  • Monica Konerman (Gastroenterology & Hepatology)
    • Pragmatic Clinical Trial of a Tailored, Adaptive Lifestyle Intervention Program for NonAlcoholic Fatty Liver Disease
    • Plans to submit as a MICHR K in September 2018 and a K 23 in Spring 2019
  • Kara Mizokami-Stout (Metabolism, Endocrinology & Diabetes)
    • Use of Continuous Glucose Monitoring (CGM) as a Diabetes Prevention Strategy
    • Plans to submit for MICHR Pilot Grant
  • Neehar Parikh (Gastroenterology & Hepatology)
    • Transarterial Chemoembolization (TACE) vs Transarterial Radioembolization (TARE) for the Treatment of Hepatocellular Carcinoma: A Multicenter Randomized Phase 2 Trial – one of the two winners for the top-scoring project
    • Plans to submit for an R01 Grant in October 2018
  • Erin Perrone (Surgery)
    • Artificial Placenta
    • Plans to submit for a R01 renewal, submit to Gerber Foundation beginning in November 2018, and March of Dimes in April 2019
  • Kristen Pettit (Hematology/Oncology)
    • Phase 1 Study of MEK Inhibitor Trametinib in Combination with Ruxolitinib in Patients with Myelofibrosis
    • Submitted LOI to Industry and will submit to Cures Within Reach Repurposing Grant in August 2018 Clinical Trials Academy 2018 Summary Statement
  • Christine Ye (Hematology/Oncology)
    • Phase 2 Study with Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma with Upfront Daratumumab-based Therapy
    • Submitted to Multiple Myeloma Research Foundation in May 2018, received funding from Pharma Faculty Mentors

Faculty Mentors and Lecturers