Clinical Trials 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.
 
The inaugural Clinical Trials Academy was successfully launched in January 2018 as a six-month program aimed 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. The program recently graduated its second class in August 2019.
 
The graduation entails submitting the finalized proposals within the time frame of the academy to the faculty group, who will review and score based on NIH criteria. The overall scores and feedback on each proposal are then sent to 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.
 
All of the participants successfully completed their clinical trial protocol and graduated from the Academy receiving a monetary award aimed to support their initial steps in launching their projects. 

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.

"We invited our most experienced clinical researchers to be part of our Clinical Trials Academy, and every one of them said yes. That speaks volumes about the level of mentorship in our department and institution, and the commitment for the next generation to succeed." - Rodica Pop-Busui, MD, PhD

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

Overview

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.

Objectives

  • 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.

Curriculum

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
  • IND/IED
  • Clinicaltrials.gov
  • CTSU
  • Manual of Operations
  • Sponsor and Monitoring

Faculty Mentors and Lecturers

Participants - Class of 2019

 

Participants / Projects / 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
    • Submited 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 

Participants - Class of 2018

 

Participants / Projects / 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
CLINICAL RESEARCH INTERNAL RESOURCES