This virtual session will take place on Saturday, December 4, 2021 and aims to:
- Enhance faculty and fellow understanding of key Hopkins players and available research resources (including study planning support and data collection tools)
- Discuss study planning and initiation (budget, contracts, IRB, research team), responsibilities of the Principle Investigator, and study start-up activities
- Detail elements of conducting a clinical trial
- Discuss challenges and solutions for establishing a successful clinical trials unit
Attendees: Gastroenterology and Hepatology clinical and research fellows, faculty, research staff
To register, click here.
AM Session – Initiating Your Clinical Trial
| 8:00-8:10 | Welcome, course overview, goals of the meeting | Mimi Canto |
| PLANNING YOUR CLINICAL TRIAL – Design, Research Team, Collaborations with Industry | Moderator: Mimi Canto | |
| 8:10-8:40 | Clinical trial designs and sample size considerations– the basics | Prasad Iyer (Mayo) |
| 8:40-9:00 | Building your research team -feasibility assessment, workflow development, staffing for clinical trials coordinator/staff oversight, hiring, management and delegation | Susan Moist (UNC) |
| 9:00-9:20 | PI responsibilities, multicenter trials, registries, sponsor and CRO interaction | Nicholas Shaheen |
| 9:20-9:40 | Collaboration with industry, how to determine if the budget is feasible, common pitfalls and examples of successful/failed clinical trials – what should I know before initiating industry-sponsored clinical trials | Mark Sulkowski
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| 9:40-10:00 | Q & A, panel discussion | Iyer, Moist, Shaheen, Sulkowski |
| 10:00-10:10 | Break | |
| PLANNING YOUR CLINICAL TRIAL – Budget, Contract, Regulatory, IRB | Moderator: Ellie Afghani | |
| 10:10-10:40 | Budget preparation - understanding billing coverage analysis, compliance | Karen Roz (Director ORA, clinical research) |
| 10:40-11:00 | IRB application review types Considerations for research participants Ethical considerations |
Megan Singleton, JD, MBE, CIP Associate Dean, Human Research Protections and Director of the Human Research Protections Program |
| 11:00-11:20 | Contract review and execution JHU contract offices and process overview Regulatory considerations for drug and device trials IND, IDE Research consulting and other opportunities for compliant interaction with industry |
Mont Brownlee (Senior Director, ORA) |
| 11:20-12:00 | Sample clinical trials for design, budget, staffing, contracting, Q & A, panel discussion | Elham Afhani, Venkat Akshintala, Megan Singleton, Karen Roz, Mont Brownlee |
| 12:00-12:20 | Lunch break |
PM Session – Conducting Your Clinical Trial and Publishing Your Results
| COMPLIANCE ISSUES, DATA COLLECTION, AND DATA MANAGEMENT | Moderators: Ken Hui/Aly Strauss | |
| 12:20-12:50 | Adverse events and protocol deviations
Assessments, documentation, and reporting to regulatory bodies and sponsors; examples |
Fred Luthardt, Jr., Suzanna Roettger (Office of Human Subjects Research)
Megan Singleton, Associate Dean, Human Research Protections |
| 12:50-1:10 | Conflict of interest in clinical trials | Ashley Carpenter (Office of Policy and Coordination) |
| 1:10- 1:30 | BEAD | Jacky Jennings (Director, BEAD) |
| 1:30:150 | ICTR | Dan Ford (Director, ICTR) |
| 1:50-2:20 | REDCap and REDCAP-EPIC connector | Scott Carey (Director, REDCap) |
| 2:20-2:40 | Informatics services for research data collection, extraction and storage: Epic and Precision Medicine Analytic Platform (PMAP) | Bonnie Woods (Director IT, ICTR) |
| 2:40-3:00 | Q & A, panel discussion | Suzanna Roettger, Fred Luthardt, Ashley Carpenter, Jacky Jennings, Dan Ford, Scott Carey, Bonnie Woods, Ken Hui, Aly Strauss |
| 3:00-3:10 | Break | |
| DATA ANALYSIS, MANUSCRIPT PREPARATION, AUTHORSHIP | Moderator: Venkat Akshintala | |
| 3:10-3:30 | Data analysis, thinking about your manuscript and where to submit | Nicholas Shaheen |
| 3:30-3:50 | Authorship | Stephen Meltzer |
| 3:50-4:10 | Q & A | Nick Shaheen, Steve Meltzer, Venkat Akshintala |
| RESEARCH CHALLENGES, CASE DISCUSSIONS, BUILDING A SUCCESSFUL CTU | Moderator: Mimi Canto | |
| 4:10-4:25 | Specific study challenges (pre-submit), feedback on specific research challenges – case discussions | Mimi, Nick, Susie |
| 4:25-4:45 | The UNC Clinical Trials Unit – how to build a successful CTU | Nick and Susie |
| 4:45-4:55 | Q & A | Mimi, Nick, Susie |
| 4:55-5:00 | Closing remarks, Adjourn | Mimi |
