1. JH Trial Innovation Unit (TIU)
JHU-TUFTS Trial Innovation Center (TIC)

2. JAMA October 4, 2016 Volume 316 Number 13, 1353

3. NIH Stewardship & “…the new era.”

4. Fundamental Policy Changes
ICs are developing clinical-trial specific FOAs with new requirements for clinical trials
UH2/UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreements
Companion FOAs for collaborating Data Coordinating Centers
Requiring specific elements on how we develop ideas, go through reviews, and run trials

5. ICs Will Soon Require Services TICs Will Offer
NCATS is positioning the TICs & RICS to help:
Grant applications, Letters of support
Focus on rationale and design, trial operations, and analysis plans
Overall stewardship, efficiency, accountability, transparency of clinical trials

6. NIH Human Subjects and Clinical Trial Information Form
Purpose
The NIH’s initiative to enhance the stewardship of clinical trials is the creation of a new application form that consolidates all Human Subjects and Clinical Trial related information into on place, and to expand the information required for studies that meet the NIH definition of a clinical trial.

7. What is a clinical trial?
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

8. Clinical Study vs. Clinical Trial

9. Funding Opportunity Announcements (FOA)
FOAs that use standard dates were reissued:
With new numbers and
With “Clinical Trial Required” or “Clinical Trial Not Allowed” or “Clinical Trial Optional”

10. Example of FOA Clinical Trial Optional

11. If the answers to the 4 questions are yes, your study meets the NIH definition of a clinical trial, even if your study:
Includes healthy participants
Does not have a comparison group (e.g., placebo or control)
Only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug
Utilizes a behavioral intervention

12. You must complete the Other Project Information page first because this determines the content of the HSCT form
Need sample size JIA , lew rome, r T4 pcori
Hopkins FWA#

13. Based on the answers provided on the Clinical Trial Questionnaire, you will need to complete the following sections:
Form Section
If you answered “yes” to all questions in the Clinical Trial Questionnaire
If you answered “no” to any of the questions in the Clinical Trial Questionnaire
Section 1-Basic Information
Required
Section 2- Study Population Characteristics
Section 3- Protection and Monitoring Plans
Section 4- Protocol Synopsis
Do Not Complete
Section 5- Other Clinical Trial related Attachments
Required if specific in the FOA

14. Key Points
NIH consolidated the inclusion of women and minorities and children into one document.
When you answer “Yes” to Human Subjects on the Other Project Information tab, your application must include at least one of the following:
1 or more full study records, OR
1 or more delayed onset study records, OR
A combination of full and delayed onset study records

15. Delayed Start vs. Delayed Onset
Delayed Start: you can describe your human subjects study fully when you apply. You include all the required supporting material with the application.
Delayed Onset: you cannot fully define your plans for the human subjects study in your application. Typically, this means you need initial results from the first part of the grant before finalizing plans for the human subjects portion.

16. The NIH also uses delayed onset awards for:
Cooperative agreement and multi-project awards that are likely to add new protocols over the course of the awards.

17. A justification is now required for Delayed Onset projects.

18. Examples using NIH Case Studies

19. Examples using NIH Case Studies cont.

20. Examples using NIH Case Studies cont.

21. Trial Innovation Network A new national collaborative initiative within the CTSA Program and is composed of three key organizational partners – the CTSA Programs, the Trial Innovation Centers (TICs), and the Recruitment Innovation Center (RIC).
How Can
We Help You?
The Trial Innovation Network offers study investigators of multi-site trials the ability to request an initial consultation or specific services for a trial, whether funded or in the planning stages.
Prior to submitting a Trial Innovation Network Project Proposal, study investigators must first discuss the proposal with his/her CTSA Liaison team and receive approval from the CTSA Program Principal Investigator.
Once a study investigator submits a proposal, the proposal undergoes a series of reviews which can possibly lead to Trial Innovation Network infrastructure and resources to support your trial.
The CTSA program seeks to partner with NIH ICs in implementing their trials.
Questions? Contact your Liaison Team Liz Martinez or Dr. Charles Flexner, Medical Director at (410) Learn more at trialinnovationnetwork.org
The Trial Innovation Network is supported by the National Center for Advancing Translational Sciences, National Institutes of Health, under award numbers U24TR001608, U24TR001597, U24TR001609, and U24TR

22. Structure of the Trial Innovation Unit: Processes and Inputs
eCRF=electronic Case Report Forms
ORA= Office of Research Administration

23. Collaborating Centers and Expertise of the Trial Innovation Unit

24. Team Trials Information/Decision Making Flow Diagram

25. Recruitment & Retention Services, Tools, & Training

26. Trial Innovation Network Multisite Trials

30. Questions/Comments
Contact Information Dr. Charles Flexner (410) Liz Martinez (410) Karen Lane (410) Dr. Dan Hanley (410)