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

JAMA October 4, 2016 Volume 316 Number 13, 1353

NIH Stewardship & “…the new era.”

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

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

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. https://grants.nih.gov/policy/clinical-trials/definition.htm

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. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html

Clinical Study vs. Clinical Trial https://grants.nih.gov/policy/clinical-trials/CT-decision-tree.pdf

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”

Example of FOA Clinical Trial Optional https://grants.nih.gov/grants/guide/pa-files/par-18-288.html

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 https://grants.nih.gov/policy/clinical-trials/definition.htm

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#

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

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

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. https://www.niaid.nih.gov/grants-contracts/human-subjects-delayed-start-or-delayed-onset

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. https://www.niaid.nih.gov/grants-contracts/human-subjects-delayed-start-or-delayed-onset

A justification is now required for Delayed Onset projects.

Examples using NIH Case Studies https://grants.nih.gov/policy/clinical-trials/case-studies.htm

Examples using NIH Case Studies cont. https://grants.nih.gov/policy/clinical-trials/case-studies.htm

Examples using NIH Case Studies cont. https://grants.nih.gov/policy/clinical-trials/case-studies.htm

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) - 614-6323. 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 U24TR001579.

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

Collaborating Centers and Expertise of the Trial Innovation Unit

Team Trials Information/Decision Making Flow Diagram

Recruitment & Retention Services, Tools, & Training

Trial Innovation Network Multisite Trials https://trialinnovationnetwork.org/

Questions/Comments Contact Information Dr. Charles Flexner (410) 955-9712 Liz Martinez (410) 614-6323 Karen Lane (410) 614-6996 Dr. Dan Hanley (410) 614-6996