JHUTUFTS Trial Innovation Center TIC JAMA October 4 2016 Volume 316 Number 13 1353 NIH Stewardship amp the new era Fundamental Policy Changes ICs are developing clinicaltrial specific FOAs with new requirements for clinical trials ID: 1047995
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1. JH Trial Innovation Unit (TIU)JHU-TUFTS Trial Innovation Center (TIC)
2. JAMA October 4, 2016 Volume 316Number 13, 1353
3. NIH Stewardship & “…the new era.”
4. Fundamental Policy ChangesICs are developing clinical-trial specific FOAs with new requirements for clinical trialsUH2/UG3/UH3 Exploratory/Developmental Phased Award Cooperative AgreementsCompanion 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 OfferNCATS is positioning the TICs & RICS to help:Grant applications, Letters of supportFocus on rationale and design, trial operations, and analysis plansOverall stewardship, efficiency, accountability, transparency of clinical trials
6. NIH Human Subjects and Clinical Trial Information Form PurposeThe 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
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. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html
8. Clinical Studyvs.Clinical Trial https://grants.nih.gov/policy/clinical-trials/CT-decision-tree.pdf
9. Funding Opportunity Announcements (FOA)FOAs that use standard dates were reissued:With new numbers andWith “Clinical Trial Required” or “Clinical Trial Not Allowed” or “Clinical Trial Optional”
10. Example of FOA Clinical Trial Optionalhttps://grants.nih.gov/grants/guide/pa-files/par-18-288.html
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 participantsDoes 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 drugUtilizes a behavioral interventionhttps://grants.nih.gov/policy/clinical-trials/definition.htm
12. You must complete the Other Project Information page first because this determines the content of the HSCT formHopkins FWA#
13. Based on the answers provided on the Clinical Trial Questionnaire, you will need to complete the following sections:Form SectionIf you answered “yes” to all questions in the Clinical Trial QuestionnaireIf you answered “no” to any of the questions in the Clinical Trial QuestionnaireSection 1-Basic InformationRequiredRequiredSection 2- Study Population CharacteristicsRequiredRequiredSection 3- Protection and Monitoring Plans RequiredRequiredSection 4- Protocol SynopsisRequiredDo Not CompleteSection 5- Other Clinical Trial related AttachmentsRequired if specific in the FOADo Not Complete
14. Key PointsNIH 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, OR1 or more delayed onset study records, ORA combination of full and delayed onset study records
15. Delayed Start vs. Delayed OnsetDelayed 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
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.https://www.niaid.nih.gov/grants-contracts/human-subjects-delayed-start-or-delayed-onset
17. A justification is now required for Delayed Onset projects.
18. Examples using NIH Case Studies https://grants.nih.gov/policy/clinical-trials/case-studies.htm
19. Examples using NIH Case Studies cont. https://grants.nih.gov/policy/clinical-trials/case-studies.htm
20. Examples using NIH Case Studies cont. https://grants.nih.gov/policy/clinical-trials/case-studies.htm
21. 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.Trial Innovation NetworkA 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). 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.orgHow Can We Help You?
22. Structure of the Trial Innovation Unit: Processes and InputseCRF=electronic Case Report FormsORA= 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 Trialshttps://trialinnovationnetwork.org/
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30. Questions/CommentsContact InformationDr. Charles Flexner (410) 955-9712Liz Martinez (410) 614-6323Karen Lane (410) 614-6996Dr. Dan Hanley (410) 614-6996