Brief Study Chair Guideines Gini Feming, MD Aiance Young Investigator s Meeting, 3 November 2016
STUDY CHAIR
Going from Idea to Concept Concept path depends on type and originating committee Prospective cinica intervention Cancer Therapy Evauation Program (NCI CTEP) Cancer Prevention or Symptom Intervention (NCI DCP) Aiance Foundation Tria (AFT) Biospecimen reqest: Use of specimens previousy coected in Aiance studies Data-ony studies: Anaysis of data from a previousy pubished tria (or set of trias)
Data-Ony Studies Aiance Data Request Form Brief background, goas, patient /tria identification, anaysis pan, budgethttps://aianceforcinicatriasinoncoogy.org/main/pub ic/standard.xhtm?path=%2fpubic%2fdatasharing Approva of sponsoring committee chair and statistician are required Committee statistician estimates effort Concepts requiring < 25 hours SDC effort are approved by SDC Concepts requiring 25 hours SDC effort are approved by Aiance Executive Committee
Biospecimen Requests Process is currenty migrating from Aiance-ed to NCI-ed Current Specimen Request Form https://aianceforcinicatriasinoncoogy.org/main/pubic/sta ndard.xhtm?path=%2fpubic%2fspecimens
Biospecimen Requests - Current process is managed by the Aiance Transationa Research Program (TRP) Aiance triage form for TRP stake hoders to review NCTN-CCSC proposa deveopment TRP executive committee fu review NCI-NCTN CCSC review Paper work and specimen reease
What is NCI-NCTN CCSC? -Core Correative Science Committee - CCSC is charged with scientific review & prioritization of proposas requesting use of banked, non-reserved biospecimens coected from NCTN trias - Incudes NCTN Network Group Representatives, Bank representatives, advocates, & NCI representatives, with appropriate cinica, statistica, and scientific expertise to provide review & consideration of use of irrepaceabe biospecimen resources.
NCTN-CCSC Proposa Form Incudes the foowing Abstract, Objectives and Hypotheses, Background and Significance Tria(s) from which sampes are being requested Preiminary data and study justification Research Design and Methods Tissue/Biospecimen type Data-sharing Pan Statistica Considerations References and Appendices Letters of coaboration from each co-investigator Confirmation sent by NCTN bank or SDC regarding sampe or data avaiabiity
Biospecimen Requests - In the near future (TBD), this process wi be managed by NCI/CTEP Aiance triage form for TRP stake hoder review Investigator submits LOI through NCI front door (TBD) NCTN-CCSC proposa deveopment TRP executive committee fu review NCI-NCTN CCSC review Paper work and specimen reease
In the near future (TBD), To identify avaiabe biospecimens from Aiance Trias, investigators can either contact Aiance TRP, OR use NCI Navigator system Navigator system is not aunched yet, but a brief video is avaiabe https://navigatoruat.wust.edu/nctn-navigator/pubic/home Aiance TRP wi provide etter of support for the proposas reviewed/approved by TRP prior to CCSC review
Letter of Support for NIH Grant Appication -The Aiance TRP can provide etters of support for NIH grants. Letters wi be signed by the TRP PI Dr. Fraser Symmans and/or Group Chair Dr. Monica Bertagnoi - For LOS or other questions regarding correative studies and specimen requests, pease contact Yujia Wen, MD, PhD Director, Transationa Research Operations E-mai: ywen@medicine.bsd.uchicago.edu Phone: 773-834-7973
Cinica Interventions-NCI NCI CTEP Letter of Intent (LOI) Form (Ph 1 and 2, <100 patients) NCI CTEP Concept Submission Form (Ph 2, 2/3, and 3 > 100 patients) DCP-sponsored symptom intervention/prevention (ist of required eements) Check with committee protoco coordinator for appropriate form
Get Buy In Speak with Aiance Committee Chair(s) Work in conjunction with associated scientific/modaity/discipine committees (eg Radiation Oncoogy, Heath Outcomes, Transpant, etc.) Co-sponsoring committee representatives (incuding statistician) shoud review fina concept draft A Aiance studies (except data sharing and TRP) require community oncoogy committee co chair and input at concept stage NCI has estabished steering committees and associated task forces for most disease sites Prior to submission to the Aiance, concepts may require submission of your idea to a disease-specific task force
Study Concept Review Committee (SCRC) Submission Forward finaized concept to committee statistician(s) at east two weeks prior to SCRC submission Aiance Committee Chair/CCP Program Manager submits concept to Aiance Study Concept Review Committee SCRC review occurs on a roing basis on Tuesday afternoons within 8-10 days of concept submission SCRC conducts operations/feasibiity review
Study Funding Aiance U24 biorepository grant supports biospecimen storage and initia processing at the Aiance biorepository. Specimen distribution, compex specimen processing and study kit distribution are not incuded in the U24 support. NCI provides funding to reimburse sites for basic specimen submission. Compex procedures (eg. research biopsy) wi require investigators to raise funding for sites.
Study Funding Additiona funds may be required for Biomarker screening Transationa research (biospecimen acquisition, processing, aboratory anaysis) Pathoogy review (especiay rea time) Any non-standard-of care tests Drug distribution Identify needs eary!!!
Potentia Funding Resources Industry Partners Grants Investigator (R01) NCI suppementa grants to the Aiance U10 grant (eg. for drug resistance biomarkers). NCI Biomarker, Imaging, & Quaity of Life Studies Funding Program (BIQSFP)
BIQSFP NCI funding for integra or integrated biomarkers, imaging and quaity of ife components (not for exporatory biomarkers) Phase III and randomized phase II concepts >100 patients are eigibe BIQSFP appications with integra correative science must accompany the initia concept to NCI BIQSFP appications with integrated correative science must occur by first protoco submission.
Study Funding Integra studies Assays and tests that must be performed in order for tria to proceed Inherent to the design of the tria (determine eigibiity, stratification, treatment assignment) Must be performed in rea time for conduct of tria Require CLIA certified aboratory Integrated studies Identified as part of the tria from the beginning Intended to vaidate or identify assays or markers and imaging tests panned for use in future trias Incude compete pans for specimen coection, aboratory measurements, cutpoints, and statistica anaysis
Study Funding You and your study team are responsibe for BIQSFP appication preparation https://www.cancer.gov/about-nci/organization/ccct/funding/biqsfp You with Aiance wi deveop budgets to present to Industry DO NOT independenty discuss budget with industry Your Aiance Executive Officer, an oncoogist part of your study team, aong with Aiance contract and budget speciaists wi direct industry negotiations
Aiance Protoco Deveopment After NCI concept approva, you must hep ensure the timey deveopment and activation of your tria by Adhering to study deveopment timeines set by Aiance protoco coordinators Attending a study team teeconferences (protoco + CRFs) Working with your Aiance co-chairs and Executive Officer to hep define and incorporate correative components Protoco deveopment process represents a coordinated activity invoving investigators, statisticians, data coordinators, executive officers, and is driven by your committee protoco coordinator
Aiance Protoco Deveopment An Aiance Mode Protoco Tempate wi be provided, aong with a schedue of protoco and forms deveopment miestones NCI Operationa Efficiency Working Group (OEWG) mandates strict protoco deveopment timeines Phase I, I/II and II study activation 450 days Phase III study activation 540 days
NCI Operationa Efficiency Working Group (OEWG) NCI CTEP Phase I, Phase I/II, and Phase II studies that wi accrue < 100 patients: fina draft submission 60 days from concept approva Phase I/II, or II protocos >/= 100 patients: fina draft submission 60 days from concept approva Phase II/III or Phase III protocos: fina draft submission 90 days from concept approva. NCI DCP Fina draft submission 90 days from concept approva
A021502 Detais of protoco deveopment
A021502 OEWG versus Actua Duration
Aiance Protoco Deveopment Carefuy consider a study eigibiity criteria and required testing/procedures Criteria shoud be absoutey required for anticipated scientific inference or patient safety Criteria shoud be unambiguousy defined and capabe of verification at time of audit Criteria shoud NOT be reguatory, ega, or other requirements Consider a testing and frequency for insurance reimbursement, patient convenience, and site management burden Fixing eigibiity and testing procedures after the fact is time consuming and abor intensive
Aiance Protoco Deveopment Aiance studies incorporate on-study guideines Guideines are not excusion criteria Aow physician judgment for any given patient Physicians shoud carefuy consider the risks and benefits of any therapy, and therefore enro patients for whom this treatment is appropriate. Physicians shoud consider whether any of the foowing may render the patient inappropriate for this protoco J Cin Onco. 1996 Apr;14(4):1364-70. Reducing patient eigibiity criteria in cancer cinica trias. George SL
Study activation requirements The foowing are required prior to study activation A NCI-fina approved protoco IRB approva Randomized phase II and III trias aong with seect NCI DCP trias wi use the NCI Centra Institutiona Review Board In the absence of the CIRB, an initia institutiona review board approva by one institution wi suffice Set-up by a systems required to support study enroment (Medidata Rave [ecrfs], OPEN, etc.) Drug avaiabiity Signed contracts and agreements supporting primary study endpoint
Once your study opens Study chairs are responsibe for answering studyspecific questions that may arise once your tria has opened, generay regarding eigibiity, treatment or dose modifications. Ensure Awareness: incude other study team members (Executive Officer, Data Manager, Statistician, Protoco Coordinator, Nurse Oncoogist) on responses Maintain Coverage: Assign backup Aiance member (eg, study co chair) if you are unavaiabe to answer study reated questions Maintain Contact Info: Provide study team members with the best way to communicate with you (eg, phone, emai) as we as contact information for assistant or secretary
Study Conduct You may not grant eigibiity waivers, athough you may interpret how a given patient meets criteria This is/is not a compete resection, a stage x This does/does not quaify as prior therapy Nobody ese may grant eigibiity waivers either
Study Conduct Abide by Aiance Poicies and Procedures Avoid providing information that woud aow patient identity to be deduced Do not furnish data to directy to industry. Foow appropriate Aiance channes. Section 14.4 (Confidentiaity of patient information) Section 12.2 (Confidentia and proprietary information)
Accrua monitoring NCI monitors accrua to a studies to ensure trias meet anticipated monthy accrua goas Phase 3 Phase 2 Phase 1 When? When? When? In quarters 5 &6 End of quarter 3 End of quarter2 What is expected accrua? >20% of target quartery accrua What is expected accrua? >/=50% of target accrua for past 6 months What is expected accrua? >/=50% of target accrua Possibe actions Possibe actions Possibe actions Stop tria if </=20% Aow 6 months to improve if > 20 but < 50% NCI wi request corrective action NCI wi request corrective action
Accrua Monitoring Study chair shoud monitor accrua Intervene if accrua is not adequate Give taks, web-in-airs, prepare side sets Identify what accrua barriers are and seek to resove them Prepare corrective action pans for NCI as needed
Pubications It is your responsibiity to ead the pubication of your tria resuts, whether in a poster, abstract or manuscript You must adhere to Aiance Poicies and Procedures regarding reease of study data and review of a pubications using Aiance data
Study Chair Training Modues Avaiabe on Aiance web site Sef-paced earning modues, approximatey 15-20 minutes Cover NCI CTEP & DCP concept submission Protoco deveopment process Study conduct poicies Pubication poicies
Getting hep At any time, if you need hep, you may contact Your committee chair Your committee statisticians Your committee protoco coordinator Your committee executive officer Cancer Contro Program (CCP) Program Manager Transationa Research Program (TRP) Executive Officer