Transforming the NCI Clinical Trials Program and Operational Efficiency:

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1 Transforming the NCI Clinical Trials Program and Operational Efficiency: Implications for Industry Collaborations Meg Mooney, MD, MBA Chief, Clinical Investigations Branch, CTEP, DCTD, NCI 3rd Annual Forum on Industry Collaboration with Cooperative Groups CBI Conference March 27, 2012

2 NCI Cooperative Group Clinical Trials Program: Update on Program Transformation & Progress on Operational Efficiency Scope of the Presentation: Update on Current Program & Progress on Transforming the Cooperative Group Program to the new NCI National Clinical Trials Network (NCTN) Update on Operational Efficiency Working Group (OEWG) Recommendations Implementation & Initial Results Update on Implementation of Common Clinical Data Management System (CDMS)

3 Overview of NCI Cooperative Group Program: A Distinctive NIH Program The NCI Clinical Trials Cooperative Group Program is distinctive among clinical trials programs supported by NIH: Groups funded by a Cooperative Agreement to conduct national trials at academic & community centers Group membership encourages volunteerism with direct involvement of investigators and patient advocacy in program and includes partnerships with international trial sites/organizations Funded Standing infra-structure to perform multiple types of trials (treatment, control, prevention) relatively inexpensively Long history of accomplishments resulting in improved outcomes and care for cancer patients Trials oriented toward mgt of diseases not agent-specific, with inclusion of correlative science, QOL, & symptom mgt questions Ability to focus on rare cancers for children and adults

4 Selected Major Accomplishments of Program: Over 30 Practice-Changing Clinical Trials including therapeutic agents and other modalities, with 4 announced in first 6 months of 2011 ACOSOG-Z0011 Surgery: SLND not inferior to Axillary Dissection in SLN+ BC NCIC-CTG MA.20 RT: Regional Nodal RT reduces LR & improves DFS in Node+ BC COG-AALL0232 Pediatrics: High Dose MTX improves EFS in pediatric ALL RTOG Multimodality: Short-term ADT with RT improves OS in prostate cancer Over 10 FDA Indications - New Oncology Agents (Yr FDA Approval) Bevacizumab CRC (2006); NSCLC (2006); Renal Cell Cancer (2009) Imatinib mesylate Pediatric CML (2006); Adjuvant GIST (2008) Nelarabine T-ALL and T-LBL (2005) Rituximab Diffuse Large B-cell Lymphoma (2006); Follicular NHL (2006) Trastuzumab - Adjuvant Therapy for Early-stage Her2+ Breast Cancer (2006) Thalidomide Newly Diagnosed Multiple Myeloma (2006) Anti-GD2 Antibody (ch14.18) in Neuroblastoma (BLA Currently in Preparation) Examples: New Indications Generic Agents (Yr Publication/Press Release) Daunorubicin in AML (2009); Dexamethasone in Multiple Myeloma (2007)

5 Overview of the Current Program 3,100 Institutions 14,000 Investigators About 25,000 pts enrolled on tx trials annually Trials FY2006 FY2007 FY2008 FY2009 FY2010 FY2011 All Phases: Treatment Trials 27,263 24,289 25,540 29,063 23,299 19,462 Accrual Distribution FY : Phase 3: 82.0% Phase 2: 15.3% Phase 1/Pilot: 2.6%

6 Changing the NCI s Clinical Trials System to Meet the Needs of the 21 st Century 2005 Clinical Trials Working Group (CTWG) Set framework for some of the changes recommended by the Institute of Medicine (IOM) report such as involvement of the extramural community in evaluation of clinical trials by Scientific Steering Committees 2009 Operational Efficiency Working Group (OEWG) OEWG was an outgrowth of the CTWG and provided recommendations NCI has implemented system-wide to improve speed & efficiency of evaluation, design, development & conduct of clinical trials 2010 IOM Report on Clinical Cooperative Groups Structural and Organizational Recommendations related to consolidation & integration of Groups operations as well as other recommendations

7 Extensive Review & Stakeholder Input Revised NCI s Clinical Trials System Cooperative Group Chairs & Group Biostatisticians Cancer Center Directors NCI Website CTWG 2005 OEWG 2010 IOM 2010 ASCO Letter 2011 NCI Mailbox NCI Advisory Boards Company Partners Patient Advocates Academic & Community Sites/Investigators Professional Analysis STPI Oncology Professional Associations

8 Progress Toward Consensus Goals for a Transformed System Improve speed & efficiency of development & conduct of trials Implementation of operational efficiency timelines Implementation of 24/7 central registration & Common Data Mgt System for all trials & provision of NCI Central IRBs (Adult & Pediatric) Incorporate innovative science and trial design NExT multiple agents under development with external peer review & Clinical Assay Development Program (CADP) Implementation of BIQSFP program for integral & integrated biomarkers, imaging, and QOL studies in trials Encourage randomized phase 2 trials Improve trial prioritization, selection, support, & completion Disease-specific and specialty Steering Committees prioritize trials Implementation of slow accrual guidelines Ensure participation of patients & physicians in system Pilot initiatives for increased reimbursement for phase 2 and 3 trials and to assess physician & patient feedback on trials

9 Structure of the Program: January 2011

10 Next Steps in Transforming the System New RFA for Integrated National Clinical Trials Network (NCTN) NCI BSA voted unanimously to approve RFA Concept for NCTN in November Consolidated Organizational Structure with Funding for 1 Pediatric Group & up to 4 Adult Groups with Review Criteria Emphasizing Integration & Collaboration for Overall Scientific Achievement and Operational Efficiency Funding Model with Increased Per-Case Reimbursement for High-Performance Academic & Community Sites Competitive Integrated Translational Science Awards Revitalize Cancer Center & Academic Centers Role in the Network (U10 Academic Center awards)

11 Introducing A New Organizational Structure NCI National Clinical Trials Network (NCTN) Other NCI Dark Grant blue boxes Programs signify NCI Contract DEA reviewed, Programs grant-funded components under Extramural this RFA & Advisory Committees

12 Network Components Review Criteria Group Operations & Statistical Centers Reconfigure NCI/NIH external peer-review of System Emphasis on incentives for a national system with trials open to all qualified sites & sites able to credit any Group to which they belong Review of all Network Groups/components at same time Scientific evaluation will shift to evaluating Group role in national network, overall scientific strategy, innovation and quality (~50%) Review criteria for operational efficiency & collaborative management of Network (~50%) Coordination with other Network Groups, NCI programs, NCI investigators outside Groups (e.g., CCOPs, MB-CCOPs, Tumor Banks, Cancer Centers, SPORES, N01s/U01s, P01s, etc.)

13 Network Description & Review Criteria Lead Academic Participating Sites Description Multiple-PI grants for academic institutions with demonstrated scientific leadership in 1 adult Network Groups, substantial accrual, & excellent data quality ( high-performance sites) Targeted at NCI Comprehensive and Clinical Cancer Centers and other leading academic centers Review Criteria Meets accrual threshold set from trials across entire Network Expertise & leadership role in Group(s) Data quality Contributions to translational science within Group trials Scientific collaborations across Cancer Center/Institution & Network

14 Network Description & Review Criteria Integrated Translational Science Awards Description Multiple-PI grants to support prominent researchers for their expertise and efforts in incorporating molecular studies into Network trials & enabling acquisition of preliminary data for further research Laboratory-based researchers will also facilitate hand-off of early phase clinical trial findings into later phase, definitive trials Review Criteria Peer-review of quality of scientific approach & plans for integration of translational science into clinical trials Leverages independently funded laboratory resources with Group clinical specimens & data to benefit Group research aims Research area likely to benefit trial efforts across Network

15 Network Description & Review Criteria Core Services & Canadian Partner Network RT and Imaging Core Services Provides scientific leadership for incorporating appropriate QA & image data management for research trials involving RT & imaging Review Criteria for scientific leadership & expertise as Network-wide resource, integrated IT platforms for capturing and storing images, & efficient procedures for accessing site data for RT & image-related trial questions Canadian Collaborating Trials Network NCI Program has had long history of collaboration with Canadian sites and non-profit Canadian clinical trial organizations Review Criteria for ability to provide appropriate regulatory oversight for US Networks trials conducted in Canada, irrespective of which Group leads trial and to be full partners in accruing patients to US Network trials

16 Overview of RFA: Cooperative Agreement 6 FOAs and Estimated # Grants Network Component Mechanism (Duration) Est. Max. # Grants Frequency New Application Accepted? Multiple PI Option? Group Operations Centers U10 (5 Yrs) 5 Every 5 Years Yes Group Statistical & Data Mgt Centers U10 (5 Yrs) 5 Every 5 Years Yes Canadian Collaborating Network Integrated Translational Science Awards RT and Imaging Core Services U10 (5 Yrs) 1 Every 5 Years Yes U10 (5 Yrs) 1 to 5 Every 5 Years Yes U24 (5 Yrs) 1 to 2 Every 5 Years Yes Lead Academic Participating Sites U10 (5 Yrs) 30 to 40 Multiple dates within 5 Year period Yes

17 Tentative Timeline for Implementation BSA Concept Review Nov 2011 NCI DEA & NIH Review FOA/Guidelines Nov 2011 July 2012 New FOA Released/Published July 2012 Receipt Competing Applications Winter 2012 [Nov Feb 2013] Review Competing Applications Summer 2013 [May Aug 2013] NCAB Review Dec 2013 Rollout of Awards in FY2014 March 2014

18 NCI Cooperative Group Clinical Trials Program: Update on Program Transformation & Progress on Operational Efficiency Scope of the Presentation: Update on Current Program & Progress on Transforming the Cooperative Group Program to the new NCI National Clinical Trials Network (NCTN) Update on Operational Efficiency Working Group (OEWG) Recommendations Implementation & Initial Results Update on Implementation of Common Clinical Data Management System (CDMS)

19 Operational Efficiency Working Group (OEWG): Overview of Recommendations and Implementation Operational Efficiency Working Group (OEWG): New process to develop trials in an interactive & collaborative fashion initiated in March 2010 with timelines for target & absolute timelines for trial development (review of proposal to activation) Developed implementation plans to achieve targets As of Apr 2010: All Group treatment trials monitored per new timelines As of Jan 2011: All trials that do not achieve absolute deadlines do not go forward

20 Historical vs OEWG Target & Absolute Timelines Absolute = 730 Protocol terminated if absolute timelines not achieved

21 Implementation by NCI/CTEP & Groups of the OEWG Recommendations Hiring of New Staff Project Managers, Medical Editors New IT Tools Secure Website for monitoring reports with specific milestones New Processes Tracking study development timelines & enforcing deadlines Conference call process with investigators & Group Operations Offices to resolve outstanding issues Medical Editors create draft Consensus Reviews with set templates & use track changes for set changes to protocol document Modified/developed internal SOPs to streamline processes and improve communication Development of Time-Outs to Adjust Targets for FDA/Drug Supply/Contracting

22 OEWG Conference Call Process Conference calls between NCI & Group study team held to clarify issues/comments in Consensus Review to prevent review iterations that may otherwise slow the approval process. Conference calls occur at several key points: After early study proposal received (LOI / Concepts) After initial protocol submission Ad hoc 493 conference calls between April March 2012 for both Cooperative Group & NCI/CTEP early phase treatment trials: (94.6% of calls set up occurred) 176 calls for new LOI s 80 calls for new Concepts 155 calls for new Protocols 82 calls for studies submitted prior to 4/1/2010

23 # of Calendar Days NCI/CTEP Early Phase Studies (Cooperative Groups & Others) as of 3/1/ Absolute Deadline: 540 Days Days (Median) 362 Days (Median) OEWG Target Timeline: 210 Days 60 Days: LOI/Concept 60 Days: Initial Protocol 90 Days: Review / Activation 0 Historical Studies (n=149 studies activated 2006 to 2008) Post OEWG Studies (n= 52 studies submitted after Apr 1, 2010) For larger Phase 2 Concepts w/ 240 Day Target, Median = 381 Days (n=12)

24 # of Calendar Days NCI/CTEP Phase 3 Studies (Cooperative Groups) as of 3/1/2012 Absolute Deadline: 730 Days Days (Median) 320 Days (Median) Historical Studies (n=67 studies activated 2006 to2008) Post OEWG Studies (n= 6 studies submitted after Apr 1, 2010) OEWG Target Timeline: 300 Days 90 Days: LOI/Concept 90 Days: Initial Protocol 120 Days: Review / Activation

25 Comparison of Number of Protocol Revisions Prior to Activation (As of December 2011) Post OEWG Group Studies (All Phases) vs Historical Studies

26 Planned Changes in OEWG Processes & Timelines Elimination of Official Time-Outs to Adjust Targets Used in variable ways across the various Groups Target and absolute deadlines would be the official metrics tracked without respect to or adjustment for timeouts Implementation March 2012 New Absolute Deadlines Decrease for Early Phase Studies (including larger Phase 2 Concepts) from 540 to 450 days Decrease for Phase 3 Studies from 730 to 540 days Implementation in Spring 2012 Institution of 6 Month Deadline for CTEP CRADA Agreements

27 New Absolute Deadline: Application to Group Early Phase Studies ( ) Change Absolute deadline of Early Phase (LOI) Studies & Phase 2 Concepts from 540 days to 450 days 1 In- Review LOI has surpassed the new proposed deadline 1 In-Review Phase 2 Concept has surpassed the new proposed deadline Studies Submitted Under OEWG (April 1 st, 2010) & Activated

28 New Absolute Deadline: Application to Phase 3 Concepts ( ) Change Phase 3 Concept Absolute Deadline from 730 days to 540 days No In-Review studies have surpassed the 540 day proposed deadline. Studies Submitted Under OEWG (April 1 st, 2010) & Activated

29 NCI Cooperative Group Clinical Trials Program: Update on Program Transformation & Progress on Operational Efficiency Scope of the Presentation: Update on Current Program & Progress on Transforming the Cooperative Group Program to the new NCI National Clinical Trials Network (NCTN) Update on Operational Efficiency Working Group (OEWG) Recommendations Implementation & Initial Results Update on Implementation of Common Clinical Data Management System (CDMS)

30 What is a Clinical Data Management System (CDMS)? Tool(s) or processes that support: Data collection Remote Data Capture (RDC) Data coding Standard libraries - Common Toxicity Criteria (CTCAE) Data management Discrepancy, delinquency, communication, correction Preparation of data for analysis Affects the entire research organization Science, safety, regulatory, operations, financial mgt, administration, Group staff, site staff

31 Need for CDMS Related to Consensus Goals on Transformation of Clinical Trials System IOM 2010 Report More resources for rapid implementation of a common electronic registration & data capture system would increase consistency across trials, conserve resources by: Reducing workload associated w/ patient enrollment & f/u Allow for more timely review of the data from a trial Enhance the knowledge gained from a trial Standardized case report forms would ease the burden of regulatory oversight and lead to better compliance ~2009: CBIIT RFP (selection of Medidata Rave) 2010: Initiate NCI common CDMS for Groups

32 Requirements to Deploy A Common CDMS for the Group Program Standard approach to: Application (Medidata Rave): Complete Core Configuration: Complete Business practices: Ongoing Data delinquency rules Integration with Global applications: Ongoing Pt enrollment, NCI accrual and adverse event reporting, User-name/password/Role (single sign-on) Case Report Forms: Ongoing Cancer Data Standards Registry and Repository (cadsr)

33 Balancing Act: Network vs Local Challenges Network Local (Adopting Organization) Use Working Groups to identify and develop Standards and/or best business practices

34 Working Group Areas Priority One (Required for launch) Core configuration Validation Data quality Data elements (i.e. ecrfs) Study build Study conduct User Management Integration Metrics Priority Two (start fall 2011) RDC Training Auditing Priority Three (TBD) Reporting Stat issues - Analysis/Deviations Ancillary studies

35 Group Deployment Plan (start 4/1/11) Stage 1 0 to 90 days Start Apr 1, 2011 First 3 sites (Alpha) begin deployment (start of stage) Allow 1yr to implement Stage 2 91 to 180 days Start Jul 1, 2011 Second 3 sites (Bravo) begin deployment (start of stage) 9-months to implement Alpha sites continue deployment activities Stage to 270 days Start Oct 1, 2011 Third 3 sites (Charlie) begin deployment (start of stage) 9-months to implement Bravo sites continue deployment activities Alpha sites complete deployment (end of stage) Target completion Alpha/Bravo stage Spring 2012 Charlie stage Summer 2012

36 What Will this Mean for Collaboration with Industry? Common Data Management System and Harmonized/Shared Policies and Procedures within a Transformed System Should ease many administrative challenges of collaboration in the Program (one general approach) & aid transformation to a Network Should increase ability to address issues related to FDA and other regulatory entities, AE reporting, common CRFs in a unified manner Increased Operational Efficiency and Shared Goals for Accruing to National Trials Should provide greater confidence regarding commitment to trials by the entire US network & activation of trials, reducing risk of collaboration on a trial that is not widely supported Should help in key areas of delay in development Increased Ability to Conduct Trials in Rare Tumors and Patient Populations within a Transformed System Ex: Trials in adolescent population between COG & adult Groups

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