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P1$@  c' -1Coordination Initiatives:$$$, Realign NCI Reward System & Academic Incentives (Implement Year 2) Reward collaborations among SPOREs, P01 s, early trials groups and NCI-supported multi-site clinical trials networks Reward Cooperative Groups and multi-site networks for participation in trials conducted throughout the NCI-supported clinical trials system Reward hand-offs between NCI-supported programs that move innovative clinical trials forward Competitive awards for mid-level, non-PI investigators who play a critical role in collaborative clinical trials41ZZZu" Z" Z" Z" Z]" Z" Zq" Z18Coordination Initiatives*($9 Enhance Coordination with Federal Agencies (Initiate Year 1) Increase cooperation between NCI, FDA, and industry in oncology clinical trials Expand awareness of the NCI-FDA expedited approval process to speed trial initiation Work with CMS to identify clinical studies that address both NCI and CMS objectives=PUU,PUS.-Prioritization/Scientific Quality Initiatives..$9Establish Transparent Prioritization System Create Investigational Drug Steering Committee to enhance design and prioritization of early phase drug development trials (Implement Year 1) Create network of Scientific Steering Committees for design and prioritization of phase III trials (Initiate Year 1; Fully Implement Year 5) Leverages current Intergroup, Cooperative Group, SPORE, and Cancer Center structures State of the Science Meetings Increase community oncologist and patient advocate involvement in clinical trial design and prioritization (Initiate Year 1) Investigate integration of all phase II trials into the overall prioritization process (Initiate Year 4).PTPsPPPPP-z b7*s  j VP%. Prioritization/Scientific Quality Initiatives8/("$  w Facilitate Correlative Studies (Initiate Year 2) Clinical trial-specific, molecular profile, imaging, and quality of life studies Priority for studies integral to the design of the trial (e.g. an entry criterion) Budget set-aside Timely prioritization and funding process Develop a standards-setting process for biomarker measurements in association with clinical trialst3Q" S " " " *" " c" QS*c/ Standardization Initiatives(($  Create Standard Clinical Research Tools Establish national cancer clinical trials IT infrastructure fully interoperable with caBIG (Initiate Year 1; Interoperable Year 5) In consultation with industry and FDA, develop standard Case Report Forms incorporating Common Data Elements (Initiate Year 1; Implement Year 3) Build a credentialing system for investigators and sites recognized by NCI and industry (Initiate Year 1; Implement Year 5) Develop commonly accepted clauses for clinical trial contracts with industry (Initiate Year 2)H+PPPPP}PP`P)\(n%W&L'"Operational Efficiency Initiatives##$Improve Cost-Effectiveness and Accrual Rates Restructure phase III funding model (Analysis Year 1; Initiate Year 2) Increase patient awareness and understanding of clinical trials (Initiate Year 1) Increase minority patient access to clinical trials (Initiate Year 1) Speed Trial Initiation at Sites Reduce institutional barriers to timely trial initiation (Analysis Year 1-2; Implement Year 3) Promote adoption of the NCI CIRB facilitated review process (Analysis Year 1-2; Implement Year 3)&.ZZ"ZZ-$#C4 :&<&&Enterprise Wide Initiatives$ Create Clinical Trials Oversight Subcommittee of the NCAB to advise the NCI Director on conduct of clinical trials across the Institute" , Enterprise Wide Initiatives(($ @+Initiatives: Interactive and Interdependent,,$ (P)Estimated CTWG Implementation Budget ($M)** < Evaluation and Outcome Measures(!0 $ I_ Conclusion&  $ 'R(Clinical Trials Working Group Membership:)$(  James H. Doroshow, M.D., Chair Richard S. Kaplan, M.D. Howard Fine, M.D., Co-Chair Michael S. Katz Maureen R. Johnson, Ph.D., Executive Director Amy S. Langer, M.B.A. James L. Abbruzzese, M.D.1 Gershon Y. Locker, M.D. Martin Abeloff, M.D. Eberhard A. Mack, M.D. Jeffrey S. Abrams, M.D. Lori Minasian, M.D. Peter Adamson, M.D.1 John E. Niederhuber, M.D. David Alberts, M.D.1 Rose Mary Padberg, R.N., M.A. Karen Antman, M.D. David R. Parkinson, M.D.1 Frederick R. Appelbaum, M.D.1 Richard Pazdur, M.D.1 Steven D. Averbuch, M.D.1 Edith A. Perez, M.D. Peter Bach, M.D., M.A.P.P. Mark J. Ratain, M.D.1 Colin Begg, Ph.D. Mack Roach, III, M.D. Kenneth H. Buetow, Ph.D. Julia H. Rowland, Ph.D. Michaele C. Christian, M.D. Richard Schilsky, M.D.1 Jean B. DeKernion, M.D. Mitchell Schnall, M.D., Ph.D. Leslie G. Ford, M.D. Daniel Sullivan, M.D. Louise B. Grochow, M.D. Sheila E. Taube, Ph.D. Ernest Hawk, M.D., M.P.H. James A. Zweibel, M.D. David H. Johnson, M.D.1 1Chair or Co-Chair of SubcommitteehP1RK"/* :EJKLMNOPQR S!T"U#V$Z([)B  0` 33` Sf3f` 33g` f` www3PP` ZXdbmo` \ғq>9y`Ӣ` 3f3ff` 3f3FKf` hk]wwwfܹ` ff>>\`Y{ff` R>&- {p_/̴>?" dd@,|?" dd@   " @ ` n?" dd@   @@``PR    @ ` ` p>> 6( Zs0P2O.R.Q `  s *A ?"  L ?? Base"pp  P  s *+D޽h ?"` 33 "Blue-red template2 0 P<B( 4v^@ < < 0  P     ^*  < 0       `* d < c $ ?    < 0Ó   @   RClick to edit Master text styles Second level Third level Fourth level Fifth level!     S < 6pɓ  `P    ^*  < 6̓  `    `* H < 0޽h ? 3380___PPT10.O (    0   P     X*   0       Z*   6P  _P    X*   6  _    Z* H  0޽h ? 3380___PPT10.{N ;a  0L0 0 '(     0, P  { Restructuring the National Cancer Clinical Trials Enterprise From the Clinical Trials Working Group National Cancer Advisory Board James H. 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