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Restructuring the National Cancer Clinical Trials Research Enterprise

Restructuring the National Cancer Clinical Trials Research Enterprise. Sheila A. Prindiville, MD, MPH Coordinating Center for Clinical Trials National Cancer Institute June 22, 2009. CTSA Clinical Research Management Workshop. Clinical Trials Working Group.

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Restructuring the National Cancer Clinical Trials Research Enterprise

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  1. Restructuring the National Cancer Clinical Trials Research Enterprise Sheila A. Prindiville, MD, MPH Coordinating Center for Clinical Trials National Cancer Institute June 22, 2009 CTSA Clinical Research Management Workshop

  2. Clinical Trials Working Group Proposed 22 initiatives designed to support a transparent clinical trials enterprise that integrates the individually strong components of the current system into a cross-disciplinary, scientifically-driven, cooperative research effort

  3. CTWG Restructuring Initiatives • Prioritization/Scientific Quality Involve all stakeholders in design and prioritization of clinical trials that address the most important questions, using the tools of modern cancer biology • Coordination • Standardization • Operational Efficiency • Enterprise-Wide/Integrated Management

  4. Cooperative Groups Community Clinical Oncology Programs Early Drug Development Program of the Investigational Drug Branch Cancer Centers Specialized Programs of Research Excellence (SPOREs) Program Project and Investigator Initiated Grants Components of NCI’s Clinical Trials System

  5. Scientific Steering Committee (SSC) System • Members are leading cancer experts and advocates from outside the Institute as well as NCI senior investigators who meet regularly to: • increase the transparency and openness of the trial design and prioritization process; • enhance patient advocate and community oncologist involvement in clinical trial design and prioritization; • convene Clinical Trials Planning Meetings to identify critical questions, unmet needs, and prioritize key strategies. • Leverage current Intergroup, Cooperative Group, SPORE, and Cancer Center structures by: • increasing information exchange at an early stage of trial development; • increasing the efficiency of clinical trial collaboration; • reducing trial redundancy (phase II and phase III); • developing, evaluating, and prioritizing concepts for phase III and large phase II clinical trials.

  6. Scientific Steering Committee (SSC) System • Investigational Drug Steering Committee (IDSC) for strategic input to NCI for the prioritization of phase I and II trials for new agents • Disease-Specific Scientific Steering Committees (SSC’s) for prioritization of phase III trials and selected phase II studies • Symptom Management and Health-Related Quality of Life Steering Committee (SxQOL) for symptom management trials and patient reported outcomes expertise • Patient Advocate Steering Committee (PASC) to share best practices for advocates across the SSCs and ensure concept evaluation considers the patient community http://restructuringtrials.cancer.gov/steering/overview

  7. CTWG Restructuring Initiatives Prioritization/Scientific Quality Coordination Coordinate clinical trials research through data sharing and providing incentives for collaboration Standardization Standardize informatics infrastructure and clinical research tools and evaluate the feasibility of common clinical trials agreement language Operational Efficiency Enterprise-Wide/Integrated Management

  8. START clauses: Standard Terms of Agreement for Research Trials • Collaborative project with Life Sciences Consortium of the CEO Roundtable*, Cancer Centers, and Cooperative Groups to developed common language as starting point for negotiations • Project Rationale: • Negotiation of clinical trials agreements is a key barrier to timely initiation of trials • Perception that negotiated agreements contain clauses reflecting common key agreement concepts • Perception that reaching common ground for each agreement requires unnecessary duplication of effort that delays trial initiation *www.ceoroundtableoncancer.org

  9. Project Methods • Involved legal and business representatives: 17 Life Science Consortium company and 26 Cancer Center members • Obtained copies of 78 clinical trials agreements from participating organizations (49 redacted final negotiated agreements and 29 templates) • Agreements included company-sponsored and investigator initiated trials • Identified key clauses through discussions with legal and business representatives: intellectual property, study data, publication rights, subject injury, confidentiality, indemnification, biological samples

  10. Project Methods cont. • Identified 45 concepts in the 7 key clauses • Captured the exact language that embodied these concepts in the 78 agreements • Organized agreement language into categories representing embodied concept • Analyzed results for similarities and differences in key concepts across final negotiated agreements and templates

  11. Project Findings • Final negotiated agreements showed greater than • 67% convergence on the vast majority of concepts analyzed • Developed common language with input from legal and business participants • Language is a starting point for negotiations • Toolkit at http://ccct.nci.nih.gov • Biological clauses and terms for Cooperative Group studies under development

  12. CTWG Restructuring Initiatives Prioritization/Scientific Quality Coordination Standardization Operational Efficiency: Use resources most efficiently through improved cost-effectiveness and accrual rates, and more rapid trial initiation Enterprise-Wide/Integrated Management

  13. Identify the institutional barriers that prolong the time from concept approval to accrual of the first patient Operational Efficiency Initiative Dilts, D. M. et al. J Clin Oncol; 24:4553-4557 2006

  14. Total Processes to Open a Cooperative Group Study Comprehensive Cancer Center Processes Cooperative Group Processes Median: 784 to 808 days* Range: 435-1604 days Median: 116 to 252 days* Range: 21-836 days *Depending Upon Site, based on the Phase III trials studied JCO 2009; 27 (11): 1761-66 Clinical Cancer Research 2008; 14(11): 3427-33

  15. Process Steps for Opening aPhase III Cooperative Group Study * Process Step Counts * The process steps reported only show one loop in the process. Actual development frequently includes multiple loops JCO 2009; 27 (11): 1761-66

  16. Actual Accrual Per Trial RangesComprehensive Cancer Centers

  17. Identify the institutional barriers that prolong the time from concept approval to accrual of the first patient, and develop solutions for overcoming these barriers Operational Efficiency Initiative Dilts, D. M. et al. J Clin Oncol; 24:4553-4557 2006

  18. Operational Efficiency Working Group Charged by the NCI’s Clinical Trials and Translational Research Advisory Committee (CTAC) to recommend strategies for reducing the time for activation of NCI-supported clinical trials Co-Chairs: Gabriel Hortobagyi, MD (MDACC) and James Doroshow, DCTD, NCI 63 members representing the broad oncology community

  19. OEWG Mission Phase I: Develop strategies and implementation tactics for reducing the time for initiation of Cooperative Group and Cancer Center trials Reduce study activation time by at least 50% Optimize NCI, sponsor, and investigator interactions to reduce delays Phase II: Develop strategies and implementation tactics for reducing the time for completion of Cooperative Group and Cancer Center trials Increase the percentage of studies successful in reaching accrual target Assure timely completion of studies

  20. OEWG Trial Activation Situations Cooperative Group Phase II and III Trials Cooperative Group Investigational Drug Branch (IDB) Trials Cancer Centers – Investigator-Initiated Trials Cancer Centers – Cooperative Group Phase II and Phase III Trials Cancer Centers – Investigational Drug Branch (IDB) Trials

  21. Topics Outside OEWG Purview Industry sponsored trials OHRP regulated issues (i.e., consent forms) CMS coverage determinations State laws and requirements Congressional funding mandates

  22. OEWG Progress For Cancer Centers and Cooperative Groups there is: Agreement on the components of the trial activation process to be examined Agreement that timelines for opening all of the clinical trial types must be reduced by about 50% Agreement on existing barriers to speedy trial activation Agreement that to substantively improve trial activation timelines will require major changes in every component of the system

  23. OEWG Next Steps & Timeline • Refine and prioritize recommendations • Develop implementation plans for prioritized recommendations • Next OEWG Meeting - September 16-17 • Prepare report by end of 2009

  24. Integrated Management Extramural Clinical Trials Community Clinical Trials and Translational Research Advisory Committee (CTAC) Coordinating Center for Clinical Trials (CCCT) NCI Director Clinical and Translational Research Operations Committee (CTROC) Divisions, Centers, and Offices

  25. Acknowledgement • CCCT Staff: Deborah Jaffe, Ray Petryshyn, LeeAnn Jensen, Steve Krosnick, Jean Lynn, Anna Levy, Sarah Fabian • START clauses: • Judy Hautala and Dale Shoemaker from Science Technology Policy Institute (STPI) • Hogan and Hartson • Legal, business, and tech transfer staff from academic medical centers, cooperative groups, and industry http://ccct.nci.nih.gov

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