AACI Clinical Research Initiative: Improving the Cancer Centers’ Clinical Trials System

1. AACI Clinical Research Initiative: Improving the Cancer Centers’ Clinical Trials System Janie Hofacker, RN, MS Director of Programs Association of American Cancer Institutes

3. Today’s Clinical Research Challenges • Increased complexity of clinical trials • Administrative and operational barriers • Increasing regulatory constraints • Staff retention and training • Lagging patient accrual • Current economy—declining NIH funding • Matching trial revenue with trial care & staff effort

4. History of AACI CRI and CCAF

5. AACI CRI Mission To establish an oncology research network where cancer center clinical research leaders examine and share best practices to promote the efficient operation of cancer center clinical research offices.

6. AACI Clinical Research Initiative • Facilitates peer-to-peer interactions • Examines and shares best practices • Aligns with AACI’s strategic goals to foster interactions

7. AACI CRI Steering Committee Members

8. Diana Naser Joyce Yasko Joy Ostroff Sherrie Reynolds Kerry Bridges Sarah Marcotte • Business Administration and Integration Industry & Academic & Government Relationships • Subsites & Networks Vickie Sallee Renee Webb Sarah McNees Lee Doherty AACI CRI • Regulatory & Pre-activation • Quality Assurance David Dilts Doug Stahl Rhoda Arzoomanian Rob DuWors NCI CTRP Trial Metrics

9. Communication & Visibility • Created the CRI Listserv CRIListServ@aaci-cancer.org • Currently over 200 members are subscribed to the listserv. • The Listserv allows our members to ask questions & obtain information from each other & to provide information on new cancer research challenges. • Allows AACI to communicate important clinical research related updates. • Developed a quarterly newsletter which communicates SIG progress as well as regulatory, industry, public policy news, and national and regulatory changes impacting oncology clinical research (e.g., NCI, FDA, CMS. etc.) • Created a CRI website providing CRI related SOPs, SIGs updates, meeting schedules and provides CRI templates and documents that are available for AACI CRI members. http://aaci-cancer.org/cri.asp

10. NCI CTRP

11. Background on the NCI CTRP • February 2009, at a CCAF meeting, the NCI CTRP implementation was identified as being problematic for cancer centers. • July 2009, at the 1st annual AACI CRI meeting, many participants voiced concerns re: CTRP and its impact on cancer center resources. • August 2009, AACI assumed responsibility for facilitating a solution to this problem identified by both CCAF & CRI and initiates a NCI CTRP SIG (R. Arzoomanian, M. Suppman, A. DellaCroce, and R. DuWors). • Fall 2010, minimal progress is made with to get NCI to listen to the concerns expressed by the SIG. • January 2010, AACI obtains support of several CC directors to meet with Dr. Doroshow to communicate their concerns. • Dr. Doroshow agrees with AACI that an oversight committee is necessary to review the CTRP implementation and its impact on the cancer centers.

12. NCI CTRP Strategic Subcommittee Members

13. NCI CTRP Strategic Subcommittee Co‐chaired by Dr. Kevin Cullen and Dr. Sheila Prindiville Met via 6 teleconference calls CRI SIG Leaders Rhoda Arzoomanian & Robb DuWors &

14. NCI CTRP Strategic Subcommittee Work pending as of As of October 2010 • Assess estimated work burden of four phases of reporting for individual centers • Assess current and future state of commercial software to facilitate submission • Make policy recommendations to clarify scope of trials, range of individual patient demographic and outcome data amendments, etc. • Hope to report by Dec 10.

15. NCI CTRP Strategic Subcommittee Work Completed by April 2011 • Specific accrual information and subject demographics to be provided by trial type. • Clarity regarding trial amendments and updates to be reported. • Cancer Center workload efforts from several cancer centers has been provided and reviewed to assess continued NCI support. • Committee is recommending trial registration information be consistent with Summary 3 and Summary 4 reporting to assure that CC sites are given credit for accruals for multisite trials. • Feedback from the commercial CTMS Vendors, Forte’s and Velos’, ability to report clinical trial data has been obtained. • Clarification of the type of trials, interventional, required to be registered to NCI CTRP.

16. NCI CTRP Strategic Subcommittee Work Completed by April 2011 (continued) • Cancer Centers without commercial vendors or automated systems proposed timeline to report to CTRP is being discussed.  • Non-interventional trial registration and subject toxicity and response reporting will be considered at later time.   • Formal Executive Summary is being drafted and committee’s recommendations will be presented to the caBIG CTMS Steering Committee shortly.  • Communication will be provided regarding the final reporting requirements to NCI CTRP Website, CCAF and AACI CRI. • Final report being prepared.

17. Timeline for CTRP Registration and Accrual

18. AACI CRI Surveys

19. Software Survey • Background • US academic institutions have a cancer center and/or have an active CTSA. Both the cancer center and the CTSA are actively involved in implementing software systems including electronic health records, clinical trials management systems, and financial billing systems.  • There is little information available about which systems are currently being used, or whether cancer centers, institutions with CTSAs and institutions as a whole are working together on these efforts.    • Rationale for the Survey • The current survey was intended to provide data concerning current practices related to these issues, with the long range goal of developing more effective, integrated systems for the entire community. 

20. Software Survey Summary * 3 AACI Members share 1 institution with a CTSA & 14 AACI member cancer centers responded who do not have a CTSA at their parent institution.

21. Question #4b: Name of Outpatient EMR Application 14 types of EMR applications N = 58 Cancer Centers

22. Question #5a: What is the Application Used for Cancer Research 11 types of CTMA applications

23. Question # 5c: What is the Application Used in CTSA 10 types of CTMA applications

24. Question #7: Does the Financial Billing Office Application Interface with the CTMA to Assure Clinical Research Billing Compliance? N = 58 Cancer Centers

25. Question #8: Describe the Efficiency of the Process N = 58 Cancer Centers

26. Summary of the Results • There is heterogeneity of systems in use for clinical and research care. • There is minimal integration of the systems to consolidate work efforts. • There are no common systems across institutions and work is done independent of each other.

27. Next Steps • Are there opportunities for institutions to collaborate in developing multi-institutional common systems such as an EPIC disease registry application? • Ask institutions what they could accomplish by working together developing common research management systems.

28. Regulatory and Pre-Activation SIG • Survey competed in January 2011 • Survey purpose - to identify barriers impacting trial activation

29. Regulatory & Pre-Activations (cont) • Reasons for not using NCI IRB: • Bad reputation • Quality of the review • Local IRB won’t permit review by NCI CIRB • The SIG is working to develop standardized IIT Protocol templates to facilitate reviews through committees. • Reviewing process steps and determining ways to consolidate reviews to complete in parallel rather than sequentially.

30. Business Administration and Integration SIG • A comprehensive clinical trial budget template exists to facilitate budget development and maximize cost recovery of clinical trial care and staff effort. • Developed a Trial Sponsor Monitoring Visit SOP to help cancer centers gain control of their clinical research office while conducing industry sponsored site visits. • Developing standardized job descriptions for budget and contract analyst positions.

31. Networks and Subsites SIG • Recently completed a survey to assess cancer center challenges in opening trials in cancer center networks and use of subsites. • Survey reveals best practices for monitoring of trial data, site selection, dispensing investigational agents to sites, numbers of dedicated staff working on network trials, etc. • SIG is looking to develop training guidelines and SOPs to be used across cancer centers.

32. Industry, Academic & Government Relationships • Partnership with the CEO Roundtable on Cancer’s Life Sciences Consortium to facilitate relationships between academic cancer centers and pharmaceutical and biotech companies • Developing a guidance document demonstrating investigator and clinical research staff research education to eliminate duplicate training requests from industry sponsors.

33. Providers and Payers Initiatives • Working with ASCO to enhance the dialogue between providers and payers regarding coverage clinical research care and eliminating administrative burden and “hassle factor” often making it challenging for timely enrollment of subjects on to a clinical trial. • Solution-oriented projects developed through information sharing among PPI members can positively impact both of these issues. • Future meeting planned in Fall 2011. • Recently worked with ASCO to provide comments to CMS requests regarding the direct coverage of Medicare Advantage plans rather than having patients submit claims to MA payers.

34. 3rd Annual AACI CRI MeetingJuly 14-16, 2011 • Intercontinental in Chicago O'Hare • New to the Meeting Program: Cancer Center Abstract presentations • Presenters: Linda Weiss and James Abrams to discuss the NCI Support of clinical research at the cancer centers. • Industry Perspective from the CEO Roundtable on Cancer Life Sciences Consortium. • FDA presentation to address FDA’s plans to speed up drug approval plans. • CRI SIG updates & meeting break out sessions