AccrualNet: A New NCI Tool for Supporting Accrual to Clinical Trials

1. AccrualNet: A New NCI Tool for Supporting Accrual to Clinical Trials Linda Parreco, RN, MS NCI, Office of Communication and Education September 29, 2010

2. Goals for Today • Appreciate the impact of insufficient accrual to clinical trials • Know where to find AccrualNet and how to use it • Leave this room today with one idea for using AccrualNet • Tell at least 5 people about AccrualNet when you get home!

3. The Problem • Only 3-5% of potentially eligible patients enroll on clinical trials • 68% of NCI trials fail to accrue sufficient numbers for analysis • >20% of studies accrue NO patients • 50% of all cancer trials are never completed Dignam JJ 2004; Lara PN 2001; Getz K 2000; Dilts D 2008, IOM 2010

4. The Impact • Poor accrual is hindering the progress of cancer research • Financial impact of maintaining open trials that are not enrolling • Demonstrates poor stewardship of our most valuable resource: study participants • Poor accrual must be addressed

5. The Time to Address Accrual Has Arrived NCI OEWG Report March, 2010 IOM Report: April, 2010 NCI/ASCO Symposium April, 2010

6. Listening • Stakeholder interviews: professional associations • Interviews and site visits: community oncology programs • In-depth case studies: 3 NCI Comprehensive Cancer Centers

7. What You Want • “If only the accrual resources were in one place…” • “I want a way to talk to others in my position about accrual challenges…” • “I don’t want to take a lot of time to sort through the literature…”

8. What You Need • Usable information - “hints and tips” • Real-time information – no time for academic reading • Ready to use tools • Best practices • Training materials

9. What We Did • Selected relevant content • Published literature • Tips, strategies, resources, templates • Sample recruitment plans • Checklists • Developed a useful interface & structure • Conceptualized a ‘gathering place’ • Involved target audience in every step

10. What we Built http://accrualnet.cancer.gov

11. How it Helps You:Recruitment Specialist • Protocol development: works with PI to address recruitment concerns • Prior to opening trial: works with protocol team to determine recruitment communication strategies and related materials and to coordinate development of materials • Active phase: provides support to sites for recruitment efforts. ACRIN, Principal Investigator Manual

12. How it Helps You:Research Associate • Quickly search for helpful information • Become familiar with the published literature • Develop pilot projects for using AccrualNet • Share your materials and ideas with colleagues

13. ACRIN Initial Trial Participation Requirements 18. Recruitment Plans • “The PI and RA have determined patient recruitment plans, including working with the institution’s public relations department, if feasible, to promote awareness of the study within the institution and community.” • “Recruitment plans should be in place before accrual begins. Sites can work with ACRIN’s recruitment specialist to develop those plans. Some institutions also offer valuable public relations resources for clinical trials.” ACRIN Principal Investigator Manual, Aug 2, 2004

14. ACRIN Ongoing Trial Participation Requirements 9. Recruitment Plans • “The site PI and RA implement participant recruitment plans to include distribution of communication materials, educational sessions at departmental meetings, regular contact of referring physicians, etc. ” • “Recruitment issues will be discussed on conference calls and at ACRIN meetings. When possible, ACRIN will provide assistance with the development of communication materials.” ACRIN Principal Investigator Manual, Aug 2, 2004

15. ACRIN Ongoing Trial Participation Requirements 10. Participant Accrual Monitoring • “The site PI and RA monitor participant accrual progress and report any specific recruitment barriers to the trial PI.” • “Sites are encouraged to work with the ACRIN recruitment specialist and the study PI if they have any questions or concerns.” ACRIN Principal Investigator Manual, Aug 2, 2004

16. Investigator Responsibilities • Interacts with participating site PIs and the ACRIN recruitment specialist to promote patient recruitment • Assists in establishment of target accrual goals for participating sites and works with ACRIN recruitment specialist to develop specific patient recruitment strategies • Responsible for contacting PIs of low accruing sites—understand barriers; suggest strategies ACRIN Principal Investigator Manual, Aug 2, 2004

17. Writing an ACRIN Protocol:Participant Accrual Considerations • Protocol should specify recruitment goals and provide the number of expected participants per site over time. • Protocol should detail the steps to be taken if the accrual goals are not met. • …develop communication materials such as brochures, flyers, letters to referring physicians. ACRIN Principal Investigator Manual, Aug 2, 2004

18. AccrualNet: Opportunities to share your successes! • ACRIN Poster presentation at the April, 2010 NCI/ASCO Accrual Symposium: “Accrual Planning for the National CT Colonography Trial: The American College of Radiology Imaging Network (ACRIN) Implements a new model for site and participant recruitment” • Successful site selection criteria • Video news release for broadcast in site markets • Monthly updates • Calls to discuss barriers and solutions

19. Registered User’s Group • Available feature on AccrualNet • National focus: the need to communicate around a specific common issue • Designated group moderator • Serve as an ambassador to support the ‘general user’ side of AccrualNet

20. Your Next Steps • Go home and use AccrualNet • Check in frequently to see new materials and new conversations • Tell your co-workers, your PI, your professional organizations, your friends, your pets!

21. And most importantly…. Find success in your accrual efforts! (And then BLOG about it!)