The Clinical Trial Accrual Challenges Facing Northern Michigan P R - - PowerPoint PPT Presentation
The Clinical Trial Accrual Challenges Facing Northern Michigan P R E S E N TE D B Y A LI CI A G A R D N E R , R N , B S N , M S A D I R E C T O R O F H E A L T H I N I T I A T I V E S - G R E A T E R M I C H I G A N , A M E R I C A N
D I R E C T O R O F H E A L T H I N I T I A T I V E S - G R E A T E R M I C H I G A N , A M E R I C A N C A N C E R S O C I E T Y , I N C .
E X E C U T I V E D I R E C T O R , M I C H I G A N S O C I E T Y O F H E M A T O L O G Y O N C O L O G Y
Prevention Screening Diagnostic Treatment Quality of Life
Phase 1:
The first step in testing a new treatment in humans. These studies test the best way
to give a new treatment and the best dose.
Phase 2:
Studies that evaluate effectiveness on a certain condition. Treatments may be
compared with similar participants receiving a different treatment, an inactive substance (placebo) or a different drug.
Phase 3:
Compare the new treatment to the current standard by studying different
populations, dosages, schedules or combinations.
Phase 4:
After FDA approval for market use and continued monitoring.
Administrator Physician PA/NP Nursing Staff Professional Staff
0% 0% 0% 0% 0%
Hospital/Health System Public Health Non-Profit Agency Payor Organization Private Clinical Practice Other
0% 0% 0% 0% 0% 0%
The Institute of Medicine’s Report
Eligibility Standard: Clinical Trial
A policy or procedure is used to
provide cancer-related clinical trial information to patients.
Standard 1.9: Clinical Trial
Yes No I Don’t Know
Yes No I Don’t Know
25% or greater 11-24% 6-10% 1-5% None I Don’t Know
0% 0% 0% 0% 0% 0%
Nearly 25% of all cancer patients are eligible for enrollment in
Reports have indicated that 40% or more of NCI sponsored trials
2011 MiBRFS reports indicated a statewide accrual rate of 4.4% of
The American College of Surgeons reported 70 patients in the
2 NCI designated Comprehensive
Cancer Programs
Educational level Knowledge/Awareness Age Transportation Issues Finances Snowbirds
0% 0% 0% 0% 0% 0%
Yes No Not Applicable I Don’t Know
Yes No Not Applicable I Don’t Know
1) NCI‐designated Cancer Centers should develop processes
2) Other Grantee Institutions conducting NCI‐supported trials
Consensus Guidelines for Healthcare Coverage of Routine Patient Care Costs Associated w ith Oncology Clinical Trials
Coverage provisions for Phase II and III cancer clinical trials that are
sponsored or approved by any one of the following:
National Institutes of Health (NIH)
National Cancer Institute
U.S. Food and Drug Administration
U.S. Department of Defense
U.S. Department of Veterans Affairs
Centers for Medicare and Medicaid Services
Centers for Disease Control and Prevention
Private insurance plans, HMOs and the Michigan Medicaid Program.
Yes No I Don’t Know
Yes No Not Applicable I Don’t Know
Lack of culturally appropriate information (n=6) Lack of cancer knowledge (n=5) Lack of physician awareness of trials (n=4)
Ford et al. (2008), Barriers to recruiting underrepresented populations to cancer clinical trials: A systemic review. Cancer, 112:228-242.
Yes No I Don’t Know
“Experimental” Personal Expense Coverage Travel Complexity of Informati.. Additional Testing and Time
0% 0% 0% 0% 0% 0%
Brochures, posters, fliers, AV materials
A free, confidential program that helps patients, their families and
Cancer Clinical Trial specialists available via tollfree phone Web access with electronic report returned
Clinical Trial Search Program LiveHelp online chat
Physician and staff Buy-In Lack of Staffing Resources Minimal patient populat... Fear of losing patients Expense Time Administration Support 0% 0% 0% 0% 0% 0% 0%
Improve communication... Electronic solutions Coverage assistance Patient awareness and ... Institutional commitment
0% 0% 0% 0% 0%
Yes Not myself, but likely ... Unlikely Unsure