Maine Center for Cancer Medicine Clinical Research 20082009

1
Maine Center for Cancer MedicineClinical
Research2008-2009

• October 29, 2009

2
Clinical Research 2008

• 2498 New Patients
• 83 Enrolled in Clinical Trials
• Enrollment Rate 3.3

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Whats different?

• Match Trials to patient population

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Disease Incidence/Trials

• Population Trials

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Whats different?

• Match Trials to patient population
• Multi-discipline cooperation and communication
  tougher Peer Review

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Trial Review Process

• Research department reviews protocol for
  practical and logistical issues ?
• Pharmacy and Nursing review for treatment issues
  and concerns ?
• MCCM Physician Peer Review for medical
  appropriateness and interest ?
• MMC Peer Review for multi-discipline buy-in

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Whats different?

• Match Trials to patient population
• Multi-discipline cooperation and communication
  tougher Peer Review
• Competitive trial consideration

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Post menopause High risk
Breast Cancer
Observational
Prevention
NCIC 4-04
Exemestane vs placebo
CALGB 369901
CALGB PACCT
Operable gt 65yr old
ER/PR, Her2/neu , node negative
2nd line metastatic
W-1-08
W-2-07
Her 2/neu pos
Adjuvant
Her 2 neg Gemcitabine or Capecitabine
Sorafenib/palcebo
1st line metastatic
3rd line metastatic
CALGB 40101
0-3 lymph nodes positive
W-1-09
AC Bev gtT Bev C1-C8 Unblind, if on Arm C
Maintenance Bev C9-18 Her 2 neg. node , high
risk node -
W-2-09
W-4-08
Her 2 Trastuzumab-MCC-DM1 Vs Herceptin and
Docetaxel
Her 2, prior herceptin T-DM1 alone PD within 6
cycles T-DM1 Pertuzumb
W-2-08
VIRGO Registry
CALGB 40502
Paclitaxel vs. nab-paclitaxel vs. Ixabepilone
Plus Bevacizumab
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Whats different?

• Match Trials to patient population
• Multi-discipline cooperation and communication
  tougher Peer Review
• Competitive trial consideration
• Studies with more open inclusion/exclusion
  criteria

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Potential Study Limitations

• Advances in personalized treatment mean
  inclusion/exclusion are more stringent. These
  are addressed before opening a study, and waivers
  are sought where possible.
• Phase I studies (1st human exposure) not done
• Out patient facility status
• Multi-discipline (medical surgical radiation)
  difficult to get overall approvals
• Population restrictions
• Staffing/Financing

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Whats different?

• Match Trials to patient population
• Multi-discipline cooperation and communication
  tougher Peer Review
• Competitive trial consideration
• Studies with more open inclusion/exclusion
  criteria
• Treatment Studies
• Pre-authorize participation

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Healthcare Coverage

• Financial structure of the healthcare industry is
  changing, increasing workloads and decreasing
  compensation.
• We focus on treatment studies those researching
  anti-cancer treatments/procedures.
• Supportive care studies addressing side effects
  or symptoms only considered if there is a gap
• Observational/Registry studies only if a gap
• Insurance increasingly rejecting any trial
  participation, so MCCM obtains pre-authorization
  prior to consent.

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MCCM Clinical Research Goals 2009 - 2010

• 6 Enrollment Rate
• More Treatment Study enrollees
• Maintain CALGB status at least 6 CALGB study
  enrollees (Other ME sites have lost CALGB status
  due to low enrollment.)
• Achieve financial break-even through mix of
  cooperative and pharmaceutical study enrollees.

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Clinical Research 2009 to date

• 2156 New Patients
• 119 enrolled in Trials 10/15/09
• Enrollment rate 5.5