Todays Clinical Trials. Tomorrow’s Cures.

Robert L. Comis, MD

1National Coalition for Cancer Research “Cancer 101” Congressional Briefing 09/10/14

2

3

Improvements:• Shorter trial development timelines• Central Institutional Review Board• Clinical trial and biorepository management

software• Closer collaboration among research groups

National Clinical Trials Network

4

Accomplishments:• Restructuring of cooperative groups has dramatically

consolidated operations and should result in increased efficiency

• Speed of trial activations has increased• Per case payments for some sites treating patients has

increased

Challenges:• Trials are much more complex and costly in era of

personalized medicine, requiring more operational support• Budget reductions

National Clinical Trials Network

5

A Decade of Flat/Decreasing Funding

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013$0

$1,000,000,000

$2,000,000,000

$3,000,000,000

$4,000,000,000

$5,000,000,000

$6,000,000,000

NCICoop Groups

6

00 01 02 03 04 05 06 07 08 09 10 11 -

20,000

40,000

60,000

80,000

100,000

120,000

140,000

160,000

180,000

Obligations

Obligations in real dol-lars (using FY2000 as reference year)

Fiscal Year

Do

llar

Am

ou

nt

(in

th

ou

san

ds)

NCI Funding 2000-2011 Deflated Using BRDPI

BRDPI= Biomedical Research and Development Price Index 7

Budget History for Components of NCI Clinical Trials Network

Base Divisional Set-Aside for

Network/Group Program *

FY2006 FY2007 FY2008 FY2009 FY2010 FY2011 (Estimated)

Grand Total

(Over 6 Yrs)

% Grand Total

Group Operations & Statistical Centers

(including Capitation for Majority of Accrual)

$128,833,204 $126,516,480 $126,141,046 $126,380,185 $127,127,666 $120,304,563 $755,303,144 78.7%

Participating Site U10s $ 12,532,773 $11,375,647 $11,074,808 $11,241,179 $11,823,333 $10,839,407 $ 68,887,147 7.2%

Core Services for Imaging & RT (RPC, QARC)

$ 4,185,608 $4,302,227 $ 4,271,987 $ 4,224,437 $ 4,307,091 $ 4,131,527 $25,422,877 2.6%

Subtotal $145,551,585 $142,194,354 $141,487,841 $141,845,801 $143,258,090 $135,275,496 ** $849,613,167  

Estimated CTSU Capitation $ 4,000,000 $ 3,779,781 $ 4,289,927 $ 5,162,362 $ 5,174,165 $ 5,040,000 $ 27,446,235 2.9%

Subtotal $ 149,551,585 $145,974,135 $145,777,768 $147,008,163 $148,432,255 $140,315,496 $877,059,402  

ACRIN $7,002,444 $15,442,054 $13,129,762 $13,509,478 $12,816,778 $10,612,813 $ 72,513,329 7.6%

ATC $1,644,551 $ 1,749,999 $ 1,716,026 $ 1,716,026 $1,716,030 $ 1,716,026 $ 10,258,658 1.1%

Grand Total $158,198,580 $163,166,188 $160,623,556 $162,233,667 $162,965,063 $152,644,335 $959,831,389 100.0%

* Does not include ARRA funding and special "one-time" supplements (e.g., transition supplements) or funding provided by other NCI/NIH Programs for Special Initiatives (e.g., complexity funding)

** Base funding was decreased by FY2011 general budget cuts 8

5-Year Annual Funding Request forNCI Clinical Trials Network

Category for Base Division Set-Aside

for Network Program

Annual Total Cost for FY14 to FY18 Based on 20%

Reduction in Accrual Compared to Average Accrual Over Last 6 Years

(Approx. 20,000 Treatment Trial Enrollments)

Funding Based on FY2011 Levels:

$ 152,644,335 Group Operations & Statistical Centers

(includes Capitation), Lead Academic Participating

Sites, and Core Services

 

Funding Request Based on New Funding Model & BIQSFP:

$ 11,520,000 Increase Capitation to "High-Performance" DCTD-funded Sites

Increase Capitation to "High-Performance” DCP-funded CCOPs & MB-CCOPs

$ 10,080,000

Increase Funding for Integral and Integrated Markers (BIQSPF)

$ 4,000,000

Subtotal: $ 25,600,000

Grand Total:

$ 178,244,335 *

* The 5-Year Total Cost Funding Request for FY2014 to FY2018 for the NCTN is $891,221,675 9

NCI Award Budgets for Current Grant Cycle

Line Item Amount (in millions)

Operations Centers $70.0Statistical Centers 37.0Canada 3.0Imaging and Radiation Therapy Core Services 7.5

Participating Site U10s (LAPS) 29.5Integrated Translational Science Awards 4.0

$151.0

10

NCTN Budget Comparison

11

2013 Actuals Award Difference %

Scientific Programs, Labs, Institutional Support, International Member Institutions, Imaging

10,155,596 7,127,766 - $3,027,830 - 29.81

Accrual Reimbursements (Therapeutic and Imaging)

5,715,932 5,342,610 - 373,322 - 6.53

Statistics and Data Management Center 7,407,237 6,078,304 - 1,328,933 - 17.9

TOTAL 23,278,765 18,548,680 - 4,730,085 - 20.3

Major Impact of Decrease in Operations Offices and Biostatistics and Data Management Centers

• Loss of experienced FTEs – 11.14 in Ops– 8.9 in BDMC

• Reduced support for scientific programs and their leadership

• $1M cut for laboratories• 72% cut ($500k) in Institutional support

12

Current NCTN Budget Situation

• Flat funding for a decade• Increased trial expenses, particularly for those

using molecular markers to select treatment• Increased funding to network sites

13

Decreased network capacity

Lack of funding to support transition to decreased capacity

Changing Trials Portfolio

• Few large phase III trials

• Few adjuvant studies

• More rare tumor trials

• Molecular screening trials

Require moreoperational support

2009 Accrual Distribution:Phase 3: 83.4%Phase 2: 15.1%

Phase 1/Pilot: 1.5%

2014 Accrual Distribution:Phase 3: 30-45%Phase 2: 45-60%

Phase 1/Pilot: ~1-2%

14

Decreased Accrual Capacity

Trials FY2006 FY2007 FY2008 FY2009 FY2010

All Phases:Treatment

Trials27,667 24,715 25,784 29,285 23,468

Trials FY2013 FY2014

All Phases:Treatment

Trials20,000 17,000

15

Fewer Trials/Fewer Patient Opportunities

• Hold on NCI review of any studies with projected accrual >1000

• If hold is lifted for a particular trial, it undergoes a second round of NCI budgetary review

• Hold on involvement of international sites in new trials

16

Final Points

• The NCI National Clinical Trials Network is an essential component of publicly-funded cancer research

• Current NCI budget constraints and holds on important types of cancer research are more serious than ever seen in the past

• Inadequate federal funding for cancer clinical research is particularly harmful and threatens the viability of ongoing work in the network

17

Questions?

18