Transcript LAPS Grant Update Anthony Elias, MD PI 2/12/15 Background of Grant • Much of SOC determined by NCTN trials • Reconfiguring of NCTN by NCI.

LAPS Grant Update
Anthony Elias, MD
PI
2/12/15
Background of Grant
• Much of SOC determined by NCTN trials
• Reconfiguring of NCTN by NCI due to declining
budgets
• 30 LAPS institutions funded by NCI U10
– NCI considers LAPS to be the mark of an elite
institution
– LAPS institutions will get priority for phase II contract
• Had to restructure elements of main member and
affiliates
• Included UCH, PVHS, and MHS as clinical sites of
the main member
LAPS/Cooperative Group Trial Activations
35
30
25
20
15
10
5
0
7/7/2014
8/7/2014
9/7/2014
10/7/2014
11/7/2014
12/7/2014
1/7/2015
7/7/2014
0
8/3/2014
0
9/8/2014
0
10/6/2014
1
11/3/2014
3
12/5/2014
3
1/5/2015
3
2/3/2015
11
2/5/2015
15
New Studies
7
5
6
4
3
0
0
1
0
LAPS Approved
7
12
18
22
25
25
28
29
29
Activated
Cause of Delays in Protocol Activation
• 3/1/14-6/30/14: activating CIRB; consent
boilerplate approvals
• RSS: evolving and increasing regulations and
requirements; opaqueness
• Care plan construction in EPIC
• Baton passing: a myriad of steps; not uniformly
identified
• Insufficient integration within UCHS
– Hospital reviews
– Pharmacy
– Eventually G&C (not a significant barrier for NCTN
trials)
Consequences
Data
Monthly NCTN Accrual
Total
16
14
12
10
8
6
4
2
0
Total
LAPS/NCTN Accrual Goals
180
160
140
120
100
Prorated
80
NonLAPS
60
40
20
0
Avg/yr 2010-2012
3/14-1/15
NCTN Accrual
120
100
80
North
60
Central
South
40
20
0
Actual
Anticipated
Why UCHS and not just UCH?
Successes
• Development of processes across system
• Greater knowledge of the people across the system –
everyone is trying hard
• Uniform pricing structure
• CIRB
• Common EMR
• Development of faculty/community disease
committees
• Enhanced patient referrals in both directions
Why UCHS and not just UCH?
Threats
• Deadly slow activation of trials
• Processes so bogged down that each protocol handled individually
• Increased frustration of North and South with Central
• Devastation to accrual (68% of prior years)
• Few protocols – worst record of the 30 LAPS institutions
• Tremendous toll on CCTO financially
• Loss of accruals leads to loss of authorship and leadership
• LAPS grant cut for year 2
• Jeopardizes ability to get phase II grant
• Have not fundamentally worked out institutional agreements
between UC and UCHS
– Bypass of University by retaining IRB and trial organization within UCHS
• Cannot yet proceed with pharma trials
Why UCHS and not just UCH?
Solutions
• Common goals
• Increase patient access to clinical trials across system
• Increase accrual to clinical trials
• Integrate clinical research with clinical care
• These lead to BETTER
PATIENT CARE
• We are all on the same side – ONE TEAM
• Need integration of pharmacies
• Need full system-wide buyin with trust
Would be great for the University/SOM to have the same
relationship with UCHS as is developing with UCH
Thank you
NCTN Accrual by Disease
35
30
Breast
GU
25
GYN
GI
20
Melanoma
Brain
15
Heme
10
Lung
H&N
5
Xray
0
Jan-00
NCTN Accrual
ACRIN
4%
4
NRG
38%
36
55
58%
SWOG
NCTN Accrual
Total
13
17
North
Central
South
65
NCTN Accrual Anticipated
Total
120
103
100
80
60
40
Total
40
24
20
0
North
Central
South