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Supporting research to make patients, and the NHS, better
Supporting the implementation of LPMS for the
good of research information...
A National Perspective
Richard Corbridge, CIO
…for the good of research
information...
“As part of the National Institute for Health Research, we ensure that
the NHS can provide the infrastructure that allows high-quality clinical
research to take place within the NHS, so that patients can benefit from
new and better treatments”
Our key roles are:
To enable the provision of research
To performance manage where provision has been provided
To provide information about research capability
To facilitate the sharing of best practice for delivery
The HLOs: Target Summary
The HLO Family
Measure:	
  Number	
  of	
  
par,cipants	
  recruited	
  in	
  a	
  
repor,ng	
  quarter	
  into	
  NIHR	
  
CRN	
  Por:olio	
  studies	
  
	
  
Calcula,on:	
  Recruitment	
  (both	
  
commercial	
  and	
  non-­‐
commercial)	
  by	
  quarter,	
  
mapped	
  to	
  an	
  English	
  site	
  
100,398
174,820
149,196
112,233
125,410 159,963
126,949
124,668
152,583114,558
139,800
133,798
0
100,000
200,000
300,000
400,000
500,000
600,000
700,000
2009/10 2010/11 2011/12
Participants
Q1 Q2 Q3 Q4 Financial Year Target
Measure:	
  HLO	
  2:	
  Propor,on	
  of	
  contract	
  studies	
  achieving	
  or	
  surpassing	
  their	
  recruitment	
  target	
  during	
  their	
  
planned	
  recruitment	
  period,	
  at	
  confirmed	
  Network	
  sites	
  
Calcula,on:	
  	
  
Part	
  1:	
  (Actual	
  Closure	
  Date-­‐Actual	
  Opening	
  Date)/(Planned	
  Closure	
  Date	
  -­‐	
  Actual	
  Opening	
  Date)	
  
Part	
  2:	
  (Recruitment	
  total	
  at	
  network	
  sites	
  /	
  Planned	
  Network	
  Sample	
  Size)	
  	
  
	
  
Studies	
  have	
  to	
  meet	
  Part	
  1	
  &	
  Part	
  2	
  to	
  count	
  toward	
  objec,ve.	
  	
  
Therefore	
  ≤	
  100%	
  to	
  ,me	
  AND	
  ≥	
  100%	
  to	
  target	
  
Closed	
  studies	
  only:	
  Actual	
  Closure	
  Date	
  will	
  determine	
  repor,ng	
  period	
  
	
  
Por:olio	
  Entry	
  Date	
  &	
  Actual	
  Opening	
  Date	
  (from	
  April	
  1st	
  2010)	
  will	
  determine	
  which	
  studies	
  are	
  included	
  
1
4 5
6
15
14
19
54
0
1
7
11 19
13
13
25
16 67
0%
50%
100%
Q1 Q2 Q3 Q4 Annual
Total
Q1 Q2 Q3 Q4 Annual
Total
2010/11 2011/12PercentageofStudies
Studies failing to achieve their recruitment target during their planned
recruitment period
Studies achieving or surpassing their recruitment target during their planned
recruitment period
Measure:	
  Number	
  of	
  commercial	
  contract	
  
studies	
  on	
  the	
  NIHR	
  CRN	
  Por:olio	
  as	
  a	
  
percentage	
  of	
  the	
  total	
  commercial	
  MHRA	
  CTA	
  
approvals	
  for	
  Phase	
  II–IV	
  studies,	
  on	
  an	
  annual	
  
basis	
  
Calcula,on:	
  	
  
No.	
  of	
  studies	
  adopted	
  on	
  to	
  the	
  CRN	
  Por:olio	
  	
  
No.	
  of	
  Industry	
  studies	
  approved	
  by	
  MHRA	
  	
  
per	
  financial	
  year	
  
63
55
71 74
263 71
84
60
98
313
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Q1 Q2 Q3 Q4 Annual
Total
Q1 Q2 Q3 Q4 Annual
Total
2010/11 2011/12
PercentageofStudies
% NIHR CRN adopted studies as a proportion of MHRA CTA
approvals
Interim Target
Final Target
Measure:	
  Propor,on	
  of	
  studies	
  
obtaining	
  NHS	
  permission	
  within	
  
40	
  calendar	
  days	
  (from	
  receipt	
  of	
  
a	
  valid	
  complete	
  applica,on)	
  
9 12
19
14 54
37
60
47 69 213
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Q1 Q2 Q3 Q4 Annual
Total
Q1 Q2 Q3 Q4 Annual
Total
2010/11 2011/12
PercentageofStudies
% Studies Achieving NHS Permission Within 40 Days
Interim Target
Final Target
Measure:	
  HLO	
  5:	
  Propor,on	
  of	
  contract	
  studies	
  achieving	
  first	
  par,cipant	
  recruited	
  within	
  30	
  
calendar	
  days	
  of	
  NHS	
  Permission	
  being	
  issued	
  or	
  First	
  Network	
  Site	
  Ini,a,on	
  Visit,	
  at	
  confirmed	
  
Network	
  sites	
  
	
  
Calcula,on:	
  	
  
Date	
  of	
  First	
  Network	
  Par,cipant	
  First	
  Visit	
  (	
  FNPFV)	
  -­‐	
  (Date	
  of	
  first	
  NHS	
  Permission	
  at	
  network	
  site	
  
OR	
  First	
  Network	
  Site	
  Ini,a,on	
  Visit,	
  whichever	
  is	
  later)	
  
3 9
12
8
32
29
20
25
30
104
4
7
5
16
8
12
9
3
32
1 5
8
14 8 9 10 8 35
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Q1 Q2 Q3 Q4 Annual
Total
Q1 Q2 Q3 Q4 Annual
Total
2010/11 2011/12
PercentageofStudies
30 Days or Less Between 31 and 60 Days
More than 60 Days Interim Target
Final Target
Measure:	
  HLO	
  6:	
  Propor,on	
  of	
  NHS	
  Trusts	
  
recrui,ng	
  each	
  year	
  into	
  NIHR	
  CRN	
  Por:olio	
  
studies	
  
Calcula,on:	
  	
  
The	
  propor,on	
  of	
  trusts	
  on	
  the	
  CCRN	
  team's	
  list	
  of	
  
member	
  organisa,ons	
  that	
  are	
  repor,ng	
  
recruitment	
  at	
  any	
  point	
  in	
  the	
  previous	
  rolling	
  
year.	
  	
  For	
  example	
  the	
  metric	
  in	
  Q3	
  2011/12	
  will	
  
examine	
  whether	
  there	
  has	
  been	
  recruitment	
  
a]ributed	
  to	
  that	
  trust	
  at	
  any	
  point	
  in	
  Q4	
  
2010/11,	
  Q1	
  2011/12,	
  Q2	
  2011/12	
  or	
  Q3	
  2011/12.	
  
90%
91%
92%
93%
94%
95%
96%
97%
98%
99%
100%
Q1 Q2 Q3 Q4 Annual
Total
Q1 Q2 Q3 Q4 Annual
Total
2010/11 2011/12
PercentageofNHSTrusts
Percentage of Trust Participating in Studies
Interim Target
Final Target
- Quarterly
- Annual
Activity Report Publication…
NIHR Clinical Research Network
Supporting the implementation of LPMS for the good of research
information…
Although the Clinical Research Network operates as one organisation,
we are made up of a number of different parts:
•  Six “Topic” Research Networks (covering Cancer, Dementia and
Neurodegenerative Diseases, Diabetes, Medicines for Children,
Mental Health and Stroke)
•  A Primary Care Research Network to support research in this part of
the health service
•  A Comprehensive Clinical Research Network, which covers all other
disease areas
dfd CPMS Context diagram
CPMS
IRAS
CRN Finance Tool
Local Portfolio
Management
Systems
Commercial
CTMS
Other NHS
Organisation Systems
CSP RDMIS
Module/ LRR
NIHR Coordinating
Centre MIS
Requirements for interfacing not
currently known.
Requirements for interfacing not
currently known.
CCT
Requirements for interfacing not
currently known.
Feasibility Tool
Study and Site Data
Study and Site Data
Study Related Data
Research Activity Data
Research Activity Data
Study and Organisation
DataStudy Related Data
Study Related Data
ISRCTN Number
Study Related Data
Study Related Data
Study Related Data
Study and Organisation
Data
Initial Study Data
ISRCTN Registration
Request and Study Data
Data Form Submissions
Site Activity and Performance Data
Version	
  2.0	
  
Strategic	
  Alignment	
  and	
  Change	
  
Modular	
  design	
  
ODS	
  Codes	
  
ODS	
  codes	
  
HEFCE	
  codes	
  
Contact	
  Mgmt	
  
Service	
  layer	
  
Hierarchies	
  
Index	
  tables	
  
Indexed	
  tables	
  
Lookups	
  
Tasks	
  by	
  role	
  
“to	
  do”	
  panes	
  
Monitor	
  
progress	
  
Structured	
  
legacy	
  data	
  
Sta,s,cs	
  
package	
  
Forecasts	
  
Trend	
  analysis	
  
Scheduled	
  data	
  
cuts	
  
Data	
  backups	
  
Guaranteed	
  Up	
  
,me	
  
Planned	
  down	
  
,me	
  
Fast	
  
Performance	
  
Scheduled	
  
changes	
  and	
  
releases	
  
NHS	
  reform	
  
Future	
  proofing	
  	
  
Version	
  2.0	
  
Commercial	
  
delivery	
  
Central Portfolio Management
System (CPMS)
What stage is it in?
Procurement activity continues on target to identify and select a preferred
supplier for the CPMS development. The programme team continue to refine
the requirements specification at pace to meet the delivery timelines.
CPMS will provide the NIHR CRN with a national information system to:
a.  Capture high quality study information
b.  Capture data on participant recruitment anywhere and everywhere in the
health research environment
c.  Enable sophisticated reporting to support performance management and
delivery of the Networks
Programme
Planning
Requirements
gathering and
Procurement
Initiation
Procurement
– Contract
Award
Design
and Build
Train and
Deploy
Programme
Close
We are here
NIHR Clinical Research Network
More than simply performance management and metrics…
•  Open Data Platform
•  Coordinated System for NHS Permissions(CSP)
•  Feasibility Tool
•  Reference Data Gateway
•  Interim Industry Tracker (IIT)
•  Industry Costing Template
•  UK Clinical Trials Gateway
•  Industry Support Systems (SIP)
Open Data Platform
Feasibility Tool
Portfolio/IIT DataHES data Results
Reference Data Gateway
Gateway Project Pilot – Context Diagram
NIHR
Client System
NIHR
Client System
NIHR
Client System
CfH
Organisation Data Service
(ODS)
Reference Data
Gateway
Reference
Database
NHS Organisation
Change plans
Updates to NHS
Organisation Structure
Administrative updates
to NHS-NIHR
relationships
Ad hoc queries
and responses
Requests for
new entries
4.2
4.5
4.4
4.1
4.3
Reference Data Gateway
includes communications
and interfaces to all parties
CRNCC Information Management
Team (IM)
Service
Requests
Reference Data
Gateway Service
Service
Requests
Service
Requests
UK Clinical Trials Gateway
Suppor,ng	
  the	
  implementa,on	
  of	
  LPMS	
  for	
  the	
  
good	
  of	
  research	
  informa,on…	
  	
  
	
  
A	
  Na,onal	
  Perspec,ve	
  
Richard Corbridge, CIO

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The EDGE 2014 User Conference

  • 1. Supporting research to make patients, and the NHS, better Supporting the implementation of LPMS for the good of research information... A National Perspective Richard Corbridge, CIO
  • 2. …for the good of research information... “As part of the National Institute for Health Research, we ensure that the NHS can provide the infrastructure that allows high-quality clinical research to take place within the NHS, so that patients can benefit from new and better treatments” Our key roles are: To enable the provision of research To performance manage where provision has been provided To provide information about research capability To facilitate the sharing of best practice for delivery
  • 5. Measure:  Number  of   par,cipants  recruited  in  a   repor,ng  quarter  into  NIHR   CRN  Por:olio  studies     Calcula,on:  Recruitment  (both   commercial  and  non-­‐ commercial)  by  quarter,   mapped  to  an  English  site   100,398 174,820 149,196 112,233 125,410 159,963 126,949 124,668 152,583114,558 139,800 133,798 0 100,000 200,000 300,000 400,000 500,000 600,000 700,000 2009/10 2010/11 2011/12 Participants Q1 Q2 Q3 Q4 Financial Year Target
  • 6. Measure:  HLO  2:  Propor,on  of  contract  studies  achieving  or  surpassing  their  recruitment  target  during  their   planned  recruitment  period,  at  confirmed  Network  sites   Calcula,on:     Part  1:  (Actual  Closure  Date-­‐Actual  Opening  Date)/(Planned  Closure  Date  -­‐  Actual  Opening  Date)   Part  2:  (Recruitment  total  at  network  sites  /  Planned  Network  Sample  Size)       Studies  have  to  meet  Part  1  &  Part  2  to  count  toward  objec,ve.     Therefore  ≤  100%  to  ,me  AND  ≥  100%  to  target   Closed  studies  only:  Actual  Closure  Date  will  determine  repor,ng  period     Por:olio  Entry  Date  &  Actual  Opening  Date  (from  April  1st  2010)  will  determine  which  studies  are  included   1 4 5 6 15 14 19 54 0 1 7 11 19 13 13 25 16 67 0% 50% 100% Q1 Q2 Q3 Q4 Annual Total Q1 Q2 Q3 Q4 Annual Total 2010/11 2011/12PercentageofStudies Studies failing to achieve their recruitment target during their planned recruitment period Studies achieving or surpassing their recruitment target during their planned recruitment period
  • 7. Measure:  Number  of  commercial  contract   studies  on  the  NIHR  CRN  Por:olio  as  a   percentage  of  the  total  commercial  MHRA  CTA   approvals  for  Phase  II–IV  studies,  on  an  annual   basis   Calcula,on:     No.  of  studies  adopted  on  to  the  CRN  Por:olio     No.  of  Industry  studies  approved  by  MHRA     per  financial  year   63 55 71 74 263 71 84 60 98 313 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Q1 Q2 Q3 Q4 Annual Total Q1 Q2 Q3 Q4 Annual Total 2010/11 2011/12 PercentageofStudies % NIHR CRN adopted studies as a proportion of MHRA CTA approvals Interim Target Final Target
  • 8. Measure:  Propor,on  of  studies   obtaining  NHS  permission  within   40  calendar  days  (from  receipt  of   a  valid  complete  applica,on)   9 12 19 14 54 37 60 47 69 213 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% Q1 Q2 Q3 Q4 Annual Total Q1 Q2 Q3 Q4 Annual Total 2010/11 2011/12 PercentageofStudies % Studies Achieving NHS Permission Within 40 Days Interim Target Final Target
  • 9. Measure:  HLO  5:  Propor,on  of  contract  studies  achieving  first  par,cipant  recruited  within  30   calendar  days  of  NHS  Permission  being  issued  or  First  Network  Site  Ini,a,on  Visit,  at  confirmed   Network  sites     Calcula,on:     Date  of  First  Network  Par,cipant  First  Visit  (  FNPFV)  -­‐  (Date  of  first  NHS  Permission  at  network  site   OR  First  Network  Site  Ini,a,on  Visit,  whichever  is  later)   3 9 12 8 32 29 20 25 30 104 4 7 5 16 8 12 9 3 32 1 5 8 14 8 9 10 8 35 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Q1 Q2 Q3 Q4 Annual Total Q1 Q2 Q3 Q4 Annual Total 2010/11 2011/12 PercentageofStudies 30 Days or Less Between 31 and 60 Days More than 60 Days Interim Target Final Target
  • 10. Measure:  HLO  6:  Propor,on  of  NHS  Trusts   recrui,ng  each  year  into  NIHR  CRN  Por:olio   studies   Calcula,on:     The  propor,on  of  trusts  on  the  CCRN  team's  list  of   member  organisa,ons  that  are  repor,ng   recruitment  at  any  point  in  the  previous  rolling   year.    For  example  the  metric  in  Q3  2011/12  will   examine  whether  there  has  been  recruitment   a]ributed  to  that  trust  at  any  point  in  Q4   2010/11,  Q1  2011/12,  Q2  2011/12  or  Q3  2011/12.   90% 91% 92% 93% 94% 95% 96% 97% 98% 99% 100% Q1 Q2 Q3 Q4 Annual Total Q1 Q2 Q3 Q4 Annual Total 2010/11 2011/12 PercentageofNHSTrusts Percentage of Trust Participating in Studies Interim Target Final Target
  • 12. NIHR Clinical Research Network Supporting the implementation of LPMS for the good of research information… Although the Clinical Research Network operates as one organisation, we are made up of a number of different parts: •  Six “Topic” Research Networks (covering Cancer, Dementia and Neurodegenerative Diseases, Diabetes, Medicines for Children, Mental Health and Stroke) •  A Primary Care Research Network to support research in this part of the health service •  A Comprehensive Clinical Research Network, which covers all other disease areas
  • 13. dfd CPMS Context diagram CPMS IRAS CRN Finance Tool Local Portfolio Management Systems Commercial CTMS Other NHS Organisation Systems CSP RDMIS Module/ LRR NIHR Coordinating Centre MIS Requirements for interfacing not currently known. Requirements for interfacing not currently known. CCT Requirements for interfacing not currently known. Feasibility Tool Study and Site Data Study and Site Data Study Related Data Research Activity Data Research Activity Data Study and Organisation DataStudy Related Data Study Related Data ISRCTN Number Study Related Data Study Related Data Study Related Data Study and Organisation Data Initial Study Data ISRCTN Registration Request and Study Data Data Form Submissions Site Activity and Performance Data
  • 14. Version  2.0   Strategic  Alignment  and  Change   Modular  design   ODS  Codes   ODS  codes   HEFCE  codes   Contact  Mgmt   Service  layer   Hierarchies   Index  tables   Indexed  tables   Lookups   Tasks  by  role   “to  do”  panes   Monitor   progress   Structured   legacy  data   Sta,s,cs   package   Forecasts   Trend  analysis   Scheduled  data   cuts   Data  backups   Guaranteed  Up   ,me   Planned  down   ,me   Fast   Performance   Scheduled   changes  and   releases   NHS  reform   Future  proofing     Version  2.0   Commercial   delivery  
  • 15. Central Portfolio Management System (CPMS) What stage is it in? Procurement activity continues on target to identify and select a preferred supplier for the CPMS development. The programme team continue to refine the requirements specification at pace to meet the delivery timelines. CPMS will provide the NIHR CRN with a national information system to: a.  Capture high quality study information b.  Capture data on participant recruitment anywhere and everywhere in the health research environment c.  Enable sophisticated reporting to support performance management and delivery of the Networks Programme Planning Requirements gathering and Procurement Initiation Procurement – Contract Award Design and Build Train and Deploy Programme Close We are here
  • 16. NIHR Clinical Research Network More than simply performance management and metrics… •  Open Data Platform •  Coordinated System for NHS Permissions(CSP) •  Feasibility Tool •  Reference Data Gateway •  Interim Industry Tracker (IIT) •  Industry Costing Template •  UK Clinical Trials Gateway •  Industry Support Systems (SIP)
  • 19. Reference Data Gateway Gateway Project Pilot – Context Diagram NIHR Client System NIHR Client System NIHR Client System CfH Organisation Data Service (ODS) Reference Data Gateway Reference Database NHS Organisation Change plans Updates to NHS Organisation Structure Administrative updates to NHS-NIHR relationships Ad hoc queries and responses Requests for new entries 4.2 4.5 4.4 4.1 4.3 Reference Data Gateway includes communications and interfaces to all parties CRNCC Information Management Team (IM) Service Requests Reference Data Gateway Service Service Requests Service Requests
  • 21. Suppor,ng  the  implementa,on  of  LPMS  for  the   good  of  research  informa,on…       A  Na,onal  Perspec,ve   Richard Corbridge, CIO