The EDGE 2014 User Conference

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

124,668 152,583 114,558

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

Part

icip

ants

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 2011/12 Perc

enta

ge o

f Stu

dies

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

Perc

enta

ge o

f Stu

dies

% 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

Perc

enta

ge o

f Stu

dies

% 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

Perc

enta

ge o

f Stu

dies

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

Perc

enta

ge o

f NH

S Tr

usts

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

CPMSIRAS

CRN Finance Tool

Local PortfolioManagement

Systems

CommercialCTMS

Other NHSOrganisation Systems

CSP RDMISModule/ LRR

NIHR CoordinatingCentre MIS

Requirements for interfacing not currently known.

Requirements for interfacing not currently known.

CCT

Requirements for interfacing not currently known.

Feasibil ity Tool

Study and Site Data

Study and Site Data

Study Related Data

Research Activity Data

Research Activity Data

Study and OrganisationDataStudy Related Data

Study Related Data

ISRCTN Number

Study Related Data

Study Related Data

Study Related Data

Study and OrganisationData

Initial Study Data

ISRCTN RegistrationRequest 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 Data HES data Results

Reference Data Gateway Gateway Project Pilot – Context Diagram

NIHRClient System

NIHRClient System

NIHRClient System

CfHOrganisation Data Service

(ODS)

Reference DataGateway

ReferenceDatabase

NHS Organisation Change plans

Updates to NHS Organisation Structure

Administrative updatesto NHS-NIHRrelationships

Ad hoc queriesand 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)

ServiceRequests

Reference DataGateway Service

ServiceRequests

ServiceRequests

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