Performance Report. Quarter /14 (July to October 2013) Database-cut: 25 October 2013 Issued: 4 December 2013

Transcription

1 Performance Report Quarter /14 (July to October 2013) Database-cut: 25 October 2013 Issued: 4 December 2013

2 CONTENTS Section 1: Introduction 2 Section 2: Executive Summary for Q2 2013/14 Performance 3 Section 3: Performance Summary 4 Section 4: Performance Analysis 5 Section 5: Appendix 21 1

3 1. INTRODUCTION Period covered by this report This report covers activity in the period 1 July 2013 to 30 October 2013, which is Quarter 2 of the 2013/14 financial year. The Portfolio Database cut date for this quarter was 25 October Where figures are given for year to date, this refers to the NIHR Clinical Research Network (CRN) financial year, which is 1 April 2013 to 31 March The information contained in the report represents the most complete information available at the time of publication. Dissemination This report is produced by the NIHR Clinical Research Network Coordinating Centre, which is responsible for collating and publishing performance data for the NIHR Clinical Research Network as a whole. It is the policy of the NIHR Clinical Research Network Coordinating Centre to be open and transparent in its activities and its associated impact. The data presented in this report may be quoted in presentations and papers. However, the title and issue date of the report should be referenced to avoid any confusion about the period to which the figures relate and the time at which the data were reported. Further information For feedback on, or queries relating to, the information contained in this report, please contact: Andrew Jackson Performance Coordinator NIHR Clinical Research Network Coordinating Centre andrew.jackson@nihr.ac.uk Telephone:

4 2. EXECUTIVE SUMMARY FOR QUARTER 1 PERFORMANCE Delivery against the NIHR Clinical Research Network s High Level Objectives is core to improving performance in our key activities. Increasing opportunities for NHS patients in England to participate in clinical studies is essential, underpinned by the continuous improvement in set up and delivery of research. Key achievements HLO1: The number of participants recruited into NIHR CRN Portfolio studies continues to meet and exceed the current target of 125,000 per quarter. However, it should be noted that total annual recruitment for 2013/14 is forecast to be lower than 2012/13, despite a higher number of studies entered onto the portfolio. This pattern reflects the changing shape of the portfolio with an increase in complexity of studies. HLO3: The NIHR CRN continues to exceed the HLO 3 target for the number of commercial contract studies supported by the CRN as a percentage of MHRA CTA approvals (67% year to date versus target of 60% by 31 March 2014) This is particularly noteworthy as the number of studies in the denominator for this metric has risen significantly over the last 12 months. HLO4: Continued reduction in the time taken for NIHR Portfolio studies to obtain NHS Permission. 76% of studies obtained NHS permission within 40 calendar days in the quarter, an increase of 5% on Quarter 1. Year to date performance on this metric is 73%, which is an increase of 28% on 2012/13. HLO6: We continue to maintain high performance on HLO 6, with 99% of NHS Trusts recruiting to Portfolio studies. 67% of NHS Trusts are recruiting to commercial contract research. Challenges Performance against HLO 5b and 5c (recruitment of first participant within 30 days, non-commercial studies) remains flat. Work to better understand the underlying causes and issues continues. Performance against the metric HLO 5a (commercial studies) remains better and the learning from this will be applied where appropriate to noncommercial performance. The CRN is pursuing earlier interaction with CTUs and is building relationships with non-commercial partners to improve performance. HLO 2 (recruitment to time and target) has also remained fairly static after a sustained period of improvement; the NIHR CRN is undertaking a number of initiatives to encourage further improvements including a feasibility project which will benefit both commercial and non-commercial studies. Major risks and issues Risks associated with specific HLOs are highlighted in the main commentary, but in terms of risks to overall NIHR CRN performance: There remains a risk of a reduction in performance during the period of transition to the new organisational structure of 15 LCRNs. A risk management plan is in place across the Network to mitigate this risk. Implementation of the new Central Portfolio Management System (CPMS) planned for early 2014 may raise a risk to complete and accurate recruitment capture for a short period, whilst study teams become familiar with the new recruitment upload mechanisms. This is being mitigated by the CPMS programme team through their training and communication plans. CRN CC is aware of claims by some Sponsor organisations that some NHS organisations may be introducing delays at certain parts of the NHS Permission process in order to demonstrate satisfactory performance against the NIHR contractual requirements Performance in Initiating and Delivering Clinical Research. CRNCC is currently investigating. 3

5 PERFORMANCE SUMMARY Table 1: Clinical Research Network High Level Objectives summary of performance to date Objective 1 125,000 [1] 2A 80% 2B 80% 2C 80% 3 60% 4 80% 5A 80% 5B 80% 5C 80% 6 98% [1] Quarterly average Final target 2013/14 performance 2010/ / /13 Target Target date performance performance performance Target Q1 Q2 Q3 Q4 31 March March March March March March March March March March ,175 [1] 148,885 [1] 159,494 [1] 500,000 [3] Year to Date 140, , ,467 [1] 21% 45% 58% 80% 63% 63% 63% 100% 54% 79% 80% 71% 72% 71% 38% 40% 75% 70% 69% 72% 71% 58% 73% 75% 60% 67% 66% 67% 8% 24% 45% 80% 71% 76% 73% 52% 61% 59% 80% 37% 59% 52% 22% [2] 23% 24% 80% 37% 39% 38% 38%[2] 34% 38% 67% 40% 37% 38% 97% 99% 99% 98% 99.7% 99.7% 99.7% [2] No interim targets were set in 2010/11 for HLO 5B or 5C as not all data points were available to measure the objective at the point when interim targets for 2010/11 were set. [3] Total RAG ratings are against the annual performance target. In cases where the target date to achieve the objective is later than the current year, the annual performance target is an interim target if different to the final target presented. 4

6 Number of Participants Recruited Number of participants recruited per quarter Number of participants recruited per financial year PERFORMANCE ANALYSIS High Level Objective 1 Maintain the number of participants recruited in a reporting year into NIHR CRN Portfolio studies 200, , , , , ,000 80,000 60,000 40,000 20,000 0 Fig 2: HLO1 Total Total Total 2009/ / /12 Quarterly Recruitment Total (Left Axis) Quarterly average target Q1 Q2 Q3 Q4 2012/13 Total Q1 2012/ /14 Q Recruitment Total (Right Axis) 0 Quarterly performance commentary In Quarter 2 the CRN recruited 154,851 participants, 24% over the quarterly target of 125,000 The Quarter 2 figure is an increase of 11% on Quarter 1 (140,083 participants). One reason for this increase could be that the annual data cut for Activity Based Funding falls in Quarter 2; in the past this has been associated with upload of significant amounts of data. Although recruitment has increased, there has been a decrease in the number of studies entered on the Portfolio in Quarter 2 compared to Quarter 1, with the number of noncommercial studies down by 31% (automatically eligible down by 30% and adopted noncommercial down by 33%). Funding is the determinant of eligibility, particularly for noncommercial studies; therefore the amount of new eligible studies is somewhat dependent on the origin and type of awarded funding. However, encouragingly the number of commercial studies has increased by 25% over Quarter 1. The proportion of observational studies added to the Portfolio has also decreased. Observational studies tend to require larger participant numbers than interventional studies and therefore higher overall recruitment per study. A decrease in observational studies entered onto the Portfolio now could result in an overall decrease in participants recruited in future (months/ years). Actions to improve/ maintain performance Effective study management and performance management to support active recruitment to CRN Portfolio studies Timely upload of recruitment data on a monthly basis 25,000 20,000 (n=388) (n=455) Risks/ issues A reduction in the number of new studies eligible for CRN support could impact on the CRN s ability to maintain achievement of this HLO. Funding is the determinant of eligibility, particularly for non-commercial studies; therefore the amount of new eligible studies is dependent on the origin and type of funding awarded. 15,000 (n=228) (n=324) (n=287) 10,000 (n=86) 5,000 (n=53) (n=45) /7 2007/8 2008/9 2009/ / / / /14 to Year and Quarter date n = Number of commercial studies adopted outcome against 2013/14 target Total achieved Target Variance RAG rating 147, ,000 22, ,467 Quarterly comparison Q4 2012/13 Q1 2013/14 Q2 2013/14 Variance from last Quarter 155, , ,851 14,768 comparison of quarterly average achieved 2010/ / / /14 to Date 141, , , ,467 Fig 3: Commercial Recruitment 5

7 Number of Participants Number of Studies Number of studies Number of studies High Level Objective 1: Supporting information Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 2011/ / /14 Year and Quarter Automatically Eligible Adopted, commercial study Adopted, non-commercial study , / / / / / /14 to date Year and Quarter Automatically Eligible Adopted, commercial study Adopted, non-commercial study Fig 4: Number of studies entered onto the CRN Portfolio by eligibility type Fig 5: Number of studies entered onto the CRN Portfolio by eligibility type (ly) 700, , , , , , ,000 1,800 1,600 1,400 1,200 1, / / / /12 Q1 Q2 Q3 Q4 Total Q1 Q / / /11 Total Q1 Q2 Q3 Q4 Total Q1 Q2 2012/ /14 Year and Quarter Interventional Not Specified Observational Year and Quarter 2012/ /14 Interventional Not Specified Observational Fig 6: Total recruitment by Primary Study Design Fig 7: Number of studies entered onto the CRN Portfolio by Primary Study 6

8 Number of Participants Recruited Number of Participants Recruited High Level Objective 1: Supporting information continued ,193 20, , , , , , , / / / /14 to date / / / /14 to date Fig 8: Recruitment into commercial studies Fig 9: Recruitment into non-commercial studies 7

9 Percentage of studies High Level Objective 2A Proportion of commercial contract studies achieving or surpassing their recruitment target during their planned recruitment period, at confirmed Network sites 100% 80% 60% 40% 20% 0% outcome against 2013/14 target Percentage achieved Target Variance RAG rating 63% 80% 17% Quarterly comparison Q4 2012/13 Q1 2013/14 Q2 2013/14 Variance from last quarter 54.0% 63.0% 62.7% 0.3% comparison of percentage achieved / / / /14 to Date 21% 45% 58% 63% Q1 Q2 Q3 Q4 Q1 Q2 2010/ / / / /14 Studies failing to achieve their recruitment target during their planned recruitment period Studies achieving 90% or more of their recruitment target during 110% or less of their planned recruitment period Recruiting to Time and Target Interim target Final target (blue border) figures Fig 10: HLO2A (Quarterly) Quarterly performance commentary 62.7% (n=37) of studies met this objective in Quarter 2. Performance has been maintained from Q1.Year to date performance still remains above previous annual averages. Of the 37 studies that achieved this performance metric, 19 (51%) of them exceed the recruitment target within the time allocated. Common reasons for failure to meet recruitment targets include study recruitment being closed ahead of time due to competitive recruitment, patients declining to participate, challenging complex study design and narrow entry criteria. Actions to improve/ maintain performance A renewed focus on regular 6 weekly performance management calls with company sponsors is underway, introducing a more structured agenda to discuss red and amber studies, highlighting areas of poor performance and reviewing study milestone schedules to ensure dates and recruitment targets remain current. This will improve consistency across the network and company partners. An increased level of support towards non-recruiting sites will be offered to boost performance. Risks/ issues None to highlight. 8

10 Percentage of studies High Level Objective 2B Proportion of non-commercial studies managed by Registered CTUs achieving or surpassing their recruitment target during their planned recruitment period 100% 80% 60% 40% 20% 0% 1 outcome against 2013/14 target Percentage achieved Target Variance RAG rating 71% 80% 9% Quarterly comparison Q4 2012/13 Q1 2013/14 Q2 2013/14 Variance from last quarter 78.9% 70.6% 72.2% 1.6% comparison of percentage achieved Q1 Q2 Q3 Q4 Q1 Q2 2010/ / / / /14 Studies failing to achieve their recruitment target during their planned recruitment period Studies achieving 90% or more of their recruitment target during 110% or less of their planned recruitment period Studies achieving or surpassing their recruitment target during their planned recruitment period Interim target Final target (blue border) figures Fig 11: HLO 2B (Quarterly) 2010/ / / /14 to Date 100% 54% 79% 71% Quarterly performance commentary 72% (n=18) of studies in Quarter 1 met the objective, 8% below the target of 80%. This is slightly up on (1%) last Quarter but still below the 2012/13 Quarterly average of 79%. However, of the 5 studies that failed to meet the target 3 of them (67%) were near misses ie achieved 90% of recruitment within 110% or less of their planned recruitment period. Although relatively static so far this year there was a fluctuation in performance over 2012/13 probably due to the small number of studies included to date. Trend analysis therefore should be treated with caution. Although below target, the percentage of studies meeting this objective has increased significantly from 54% in 2011/12 to 79% in 2012/13 and we hope this improvement in the percentage of studies managed by CTUs that achieve or surpass their recruitment to time and target will be maintained and improved on in the coming year It should be noted CTU studies are more likely to be RCTs, and can often be more complex to recruit to. Actions to improve/ maintain performance Increased use of RAG reports by Networks/CTUs to actively manage the performance of non-commercial studies Continued focus on the timely upload of recruitment data to provide up-to-date figures to support active performance management Continued proactive interactions with CTUs to reach a common understanding and to explore mutual benefits in setting up and delivering studies more effective; work is underway in forging productive relationships at a national level All of the above actions are expected to have a positive impact on performance by 2013/14, because of the duration of CTU managed studies We are also working with funders to encourage them to engage actively with the CRN to explore mutual benefits in setting up and delivering studies more effectively. This is expected to impact positively on HLO 2B and HLO 2C performance during 2013/14. Risks/ issues Feasibility and pilot studies, included within HLO 2B and C, for which the recruitment to time and target measure is less appropriate than others may pose a significant risk to the ability of CRN to meet the objective 9

11 Percentage of studies High Level Objective 2C Proportion of non-commercial studies not managed by Registered CTUs achieving or surpassing their recruitment target during their planned recruitment period 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Q1 Q2 Q3 Q4 Q1 Q2 2010/ / / / /14 Studies failing to achieve their recruitment target during their planned recruitment period Studies achieving 90% or more of their recruitment target during 100% or less of their planned recruitment period Studies achieving or surpassing their recruitment target during their planned recruitment period Interim target Final target (blue border) figures Fig 12: HLO 2C (Quarterly) Percentage achieved Target Variance RAG rating 71% 70% 1% Quarterly comparison Variance from last quarter 75% 69% 72% 3% Q4 2012/13 Q1 2013/14 Q2 2013/14 comparison of percentage achieved 2010/ / / /14 to Date 38% 40% 75% 71% Quarterly performance commentary In Quarter 1 71% (n=133) of studies met the objective, 1% over the 2013/14 interim target of 70%, and 2% above the last Quarter. On target to meet the yearly average of 70 %. This can be attributed to the continued active performance management approach taken by Networks, as well as activities undertaken to streamline processes and eliminate duplication. Although on target, there is a slight decrease this year compared to 2012/13 (average of 75 %) This could be attributed to an increase in the number of studies (133 studies up from 104 in Quarter 4 of 2012/13), or the amount of feasibility and pilot studies (30%). Feasibility and pilot studies are measured with flexible target sample sizes, in order to realise a specific objective. Studies therefore may technically fail the HLO, but are judged a success by the study team Actions to improve/ maintain performance In addition to those highlighted for HLO 2B: A comprehensive and continuing cleanse of data for migration into CPMS is underway. Particular focus is being placed on open and recently closed studies. Missing data and inconsistencies within study records and recruitment uploads are being addressed. See active funder engagement bullet point in HLO 2B Risks/ issues See risk highlighted under HLO 2B 10

12 HLO 2C HLO 2B HLO 2A High Level Objective 2: Supporting information (tables 13 15) Year Studies Network 2012/13 All quarters All quarters Q1 Q2 Year to Date Total Achieved Near miss Total Achieved Near miss Total Achieved Near miss Total Achieved Near miss Total Achieved Near miss N N % N % N N % N % N N % N % N N % N % N N % N % CCRN % 7 11% % 7 6% % 3 9% % 0 0% % 3 4% DeNDRoN % 1 10% % 0 0% % 0 0% 0 0 None 0 None % 0 0% DRN % 0 0% % 0 0% 2 0 0% 0 0% % 0 0% % 0 0% MCRN % 2 11% % 0 0% % 0 0% % 0 0% % 0 0% MHRN 0 0 None 0 None % 1 17% 0 0 None 0 None % 0 0% % 0 0% NCRN % 0 0% % 1 3% % 0 0% % 0 0% % 0 0% PCRN % 0 0% % 1 11% % 0 0% % 0 0% % 0 0% SRN 0 0 None 0 None 0 0 None 0 None 0 0 None 0 None 0 0 None 0 None 0 0 None 0 None TOTAL % 10 8% % 10 5% % 3 5% % 0 0% % 3 3% Year Studies Network 2011/ /13 All quarters All quarters Q1 Q2 Year to Date Total Achieved Near miss Total Achieved Near miss Total Achieved Near miss Total Achieved Near miss Total Achieved Near miss N N % N % N N % N % N N % N % N N % N % N N % N % CCRN % 0 0% % 0 0% % 2 40% % 1 33% % 3 38% DeNDRoN 0 0 None 0 None % 0 0% 0 0 None 0 None % 0 0% % 0 0% DRN % 0 0% % 0 0% 0 0 None 0 None 1 0 0% 1 100% 1 0 0% 1 100% MCRN 1 0 0% 0 0% % 0 0% % 0 0% % 0 0% % 0 0% MHRN % 0 0% % 0 0% 0 0 None 0 None % 0 0% % 0 0% NCRN % 0 0% % 1 6% % 0 0% % 0 0% % 0 0% PCRN % 2 25% % 0 0% % 0 0% % 1 17% % 1 9% SRN 2 0 0% 0 0% % 0 0% % 0 0% % 0 0% % 0 0% TOTAL % 2 7% % 1 1% % 2 12% % 3 17% % 5 14% Year Studies Network 2011/ / /13 All quarters All quarters Q1 Q2 Year to Date Total Achieved Near miss Total Achieved Near miss Total Achieved Near miss Total Achieved Near miss Total Achieved Near miss N N % N % N N % N % N N % N % N N % N % N N % N % CCRN % 11 9% % 9 4% % 8 12% % 3 5% % 11 9% DeNDRoN % 0 0% % 1 5% % 0 0% % 0 0% % 0 0% DRN % 1 7% % 0 0% % 0 0% % 0 0% % 0 0% MCRN % 0 0% % 0 0% % 0 0% % 0 0% % 0 0% MHRN % 5 11% % 7 11% % 1 4% % 0 0% % 1 2% NCRN % 2 7% % 2 4% % 0 0% % 1 11% % 1 5% PCRN % 3 8% % 0 0% % 3 27% % 2 12% % 5 18% SRN % 2 25% % 0 0% % 0 0% % 0 0% % 0 0% TOTAL % 24 9% % 19 4% % 12 9% % 6 5% % 18 7% Note: near miss studies are those achieving 90% or more of their recruitment target during 110% or less of their planned recruitment period 2013/ / /14 11

13 Percentage of studies High Level Objective 3 Number of commercial contract studies on the NIHR CRN Portfolio as a percentage of the total commercial MHRA CTA approvals for Phase II IV studies, on an annual basis 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% / /12 Q1 Q2 Q3 Q4 2012/ / /14 Commercial contract studies delivered through the NIHR CRN Portfolio as a percentage of the total commercial MHRA CTA approvals for phase II-IV studies Interim target Q1 Q2 Quarterly performance commentary The CRN supported 66% (n=95) of new studies in Quarter 2 approved by the MHRA during the same time period; this is slightly down from 67% in Quarter /14 performance to date is 67%. We continue to exceed the final 2014 target of 60%. Interquartile variable is not unexpected. However, the number of CTA approvals remained static and the number of commercial contract studies initialises d onto the CRN portfolio decreased by 1 study. Actions to improve/ maintain performance A continued focus on CRO engagement and strategic partnerships is allowing the NIHR CRN to gain better insights into the global market place for commercial contract research, have greater opportunity to influence country study placement and to understand the reasons for sponsors not considering the UK. Risks/ issues None to report Final target Fig 16: HLO 3 (Quarterly) outcome against 2013/14 target Percentage achieved Target Variance RAG rating 67% 60% 7% 1 Quarterly comparison Variance from last quarter 86% 67% 66% 1% Q4 2012/13 Q1 2013/14 Q2 2013/14 comparison of percentage achieved 2010/ / / /14 to Date 58% 73% 75% 67% 12

14 Percentage of studies High Level Objective 4 Proportion of studies obtaining NHS Permission within 40 calendar days (from receipt of a valid complete application) 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% outcome against 2013/14 target Percentage achieved Q1 Q2 Q3 Q4 Q1 Q2 2010/112011/ / / /14 % Studies achieving NHS permission within 40 Days Interim target Final target Fig 17: HLO 4 (Quarterly) Target Variance RAG rating 73% 80% 7% 1 Quarterly comparison Q4 2012/13 Q1 2013/14 Q2 2013/14 Variance from last quarter 59.5% 71.1% 75.5% 4.4% comparison of percentage achieved 2010/ / / /14 to Date 8% 24% 45% 73% Quarterly performance commentary HLO 4 reflects continued improvement in NIHR CSP delivery, with 76% of studies achieving NHS Permission within 40 days in this quarter (compared to 71% in Quarter , and 59% in Quarter ). The median time for the study-wide review stage (of the CSP process for gaining NHS Permission for as study) continues to be reduced: 14 days in Quarter 2, compared to 17 days in Quarter and 21 days for the year The median time for the local review stage of CSP was 15 days in Quarter 2, unchanged from Quarter 1; this compares to a median of 21 days for studies approved in the year The median processing times for both the study wide and local review stages are the lowest (i.e. best) achieved to date. The number of new studies entering CSP this quarter was 472; the current throughput is approximately 6% higher than in Actions to Improve/maintain performance The CLRNs continue to review models of delivery in order to continuously improve study wide and local review processes. A key focus is harmonisation arrangements (learning from the Central & East London pilot, among other initiatives), which has been a main theme in planning workshops for the new LCRNs. Additional training is being provided to any network failing to deliver local reviews and study wide reviews in the required timescales. Emphasis continues to be placed on the rules on use of suspension, to ensure that this use is appropriate and only in specified circumstances. The creation and accessibility of ODP has allowed networks to access correct and clean data for local performance management. This has improved the consistency of reporting at a local level and allowed networks to produce bespoke reports for local improvement activities. Risks and Issues Changes are required to the CSP Module so that it is configured for the 15 LCRNs (currently it is configured for 25 CLRNs). These changes need to be undertaken and tested in advance of 1 April This work (CSP Release 2.4) is significantly behind schedule. Additional resource is required to progress this work more rapidly and CRNCC is in discussion with DH to secure this additional resource. At present there is a high risk that release 2.4 will not be complete and live by 1 April

15 Calendar Days Number of Applications Calendar days Calendar Days High Level Objective 4: Supporting information Average 2010/11 83 Average 2011/ Q1 Q2 Q3 Q4 Q1 Q2 2012/13 Year and Quarter Average 2012/13 Median Lower quartile Upper quartile Fig 18: Median average time to issue NHS Permission / Average 2010/11 51 Average 2011/ Q1 Q2 Q3 Q4 Q1 Q /13 Average Year and Quarter 2012/13 Median Lower quartile Upper quartile Fig 19: Median average time to complete study-wide review / Average 2010/ Average 2011/ Q1 Q2 Q3 Q4 Q1 Q2 2012/13 Year and Quarter Average 2012/13 Median Lower quartile Upper quartile Fig 20: Median average time to complete local review 2013/ Q1 Q2 Q3 Q4 Q1 Q2 2009/ / / / /14 Year and Quarter Fig 21: Number of applications into CSP 14

16 Percentage of studies High Level Objective 5A Proportion of commercial contract studies achieving first participant recruited within 30 calendar days of NHS Permission being issued or First Network Site Initiation Visit, at confirmed Network sites 100% % % % % 8 50% 40% 2 30% % 7 10% 0% Q1 Q2 Q3 Q4 Q1 Q2 2010/ / / / / /14 30 days or less Between 31 and 60 days More than 60 days Interim Target Final Target (blue border) figures Fig 22: HLO 5A (Quarterly) Quarterly performance commentary 59.5% (n=22) of studies achieved the objective in Quarter 2, a positive increase and improvement from Quarter 1. Actions to improve/ maintain performance Continued efforts to work collaboratively with companies and site teams to take a planned, proactive approach to recruitment is helping to improve the speed at which the first participant is recruited and ensure overall targets are met on time. Improvements in the visibility of CSP data and ability to track when research sites are likely to /do obtain NHS permission will support effective, proactive performance management by the CRN Industry teams. Risks/ issues The range of complexity of studies opening for recruitment in each quarter is indiscriminate and does cause variation which is outside the CRNs control. The predictableness of some study patient populations within an acute setting/particular biomarker profile is often unknown and the ability to recruit the first patient within 30 days is often due to chance. outcome against 2013/14 target Percentage achieved Target Variance RAG rating 52% 80% 28% 1 Quarterly comparison Q4 2012/13 Q1 2013/14 Q2 2013/14 Variance from last quarter 57.0% 36.8% 59.5% 22.6% comparison of percentage achieved 2010/ / / /14 to Date 52% 61% 59% 52% 15

17 Percentage of studies High Level Objective 5B Proportion of non-commercial studies managed by Registered CTUs achieving first participant recruited within 30 calendar days of NHS Permission being issued 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Percentage achieved Target Variance RAG rating 38% 80% 42% 0 Quarterly comparison Variance from last quarter 23% 37% 39% 2% Q4 2012/13 Q1 2013/14 Q2 2013/14 comparison of percentage achieved / / / /14 to Date 22% 23% 24% 38% Q1 Q2 Q3 Q4 Q1 Q2 2010/ / / / /14 30 days or less Between 31 and 60 days More than 60 days Interim target Final target (blue border) figures Fig 23: HLO 5B (Quarterly) Quarterly performance commentary 38% (n=31) of studies met the objective in Quarter 2. This is well below the 80% target, but a slight (1%) increase on that achieved in Quarter 1 and a 24% increase from the 2012/13 average; the highest to date. Performance until now has been relatively static on this objective since 2010/11, in which 22% of studies met the objective and 23% in 2011/12. There are still relatively few studies closing each quarter, so it is difficult to conduct meaningful trend analysis; however the increase this year could be due to the focus of NHS providers on the NIHR 70 day benchmark. Data limitations mean we are unable to take into account some external factors in measuring HLO 5B and HLO 5C (e.g. timing of site initiation visits), so the measure currently includes some activities which are outside of the Networks control Study design and complexity in some cases make this objective challenging to achieve Actions to improve/ maintain performance Networks are pursuing earlier interaction with CTUs, study teams and investigators during development of study protocols, in order to take proactive steps in mitigating risks to study delivery. Impact of this work is expected to be relatively long-term. Risks/ issues Factors outside of the CRN s control affect performance on this objective. For instance, in some cases proactive study teams obtain NHS Permission early (start point for measurement on this objective), but do not intend to begin recruiting to the study immediately. 16

18 Percentage of studies High Level Objective 5C Proportion of non-commercial studies not managed by Registered CTUs achieving first participant recruited within 30 calendar days of NHS Permission being issued 100% Quarterly performance commentary 38% (n=174) of studies met the objective in Quarter 2, against the interim 90% target of 67%. This is slightly below that achieved in Quarter 1 (40%) but comparable to the 2012/13 average (38%) % Although this increased over the last two quarters of 2012/13 and slightly 99 from the 34% achieved in 2011/12, performance remains relatively static 70% quarter on quarter, and year on year As for HLO 5B, data limitations, and in some cases, study design and 60% complexity present challenges for the CRN in meeting this objective for 32 50% all studies Actions to improve/ maintain performance 40% 33 In addition to those highlighted for HLO 5B above: 30% A root cause analysis pilot is being undertaken on HLO 5, and the 81 20% lessons learned from this work will be applied during 2013/14 through a series of action plans 10% Risks/ issues 0% See risk highlighted for HLO 5B Q1 Q2 Q3 Q4 Q1 Q2 2010/ / / / /14 30 days or less Between 31 and 60 days More than 60 days Interim target Final target (blue border) figures Fig 24: HLO 5C (Quarterly) outcome against 2013/14 target Percentage achieved Target Variance RAG rating 38% 67% 28% 0 Quarterly comparison Variance from last quarter 47% 40% 37% 3% Q4 2012/13 Q1 2013/14 Q2 2013/14 comparison of percentage achieved 2010/ / / /14 to Date 38% 34% 38% 38% 17

19 HLO 5C HLO 5B HLO 5A High Level Objective 5: Supporting Information (tables 25 27) Year Studies Network 2012/13 All quarters All quarters Q1 Q2 Year to Date Total 30 days days Total Achieved Near miss Total 30 days days Total 30 days days Total Achieved Near miss N N % N % N N % N % N N % N % N N % N % N N % N % CCRN % 18 18% % 21 19% % 1 7% % 4 20% % 5 14% DeNDRoN % 3 21% % 2 25% % 0 0% 1 0 0% 1 100% % 1 50% DRN % 2 18% % 3 38% 0 0 None 0 None 0 0 None 0 None 0 0 None 0 None MCRN % 1 13% % 4 36% 0 0 None 0 None % 0 0% % 0 0% MHRN 1 0 0% 0 0% % 0 0% 0 0 None 0 None % 0 0% % 0 0% NCRN % 7 23% % 12 28% 1 0 0% 1 100% % 1 9% % 2 17% PCRN % 1 20% % 3 38% 0 0 None 0 None % 0 0% % 0 0% SRN % 0 0% % 0 0% % 0 0% 0 0 None 0 None % 0 0% TOTAL % 32 19% % 45 23% % 2 11% % 6 16% % 8 14% Year Studies Network 2012/13 All quarters All quarters Q1 Q2 Year to Date Total 30 days days Total Achieved Near miss Total 30 days days Total 30 days days Total Achieved Near miss N N % N % N N % N % N N % N % N N % N % N N % N % CCRN % 7 13% % 19 33% % 4 33% % 4 25% % 8 29% DeNDRoN % 0 0% % 0 0% 0 0 None 0 None % 1 50% % 1 50% DRN % 0 0% 2 0 0% 0 0% % 0 0% % 0 0% % 0 0% MCRN 5 0 0% 0 0% % 0 0% 0 0 None 0 None 0 0 None 0 None 0 0 None 0 None MHRN % 0 0% 2 0 0% 0 0% % 0 0% 0 0 None 0 None % 0 0% NCRN % 6 13% % 5 11% % 1 17% % 0 0% % 1 11% PCRN % 2 10% % 5 19% % 2 40% % 3 38% % 5 38% SRN 4 0 0% 0 0% 2 0 0% 0 0% 0 0 None 0 None % 0 0% % 0 0% TOTAL % 15 11% % 29 20% % 7 26% % 8 26% % 15 26% Year Studies Network 2011/ / / /13 All quarters All quarters Q1 Q2 Year to Date Total 30 days days Total Achieved Near miss Total 30 days days Total 30 days days Total Achieved Near miss N N % N % N N % N % N N % N % N N % N % N N % N % CCRN % 56 17% % 91 20% % 24 21% % 31 31% % 55 26% DeNDRoN % 2 7% % 2 7% % 1 20% % 1 9% % 2 13% DRN % 5 15% % 7 20% % 0 0% % 1 20% % 1 11% MCRN % 2 33% % 2 15% % 0 0% 2 0 0% 1 50% % 1 25% MHRN % 11 18% % 11 14% % 3 12% % 8 35% % 11 23% NCRN % 12 16% % 9 15% % 7 41% % 7 39% % 14 40% PCRN % 5 11% % 11 17% % 3 25% % 1 8% % 4 16% SRN % 3 12% % 1 6% % 0 0% 2 0 0% 1 50% % 1 20% TOTAL % 96 16% % % % 38 21% % 51 29% % 89 25% 2013/ / /14 18

20 Percentage of NHS Trusts High Level Objective 6 Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio studies 100% 99% 98% 97% 96% 95% 94% 93% 92% 91% 90% average average Q1 Q2 Q3 Q4 average 2010/ / / / /14 Percentage of Trusts participating in studies (rolling 12 months) Interim Target Final Target n= Number of Trusts actively recruiting in studies Fig 28: HLO 6 (Quarterly) Q1 Q2 Quarterly performance commentary Performance this Quarter indicates that the metric has now been exceeded for over two years, remaining static in this quarter with 99.7% of NHS Trusts reporting recruitment All active NHS Trusts have recruited within the last 12 months Although there is little historic data relating to exclusively Primary Care levels activity, the available data indicates that ~14% of Primary Care sites are reporting activity which is in excess of 2000 sites Actions to improve/ maintain performance The on-going work led by Local Research Networks at organisational level and the national Specialty Groups at disease level has proven successful in maintaining engagement in areas with traditionally lower levels of activity eg Community Trusts and Ambulance Trusts. It is important that this engagement is maintained as changes in infrastructure continue to affect the NHS and the network. Risks/ issues CRN needs to work closely with Primary Care to find an effective long term solution for capturing recruitment now PCTs are no longer in existence. outcome against 2013/14 target Percentage achieved Target Variance RAG rating 99.7% 98% 1.7% 1 Quarterly comparison Q4 2012/13 Q1 2013/14 Q2 2013/14 Variance from last quarter 100.0% 99.7% 99.7% 0% comparison of percentage achieved 2010/ / / /14 to Date 97% 99.3% 99.3% 99.7% 19

21 Percentage of NHS Trusts High Level Objective 6: Supporting information 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% /11 average 2011/12 average Q1 Q2 Q3 Q4 2012/13 average Q1 2012/ /14 n= Number of Trusts actively recruiting in commercial contract studies Fig 29: Percentage of NHS Trusts participating in commercial contract studies Q2 20

22 5. APPENDIX Clinical Research Network High Level Objectives further information The Clinical Research Network High Level Objectives are our overarching objectives for the five-year period However, High Level Objective 1 takes 1 April 2009 as the start point. The objectives are focused on delivery outcomes. They act as a management mechanism for driving forward our performance, and provide defined and agreed criteria for gauging improvement over time. Table 30 presents the following information: Objective: the organisational goal for the Clinical Research Network Measure: the number or quantity that will be used to measure progress against the objective Target: the value of the measure that is the target value Timescale: the date by which the target value will be achieved, and therefore the timescale for the Clinical Research Network to reach the target (from the start date of 1 April 2010) The introduction of the High Level Objectives has necessitated some new information gathering requirements and also some changes to underlying information systems. These changes have been rolled out in a phased way, with full reporting on all High Level Objectives having commenced from April

23 Table 30: Clinical Research Network High Level Objectives Objective Measure Target 2013/14 Target 1 Maintain the number of participants recruited into NIHR CRN Portfolio studies Number of participants recruited in a reporting year into NIHR CRN Portfolio studies 500, ,000 2 Increase the proportion of studies in the NIHR CRN Portfolio delivering to recruitment target and time 2A: Proportion of commercial contract studies achieving or surpassing their recruitment target during their planned recruitment period, at confirmed Network sites 2B: Proportion of non-commercial studies managed by Registered CTUs achieving or surpassing their recruitment target during their planned recruitment period 2C: Proportion of non-commercial studies not managed by Registered CTUs achieving or surpassing their recruitment target during their planned recruitment period 80% 80% 80% 80% 80% 70% 3 Maintain the percentage of commercial contract studies delivered through the NIHR CRN Number of commercial contract studies on the NIHR CRN Portfolio as a percentage of the total commercial MHRA CTA approvals for Phase II IV studies, on an annual basis 60% 60% 4 Reduce the time taken to achieve NHS Permission through CSP for NIHR studies Proportion of studies obtaining NHS Permission within 40 calendar days (from receipt of a valid complete application) 80% 80% 5 Reduce the time taken to recruit first participant into NIHR CRN Portfolio studies 5A: Proportion of commercial contract studies achieving first participant recruited within 30 calendar days of NHS Permission being issued or First Network Site Initiation Visit, at confirmed Network sites 5B: Proportion of non-commercial studies managed by Registered CTUs achieving first participant recruited within 30 calendar days of NHS Permission being issued 80% 80% 80% 80% 5C: Proportion of non-commercial studies not managed by Registered CTUs achieving first participant recruited within 30 calendar days of NHS Permission being issued 80% 67% 6 Increase the percentage of NHS Trusts participating in NIHR CRN Portfolio studies Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio studies 98% 98% 22

24 Key to performance indicators The following performance indicators have been used in this report: Red/Amber/Green (RAG) ratings The RAG thresholds used throughout the report are: Red: less than 90% of the annual performance target Amber: 90% or more of the annual performance target but less than 100% of the annual performance target Green: 100% or more of the annual performance target In all instances, RAG ratings are against the annual performance target. In cases where the target date to achieve the objective is later than the current year, the annual performance target is an interim target. Direction of travel arrows Arrows are used in the report to illustrate trends in performance across quarters and years. The arrows used are: there is a positive trend in performance there is a negative trend in performance performance from the previous period has been maintained at the same level A RAG colour is also applied to the arrows. This is based on performance against the annual performance target. For instance, a red upward arrow ( ) illustrates that there is a positive trend in performance since the previous period, but that performance is less than 90% of the annual performance target. 23

25 Table 31: CRN Database Cut Schedule NIHR CRN Database Cut Schedule Data Period Database Cut 2009/10 Year data finalised 30 June /11 Year data finalised 30 June /12 Year data finalised 30 June /13 Year data finalised 26 April 2013 Q1 2013/14 26 July 2013 Q2 2013/14 25 October 2013 Q3 2013/14 24 January 2014 Q4 2013/14 25 April 2014 Full year 2013/14 Year data finalised 25 April

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