Performance in Initiating Clinical Research

Research & Development
Performance in Initiating & Delivering Research
January, 2017

This document has been produced in line with guidance provided by the National Institute for Health Research (NIHR). It details the performance of clinical research trials at University Hospitals of North Midlands, covering the period 1st January 2016 – 31st December 2016

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Introduction

Clinical trial performance at The University Hospital of North Midlands is now measured against two national benchmarks to improve the initiation and delivery of all clinical trials approved by the Trust. From April 2013 NIHR funding to the Trust will be conditional on meeting these benchmarks.

Initiation – it should take no more than 70 days from receipt of Valid Research Application (signed SSI form) by the R&D Department to the recruitment of (i.e. consenting) the first patient to the trial. For HRA approved studies it should take no more than 70 days from the date the site is selected to the recruitment of (i.e. consenting) the first patient to the trial

Delivery – for all commercial clinical trials hosted by the Trust, the agreed number of patients must be recruited within the agreed recruitment period

Performance in Initiating Clinical Research

NHS Permission Studies

Research Ethics Committee Reference Number / Integrated Research Application System Number / Name of Trial / Date of Receipt of Valid Research Application / Date of NHS Permission / First Patient Recruited? / Date of First Patient Recruited / Duration between VRA and NHS Permission / Duration between NHS Permission and First Patient / Duration between VRA and First Patient / Benchmark Met / Comments
15/LO/0894 / 180555 / NEUR 4110 (CGAM) / 12/05/2016 / 22/08/2016 / No / 102 / No / RARE STUDY
16/LO/0340 / 197371 / DERM 5658 (Auriel) / 07/12/2015 / 23/05/2016 / Yes / 31/05/2016 / 168 / 8 / 176 / No / Process crossover study
15/LO/0443 / 172123 / Pomalidomidevsbortezomib in MM (CC-4047-MM007) (OPTIMISM) / 15/06/2016 / 15/08/2016 / No / 61 / No / RARE STUDY
15/NS/0070 / 183761 / BASIL-3 / 01/05/2016 / 28/09/2016 / Yes / 28/10/2016 / 150 / 30 / 180 / No / Process crossover study
15/LO/1018 / 174522 / OPTIMUM Trial / 13/07/2016 / 28/10/2016 / No / 107 / No / RARE STUDY
14/WA/1056 / 154468 / AML 19 / 09/08/2016 / 11/08/2016 / No / 2 / No / RARE STUDY
15-YH-0398 / 180504 / MERIDIAN 2-3 year follow up study / 19/09/2016 / 26/10/2016 / Yes / 24/11/2016 / 37 / 29 / 66 / Yes / Process crossover study
15/SC/0691 / 179484 / RePHILL (Resuscitation with PreHospItaLbLood products) / 05/05/2016 / 17/10/2016 / Yes / 20/12/2016 / 165 / 64 / 229 / No / Process crossover study
16/WM/0006 / 192580 / WHIST / 22/07/2016 / 28/09/2016 / Yes / 01/11/2016 / 68 / 34 / 102 / No / Process crossover study
16/SS/0134 / 199690 / STO 4724 (Pfizor IGH) / 11/04/2016 / 13/10/2016 / No / 185 / No / RARE STUDY
14/SC/017 / 120104 / ADD-ASPIRIN / 23/02/2016 / 11/10/2016 / No / 231 / No / RARE STUDY
13/SC/0645 / 143871 / PEACOCK (Phoenix-2) study / 21/04/2015 / 10/10/2016 / Yes / 27/10/2016 / 538 / 17 / 555 / No / Permissions delay
11/SS/0100 / 84669 / FOCUS - The effect of routine administration of Fluoxetine in patients with recent stroke / 02/02/2016 / 04/03/2016 / Yes / 07/04/2016 / 31 / 34 / 65 / Yes
14/SS/1048 / 164169 / RENA 4161 (otsuka) / 03/03/2015 / 22/07/2016 / Yes / 25/07/2016 / 507 / 3 / 510 / No / Permissions delay
16/NE/0024 / 195903 / ORAL 5144 / 08/06/2016 / 12/10/2016 / Yes / 24/10/2016 / 126 / 12 / 138 / No / Permissions delay
15/NW/0917 / 190004 / JAVELIN Lung 100 - CANC 5225 / 16/06/2016 / 22/06/2016 / Yes / 24/11/2016 / 6 / 155 / 161 / No / Permissions delay
16/LO/0568 / 200579 / Roche P3 RRMS study MA30005 (NEUR 5342) (CASTING) / 29/02/2016 / 05/10/2016 / No / 219 / No / RARE STUDY
Research Ethics Committee Reference Number / Integrated Research Application System Number / Name of Trial / Date of Receipt of Valid Research Application / Date of NHS Permission / First Patient Recruited? / Date of First Patient Recruited / Duration between VRA and NHS Permission / Duration between NHS Permission and First Patient / Duration between VRA and First Patient / Benchmark Met / Comments
15/LO/1729 / 189383 / CHIL 5036 / 28/07/2016 / 23/09/2016 / No / 57 / No / RARE STUDY
16/EE/0009 / 189564 / CANC 5158 / 24/02/2016 / 23/06/2016 / No / 120 / No / RARE STUDY
16/LO/0285 / 199031 / GAST 5487 / 16/02/2016 / 27/07/2016 / Yes / 23/08/2016 / 162 / 27 / 189 / No / RARE STUDY
15/EE/0298 / 186974 / LuCID Lung Cancer Indicator Dectection / 11/04/2016 / 04/08/2016 / Yes / 19/08/2016 / 115 / 15 / 130 / No / Permissions delay
15/LO/0472 / 167100 / OPHT 3738 / 07/01/2016 / 08/01/2016 / No / 1 / No / RARE STUDY
14/EM/0121 / 143800 / RITUXILUP, Version 1.1 / 14/01/2016 / 18/01/2016 / Yes / 19/01/2016 / 4 / 1 / 5 / Yes
14/SC/1161 / 155743 / e-ULTIMASTER / 18/01/2016 / 18/01/2016 / Yes / 18/01/2016 / 0 / 0 / 0 / Yes
15/WM/0092 / 137113 / LOTUS / 21/01/2016 / 22/01/2016 / Yes / 25/02/2016 / 1 / 34 / 35 / Yes
15/WM/0365 / 188589 / CARD 4507 FINESSE-HF / 25/01/2016 / 26/01/2016 / No / 1 / No / Withdrawn
14/NW/1195 / 157154 / LCI-SEARCH / 25/01/2016 / 26/01/2016 / Yes / 02/02/2016 / 1 / 7 / 8 / Yes
15/NE/0277 / 178822 / OPTIMUM Multiple Sclerosis Trial / 25/01/2016 / 29/01/2016 / No / 4 / No / RARE STUDY
14/NE/1062 / 140391 / The PHOTO Trial / 02/02/2016 / 04/02/2016 / Yes / 11/02/2016 / 2 / 7 / 9 / Yes
15/LO/1324 / 181497 / CARD 4569 AMULET / 08/02/2016 / 08/02/2016 / Yes / 10/02/2016 / 0 / 2 / 2 / Yes
14/EM/1174 / 158992 / PD-HF / 09/02/2016 / 11/02/2016 / No / 2 / No / RARE STUDY
15/WM/0166 / 155128 / Feasibility of a guided workbook intervention for cancer patients / 11/02/2016 / 25/02/2016 / Yes / 07/04/2016 / 14 / 42 / 56 / Yes
15/NW/0171 / 168748 / Dex - CSDH Trial / 16/02/2016 / 29/02/2016 / Yes / 08/06/2016 / 13 / 100 / 113 / No / RARE STUDY
14/YH/0085 / 126738 / FLAIR: Front-Line therapy in CLL: Assessment of Ibrutinib + Rituximab / 23/02/2016 / 29/02/2016 / Yes / 01/06/2016 / 6 / 93 / 99 / No / RARE STUDY
15/EE/0047 / 168114 / STRO 4441 PHADER / 08/03/2016 / 11/03/2016 / Yes / 20/05/2016 / 3 / 70 / 73 / No / No patients seen
15/EE00/10 / 138590 / PITCHES: Phase III trial of UDCA in ICP: V1 / 09/03/2016 / 15/03/2016 / Yes / 21/04/2016 / 6 / 37 / 43 / Yes / RARE STUDY
15/NW/0950 / 194241 / CGAH: The Evolve-2 Study (Treatment for Episodic Migraine) / 10/03/2016 / 17/03/2016 / Yes / 11/04/2016 / 7 / 25 / 32 / Yes
15/WM/0456 / 193461 / CGAI - The REGAIN Study (Treatment for Chronic Migraine) / 10/03/2016 / 17/03/2016 / Yes / 23/03/2016 / 7 / 6 / 13 / Yes
15/WM/0457 / 195511 / CANC 5294 / 18/03/2016 / 22/03/2016 / Yes / 04/05/2016 / 4 / 43 / 47 / Yes / RARE STUDY
Research Ethics Committee Reference Number / Integrated Research Application System Number / Name of Trial / Date of Receipt of Valid Research Application / Date of NHS Permission / First Patient Recruited? / Date of First Patient Recruited / Duration between VRA and NHS Permission / Duration between NHS Permission and First Patient / Duration between VRA and First Patient / Benchmark Met / Comments
14/NW/1396 / 165097 / B-AHEAD3: Breast Activity and Healthy Eating After Diagnosis 3 / 21/03/2016 / 24/03/2016 / No / 3 / No / RARE STUDY
16/LO/0240 / 199083 / Prose - Cosentyx?/Secukinumab/AIN457 / 23/03/2016 / 29/03/2016 / Yes / 05/05/2016 / 6 / 37 / 43 / Yes / RARE STUDY
15/SC/0600 / 187954 / SIMPLE. / 17/03/2016 / 30/03/2016 / Yes / 20/04/2016 / 13 / 21 / 34 / Yes
16/WM/0072 / 199402 / The effect on Endothelial progenitor cells (EPCs) by statin loading in ?all comers? with an Acute Coronary Syndrome (ACS). / 21/03/2016 / 30/03/2016 / Yes / 08/04/2016 / 9 / 9 / 18 / Yes
15/LO/0217 / 163086 / ERIC-PPCI / 24/03/2016 / 31/03/2016 / Yes / 12/05/2016 / 7 / 42 / 49 / Yes / RARE STUDY
16/WS/0013 / 196924 / BASE EP0077 (NEUR 5478) / 14/03/2016 / 21/03/2016 / No / 17 / No / RARE STUDY
15/NI/00243 / 191267 / Study of CTX 4430 in Cystic Fibrosis Patients / 01/04/2016 / 11/04/2016 / No / 10 / No / RARE STUDY
16/WM/0055 / 192978 / The relationship between CTCA and EPC count. / 12/04/2016 / 12/04/2016 / Yes / 23/05/2016 / 0 / 41 / 41 / Yes
16/EE/0011 / 194393 / Phase III Otonomy Study 104-201508 / 06/04/2016 / 22/04/2016 / Yes / 27/10/2016 / 16 / 188 / 204 / No / RARE STUDY
13/LO/0288 / 119790 / Evaluation of a website for parents of children with Juvenile Idiopathic Arthritis / 24/03/2016 / 03/05/2016 / Yes / 16/05/2016 / 40 / 13 / 53 / Yes
14/NE/1176 / 161888 / UK FROST (United Kingdom Frozen Shoulder Trial) / 22/04/2016 / 04/05/2016 / No / 12 / No / RARE STUDY
14/SS/1043 / 142447 / UNIRAD / 07/04/2016 / 14/06/2016 / Yes / 11/08/2016 / 68 / 58 / 126 / No / RARE STUDY
16/EM/0082 / 192525 / DEME 5249 / 18/04/2016 / 27/06/2016 / No / 70 / No / RARE STUDY
16/EM/0081 / 192524 / Clinical Efficacy & Safety of AP CD/LD in Fluctuating PD / 18/04/2016 / 27/06/2016 / No / 70 / No / RARE STUDY
14/YH/0076 / 141623 / BALANCED / 09/04/2016 / 27/06/2016 / Yes / 18/07/2016 / 79 / 21 / 100 / No / Software delay
14/SS/1031 / 159610 / STOPPIT-2 / 28/06/2016 / 30/06/2016 / Yes / 26/07/2016 / 2 / 26 / 28 / Yes
14/NW/1219 / 160371 / NERVES / 29/06/2016 / 30/06/2016 / No / 1 / No / RARE STUDY
15/SW/0156 / 167123 / TARGET TRIAL / 01/04/2016 / 15/08/2016 / No / 136 / No / RARE STUDY

HRA Approved Studies

Research Ethics Committee Reference Number / Integrated Research Application System Number / Name of Trial / Date Site Selected / Date Site Confirmed By Sponsor / First Patient Recruited? / Date of First Patient Recruited / Comments
16/NW/0304 / 194760 / DIRMP / 24/06/2016 / 24/06/2016 / Yes / 10/08/2016
15/NI/0064 / 172879 / Vertex VX14-661-106 Cystic Fibrosis / 11/03/2016 / 11/03/2016 / Yes / 26/07/2016
16/LO/1133 / 203679 / CANC 5543 KEYNOTE 038 / 11/07/2016 / 31/07/2016 / No / RARE STUDY
16/SC/0390 / 190073 / NEUR 5596 NEUR 5551 (NOVARTIS) / 18/07/2016 / 27/10/2016 / No / RARE STUDY
16/EM/0166 / 193475 / MAPP: Back pain prevention in multiple myeloma using a spinal brace / 04/04/2016 / 19/12/2016 / No / Screening failures
16/WM/0317 / 206807 / STRO 4889 (Restore) / 12/08/2016 / 18/08/2016 / No / RARE STUDY
16/YH/0154 / 202759 / CHIL 5709 (Domperidone) / 04/02/2016 / 04/02/2016 / No / RARE STUDY
16/EE/0243 / 207331 / EARN 30709 (OTO-104 EXTENSION) / 02/08/2016 / 21/10/2016 / Yes / 06/01/2017
16/EM/0194 / 194984 / MIAA / 04/10/2016 / 25/11/2016 / No / Software issues
15/SW/0248 / 186033 / CHIL 4871 (VX14-661-110) (VERTEX 110 EXTENSION) / 07/11/2016 / 16/12/2016 / Yes / 14/01/2017
15/NW/0545 / 156861 / DexEnceph 1.0 / 18/05/2016 / 06/12/2016 / No / RARE STUDY
16/LO/1354 / 199180 / Lily I5Q-MC-CGAR / 21/11/2016 / 27/10/2016 / No / RARE STUDY
14/SC/1416 / 156215 / ImmunoglobuliN in the Treatment of Encephalitis (The IgNiTE study) / 02/06/2016 / 25/07/2016 / No / RARE STUDY
16/SC/0159 / 195312 / TWILIGHT Study / 15/11/2016 / 09/12/2016 / No / RARE STUDY
16/YH/0234 / 197040 / TOPSAT2 / 10/08/2016 / 25/10/2016 / No / RARE STUDY
16/SC/0462 / 208830 / DRAFFT 2 - Distal Radius Acute Fracture Fixation Trial 2 / 14/11/2016 / 18/11/2016 / No / Within 70 days
16/EE/0195 / 200168 / CANC 5156 - CASCADE / 21/07/2016 / 11/10/2016 / No / RARE STUDY
16/LO/0886 / 204525 / Quintiles- Biogen Idec Acute Ischemic Stroke 101SK202 (ACTION II) / 07/07/2016 / 28/09/2016 / Yes / 20/10/2016 / RARE STUDY

Performance in Delivering Clinical Research

Research Ethics Committee Reference Number / Integrated Research Application System Number / Name of Trial / Target Number Of Patients Agreed? / Minimum Number Of Patients Agreed / Maximum Number Of Patients Agreed / Target Date To Recruit Patients Agreed? / Date Agreed to recruit target number of patients / Total Number Of Patients Recruited At The Agreed Target Date / Date That The Trial Closed To Recruitment
14/EM/1059 / 152516 / CCRN 3064 (Chronic Immune Thrombocytopenic Purpura) / Number Agreed / 5 / 5 / Date Agreed / 30/08/2015 / 2 / 04/01/2016
15/EE/0261 / 180616 / NEUR 3910 / Number Agreed / 6 / 6 / Date Agreed / 23/05/2016 / 2 / 26/01/2016
14/SS/1048 / 154401 / RENA3734 (REPRISE) / Number Agreed / 5 / 5 / Date Agreed / 24/10/2016 / 12 / 02/02/2016
15/EE/0273 / 174903 / OPHT 4792 / Number Agreed / 8 / 8 / Date Agreed / 31/03/2016 / 6 / 31/01/2016
15/SC/0165 / 173920 / Evicel Neurosurgery / Number Agreed / 10 / 10 / Date Agreed / 01/07/2017 / 3 / 09/02/2016
15/LO/0472 / 167100 / OPHT 3738 / Number Agreed / 4 / 4 / Date Agreed / 31/12/2016 / 0 / 23/02/2016
15/WM/0365 / 188589 / CARD 4507 FINESSE-HF / Number Agreed / 10 / 10 / Date Agreed / 30/06/2018 / 0 / 11/03/2016
13/SC/0173 / 108971 / VIABLE / Number Agreed / 3 / 3 / Date Agreed / 31/03/2017 / 0 / 11/04/2016
15/WM/0050 / 172460 / DERM 3732 / Number Agreed / 14 / 14 / Date Agreed / 01/02/2016 / 18 / 03/02/2016
15/EM/0294 / 180267 / INN-TOP-005 gentamicin collagen Sponge in Diabetic Foot Ulcers / Number Agreed / 6 / 6 / Date Agreed / 31/07/2016 / 0 / 29/07/2016
11/NW/0411 / 61620 / STUDY COMPARING CONTROLLED MONOTHERAPY LACOSAMIDE V'S CARBAMAZEPINE / Number Agreed / 7 / 7 / Date Agreed / 11/11/2015 / 3 / 25/10/2016
11/NW/0412 / 71042 / CCRN 631 (Epilepsy) Comparing long term safety of LCM vs CBZ-CR in patients from SP0993 (SP0994) / Number Agreed / 5 / 5 / Date Agreed / 11/11/2015 / 2 / 11/03/2016
10/H0903/7 / BIOGEN 203 / Number Agreed / 0 / 0 / Date Agreed / 01/05/2015 / 0 / 20/09/2016
10/H0406/34 / 42673 / NCRN150 MARIANNE - T-DM1 +/- pertuzumabvs Herceptin + taxane first line in HER2 + locally adv/MBCr / Number Agreed / 3 / 3 / Date Agreed / 01/03/2017 / 0 / 04/07/2016
Research Ethics Committee Reference Number / Integrated Research Application System Number / Name of Trial / Target Number Of Patients Agreed? / Minimum Number Of Patients Agreed / Maximum Number Of Patients Agreed / Target Date To Recruit Patients Agreed? / Date Agreed to recruit target number of patients / Total Number Of Patients Recruited At The Agreed Target Date / Date That The Trial Closed To Recruitment
13/LO/0826 / 131006 / CCRN 2553 (C DIFF Vaccine) / Number Agreed / 22 / 22 / Date Agreed / 17/12/2016 / 20 / 27/09/2016
14/LO/1837 / 162372 / NEUR 3413 ARPEGGIO / Number Agreed / 5 / 5 / Date Agreed / 26/08/2017 / 0 / 30/05/2016
14/LO/2011 / 159926 / CCRN 2833 ARE-DUAL PCI / Number Agreed / 16 / 16 / Date Agreed / 31/07/2017 / 7 / 30/10/2016
15/LO/0273 / 149700 / M14-011: Efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvantchemotherpay versus standard neoadjuvant chemotherapy in subject with early stage triple negative breast cancer (TNBC) / Number Agreed / 8 / 8 / Date Agreed / 01/12/2026 / 1 / 18/03/2016
15/LO/0521 / 166050 / NEUR 3520 / Number Agreed / 6 / 6 / Date Agreed / 21/01/2017 / 5 / 03/03/2016
14/SS/1087 / 164169 / RENA4131 / Number Agreed / 5 / 5 / Date Agreed / 31/12/2018 / 4 / 26/03/2016
15/SC/0448 / 183584 / RENA 3971 / Number Agreed / 15 / 15 / Date Agreed / 27/02/2019 / 1 / 01/12/2016
15/SW/0194 / 185459 / DIAB 3953 / Number Agreed / 15 / 15 / Date Agreed / 27/02/2019 / 0 / 01/12/2016
14/NE/1018 / 150960 / CCRN 2873 (COPD) / Number Agreed / 2 / 2 / Date Agreed / 15/05/2017 / 2 / 09/11/2016
15/WM/0365 / 188589 / FINESSE-HF / Number Agreed / 10 / 10 / Date Agreed / 30/06/2018 / 0 / 11/03/2016
15/LO/1324 / 181497 / CARD 4569 AMULET / Number Agreed / 14 / 14 / Date Agreed / 01/09/2017 / 12 / 12/09/2016
15/WM/0456 / 193461 / A phase 3 randomised double blind placebo controlled study of LY2951742 in patients with chronic migraine - the REGAIN study (Neur 4154) / Number Agreed / 8 / 8 / Date Agreed / 30/04/2018 / 9 / 22/09/2016
15/NI/0064 / 172879 / Vertex VX14-661-106 Cystic Fibrosis / Number Agreed / 4 / 4 / Date Agreed / 31/10/2016 / 6 / 11/07/2016
16/LO/1133 / 203679 / CANC 5543 Keynote 048 / Number Agreed / 1 / 1 / Date Agreed / 22/12/2016 / 0 / 22/12/2016
15/NW/0950 / 194241 / CGAH: The evolve-2 study (treatment for episodic migraine) / Number Agreed / 6 / 6 / Date Agreed / 19/09/2017 / 5 / 26/07/2016
16/LO/0340 / 197371 / DERM 5658 / Number Agreed / 5 / 5 / Date Agreed / 26/08/2016 / 2 / 06/12/2016