Performance in Initiating Clinical Research

Research & Development
Performance in Initiating & Delivering Research
January, 2016

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 2015 – 31st December 2015

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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

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

Research Ethics Committee Reference 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 / Reasons for delay correspond to:
14/SS/1048 / Trial to compare the efficacy and safety of tovaptan (OTSUKA) / 04/03/2015 / 04/03/2015 / Yes / 11/05/2015 / 0 / 68 / 68 / Yes
14/EE/1001 / OTO-104 Meniere’s Disease / 27/01/2015 / 28/01/2015 / Yes / 05/02/2015 / 1 / 8 / 9 / Yes
14/NW/1405 / Patara: Treatment of Chronic Cough with pa101 / 04/03/2015 / 05/03/2015 / Yes / 02/04/2015 / 1 / 28 / 29 / Yes
14/WM/1145 / PRISM CIDP / 02/03/2015 / 02/03/2015 / No / 0 / No / RARE STUDY
14/YH/1235 / A Study comparing treatments of severe Influenza A / 16/02/2015 / 17/02/2015 / No / 1 / No / Sponsor
13/WA/0004 / Oral steroids for otitis media with effusion in children study (OSTRICH) / 07/01/2015 / 07/01/2015 / Yes / 27/01/2015 / 0 / 20 / 20 / Yes
14/LO/1139 / AMG-334 (AMGEN) – CCRN 3208 / 05/03/2015 / 05/03/2015 / Yes / 18/03/2015 / 0 / 13 / 13 / Yes
14/YH/1090 / Quiet 1 – The Quest in Eliminating Tinnitus / 30/01/2015 / 11/02/2015 / Yes / 29/04/2015 / 12 / 77 / 89 / No / NHS Provider
14/NW/1258 / ARAMIS (Rare disease study) / 12/03/2015 / 13/03/2015 / No / 1 / No / RARE STUDY
14/LO/2011 / RE: Dual PCI (CCRN 2833) / 05/03/2015 / 09/03/2015 / Yes / 13/05/2015 / 4 / 65 / 69 / Yes
13/SC/0470 / Point: Patient Orientated Inhibition in New TIA and Minor Ischemic Stroke / 13/01/2015 / 26/02/2015 / Yes / 26/02/2015 / 44 / 0 / 44 / Yes
14/WM/0083 / LORIS (Rare disease study) / 11/05/2015 / 14/05/2015 / No / 3 / No / RARE STUDY
14/EM/1060 / HAEM 3426(DTIP)FIT 049 / 28/04/2015 / 29/04/2015 / Yes / 11/05/2015 / 1 / 12 / 13 / Yes
14/NW/1235 / ROTIGOTINE AND MEMORY IN PARKINSON’S DISEASE / 13/04/2015 / 13/04/2015 / Yes / 06/05/2015 / 0 / 23 / 23 / Yes
14/LO/1837 / ARPEGGIO / 06/05/2015 / 08/05/2015 / No / 2 / No / RARE STUDY
14/YH/1124 / EXTEND / 09/04/2015 / 14/04/2015 / No / 5 / No / Sponsor
15/SC/0645 / PHONEX / 24/04/2015 / 27/04/2015 / Yes / 15/05/2015 / 3 / 18 / 21 / Yes
Research Ethics Committee Reference 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 / Reasons for delay correspond to:
14/LO/2101 / GWEP1330 – A study of GWP42006 in people with focal seizures / 20/05/2015 / 21/05/2015 / No / 1 / No / NHS Provider
15/WM/0111 / Mobilisation of endothelial progenitor cells by statin therapy in patients with coronary disease. A proof of concept pilot study / 20/04/2015 / 20/04/2015 / Yes / 12/05/2015 / 0 / 22 / 22 / Yes
14/NW/0130 / Response (CCRN 3138) / 30/04/2015 / 30/04/2015 / Yes / 14/06/2015 / 0 / 45 / 45 / Yes
15/WM/0050 / (DERM 3732) Rapid Act LP0041-11120 / 29/04/2015 / 29/04/2015 / Yes / 21/05/2015 / 0 / 22 / 22 / Yes
15/LO/0273 / BrighTNess – Randomised, Phase 3 Study for subjects with Early Stage TNBC / 16/07/2015 / 20/07/2015 / No / 4 / No / RARE STUDY
15/SC/0165 / Evicel Neurosurgery / 22/05/2015 / 22/09/2015 / No / 0 / No / RARE STUDY
15/LO/0521 / NEUR 3520: AMG 334 Label Extension / 07/07/2015 / 09/07/2015 / Yes / 12/08/2015 / 2 / 34 / 36 / Yes
14/LO/1800 / EME - TIPAC / 09/07/2015 / 13/07/2015 / No / 4 / No / NHS Provider
15/NW/0142 / Adapt Response / 04/08/2015 / 04/08/2015 / Yes / 26/08/2015 / 0 / 22 / 22 / Yes
14/WS/1146 / NAVIGATE_ESUS / 23/07/2015 / 23/07/2015 / No / 0 / No / NHS Provider
14/SC/1345 / PRISM / 03/09/2015 / 07/09/2015 / No / 4 / Within 70 Days
15/EM/0294 / INNOCAOLL DIABETIC FOOT ULCER / 22/09/2015 / 24/09/2015 / No / 2 / Within 70 Days
13/SS/0007 / MS-SMART / 13/08/2015 / 17/08/2015 / Yes / 08/10/2015 / 4 / 52 / 56 / Yes
14/NW/1067 / PROteKT / 07/10/2015 / 09/10/2015 / Yes / 30/11/2015 / 2 / 52 / 54 / Yes
14/NS/0089 / Hip'OP / 19/11/2015 / 23/11/2015 / No / 4 / RARE STUDY
13/SC/0173 / Sotio - Viable / 03/11/2015 / 03/11/2015 / No / 0 / NHS Provider
Research Ethics Committee Reference 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 / Reasons for delay correspond to:
14/SS/1096 / RAPID CTCA / 26/10/2015 / 27/10/2015 / Yes / 12/11/2015 / 1 / 16 / 17 / Yes
15/EE/0273 / Changes in ocular signs and symptoms in patients with ocular hypertens (Santen Glaucoma) / 10/11/2015 / 13/11/2015 / Yes / 01/12/2015 / 3 / 18 / 21 / Yes
13/WM/0419 / MAMMO-50 / 07/10/2015 / 09/10/2015 / Yes / 16/11/2015 / 2 / 38 / 40 / Yes
15/NW/0481 / ASPECTS (CRIT 3290) / 02/11/2015 / 03/11/2015 / No / 1 / RARE STUDY
14/SW/0075 / REDUCE / 29/10/2015 / 03/11/2015 / Yes / 25/11/2015 / 5 / 22 / 27 / Yes
14/YH/0116 / CULPRIT SHOCK / 08/12/2015 / 09/12/2015 / No / 1 / WITHIN 70 DAYS
15/EM/0279 / Improving compliance to radiotherapy in prostate cancer management. / 07/10/2015 / 07/10/2015 / No / 0 / NHS Provider
15/SC/0448 / DIAB 3971 - FIGARO / 17/11/2015 / 19/11/2015 / No / 2 / WITHIN 70 DAYS
15/SW/0194 / DIAB 3953 - FIDELIO / 17/11/2015 / 19/11/2015 / No / 2 / WITHIN 70 DAYS
14/NE/1018 / GALATHEA (CCRN 2873 COPD) / 12/11/2015 / 16/11/2015 / No / 4 / WITHIN 70 DAYS
15/NW/0751 / Pneumacare SLP validation in infants and in clinical bronchiolitis / 17/11/2015 / 19/11/2015 / Yes / 23/11/2015 / 2 / 4 / 6 / Yes
15/EE/0261 / A Phase 3 Study to Evaluate AMG334 in Episodic Migraine Prevention - STRIVE / 12/11/2015 / 13/11/2015 / Yes / 07/12/2015 / 1 / 24 / 25 / Yes
15/WA/0106 / PROBESE / 18/12/2015 / 22/12/2015 / No / 4 / WITHIN 70 DAYS

Performance in Delivering Clinical Research

Research Ethics Committee Reference Number / Name of Trial / Target Number of Patients Available / Target Number of Patients / Date Agree to recruit target number of patients / Trial Status / Target met within the agreed time / Comments
12/YH/0249 / Extension study of Brivaracetam in Patients with Epilepsy / Available / 5 / 24/09/2016 / Withdrawn / N/A
12/NW/0180 / PD ONE: Evaluation of low sodium PDF in hypertensive PD patients / Available / 4 / 31/12/2014 / Closed - In Follow Up / Y / 7 patient recruited
12/SC/0035 / VESTRI (child) / Available / 5 / 05/08/2014 / Closed - In Follow Up / Y / 5 patients recruited
12/SC/0098 / AUSTRI (adult) / Available / 6 / 17/06/2014 / Closed – Follow Up Complete / N
10/H0402/38 / ELIXA / Available / 3 / 13/03/2015 / Closed - In Follow Up / N / 1 patient recruited.
12/LO/1679 / Momentum: Safety and Efficacy of 3 doses of MT-1303 over 24 weeks in RRMS / Available / 4 / 24/12/2014 / Closed - In Follow Up / N / 3 patients recruited
11/WM/0375 / MEDI-573 / Available / 4 / 31/07/2013 / Closed –Follow up complete / N / Closed by lead centre
12/EM/0280 / FALCON Breast / Available / 2 / 21/07/2014 / Closed - In Follow Up / Y / 3 patients recruited
12/LO/0720 / A Phase 1/2 randomized, dose-finding study of MEDI-551 in subjects with relapsing-remitting multiple sclerosis / Available / 2 / 25/07/2014 / Closed - In Follow Up / N
11/SC/0481 / Study E7080-703. Randomized Phase II Study of E7080 in NSCLC / Available / 3 / 13/12/2012 / Closed - In Follow Up / N / Sponsor closed. Target met.
11/H1203/7 / SOS-Penumbra: A study of survival and outcome after Stroke / Available / 5 / 01/09/2014 / Closed - In Follow Up / Y / 13 Patients Recruited
11/LO/1415 / DeNDRoN 070 (OXN PR for severe PD associated pain) / Available / 5 / 30/04/2013 / Closed –Follow up complete / N / 2 patients were recruited before closure
11/NE/0226 / GTR and Copaxone equivalence study (GATE) - CCRN 508 (MS) / Available / 5 / 12/03/2013 / Closed - In Follow Up / N / 1 patient recruited.
11/LO/1750 / THERESA - TDM1 in 3rd line HER2+ breast cancer / Available / 4 / 01/09/2013 / Closed –Follow up complete / Y
11/NW/0489 / OPERA - CCRN 659 (MS) / Available / 6 / 23/03/2015 / Closed - In Follow Up / N / Sponsor closed study after it met trial target
11/YH/0140 / CCRN 558 (LUMINOUS) / Available / 470 / 07/12/2014 / Closed - In Follow Up / Y / 522 patients recruited
11/SS/0018 / APHINITY - Traz + Pertuzumab in HER2+ as adjuvant therapy in HER2+ Br Ca / Available / 7 / 19/06/2013 / Closed - In Follow Up / Y / Sponsor Closed, Target Met
Research Ethics Committee Reference Number / Name of Trial / Target Number of Patients Available / Target Number of Patients / Date Agree to recruit target number of patients / Trial Status / Target met within the agreed time / Comments
11/NW/0411 / Epilepsy - Study Comparing controlled monotherapyLacosamidevs Carbamazepine / Available / 7 / 31/03/2013 / Closed - In Follow Up / N / 4 patients recruited
11/NW/0412 / Comparing long term safety of LCM vs CBZ-CR in patients from SP0993 (SP0994) / Available / 5 / 11/11/2015 / Open / N/A / Study still open
12/WS/0300 / ODYSSEY: A study of SAR236553/REGN727 in patients with Acute Coronary Syndrome / Available / 12 / 01/08/2014 / Closed – In Follow Up / N / 2 patients recruited
13/LO/0021 / NCRN449 PRESENT: Neuvax in adjuvant low/intermediate HER2 breast cancer / Available / 10 / 31/10/2014 / Closed - In Follow Up / Y
12/EE/0005 / STEPS / Available / 6 / 11/06/2014 / Closed - In Follow Up / Y / 16 patients recruited
13/LO/0033 / PEGGY / Available / 4 / 01/05/2014 / Closed - In Follow Up / N
13/NW/0171 / Inhaled CVT301 in subjects with Parkinson's Disease / Available / 5 / 13/12/2013 / Withdrawn / N / Sponsor withdrew our site from the study, due to no subject screening visits
12/NW/0802 / CONCERTO: Study of Oral Laquinimod in Subjects with Multiple Sclerosis / Available / 5 / 04/06/2018 / Closed - Follow Up Complete / N/A / Sponsor decided to close sites earlier than expected that had not recruited. Our target date was 04/06/2018
13/YH/0111 / FIAsp versus aspart in type 2 diabetes - ONSET2 / Available / 5 / 01/10/2014 / Closed - In Follow Up / N/A / PIC sites were to identify patients for this study, our nurses were not allowed to contact patients, therefore this was out of our control
13/LO/0826 / Efficacy, Immunogenicity, and Safety Study of Clostridium difficile Toxoid Vaccine in subjects at risk for C. difficile infection / Available / 72 / 17/12/2016 / Open / N/A / Study still open
13/LO/0195 / Momentum Extension: A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study / Available / 3 / 01/01/2015 / Closed – In Follow Up / N
Research Ethics Committee Reference Number / Name of Trial / Target Number of Patients Available / Target Number of Patients / Date Agree to recruit target number of patients / Trial Status / Target met within the agreed time / Comments
10/H0904/4 / A single arm, openlabel, multicenter study evaluating the longterm safety and tolerability of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with relapsing forms of multiple sclerosis / Available / 10 / 30/11/2012 / Closed - In Follow Up / N / recruited 9
10/H0711/6 / Alecardio / Available / 10 / Withdrawn / N/A
11/H0502/1 / 1200.98 BIBW 2992 / Available / 4 / 31/12/2014 / Withdrawn / N/A
09/H0505/9 / A dose-blind, multicentre, extension study to determine the long-term safety and efficacy of two doses of B606012 momtherapy in subjects with relapsing MS (Biogen 303 109MS303) / Available / 1 / 01/07/2012 / Closed - In Follow Up / Y
06/MRE04/18 / A multinational, multicentre, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3mg and 0.6mg) of laquinimod, orally administered in relapsing-remitting (R-R) MS subjects / Available / 1 / 09/10/2014 / Closed - In Follow Up / Y / 1 patient recruited.
09/H1307/1 / APITOPE Safety and proof of principle study of ATX-MS-1467 in patients with Relapsing Multiple Sclerosis: Open label upward titration over five dose levels and using two routes of administration (intradermal and subcutaneous) / Available / 4 / 01/10/2011 / Closed - In Follow Up / N / 0 patients recruited
13/LO/0537 / Athersys B01-02 Phase II Trial of MultiStem in Adults with Ischemic Stroke / Available / 4 / 11/06/2014 / Closed - In Follow Up / Y / 16 patients recruited
12/YH/0462 / PBASE / Available / 80 / Withdrawn / N/A
11/YH/0142 / PREMIERE / Available / 6 / 31/10/2006 / Closed - In Follow Up / N / 2 patients recruited
08/H0906/1 / SRN014 DIAS 4 / Available / 10 / 07/07/2014 / Closed - Follow Up Complete / Y
13/EM/0460 / Study of Adjuvant Kadcylavs Herceptin, HER2+ve Primary Breast Cancer (Kaitlin) / Available / 8 / 24/02/2016 / Suspended / Y / Study recruitment suspended
11/EE/0037 / Validation of Structured Light Plethysmography against Spirometry / Available / 150 / 31/03/2016 / Closed – In Follow Up / Y / 157 Patients Recruited
13/EE/0241 / SIGNATURE Study CAIN457AGB01 / Available / 3 / 16/01/2015 / Closed – in Follow up / N / 1 patient recruited
14/EM/0032 / CAIN457A2317 - A long-term study of the efficacy and safety of secukinumab compared with ustekinumab in adult subjects with moderate to severe plaque psoriasis / Available / 3 / 02/06/2014 / Closed - In Follow Up / Y / 5 patients Recruited
Research Ethics Committee Reference Number / Name of Trial / Target Number of Patients Available / Target Number of Patients / Date Agree to recruit target number of patients / Trial Status / Target met within the agreed time / Comments
12/SS/0162 / CLOTBUSTER / Available / 12 / 03/04/2015 / Closed – in Follow up / N / 8 patients recruited
12/WM/0341 / FOURIER: Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects With Elevated Risk / Available / 21 / 20/01/2015 / Closed – In Follow Up / N / 3 patients recruited
13/LO/1517 / Dolomites / Available / 5 / 01/04/2016 / Open / N/A / Study still open
14/EM/0023 / MER ACETATE - Phase II Plovamer Acetate Doses Compared to Copaxone in MS Patients / Available / 4 / 01/03/2017 / Withdrawn / N / 1 patient recruited, sponsor withdrew study
14/LO/0680 / ATLANTIC / Available / 2 / 31/10/2015 / Open / N/A / Study still open
14/SC/1059 / Optimize Study / Available / 8 / 01/08/2016 / Open / N/A / Study still open
13/WM/0263 / AEGEAN study / Available / 6 / 19/12/2014 / Closed - In Follow Up / N / 1 patient recruited
13/SC/0616 / NTHi004 - copd exacerbation vaccine study / Available / 8 / 30/11/2015 / Open / N/A / Study still open
14/LO/0324 / ORBIT III / Available / 4 / 10/06/2016 / Open / N/A / Study still open
14/EM/1059 / FIT 047 / Available / 5 / 31/12/2015 / Open / N/A / Study still open
14/SC/0129 / CREDENCE / Available / 20 / 04/01/2019 / Open / N/A / Study still open
14/LO/1443 / PYRENESS / Available / 7 / 01/02/2018 / Open / N/A / Study still open
14/WM/0094 / EISAI EPILEPSY / Available / 5 / 01/01/2016 / Open / N/A / Study still open
13/LO/0326 / GALAXY 2 / Available / 3 / 21/10/2015 / Open / N/A / Study still open
14/LO/0566 / OLYMPIA / Available / 3 / 28/02/2018 / Open / N/A / Study still open
14/SS/1048 / Trial to compare the efficacy and safety of Tovaptan (OTSUKA) - Reprise / Available / 5 / 24/10/2016 / Open / N/A / Study still open
14/EE/1001 / OTO-104 Meniere’s disease / Available / 8 / 25/02/2016 / Open / N/A / Study still open
14/NW/1405 / RESP 39139 – Patara: Treatment of Chronic Cough with PA101 / Available / 6 / 28/12/2015 / Open / N/A / Study still open
14/WM/1145 / PRISM CDIP / Available / 2 / 01/09/2016 / Open / N/A / Study still open
14/YH/1235 / CCRN 2773 – A study comparing treatments of severe influenza A / Available / 5 / 15/10/2016 / Open / N/A / Study still open
14/LO/1139 / CCRN 3208 AMG-334 (AMGEN) / Available / 6 / 08/10/2015 / Open / N/A / Study still open
14/YH/1090 / CCRN 3217 Quiet 1 – The Quest in Eliminating Tinnitus / Available / 6 / 12/10/2015 / Open / N/A / Study still open
14/NW/1258 / ARAMIS / Available / 8 / 30/06/2020 / Open / N/A / Study still open
14/LO/2011 / CCRN 2833 RE Dual PCI / Available / 16 / 31/07/2017 / Open / N/A / Study Still open
12/EE/0371 / CCRN 2692 APEX Study / Available / 8 / 31/10/2015 / Open / N/A / Study still open
Research Ethics Committee Reference Number / Name of Trial / Target Number of Patients Available / Target Number of Patients / Date Agree to recruit target number of patients / Trial Status / Target met within the agreed time / Comments
14/EM/1060 / HAEM 3426 (DTIP) FIT 049 / Available / 5 / 23/02/2017 / Open / N/A / Study Still Open
14/LO/1837 / Arpeggio / Available / 5 / 26/08/2017 / Open / N/A / Study still open
14/LO/2101 / GWEP1330 – A study of GWP 42006 in people with focal seizures / Available / 7 / 21/05/2016 / Open / N/A / Study still open
14/NW/0130 / RESPONSE (CCRN 3138) / Available / 3 / 30/09/2015 / Open / N/A / Study still open
15/WM/0050 / (DERM 3732) RAPID ACT LP0041 - 11120 / Available / 14 / 01/06/2016 / Open / N/A / Study Still Open
15/SC/0165 / EVICEL NEUROSURGERY / Available / 10 / 01/07/2017 / Open / N/A / Study Still Open
15/LO/0521 / NEURO 3520 AMG 334 Open Label Extension / Available / 6 / 21/01/2017 / Open / N/A / Study Still Open
15/NW/0142 / ADAPT RESPONSE / Available / 20 / 13/07/2020 / Open / N/A / Study Still Open
14/WS/1146 / NAVIGATE_ESUS / Available / 15 / 15/12/2017 / Open / N/A / Study Still Open
15/EM/0294 / Innocoll Diabetic Foot Ulcer / Available / 6 / 31/07/2016 / Open / N/A / Study Still Open
15/NW/0481 / ASPECTS (CRIT 3290) / Available / 2 / 31/03/2018 / Open / N/A / Study still open
15/WA/0324 / ANNEXA-4 / Available / 3 / 03/01/2021 / Open / N/A / Study still open
15/SC/0448 / DIAB 3971 - FIGARO / Available / 15 / 27/02/2019 / Open / N/A / Study still open
15/SW/0194 / DIAB 3953 - FIDELIO / Available / 15 / 27/02/2019 / Open / N/A / Study still open
14/YH/1124 / EXTEND: / Available / 2 / 01/11/2015 / Suspended / N / Study Suspended
15/LO/0273 / brighTNess - Randomised, Phase 3 study for subjects with Early Stage TNBC / Available / 8 / 01/12/2026 / Open / N/A / Study still open
13/SC/0173 / Sotio - Viable / Available / 3 / 31/03/2017 / Open / N/A / Study still open
15/EE/0273 / Changes in ocular signs and symptoms in patients with ocular hypertens (Santen Glaucoma) / Available / 8 / 31/03/2016 / Open / N/A / Study still open
15/NW/0142 / Adapt Response / Available / 20 / 13/07/2020 / Open / N/A / Study still open
14/NE/1018 / GALATHEA (CCRN 2873 COPD) / Available / 2 / 15/05/2017 / Open / N/A / Study still open
15/EE/0261 / A Phase 3 Study to Evaluate AMG334 in Episodic Migraine Prevention - STRIVE / Available / 6 / 23/05/2016 / Open / N/A / Study still open