HRA Approval Date. confirmed by sponsor 07/04/ /04/ /04/ /04/ /04/ /04/ /05/2016

Transcription

1 Reference Reason for delay in recruiting first 1 15/NE/ AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA /04/ /04/ /04/ /04/ /04/ /04/ /05/ /WM/ An Open-Label Treatment Use Protocol for Daratumumab in Subjects with Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and an Immunomodulatory Agent) or are Double Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent 30/03/ /03/ /04/ /04/ /04/ /04/ /05/ /SS/ A Phase 2 Pilot, Multicenter, Single Arm Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GSK plus Standard of Care for the Prevention of Delayed Graft Function in Adult Subjects After Renal Transplantation 05/05/ /05/ /05/ /05/ /05/ /05/2016 An extensive screening log has been kept with numerous s on it however, no suitable s have been eligible due to the strict exclusion criteria 4 15/SC/ A Phase 2, randomized, open-label, multicenter study to assess safety and efficacy of nabpaclitaxel (ABI-007) with epigenetic modifying therapy of CC-486, and nab-paclitaxel monotherapy as second-line treatment in subjects with advanced nonsquamous non-small cell lung cancer (NSCLC): ABOUND.2L 12/04/ /04/ /04/ /06/ /06/ /06/ /07/2016 The setup of this study was delayed by the new HRA procedure, which meant it missed the 70 day deadline 5 16/WS/ Can DiaGO reliably and sensitively detect Graves' orbitopathy? 30/04/ /04/ /04/ /06/ /06/ /06/ /07/2016 The application for approval was submitted on 09/03/16 but was redirected through HRA and got HRA approval on 17/06/2016 which held up the permissions process, got capacity and capability and green light on 22/06/16, this gave 17 days to recruit a prior to the 70 day window target, unfortunately a wasn't recruited within this 17 days 6 16/LO/ n open-label, prospective, nonrandomized, multicenter study to evaluate clear skin effect on healthrelated quality of life outcomes at 16 and 52 weeks in s with moderate to severe plaque psoriasis treated with secukinumab 300 mg s.c. with or without previous exposure to systemic therapy 14/03/ /05/ /05/ /06/ /06/ /06/ /07/2016

2 Reference Reason for delay in recruiting first 7 16/NE/ Development and Feasibility testing of a behavioural intervention targeting multiple lifestyle behaviours to improve long term outcomes following liver transplantation 20/05/ /05/ /05/ /06/ /06/ /06/ /08/2016 There was a slight delay due to funding issues i.e. sorting out an account and forms being lost in internal post which has now been sorted 8 15/EE/ Quality assessment of human kidneys by ex-vivo normothermic perfusion prior to transplantation 22/04/ /04/ /04/ /06/ /06/ /06/ /NE/ ALternatives to prophylactic Antibiotics for the treatment of Recurrent UTIs 03/05/ /05/ /06/ /06/ /06/ /06/ /07/2016 Study missed the 70 day benchmark because of delays with the new HRA process and no was seen in the 20 day window which was left 10 16/NE/ A Single-Blind, Phase 2 Study To Evaluate The Safety And Efficacy Of Tideglusib 400mg Or 1000mg For The Treatment Of Adolescent And Adult Congenital And Juvenile-Onset Myotonic Dystrophy 31/05/ /05/ /07/ /07/ /07/ /07/ /07/ /YH/ A multicenter, randomized, open label, parallel group study comparing predischarge and post-discharge treatment initiation with LCZ696 in heart failure patients with reduced ejection-fraction hospitalized for an acute decompensation event (ADHF) (the TRANSITION study) 27/05/ /05/ /06/ /07/ /07/ /07/ /09/2016 Delays were due to the not providing the necessary IVRS training until late in August 12 15/WA/ Expanding MRI Access for Patients with New and Existing ICDs and CRT-Ds 25/05/ /05/ /05/ /06/ /07/ /07/2016 Study was suspended by due to unanticipated advers event at the MRI Visit 13 16/WM/ A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2A STUDY TO ASSESS THE EFFICACY OF RO IN PATIENTS WITH PRIMARY SJÖGREN S SYNDROME 24/05/ /05/ /07/ /07/ /07/ /07/ /09/2016 Study was activated from on 29th July 2016, CRF green light on 1st August HRA delays caused delays which left 8 days to recruit. This was first in Europe to be recruited 14 16/SC/ /EM/ A Multicentre Randomised Controlled Trial of Induced Endometrial Scratch in Women Undergoing First Time IN Vitro Fertilisation (IVF) A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies 09/06/ /06/ /06/ /07/ /07/ /07/ /07/2016 Please select 06/05/ /06/ /05/ /07/ /07/ /07/ /07/2016 Please select

3 Reference Reason for delay in recruiting first 16 16/LO/ An open label, Phase 3 study examining the long term safety, tolerability and efficacy of APL in Levodopa responsive s with Parkinson s disease complicated by motor fluctuations ( OFF episodes). 05/07/ /07/ /06/ /07/ /08/ /08/2016 Missed the 70 day deadline as the study is very difficult to recruit to based on the inclusion/exclusion criteria 17 16/NE/ A dose ranging study of the efficacy, safety and pharmacokinetics of Deferiprone delayed release tablets in s with Parkinson s disease. LA /05/ /05/ /07/ /05/ /05/ /06/2016 Study took 70 days from submission to NHS approval due to HRA changes. However, potential s have been identified but considered ineligible to participate due to Geographic location. Sponsor considered it best that these should be recruited at Manchester site once opened. Other s seen but screen failed 18 16/NE/ An Observer-Blinded, Placebo- Controlled, Multible-Ascending, Dose- Escalation Study To Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of repeat Intravenous Administrations UTTR1147A in Healthy Volunteers and Patients with Ulcerative Colitis 19/05/ /07/ /04/ /07/ /08/ /08/2016 This study was late getting receiving the green light from the, due to an additional nonsubstantial amendment for a clincal test which needed to be done at another site. Eligible participants have been seen but declined to consent to participate in the trial 19 16/EM/ A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of NGM282 Administered for 12 Weeks in Patients with Primary Sclerosing Cholangitis (PSC) 25/05/ /06/ /05/ /08/ /08/ /08/2016 Due to HRA process study was late getting NHS approval. Patient population is a working population so difficult to get s to attend for study visits during working hours 20 15/EE/ Clinical Trial of Nivolumab (BMS ) Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Therapy of Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma 07/06/ /06/ /06/ /08/ /08/ /08/2016 The combination arm for this trial became standard treatment at the same time the study opened. As a result s are now extremely difficult to recruit to this study 21 15/YH/ LaCeS feasibility: A multicentre, randomised controlled feasibility trial of Laparoscopic versus Open Colorectal Surgery in the Acute Setting 21/04/ /04/ /05/ /08/ /08/ /08/ /09/ Days window was missed because of HRA processes. Also there had been no emergency admissions with a colorectal cause whilst the surgeons had been on duty. Although there were posters advistising the study in on call rooms, radiology and theatre staff were aware of the research and the surgeons are on high alert 22 16/WM/ World Hip Trauma Evaluation Four: A randomised controlled trial of the sliding hip screw versus X-Bolt dynamic plating system for the fixation of trochanteric fractures of the hip. 20/06/ /06/ /06/ /08/ /08/ /08/ /09/2016 The study missed the 70 day window by 3 days because of the new HRA process.

4 Reference Reason for delay in recruiting first 23 16/EM/ A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The dal-gene trial 09/06/ /06/ /06/ /08/ /08/ /08/2016 Study was delayed due to the HRA process and the team did not receive the green light from the until the 26/9/ /LO/ A Phase I/II, Multicenter, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Patients with Previously Treated Solid Tumors 27/06/ /06/ /08/ /08/ /08/ /08/2016 The study is open at Newcastle, but recruitment has been on hold in between dose evaluation. We have 3 s on the waiting list, but a slot is unlikely to be available until December 25 16/NE/ Serum Sample Collection to Determine Analytical Performance Characteristics of the ADVIA Centaur Pregnancy Associated Plasma Protein A and ADVIA Centaur Free Beta Human Chorionic Gonadotropin assays 06/06/ /06/ /06/ /07/ /07/ /08/ /08/ /LO/ The Efficacy and Mechanism Evaluation of Treating Idiopathic Pulmonary Fibrosis with the Addition of Co-trimoxazole (EME-TIPAC) 05/07/ /07/ /05/ /08/ /08/ /08/2016 HRA approval delays caused the study to be delayed in opening and no eligible participants have been identified to date 27 15/NI/ Five year observational follow-up of the IVAN trial cohort: a study of function and morphology 09/06/ /06/ /06/ /07/ /08/ /08/2016 Delays caused by the HRA and the study centre not given the green light in time 28 16/NE/ A Phase 3b Open-label Extension Study to Evaluate the Safety and Efficacy of Aceneuramic Acid Extended-Release (Ace- ER) Tablets in Patients with GNE Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM) 15/08/ /08/ /08/ /09/ /09/ /09/ /EE/ Safety and proof of principle study of ATX-GD-59 in male and female subjects with Graves' disease not currently treated with anti-thyroid therapy: An Open label study, with an upward titration over five dose levels administered by Intradermal injection 01/07/ /07/ /07/ /08/ /09/ /09/2016 HRA approval took 62 days which left 8 days to recruit first. The first globally has just been consented and we are hopeful they will be recruited 30 16/SC/ A Phase IIb multicentre, double-blind, dose-ranging, randomised, placebocontrolled study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism 15/08/ /08/ /08/ /09/ /09/ /09/2016

5 Reference Reason for delay in recruiting first 31 15/NE/ Trabectedin for recurrent grade II or III meningioma: A randomised phase II study of the EORTC Brain Tumor Group 11/08/ /08/ /09/ /09/ /09/ /09/2016 This study was going through the new HRA process but unfortunately missed the submission deadline and therefore the process had to start again which added to the time delay. No s have been identified yet 32 16/LO/ A Cancer UK Phase I trial of CCT (a CHK1 inhibitor) administered orally in s with advanced cancer 29/08/ /08/ /05/ /09/ /09/ /09/ /LO/ A Cancer UK Phase I trial of oral CCT (a CHK1 inhibitor) given in combination with gemcitabine plus cisplatin or gemcitabine alone in s with advanced cancer 29/08/ /08/ /05/ /09/ /09/ /09/ /LO/ A PHASE 1, OPEN-LABEL, DOSE FINDING STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PRELIMINARY EFFICACY OF CC IN SUBJECTS WITH RELAPSED AND/OR REFRACTORY SOLID TUMORS AND NON- HODGKIN S LYMPHOMAS 09/08/ /08/ /08/ /08/ /09/ /09/ /EM/ Phase II trial of anetumab ravtansine (BAY ) in s with advanced or metastatic malignant pleural mesothelioma (MPM) overexpressing mesothelin after first line treatment with platinum in combination with pemetrexed 15/08/ /08/ /07/ /09/ /09/ /09/ /EM/ A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active- Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson s Disease Patients 07/06/ /06/ /06/ /09/ /09/ /09/2016 The study took 106 days from submission to NHS approval and missed the 70 day window because of the new HRA process. However, the team is waiting for Gastro test videos to be uploaded and the physical copies of the signed contracts received from to communicate to them the day site may be considered active 37 16/EM/ An open label, multi-centre, follow-up study designed to evaluate the long term effects of AP-CD/LD in fluctuating Parkinson s disease subjects who completed study IN /06/ /06/ /06/ /09/ /09/ /09/2016 The study took 106 days from submission to NHS approval because of the HRA process. However, s need to complete the main study (Clinical Efficacy & Safety of AP CD/LD in Fluctuating PD) to be eligible to participate in this extension study and both studies opened at the same time 38 15/SC/ Registry of Deep Brain Stimulation with the VERCISE System for treatment of Dystonia: Vercise DBS Dystonia Registry 19/07/ /07/ /07/ /09/ /09/ /09/2016 Due to HRA process study was late getting NHS approval. No eligible s have yet been identified

6 Reference 39 13/WS/ /LO/ /EM/ /YH/ A randomised, double blind, placebocontrolled, parallel group Trial of lowdose adjunctive alteplase during primary PCI. Assessment of Midodrine in the prevention of vasovagal syncope: The prevention of syncope trial IV (POST 4). Global multicenter, open-label, randomized, event-driven, activecontrolled study comparing a rivaroxaban-based antithrombotic strategy to an antiplatelet-based strategy after transcatheter aortic valve replacement (TAVR) to Optimize clinical outcomes. TREATMENT OF POOR-GRADE SUBARACHNOID HAEMORRHAGE TRIAL 2 21/01/ /06/ /06/ /09/ /09/ /09/ /02/ /02/ /06/ /08/ /09/ /09/ /06/ /06/ /05/ /06/ /09/ /09/ /07/ /07/ /07/ /09/ /09/ /09/2016 Reason for delay in recruiting first The 70 day target for this study was the 5/9/16. We received the pharmacy green light on the 15/9/16, we were then informed by the that they would like the MRI software to be updated to Myomaps for the study (they initially said that this would not be required) we are currently waiting for this to be installed The team missed the 70 day target because of the new HRA approval also the green light from the has still not been given The 70 day target was missed for this study because of the new HRA process and the study is still waiting for the green light from the The study got HRA approval on 13th July 2016, and didnt get confirmation of capacity until 14th September there were delays in finalising the contract. The gave a green light on 20 September Since then the PI was on holiday for a week then there have been no eligible s since 43 16/LO/ Treatment of Pustular Psoriasis with the IL-1 receptor antagonist anakinra: a randomised, placebo controlled trial and associated mechanistic studies (APRICOT) 15/08/ /08/ /07/ /09/ /09/ /09/2016 The gave a green light on 20 September Since then the PI was on holiday for a week then there have been no eligible s since 44 16/NE/ A Multicenter, Randomized, Double- Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Nonalcoholic Steatohepatitis (NASH) and fibrosis 08/08/ /08/ /06/ /09/ /09/ /09/ /LO/ Clinical evaluation of a CE marked Medical Device to be used as an adjunct therapy to the standard to routine scaling in s with moderate to severe periodontal disease 15/08/ /08/ /08/ /09/ /09/ /09/ /09/ /NE/ A mixed methods feasibility study of electronic cigarette use by s with periodontitis 12/09/ /09/ /09/ /09/ /09/ /09/ /09/2016