Performance in Initiating and Delivering Clinical Research

Transcription

1 Performance in Initiating and Delivering Clinical Research As part of the National Institute for Health Research s initiative to promote efficiency in clinical trials, all NHS providers who hold NIHR contracts are required to monitor and report the time taken to initiate and deliver clinical trials. The information presented below summarises the set-up times for studies undertaken at Moorfields Eye Hospital NHS Foundation Trust for trials granted NHS permissions between July 1 st 2012 and 30 th June All Trusts are measured against a national target of 70 days to obtain NHS permissions and recruit the first patient into the clinical trial. Our performance against this benchmark is summarised in Table 1 below. Where this has not been achieved, we have provided some further information to illustrate why there were delays. Occasionally delays during study set-up are unavoidable for reasons such as scarcity of eligible patients, delays with third party organisations during contract negotiations and additional measures to ensure that all safety aspects have been addressed prior to initiation. It is expected that NHS Trusts will achieve 80% compliance with the 70-day target. Trusts performance in delivering commercial contract clinical trials in line with their initial time and recruitment targets as specified by the sponsor organisation is also monitored and presented in the summary data, for studies active during the past year. This data is presented in table 2 below. Please contact richard.seeberan@moorfields.nhs.uk for any further enquires relating to this data. Version: 0 Status: DRAFT Approved: 00 Month 0000 Ratified: 00 Month 0000

2 Contents Section/Chapter Page Table 1: Performance in Initiating Clinical Research Error! Bookmark not defined. Table 2: Performance in Delivering Clinical Research 7 1

3 Table 1: Performance in Initiating Clinical Research This table summarises Moorfields Eye Hospital s performance in initiating clinical trials by recruiting the first patient to the trial within 70 days of receiving a valid application for NHS permissions. The benchmark column indicates whether this target has been met. Where it was not, further information on the reason for any delays are provided in the final column. Name of Trial Pilot study in investigate the feasibility of creating models of macular and retinal diseases in the form of RPE monolayers derived from induced pluripotent stem cells (ipsc) A 24 month, phase IIIb, label, randomised, activecontrolled, 3 arm, multicentre study assessing the efficacy and safety of an individualised, stabilisation-criteriadriven PRN dosing regime with 0.5mg ranibizumab intravitreal Research Ethics Committee Reference Number Date of Receipt of Valid Research Applicatio n Date of NHS Permissio n Date of First Patient Recruited 12/LO/ /08/ /09/ /09/2012 Benchm ark Met Reason if the study did not meet the benchmark 12/SC/ /03/ /07/ /07/2012 No Sponsor (Equipment) injections applied MATISSE 12/LO/ /04/ /07/ /08/2012 No Sponsor (Protocol Amendments) Contracting 2

4 Dacrycocystorhinostom y surgery under general anaesthetic with and without local anaesthesia. A comparison of anaesthetic and patient related outcomes in both groups Corneal biomechanics: a biomarker for glaucoma? A pilot study investigating the relationship between stereoacuity and subjective appreciation of active shutter 3D television Health-related Quality of Life in two treatment pathways for newly diagnosed angle glaucoma and ocular hypertension: an unmasked, multicentre, randomised controlled trial of initial selective laser trabeculectomy vs conventional medical therapy In vivo experiments to determine wound healing effects of retinal lasers 12/LO/ /07/ /07/ /09/2012 No Staff availability issues No patients seen 11/LO/ /01/ /01/ /02/2013 No Sponsor (Change of sponsor) Contracting 11/LO/ /10/ /10/ /11/2012 No Permissions delayed/denie d 12/LO/ /09/ /09/ /10/2012 Original funding declined 12/LO/ /10/ /10/2012 No Equipment is off site for repairs 3

5 An -label study to evaluate the effects of repeated treatments of oral QLT on safety and vision outcome in subjects with LCA or RP due to inherited deficiencies in RPE65 or LRAT. Extension study A 3 year, multi-centre study to evaluate optical coherence tomography as an outcome measure in patients with multiple sclerosis 12/LO/ /10/ /10/ /10/ /LO/ /03/ /09/ /11/2012 No Contracting Staff Availability Sponsor (Contracting) A randomised, activecontrolled, -label, multiple-dose, proof of concept study of intravitreal LFG316 in patients with MFC 12/SW/ /12/ /01/2013 No No patients seen Rare disease Follow-up study for patients with Retinal Cells Derived from Stem Cells for Stardgart's Macular Dystrophy GTAC198 27/11/ /01/ /01/2013 Development of an intraocular pressure management device for glaucoma management 12/MW/ /01/ /03/ /03/2013 4

6 EUROCONDOR 12/NW/ /10/ /01/ /01/2013 No Sponsor (Equipment) A Multicentre Prospective Open-label Randomised Clinical Trial Comparing the Efficacy of Fixed versus PRN dosing of 700 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) in patients with refractory diabetic macular odema. 12/LO/ /01/ /01/ /02/2013 Staff Availability A prospective, two centre, randomised controlled exploratory study of the PresView Scleral Implant (PSI) for the treatment of ocular hypertension and primary angle glaucoma REPARO NGF0212 Phase I/II Neurotrophic Keratitis Trial A 3 month multicenter double-masked safety and efficacy study of Travoprost Ophthalmic solution, 0.004% to Timolol (0.5% or 0.25%) in paediatric glaucoma patients 12/SW/ /01/ /02/ /02/ /LO/ /04/ /05/ /07/2013 No No patients seen 13/EM/ /04/ /04/ /06/2013 Rare disease 5

7 OCTAVE, Ranibizumab in neovascular agerelated macular degeneration 13/LO/ /05/ /06/ /07/2013 A prospective evaluation of an automated screening software system versus human graders in the evaluation of normal and diabetic retinopathy images 13/LO/ /05/ /06/ /07/2013 Contact lenses to optimise vision in adults with idiopathic infantile nystagmus: a pilot parallel randomised controlled trial of refractive corrective contact lenses versus plano contact lenses plus glasses if required A Randomised, Double-Blind, Parallel- Group, Placebo controlled study to assess the efficacy, safety, tolerability and pharmacokinetics of BIIB033 in subjects with first episode of acute optic neuritis 13/LO/ /06/ /06/ /07/ /SC/ /11/ /07/2013 No Delay in notification Contracting 6

8 Table 2: Performance in Delivering Clinical Research This table summarises Moorfields Eye Hospital s performance in delivering clinical trials in line with the recruitment targets specified by the trials sponsor. The data illustrates whether the agreed number of patients were recruited by the site by the specified recruitment end date. Name of Trial Research Ethics Committee Reference Number Target number of patients Date Agreed to recruit target number of patients Trial Status Target met within the agreed time (and reason if N) A multicentre, double-masked, randomised, active-controlled, parallel study of the safety and efficacy of once-daily Bimatoprost preservative-free ophthalmic solution compared to twice-daily Timolol ophthalmic solution in paediatric patients with glaucoma A 24 month, phase IIIb, label, randomised, activecontrolled, 3 arm, multicentre study assessing the efficacy and safety of an individualised, stabilisation-criteria-driven PRN dosing regime with 0.5mg ranibizumab intravitreal injections applied A 24 month, phase IIIb, label, single-arm, multicentre study assessing the efficacy and safety of an individualised, stabilisation-criteria-driven PRN dosing regime with 0.5mg ranibizumab intravitreal injections applied as monotherapy in patient A Phase III, Multinational, Multicenter, Randomized, Double- Masked, Study Assessing the Safety and Efficacy of Intravitreal Injections of DE-109 (three doses) for the Treatment of active, Non- Infectious Uveitis of the Posterior Segment of the eye 11/LO/ /02/2015 Open N/A - Trial still 12/SC/ /10/2015 Closed - 12/SC/ /10/2015 Closed - 11/LO/ /10/2013 Open N/A - Trial still 7

9 A 12 Month, Multicentre, randomised parallel group study to compare the efficacy and safety of Ozurdex vs Lucentis in patients with Branch Vein Occlusion (BRVO) (COMO study) Continuous recording of short time fluctuations in intraocular pressure using the Sensimed Triggerfish sensor 11/LO/ /11/2013 Open N/A - Trial still 12/LO/ /12/2012 Closed - Follow Complete Primary Tube versus Trabeculectomy (PTVT) Study 08/H0721/ /10/2015 Open Study to gather data to enable the validation of a new automated strabismus screening technology against gold standard orthoptic diagnoses obtained from a group of paediatric patients with strabismus or suspected strabismus A double-masked, placebo controlled, randomised, parallel group phase IIa study to assess the tolerability, safety and efficacy of AZD4017 for raised intraocular pressure LUMINOUS: Study to observe the effectiveness and safety of LUCENTIS through individualised patient treatment and associated outcomes A retrospective, non-interventional study to assess the effectiveness of existing anti-vascular treatment regimes in patients with wet agerelated macular degeneration (AURA) 12/LO/ /04/2013 Closed - Follow Complete 10/H0402/ /04/2013 Closed - 11/YH/ /06/2016 Closed - 11/NW/ /11/2012 Closed - No (Recruitment terminated at proposed time as study drug to expire) 8

10 A A Prospective, Noninterventional, longitudinal cohort study to evaluate the longterm safety of Xalatan (Latanoprost) Treatment in Paediatric Populations A multicentre study of the efficacy and safety of the human anti-tnf monoclonal antibody Adalimumab as maintenance therapy in subjects requiring high dose corticosteroids for active noninfectious intermediate-, posterior-, or pan-uveitis A multi-centre -label study of the long-term safety and efficacy of the human anti-tnf monoclonal antibody Adalimumab in subjects with non-infectious intermediate-, posterior-, or panuveitis A Multi-Centre Double-Masked, Parallel Group, Placebo- Controlled Study to Assess the Efficacy and Safety of Voclosporin as Therapy in Subjects with Active Noninfectious Intermediate, Posterior, or Pan-Uveitis Prospective clinical trial to evaluate the clinical results of implantation of the Revision Optics Inlay for treatment of presbyopia A Phase I/II, label, multicentre, prospective study to determine the safety and tolerability of sub-retinal transplantation of human Embryonic Stem Cell derived Retinal Pigmented Epithelial (hesc-rpe) cells in patients with Stargardt's Macular 10/H0721/ /07/2016 Closed - 10/H0406/ /07/2013 Open No (Global study target reached) 10/H0406/ /12/2013 Open N/A - Trial still 10/H0301/ /12/2012 Closed - Follow Complete No (Global study target reached) 10/H0721/ /03/2014 Open N/A - Trial still GTAC /08/2013 Open N/A - Trial still 9

11 An Open-Label, Phase 1b Safety/Proof of Concept study to Evaluate the Effects of Oral QLT in Subjects with Leber congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP) Due to Inherited Deficiencies of Retinal Pigment Epithelial 65 Protein 9RPE An -label study to evaluate the effects of repeated treatments of oral QLT on safety and vision outcome in subjects with LCA or RP due to inherited deficiencies in RPE65 or LRAT. 11/NE/ /09/2012 Closed - 12/LO/ /01/2014 Closed - Extension study MATISSE 12/LO/ /12/2012 Closed - A 3 year, multi-centre study to evaluate optical coherence tomography as an outcome measure in patients with multiple sclerosis 12/LO/ /09/2016 Open N/A - Trial still Exploring the endogenous regenerative potential of the adult human retina 10/H0106/57-11ETR /04/2017 Open N/A - Trial still Follow-up study for patients with Retinal Cells Derived from Stem Cells for Stardgart's Macular Dystrophy GTAC /01/2019 Open N/A - Trial still A randomised, active-controlled, -label, multiple-dose, proof of concept study of intravitreal LFG316 in patients with MFC 12/SW/ /04/2014 Open N/A - Trial still 10

12 REPARO NGF0212 Phase I/II Neurotrophic Keratitis Trial 13/LO/ /06/2015 Open N/A - Trial still A 3 month multicenter doublemasked safety and efficacy study of Travoprost Ophthalmic solution, 0.004% to Timolol (0.5% or 0.25%) in paediatric glaucoma patients OCTAVE, Ranibizumab in neovascular age-related macular degeneration 13/EM/ /10/2013 Open N/A - Trial still 13/LO/ /04/2016 Open N/A - Trial still 11