Performance report q4 12-13.xls

Performance in Delivering
Research
Date Agreed to
Date Agreed
recruit target
Target met
number of
to recruit
Committee Name of Trial
number of
number of
within the
Comments
patients
target number Status
Reference
patients
patients
agreed time
available?
of patients
available
A Phase I-II evaluation of the safety and efficacy of the oral HSP90 inhibitor Debio 0932 in combination with standard of care in first and second line therapy of patients with Stage IIIb or IV Non-small Cell Lung Cancer - the HALO study (HSP90 inhibition A Randomized, Open-label, Single Dose, Two-way Cross-Over Study to Investigate the Relative Commercial Xeloda? Tablets Following Oral Administrations in Adult Patients with S A multicentre, open label, early stopping design, proof of concept study with tasquinimod in advanced or metastatic hepatocellular, ovarian, renal cell and gastric carcinomas An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics of VX-970 in Combination with Either Gemcitabine or Cisplatin and Etoposide in Subjects with Advanced Solid TumorsA Cancer Research UK Phase I Trial of AZD3965, a monocarboxylate transporter 1 inhibitor (MCT1) in patients with advanced cancer.
A single-arm, open-label, phase II, multicentre study to assess the safety of 0449) in patients with locally advanced or metastatic basal cell carcinoma.
A Phase 1, open-label, multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of Selumetinib (AZD6244; ARRY-142886) in combination with first line chemotherapy regimens in patients with non-small cell lung cancer.
A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the DOPA in subjects with Parkinson?s disease exhibiting delayed gastric emptying A Randomized, Placebo-Controlled, Phase 2 Study of the Safety, Pharmacokinetics, and Levodopa Powder) in Patients with Parkinson's Disease and Motor Response Fluctuations ("Off" Episodes) Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Two Year Study to Evaluate the Subcutaneous RO4909832 on Cognition and Function in Prodromal Alzheimer's Disease (Scarlett Road) An open-label, Multicentre, Extension Study to Evaluate the Long-Term Safety BIIB050) in Subjects With Amyotrophic Lateral Sclerosis Efficacy and safety of 3 doses of S 38093 (2, 5 and 20 mg/day) versus placebo, in co-administration with donepezil (10 mg/day) in patients with moderate Alzheimer?s Disease. A 24-week international, multi-centre, randomised, double-blind, placebo-controll ENHANCE: A Prospective Long-term EvaluatioN of the Use of Permacol? Biological Implant in tHe Repair of Complex AbdomiNal Wall CasEs A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Subjects with Primary Biliary Cirrhosis Who had an Inadequate Response to Ursodeoxycholic Acid (UDCA) An open-label, multicenter, follow-up study to evaluate the long-term safety and efficacy of Brivaracetam used as adjunctive treatment in subjects aged 16 years or older with Partial Onset Seizures A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to and Safety of Brivaracetam in Subjects (=16 to 80 Years Old) with Partial Onset SeizuresA prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEG A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ferrous preparations have failed or cannot be used (AEGIS Retreatment of recurrent contractures in joints effectively treated with AA4500 (Collagenase Histolyticum) in an Auxilium sponsored phase 3 study in the United States, Australia and Europe.
A Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of 700 ?g Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) to Ranibizumab in Patients With Diabetic Macular Edema A Prospective, Multi-Centre, Post Market, Single Arm Observational Study to Collect Clinical Outcome Data on the Use of Permacol Collagen Paste in the Treatment of Anorectal Fistulas.
A Randomised, Double Blind, Placebo Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients with Heterozygous Familial Hypercholesterolemia Not Adequately Controlled with Their Lipid Modifying Therapy.
An Open-Label Study for Previously Treated Ataluren (PTC124?) Patients with Nonsense Mutation Dystrophinopathy A phase III, multi-centre, open label, uncontrolled trial to investigate the efficacy and safety of MK-8962 (corifollitropin alfa) in combination with human Chorionic Gonadotropin (hCG) in inducing increased testicular volume and spermatogenesis in adult A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or GSK1605786A in Subjects with Moderately-to-Severely Active Crohn?s DiseaseA Post market clinical study evaluating the safety, device performance and possible emergent risks of Celotres in the improvement of wound healing and the resulting scar consequences following suturing of a wound.
A Phase 3b open-label historically controlled study to assess the safety and efficacy of two of AA4500 in adult subjects with multiple Dupuytren's contractures with palpable cords.
A phase3, multicentre, randomized, double-blind, parallel assess the efficacy and safety of reparixin in pancreatic islet transplantationNon-interventional study on the A Global Comparative Observational Study in Rheumatoid Arthritis (RA) Patients who are treated with a TNF Inhibitor or Tocilizumab as the first Biologic Therapy Trial consisting of an 8-week double-blind placebo-controlled followed by a 16-week openA 6-month study of inhaled fluticasone propionate/salmeterol combination versus inhaled fluticasone propionate in the treatment of 6,200 paediatric subjects 4-11 years old with persistent asthma.
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Adjunctive Therapy to Reduce Steroid Use in Subjects with Severe Refractory Asthma Short course daily prednisolone therapy at the time of upper respiratory tract 12/NW/0766 infection in children Available with relapsing steroid sensitive nephrotic syndrome; the PREDNOS 2 study Outcome after StrokeXANTUS-Xarelto? on Prevention of Stroke and Non-Central Nervous System 12/WS/0216 Systemic Embolism in Available Patients with Non-Valvular Atrial Fibrillation: A Non-Interventional StudyWOLLF - Wound The administration of Parathyroid hormone affects functional recovery from pertrochanteric fractured neck of femur: A prospective randomised comparative pilot study with blinded objective functional outcome assessment.
Management of Distal Arm Pain.
Fractures and Bisphosphonates: A double-blind, randomised controlled alendronic acid on healing and clinical outcomes of wrist fracturesPilot Study of BB3 to Improve Renal Function in Patients with Signs and Symptoms of Significant Renal Injury after Kidney Transplantation from Donors after Cardiac Death A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the (OAB) Treated with Antimuscarinics and Dissatisfied due to Lack of Efficacy.
An Observational, Multi-Center, Multi-National, Long Term Follow-Up Study of Atypical Hemolytic Uremic Syndrome (aHUS) Patients Treated with Eculizumab in a Prior Clinical Study A Prospective Multicenter Randomized Study Comparing Photoselective Prostate for the Treatment of Benign Prostatic Hyperplasia (Goliath) A Phase III, multicentre, randomized, double-blind clinical study, PGL4001 for the long-term management of symptomatic uterine fibroids TMC435HPC3001: A Phase III, randomized, double-blind trial to evaluate the efficacy, safety and tolerability of TMC435 vs. combination with PegIFNa-2a and ribavirin, in chronic hepatitis C genotype-1 infected subjects who were null orA Phase 3, A phase II/III, multi centre, partially randomised, open label trial investigating safety demand and prophalactic treatment with BAY 94-9027 in Severe Hemophilia A A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open Label Study to Assess the Safety of Assisted- and Self- Administered Subcutaneous Trastuzumab as Adjuvant Therapy in Patients with Operable Her2-Positive Early Breast CaA Phase III, randomized, double-blinded study comparing the combination of the BRAF inhibitor, dabrafenib and the trametinib to dabrafenib and placebo as first-line therapy in subjects with unresectable (Stage IIIC) or metastatic (Stage IV) A Multicenter, Single arm, Open Label Clinical Trial to Evaluate the Safety and Health-Related Colorectal Cancer (mCRC) Previously Treated with an Oxaliplatin-Containing Regimen An Observational Study Of Avastin? (Bevacizumab) In Combination With Treatment Of First Line Metastatic Colorectal Adenocarcinoma.
A Multicentre, Open-label, Single-arm Study of Pertuzumab in Combination with Trastuzumab and a Taxane in First Line Treatment with HER2-Positive Advanced (Metastatice or Locally Advanced Recurrent) Breast Cancer An International, Randomised, Double-Blind, Two-Arm Study to Evaluate the Safety and Efficacy of Vandetanib 150 and Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma with Progressive or Symptomatic Disease A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma A multicentre, open label, randomized Phase II trial of the MEK inhibitor Pimasertib or Dacarbazine in previously untreated subjects with N-Ras mutated locally advanced or metastatic malignant cutaneous melanomaA Phase 3 Randomized, Open-Label Study of Ponatinib versus Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase A Phase 3, Randomized, DoubleBlind, PlaceboControlled Study Evaluating the Efficacy and Safety of GS 1101 (CAL 101) in Combination with Rituximab for Previously Treated Chronic Lymphocytic Leukemia A 24-month, phase IIIb, open-label, single arm, multicenter study assessing the efficacy and safety of an individualized, driven PRN dosing regimen with 0.5-mg ranibizumab intravitreal injections applied as monotherapy in patients w A 24-month, phase IIIb, randomi active-controlled, three-arm, multicenter study assessing the efficacy and safety of an criteria driven PRN dosing regimen with 0.5 mg ranibizumab intravitreal injection applied as monotherapy or wi Progressive Multiple SclerosisA descriptive study of Relapsing-Remitting Multiple Sclerosis (RRMS) treated with first disease modifying therapies clinical practice: patterns of clinical decision making and the patient experience of relapseEvaluation of Xience Prime or Xience V versus Coronary Artyert Bypass Effectiveness of Left Main Revascularization Leaders Free: a prospective randomized comparison of the biofreedomtm coated stent versus the gazelle? bare metal stent in patients at high risk for bleeding A randomized, double-blind, parallel-group, 26-week study comparing the efficacy and safety of indacaterol (Onbrez? o.d.) with salmeterol/fluticasone propionate (Seretide? Accuhaler? 50 ?g/500 ?g b.i.d.) in patients with moderate chroni A Phase 3, Randomized, Single-blind, Controlled Trial CDEB025A2313: A multi-centre 3-year follow-up study to assess the viral activity in patients sustained virologic response in Novartis-sponsored Alisporivir-studies for chronic Hepatitis C patientsCDEB025A2312: Follow up study for DEB025 SVR24 Hepatitis C patientsA Multicentre, Double-Blind, Placebo-Controlled, Adaptive Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough. Sponsor code: BC1036-001, (HCR: 1780/BCO).
A 12-week, multi-centre, randomised, double-blind, parallel-group study to assess the efficacy, safety and tolerability of the NVA237 + indacaterol once daily vs. indacaterol once daily in patients with moderate to severe COPD.
A randomised, double-blind, double-dummy, placebo and active-controlled, three-way crossover study to 12/NW/0454 evaluate the safety, Available tolerability and efficacy of 28-day inhaled CHF 6001 DPI (1200 ?g daily) in subjects with COPD A randomised double-blind, parallel group, dose-ranging study to evaluate the efficacy and safety of three different total daily propionate inhaled from a new dry powder inhaler in subjects with severe persistent asthma requiring oral A phase III randomised, partially double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin for chronic genotype 1 hepatitis C infection in an extended population of treatment na?ve patients that includes those i A Phase III, International, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Event Driven Study to Compare the Time to First Clinical Worsening in Subjects with Pulmonary Arterial Hypertension Receiving UT-15C in Combination with PDE5-1 or ERA Open-Label Extension Study of UT-15C in Subjects with Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310 A randomised, double-blind, parallel group, multicentre phase IIIb study to compare ticagrelor with clopidogrel treatment cardiovascular death, myocardial infarction and ischaemic stroke in patients with established Peripheral Artery Diseas Investigation of Flow Altered, Short Transcervical Carotid Artery Stenting in Patients with Significant Carotid Artery Disease with Filter A 24-month, phase IIIb, open-label, single arm, multicenter study assessing the efficacy and safety of an individualized, driven PRN dosing regimen with 0.5-mg ranibizumab intravitreal injections applied as monotherapy in patients w A 24-month, phase IIIb, randomi active-controlled, three-arm, multicenter study assessing the efficacy and safety of an criteria driven PRN dosing regimen with 0.5 mg ranibizumab intravitreal injection applied as monotherapy or wi A Multicenter, Double-masked, Randomized Study to Compare the Safety and Efficacy of an Investigational Eye Drop Formulation with OPTIVE? Unit-Dose for 3 Months in Subjects with Dry Eye Disease

Source: http://www.newcastlejro.org.uk/wp-content/uploads/2013/08/Performance-in-Delivering-Report-Q4-12-13.pdf