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View article: Dinutuximab Beta Added to Temozolomide-Based Chemotherapy for Children With Relapsed and Refractory Neuroblastoma: Results of the ITCC-SIOPEN BEACON Immuno Phase II Trial
Dinutuximab Beta Added to Temozolomide-Based Chemotherapy for Children With Relapsed and Refractory Neuroblastoma: Results of the ITCC-SIOPEN BEACON Immuno Phase II Trial Open
PURPOSE Outcomes for children with relapsed and refractory high-risk neuroblastoma (RR-HR-NBL) remain dismal. Here, we investigate addition of the anti-GD2 monoclonal antibody, dinutuximab beta (dB), to temozolomide (T)-based chemotherapy.…
View article: Multicentre adaptive randomised trial of GvHD prophylaxis following unrelated donor stem cell transplantation comparing Thymoglobulin versus calcineurin inhibitor-based or sirolimus-based post-transplant cyclophosphamide (Methods of T cell Depletion, MoTD trial)
Multicentre adaptive randomised trial of GvHD prophylaxis following unrelated donor stem cell transplantation comparing Thymoglobulin versus calcineurin inhibitor-based or sirolimus-based post-transplant cyclophosphamide (Methods of T cell Depletion, MoTD trial) Open
Introduction Graft-versus-host disease (GvHD) remains a major complication of allogeneic stem cell transplantation (allo-SCT), affecting 30–70% of patients (representing 800 new patients per year in the UK). The risk is higher in patients …
View article: Biomarker-Guided Antibiotic Duration for Hospitalized Patients With Suspected Sepsis
Biomarker-Guided Antibiotic Duration for Hospitalized Patients With Suspected Sepsis Open
Importance For hospitalized critically ill adults with suspected sepsis, procalcitonin (PCT) and C-reactive protein (CRP) monitoring protocols can guide the duration of antibiotic therapy, but the evidence of the effect and safety of these…
View article: Correction: Bailey et al. Clinical Trials in High-Risk Medulloblastoma: Evolution of the SIOP-Europe HR-MB Trial. Cancers 2022, 14, 374
Correction: Bailey et al. Clinical Trials in High-Risk Medulloblastoma: Evolution of the SIOP-Europe HR-MB Trial. Cancers 2022, 14, 374 Open
In the original publication [...]
View article: Bevacizumab, Irinotecan, or Topotecan Added to Temozolomide for Children With Relapsed and Refractory Neuroblastoma: Results of the ITCC-SIOPEN BEACON-Neuroblastoma Trial
Bevacizumab, Irinotecan, or Topotecan Added to Temozolomide for Children With Relapsed and Refractory Neuroblastoma: Results of the ITCC-SIOPEN BEACON-Neuroblastoma Trial Open
PURPOSE Outcomes for children with relapsed and refractory high-risk neuroblastoma (RR-HRNB) remain dismal. The BEACON Neuroblastoma trial (EudraCT 2012-000072-42) evaluated three backbone chemotherapy regimens and the addition of the anti…
View article: Landiolol and Organ Failure in Patients With Septic Shock
Landiolol and Organ Failure in Patients With Septic Shock Open
Importance Patients with septic shock undergo adrenergic stress, which affects cardiac, immune, inflammatory, and metabolic pathways. β-Blockade may attenuate the adverse effects of catecholamine exposure and has been associated with reduc…
View article: Subacromial spacers for adults with symptomatic, irreparable rotator cuff tears: the START:REACTS novel group sequential adaptive RCT
Subacromial spacers for adults with symptomatic, irreparable rotator cuff tears: the START:REACTS novel group sequential adaptive RCT Open
Background A balloon spacer is a relatively simple addition to an arthroscopic debridement procedure for irreparable rotator cuff tears. Objective To evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individu…
View article: biomArker-guided Duration of Antibiotic treatment in hospitalised Patients with suspecTed Sepsis (ADAPT-Sepsis): A protocol for a multicentre randomised controlled trial
biomArker-guided Duration of Antibiotic treatment in hospitalised Patients with suspecTed Sepsis (ADAPT-Sepsis): A protocol for a multicentre randomised controlled trial Open
Aim: To describe the protocol for a multi-centre randomised controlled trial to determine whether treatment protocols monitoring daily CRP (C-reactive protein) or PCT (procalcitonin) safely allow a reduction in duration of antibiotic thera…
View article: Induction of labour for predicted macrosomia: study protocol for the ‘Big Baby’ randomised controlled trial
Induction of labour for predicted macrosomia: study protocol for the ‘Big Baby’ randomised controlled trial Open
Introduction Large-for-gestational age (LGA) fetuses have an increased risk of shoulder dystocia. This can lead to adverse neonatal outcomes and death. Early induction of labour in women with a fetus suspected to be macrosomic may mitigate…
View article: Clinical Trials in High-Risk Medulloblastoma: Evolution of the SIOP-Europe HR-MB Trial
Clinical Trials in High-Risk Medulloblastoma: Evolution of the SIOP-Europe HR-MB Trial Open
Medulloblastoma patients receive adapted therapies stratified according to their risk-profile. Favourable, standard, and high disease-risk groups are each defined by the status of clinical and pathological risk factors, alongside an evolvi…
View article: One Eye or Two: Statistical Considerations in Ophthalmology With a Focus on Interventional Clinical Trials
One Eye or Two: Statistical Considerations in Ophthalmology With a Focus on Interventional Clinical Trials Open
Research in ophthalmology is unusual in comparison with other many medical specialties by having 2 targets where frequent and accessible data can be collected and analyzed. The major factor is that 2 eyes are not independent as they belong…
View article: CATALYST trial protocol: a multicentre, open-label, phase II, multiarm trial for an early and accelerated evaluation of the potential treatments for COVID-19 in hospitalised adults
CATALYST trial protocol: a multicentre, open-label, phase II, multiarm trial for an early and accelerated evaluation of the potential treatments for COVID-19 in hospitalised adults Open
Introduction Severe SARS-CoV-2 infection is associated with a dysregulated immune response. Inflammatory monocytes and macrophages are crucial, promoting injurious, proinflammatory sequelae. Immunomodulation is, therefore, an attractive th…
View article: Namilumab or infliximab compared to standard of care in hospitalised patients with COVID-19 (CATALYST): a phase 2 randomised adaptive trial
Namilumab or infliximab compared to standard of care in hospitalised patients with COVID-19 (CATALYST): a phase 2 randomised adaptive trial Open
Summary Background Dysregulated inflammation is associated with poor outcomes in Coronavirus disease 2019 (COVID-19). We assessed the efficacy of namilumab, a granulocyte-macrophage colony-stimulating factor inhibitor and infliximab, a tum…
View article: Adrenaline to improve survival in out-of-hospital cardiac arrest: the PARAMEDIC2 RCT
Adrenaline to improve survival in out-of-hospital cardiac arrest: the PARAMEDIC2 RCT Open
Background Adrenaline has been used as a treatment for cardiac arrest for many years, despite uncertainty about its effects on long-term outcomes and concerns that it may cause worse neurological outcomes. Objectives The objectives were to…
View article: CATALYST trial protocol: A multicentre, open-label, phase II, multi-arm trial for an early and accelerated evaluation of the potential treatments for COVID-19 in hospitalised adults
CATALYST trial protocol: A multicentre, open-label, phase II, multi-arm trial for an early and accelerated evaluation of the potential treatments for COVID-19 in hospitalised adults Open
Introduction Severe SARS-CoV-2 infection is associated with a dysregulated immune response. Inflammatory monocytes and macrophages are crucial, promoting injurious, pro-inflammatory sequelae. Immunomodulation is, therefore, an attractive t…
View article: Study into the reversal of septic shock with landiolol (beta blockade): STRESS-L Study protocol for a randomised trial
Study into the reversal of septic shock with landiolol (beta blockade): STRESS-L Study protocol for a randomised trial Open
Introduction In 2013, a single-centre study reported the safe use of esmolol in patients with septic shock and tachycardia who required vasopressor therapy for more than 24 hours. Although not powered to detect a change in mortality, marke…
View article: Cost-effectiveness of adrenaline for out-of-hospital cardiac arrest
Cost-effectiveness of adrenaline for out-of-hospital cardiac arrest Open
Background The ‘Prehospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug Administration In Cardiac Arrest’ (PARAMEDIC2) trial showed that adrenaline improves overall survival, but not neurological outcomes. We …
View article: Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS)
Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) Open
Introduction Shoulder pain due to irreparable rotator cuff tears can cause substantial disability, but treatment options are limited. A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it…
View article: Do we need to adjust for interim analyses in a Bayesian adaptive trial design?
Do we need to adjust for interim analyses in a Bayesian adaptive trial design? Open
Background:Bayesian adaptive methods are increasingly being used to design clinical trials and offer several advantages over traditional approaches. Decisions at analysis points are usually based on the posterior distribution of the treatm…
View article: To be decoded. (Mini-commentary on BJOG-19-1802.R1 & BJOG-19-1803.R1)
To be decoded. (Mini-commentary on BJOG-19-1802.R1 & BJOG-19-1803.R1) Open
Mini-commentary on BJOG-19-1802.R1 & BJOG-19-1803.R1Title: To be decodedZarko Alfirevic,Department of Women’s and Children’s Health, University of LiverpoolSimon GatesCancer Research UK Clinical Trials Unit, University of BirminghamEmail c…
View article: Statistical review of A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 by B. Cao et al
Statistical review of A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 by B. Cao et al Open
The following review has been prepared in collaboration with members of the MRC-NIHR Trials Methodology Research Partnership. The reviewers named above, and other, unnamed discussants of the paper, are all qualified statisticians with expe…
View article: Statistical review of Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial .
Statistical review of Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial . Open
The following review has been prepared by members of the MRC-NIHR Trials Methodology Research Partnership. The reviewers are all qualified statisticians with experience in clinical trials. Our objective is to provide a rapid review of publ…