Clinical Trials, Phase III as Topic Concept

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• SQ sublingual immunotherapy tablets for children with allergic rhinitis: A review of phase three trials  Journal Articles
• A Guide to Implementation Science for Phase 3 Clinical Trialists: Designing Trials for Evidence Uptake.  Journal Articles
• A critical appraisal of bleeding events reported in venous thromboembolism prevention trials of patients undergoing hip and knee arthroplasty  Journal Articles
• A multi-centre, participant-blinded, randomized, 3-year study to compare the efficacy of Virtual Surgical Planning (VSP) to Freehand Surgery (FHS) on bony union and quality of life outcomes for mandibular reconstruction with fibular and scapular free flaps: study protocol for a randomized phase II/III trial.  Journal Articles
• A randomised placebo-controlled trial of the effectiveness of early metformin in addition to usual care in the reduction of gestational diabetes mellitus effects (EMERGE): study protocol  Journal Articles
• A systematic review of contemporary trials of anticoagulants in orthopaedic thromboprophylaxis: suggestions for a radical reappraisal  Journal Articles
• A tutorial on pilot studies: the what, why and how  Journal Articles
• Added value of health-related quality of life measurement in cancer clinical trials: the experience of the NCIC CTG  Journal Articles
• Alendronate for osteoporosis. Safe and efficacious nonhormonal therapy.  Journal Articles
• Andexanet alfa for the treatment of hemorrhage  Journal Articles
• Antacid therapy and disease outcomes in idiopathic pulmonary fibrosis: a pooled analysis  Journal Articles
• Association Between RECIST Changes and Survival in Patients with Metastatic Castration-resistant Prostate Cancer Receiving Docetaxel  Journal Articles
• Association of body weight with efficacy and safety outcomes in phase III randomized controlled trials of direct oral anticoagulants: a systematic review and meta‐analysis  Journal Articles
• Assumptions of Expected Benefits in Randomized Phase III Trials Evaluating Systemic Treatments for Cancer  Journal Articles
• Bivariate evaluation of thromboembolism and bleeding in clinical trials of anticoagulants in patients with atrial fibrillation  Journal Articles
• Bleeding Complications and Management on anticoagulant therapy  Journal Articles
• Bleeding with Direct Oral Anticoagulants vs Warfarin: Clinical Experience  Journal Articles
• Bleeding with direct oral anticoagulants vs warfarin: clinical experience  Journal Articles
• Breaking the biomarker code: PD-L1 expression and checkpoint inhibition in advanced NSCLC  Journal Articles
• Burden of Proof for Tolvaptan in ADPKD  Journal Articles
• Cardiovascular Outcomes Trials in Type 2 Diabetes: Where Do We Go From Here? Reflections From aDiabetes CareEditors’ Expert Forum  Journal Articles
• Central Nervous System–Specific Outcomes of Phase 3 Randomized Clinical Trials in Patients With Advanced Breast Cancer, Lung Cancer, and Melanoma  Journal Articles
• Chemotherapy for Relapsed Small Cell Lung Cancer: A Systematic Review and Practice Guideline  Journal Articles
• Chemotherapy for advanced non-small-cell lung cancer: how much benefit is enough?  Journal Articles
• Clinical Experience With the New Oral Anticoagulants for Treatment of Venous Thromboembolism  Journal Articles
• Clinical data gap between phase III clinical trials (pre-marketing) and phase IV (post-marketing) studies: evaluation of etanercept in rheumatoid arthritis.  Journal Articles
• Clinical trial design in metastatic breast cancer: a commentary.  Journal Articles
• Clinical trials of new anticoagulants.  Journal Articles
• Common Sense Oncology principles for the design, analysis, and reporting of phase 3 randomised clinical trials.  Journal Articles
• Comparing mortality in patients with atrial fibrillation who are receiving a direct‐acting oral anticoagulant or warfarin: a meta‐analysis of randomized trials  Journal Articles
• Comparison of Outcomes of Phase II Studies and Subsequent Randomized Control Studies Using Identical Chemotherapeutic Regimens  Conferences
• Complementary Medicine Use Amongst Patients with Metastatic Cancer Enrolled in Phase III Clinical Trials  Journal Articles
• Consistency of Phase III Clinical Trial Abstracts Presented at an Annual Meeting of the American Society of Clinical Oncology Compared With Their Subsequent Full-Text Publications  Conferences
• Correlation of single arm versus randomised phase 2 oncology trial characteristics with phase 3 outcome  Journal Articles
• Cost-effectiveness of becaplermin for nonhealing neuropathic diabetic foot ulcers.  Journal Articles
• Dabigatran Etexilate: Future Directions in Anticoagulant Treatment  Journal Articles
• Dabigatran etexilate for prevention of venous thromboembolism  Journal Articles
• Dabigatran versus Warfarin for Acute Venous Thromboembolism in Elderly or Impaired Renal Function Patients: Pooled Analysis of RE-COVER and RE-COVER II  Journal Articles
• Dabigatran versus Warfarin for Acute Venous Thromboembolism in Elderly or Impaired Renal Function Patients: Pooled Analysis of RE-COVER and RE-COVER II.  Journal Articles
• Definition of clinically relevant non‐major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non‐surgical patients: communication from the SSC of the ISTH  Journal Articles
• Demographic, clinical, and patient-reported outcome data from 2 global, phase 3 trials of chronic cough  Journal Articles
• Design and rationale of the CLEAR SYNERGY (OASIS 9) trial: A 2x2 factorial randomized controlled trial of colchicine versus placebo and spironolactone vs placebo in patients with myocardial infarction  Journal Articles
• Design of the INPULSIS™ trials: Two phase 3 trials of nintedanib in patients with idiopathic pulmonary fibrosis  Journal Articles
• Direct oral anticoagulants compared with vitamin K antagonists for acute venous thromboembolism: evidence from phase 3 trials  Journal Articles
• Direct oral anticoagulants compared with vitamin K antagonists for acute venous thromboembolism: evidence from phase 3 trials.  Journal Articles
• Direct-acting antiviral therapies for hepatitis C genotype 1 infection: a multiple treatment comparison meta-analysis  Journal Articles
• Do alternative methods of measuring tumor size, including consideration of multicentric/multifocal disease, enhance prognostic information beyond TNM staging in women with early stage breast cancer: an analysis of the NCIC CTG MA.5 and MA.12 clinical trials  Journal Articles
• Economic analysis of a randomized phase III trial of gemcitabine plus vinorelbine compared with cisplatin plus vinorelbine or cisplatin plus gemcitabine for advanced non-small-cell lung cancer (Italian GEMVIN3/NCIC CTG BR14 trial)  Journal Articles
• Effect of Radiotherapy on Painful Bone Metastases  Journal Articles
• Effect of extended‐duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis  Journal Articles
• Efficacy and safety of rolapitant for prevention of chemotherapy-induced nausea and vomiting over multiple cycles of moderately or highly emetogenic chemotherapy  Journal Articles
• Evaluation of metformin in early breast cancer: a modification of the traditional paradigm for clinical testing of anti-cancer agents  Journal Articles
• Exclusion of Patients With Brain Metastases in Published Phase III Clinical Trials for Advanced Breast Cancer  Journal Articles
• External applicability of the COMPASS trial: an analysis of the reduction of atherothrombosis for continued health (REACH) registry  Journal Articles
• Factor Xa inhibition in the prevention of venous thromboembolism and treatment of patients with venous thromboembolism  Journal Articles
• Factors that influence the recruitment of patients to Phase III studies in oncology  Journal Articles
• Fondaparinux  Journal Articles
• Fondaparinux, the first selective factor Xa inhibitor  Journal Articles
• Generalisability of pharmaceutical randomised controlled trial eligibility criteria for progressive pulmonary fibrosis.  Journal Articles
• Genome-Wide Associations and Functional Genomic Studies of Musculoskeletal Adverse Events in Women Receiving Aromatase Inhibitors  Journal Articles
• Genome-wide host methylation profiling of anal and cervical carcinoma  Journal Articles
• Go, no-go decision making for phase 3 clinical trials: ACT IV revisited – Authors' reply  Journal Articles
• Hypofractionated radiotherapy for prostate cancer (HYDRA): an individual patient data meta-analysis of randomised trials in the MARCAP consortium.  Journal Articles
• Identification of a Novel Hepatitis C Virus Genotype From Punjab, India: Expanding Classification of Hepatitis C Virus Into 8 Genotypes  Journal Articles
• Identification of prognostic factors in childhood T‐cell acute lymphoblastic leukemia: Results from DFCI ALL Consortium Protocols 05‐001 and 11‐001  Journal Articles
• Impact of CYP19A1 and ESR1 variants on early-onset side effects during combined endocrine therapy in the TEXT trial  Journal Articles
• Impact of Frailty on the Benefits of Dual Pathway Inhibition for the Secondary Prevention of Cardiovascular Events in the COMPASS Randomised Trial  Journal Articles
• Impact of single-agent daily prednisone on outcomes in men with metastatic castration-resistant prostate cancer  Journal Articles
• Implementation of Timeline Reforms Speeds Initiation of National Cancer Institute-Sponsored Trials  Journal Articles
• Implications of variability in definition and reporting of major bleeding in randomized trials of oral P2Y12 inhibitors for acute coronary syndromes  Journal Articles
• Incidence of delayed venous thromboembolic events in patients undergoing abdominal and pelvic surgery for cancer: a systematic review and meta‐analysis  Journal Articles
• Incorporating edoxaban into the choice of anticoagulants for atrial fibrillation  Journal Articles
• Influence of an independent review committee on assessment of response rate and progression-free survival in phase III clinical trials  Journal Articles
• Influence of model-predicted rivaroxaban exposure and patient characteristics on efficacy and safety outcomes in patients with acute coronary syndrome  Journal Articles
• Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma  Journal Articles
• Intraperitoneal chemotherapy in the first‐line treatment of women with stage III epithelial ovarian cancer  Journal Articles
• Lessening Organ dysfunction with VITamin C (LOVIT): protocol for a randomized controlled trial  Journal Articles
• Magnitude of benefit of the addition of bevacizumab to first-line chemotherapy for metastatic colorectal cancer: meta-analysis of randomized clinical trials  Conferences
• Major Bleeding, Mortality, and Efficacy of Fondaparinux in Venous Thromboembolism Prevention Trials  Journal Articles
• Management of Patients with Acute Coronary Syndromes  Journal Articles
• Mepitel Film and Mepilex Lite for the prophylaxis and treatment of skin toxicities from breast radiation  Journal Articles
• Milvexian vs apixaban for stroke prevention in atrial fibrillation: The LIBREXIA atrial fibrillation trial rationale and design.  Journal Articles
• National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. Design of Clinical Trials Working Group Report  Journal Articles
• New Anticoagulant Drugs  Journal Articles
• New Anticoagulants for Atrial Fibrillation  Journal Articles
• New Anticoagulants for Treatment of Venous Thromboembolism  Journal Articles
• New Antithrombotic Drugs  Journal Articles
• New Antithrombotic Drugs  Journal Articles
• New oral anticoagulant agents – general features and outcomes in subsets of patients  Journal Articles
• Optimizing Survival and the Changing Landscape of Targeted Therapy for Intermediate and Advanced Hepatocellular Carcinoma: A Systematic Review  Journal Articles
• Optimizing the safety of treatment for venous thromboembolism in the era of the direct oral anticoagulants  Journal Articles
• Oral factor xia inhibitor milvexian after a recent acute coronary syndrome: Rationale and design of the phase 3 (Librexia ACS).  Journal Articles
• Overstated Conclusions of a Pooled Analysis of Bevacizumab in Colon Cancer  Journal Articles
• Overview of the New Oral Anticoagulants  Journal Articles
• Overview of the clinical results of pentasaccharide in major orthopedic surgery.  Journal Articles
• PSMA PET/CT guided intensification of therapy in patients at risk of advanced prostate cancer (PATRON): a pragmatic phase III randomized controlled trial  Journal Articles
• Panorama From the Oncolytic Virotherapy Summit  Journal Articles
• Pentasaccharide Org31540/SR90107A clinical trials update: Lessons for practice  Journal Articles
• Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial  Journal Articles
• Phase 3 Trials of Stereotactic Radiosurgery With or Without Whole-Brain Radiation Therapy for 1 to 4 Brain Metastases: Individual Patient Data Meta-Analysis  Journal Articles
• Placebo Rates in Crohn's Disease Randomized Clinical Trials: An Individual Patient Data Meta-Analysis.  Journal Articles
• Pointed Progress in Second-Line Advanced Non–Small-Cell Lung Cancer: The Rapidly Evolving Field of Checkpoint Inhibition  Journal Articles
• Posttreatment prognostic nomogram for patients with metastatic urothelial cancer completing first-line cisplatin-based chemotherapy  Journal Articles
• Potential net clinical benefit of population-wide implementation of apixaban and dabigatran among European patients with atrial fibrillation  Journal Articles
• Practical Understanding of Mean Percent Psoriasis Area and Severity Index Reduction for Biologics  Journal Articles
• Practical help for specifying the target difference in sample size calculations for RCTs: the DELTA2 five-stage study, including a workshop  Journal Articles
• Practical management of bleeding in patients receiving non-vitamin K antagonist oral anticoagulants  Journal Articles
• Pragmatic monitoring of emerging efficacy data in randomized controlled trials.  Journal Articles
• Profile of betrixaban and its potential in the prevention and treatment of venous thromboembolism  Journal Articles
• Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial  Journal Articles
• Protocol for a phase III RCT and economic analysis of two exercise delivery methods in men with PC on ADT  Journal Articles
• Proton Pump Inhibitors and Survival Outcomes in Patients With Metastatic Renal Cell Carcinoma  Journal Articles
• Proton pump inhibitors: the beginning of the end or the end of the beginning?  Journal Articles
• Quantitative evaluation of single-arm versus randomized phase II cancer clinical trials  Journal Articles
• Quizartinib for the treatment of acute myeloid leukemia  Journal Articles
• Randomized, controlled clinical trials in sepsis: Has methodological quality improved over time?  Journal Articles
• Rapid normalization of vitamin D deficiency in PICU (VITdALIZE-KIDS): study protocol for a phase III, multicenter randomized controlled trial.  Journal Articles
• Rationale and Design of the Statin Use in Intracerebral Hemorrhage Patients (SATURN) Trial  Journal Articles
• Rationale and design of the ATTRACT Study: A multicenter randomized trial to evaluate pharmacomechanical catheter-directed thrombolysis for the prevention of postthrombotic syndrome in patients with proximal deep vein thrombosis  Journal Articles
• Rationale, design and baseline characteristics of the effect of ticagrelor on health outcomes in diabetes mellitus patients Intervention study  Journal Articles
• Real-world vs. randomized trial outcomes in similar populations of rivaroxaban-treated patients with non-valvular atrial fibrillation in ROCKET AF and XANTUS  Journal Articles
• Refining risk classification in childhood B acute lymphoblastic leukemia: results of DFCI ALL Consortium Protocol 05-001  Journal Articles
• Response of Primary Renal Cell Carcinoma to Systemic Therapy  Journal Articles
• Reversal of Direct Oral Anticoagulants: Current Status and Future Directions  Journal Articles
• Riociguat: A Novel Therapeutic Option for Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension  Journal Articles
• Rivaroxaban for the prevention and treatment of venous thromboembolism  Journal Articles
• Rivaroxaban for the prevention of venous thromboembolism after hip or knee arthroplasty  Journal Articles
• Rivaroxaban versus enoxaparin after total knee arthroplasty  Journal Articles
• Rolapitant for the Treatment of Chemotherapy-Induced Nausea and Vomiting: A Review of the Clinical Evidence  Journal Articles
• Role of Bone-Modifying Agents in Metastatic Breast Cancer: An American Society of Clinical Oncology–Cancer Care Ontario Focused Guideline Update  Journal Articles
• Role of new anticoagulants for the prevention of venous thromboembolism after major orthopaedic surgery and in hospitalised acutely ill medical patients  Journal Articles
• Safety Outcomes in Meta-analyses of Phase 2 vs Phase 3 Randomized Trials  Journal Articles
• Seasonal influenza vaccines: Variability of immune responses to B lineage viruses.  Journal Articles
• Second-line or Subsequent Systemic Therapy for Recurrent or Progressive Non-Small Cell Lung Cancer: A Systematic Review and Practice Guideline  Journal Articles
• Second‐line treatment of hepatocellular carcinoma after sorafenib: Characterizing treatments used over the past 10 years and real‐world eligibility for cabozantinib, regorafenib, and ramucirumab  Journal Articles
• Seeking informed consent to cancer clinical trials:  Journal Articles
• Stereotactic ablative radiotherapy for the comprehensive treatment of 1–3 Oligometastatic tumors (SABR-COMET-3): study protocol for a randomized phase III trial  Journal Articles
• Systemic adjuvant therapy for adult patients at high risk for recurrent melanoma: A systematic review  Journal Articles
• Systemic therapy in the curative treatment of head and neck squamous cell cancer: A systematic review  Journal Articles
• TLE3 is not a predictive biomarker for taxane sensitivity in the NCIC CTG MA.21 clinical trial  Journal Articles
• Targeting Angiogenesis With Integrative Cancer Therapies  Journal Articles
• Taxanes as first-line therapy for advanced non-small cell lung cancer: A systematic review and practice guideline  Journal Articles
• The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Moderna COVID-19 Vaccine — United States, December 2020  Journal Articles
• The Diaphragmatic Initiated Ventilatory Assist (DIVA) trial: study protocol for a randomized controlled trial comparing rates of extubation failure in extremely premature infants undergoing extubation to non-invasive neurally adjusted ventilatory assist versus non-synchronized nasal intermittent positive pressure ventilation  Journal Articles
• The Importance of Reporting Patient Recruitment Details in Phase III Trials  Journal Articles
• The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given ‘as needed’ in mild asthma: study protocols for two randomised controlled trials  Journal Articles
• The association between radiographic response and overall survival in men with metastatic castration‐resistant prostate cancer receiving chemotherapy  Journal Articles
• The effects of rivaroxaban on the complications of surgery after total hip or knee replacement  Journal Articles
• The role of early-phase trials and real-world evidence in drug development  Journal Articles
• The unclear zone in phase II clinical trials  Journal Articles
• Therapy for relapsed multiple myeloma  Journal Articles
• Thromboembolic events, recurrent bleeding and mortality after resuming anticoagulant following gastrointestinal bleeding  Journal Articles
• Thrombopoietin Receptor Agonists in Primary Immune Thrombocytopenia  Journal Articles
• Treatment Success in Cancer: Industry Compared to Publicly Sponsored Randomized Controlled Trials  Journal Articles
• Treatment of idiopathic pulmonary fibrosis: an update on emerging drugs in phase II & III clinical trials  Journal Articles
• Treatment-Dose LMWH versus Prophylactic/Intermediate Dose Heparins in High-Risk COVID-19 Inpatients: Rationale and Design of the HEP-COVID Trial  Journal Articles
• Trends in the application of dynamic allocation methods in multi-arm cancer clinical trials  Journal Articles
• Use of Adjuvant Bisphosphonates and Other Bone-Modifying Agents in Breast Cancer: ASCO-OH (CCO) Guideline Update  Journal Articles
• Use of Modified Multiplier of the Simple Endoscopic Score for Crohn's Disease Endoscopic Improvement Thresholds Enhances Effect Size Differentiation Between Adalimumab Versus Placebo: A Post Hoc Analysis of the EXTEND Trial.  Journal Articles
• Users’ guide to the surgical literature: how to assess an article using surrogate end points  Journal Articles
• Validation of the Association of RECIST Changes With Survival in Men With Metastatic Castration-Resistant Prostate Cancer Treated on SWOG Study S0421  Journal Articles
• Venous thromboembolism prophylaxis: role of factor xa inhibition by fondaparinux.  Journal Articles
• What's New in Stroke? Phase III Randomized Clinical Trials of 2012–2014  Journal Articles
• When is it safe to stop for safety?  Journal Articles
• Workshop on Partial Breast Irradiation: State of the Art and the Science, Bethesda, MD, December 8-10, 2002  Journal Articles