Clinical Trials, Phase III as Topic - Statistics & numerical data
Research News and Information

Monday, November 23, 2009

Mixtures of prior distributions for predictive Bayesian sample size calculations in clinical trials.

28 Jul 2009 In this paper we propose a predictive Bayesian approach to sample size determination (SSD) and re-estimation in clinical trials, in the presence of multiple sources of prior information. The method we suggest is based on the use of mixtures of prior ... Read more...

Interpretation of benefit-risk of enoxaparin as comparator in the RECORD program: rivaroxaban oral tablets (10 milligrams) for use in prophylaxis in deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.

13 Jul 2009 The Regulation of Coagulation in Major Orthopedic surgery reducing the Risk of DVT and PE (RECORD) clinical program of rivaroxaban consists of 4 phase III clinical trials comparing rivaroxaban with enoxaparin for the prevention of venous ... Read more...

Safety profile of cefditoren. A pooled analysis of data from clinical trials in community-acquired respiratory tract infections.

30 May 2009 INTRODUCTION: A high number of individuals in the population are exposed to antibiotics for the treatment of respiratory tract infections. It is important to review the adverse events profile related to antibiotic exposure during the clinical ... Read more...

Latest indexed articles for 'Clinical Trials, Phase III as Topic - Statistics & numerical data'

These are the very latest articles for this heading:

• Mixtures of prior distributions for predictive Bayesian sample size calculations in clinical trials. 28 Jul 2009
• Interpretation of benefit-risk of enoxaparin as comparator in the RECORD program: rivaroxaban oral tablets (10 milligrams) for use in prophylaxis in deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery. 13 Jul 2009
• Safety profile of cefditoren. A pooled analysis of data from clinical trials in community-acquired respiratory tract infections. 30 May 2009
• The history and future of chemotherapy for melanoma. 30 May 2009
• [Micafungin in invasive candidiasis among oncohematological patients] 5 May 2009
• Confirmatory adaptive designs with Bayesian decision tools for a targeted therapy in oncology. 29 Apr 2009
• Optimal choice of the number of treatments to be included in a clinical trial. 28 Apr 2009
• Future developments in the management of malignant pleural mesothelioma. 30 Mar 2009
• Dose selection in seamless phase II/III clinical trials based on efficacy and safety. 13 Mar 2009
• Tolerability of first-line therapy for metastatic renal cell carcinoma. 24 Feb 2009
• Novel agents for renal cell carcinoma require novel selection paradigms to optimise first-line therapy. 13 Feb 2009
• The European contribution to "Sugarbaker's protocol" for the treatment of colorectal peritoneal carcinomatosis. 30 Jan 2009
• Access to medications and medical care after participation in HIV clinical trials: a systematic review of trial protocols and informed consent documents. 30 Dec 2008
• An effective approach for obtaining optimal sampling windows for population pharmacokinetic experiments. 30 Dec 2008
• A group-sequential design for clinical trials with treatment selection. 18 Dec 2008
• [Rivaroxaban (Xarelto): efficacy and safety] 29 Nov 2008
• Rates of inclusion of teenagers and young adults in England into National Cancer Research Network clinical trials: report from the National Cancer Research Institute (NCRI) Teenage and Young Adult Clinical Studies Development Group. 23 Nov 2008
• The use of clinical irrelevance criteria in covariate model building with application to dofetilide pharmacokinetic data. 13 Nov 2008
• [Efficacy of raltegravir: from healthy volunteers to phase III trials] 30 Oct 2008
• [Maraviroc efficacy in clinical studies on the development of the molecule] 29 Sep 2008

See a longer list of these articles.

Technical information about 'Clinical Trials, Phase III as Topic'

Definition: Comparative studies to verify the effectiveness of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques determined in phase II studies. During these trials, patients are monitored closely by physicians to identify any adverse reactions from long-term use. These studies are performed on groups of patients large enough to identify clinically significant responses and usually last about three years. This concept includes phase III studies conducted in both the U.S. and in other countries.

Descriptor UI: D017326

Alternative terms: Clinical Trials, Phase III as Topic; Clinical Trials, Phase 3 as Topic; Evaluation Studies, FDA Phase III as Topic; Drug Evaluation, FDA Phase III as Topic; Drug Evaluation, FDA Phase 3 as Topic; Evaluation Studies, FDA Phase 3 as Topic;

Allowable Qualifiers: adverse effects; classification; economics; history; instrumentation; methods; mortality; nursing; psychology; standards; trends; utilization; veterinary; statistics & numerical data; contraindications; ethics; legislation & jurisprudence;

Tree Number: E05.318.760.535.220; E05.337.250.220; N05.715.360.775.235.220; N06.850.520.450.535.220;

History Note: 2008(1993)

Technical Notes: for general design, methodology, economics, etc. of phase III clinical trials; a different heading CLINICAL TRIAL, PHASE III is used for reports of a specific phase III clinical trial