Experience collecting interim data on mortality: an example from the RALES studyOn changing a long-term clinical trial midstreamCelecoxib for the prevention of sporadic colorectal adenomasCelecoxib for the prevention of colorectal adenomatous polypsOn independent data monitoring committees in oncology clinical trials.The data monitoring experience in the MOXCON trial.The treatment of missing data in a large cardiovascular clinical outcomes study.Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board.Forming your phase III trial's data and safety monitoring board: a perspective on safety.Safety and reactogenicity of an MSP-1 malaria vaccine candidate: a randomized phase Ib dose-escalation trial in Kenyan children.Blood stage malaria vaccine eliciting high antigen-specific antibody concentrations confers no protection to young children in Western Kenya.Missing inaction: preventing missing outcome data in randomized clinical trials.Sample size calculations for randomized controlled trials.Bardoxolone methyl and kidney function in CKD with type 2 diabetes.Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis.Bardoxolone methyl in type 2 diabetes and stage 4 chronic kidney disease.Towards an RTS,S-based, multi-stage, multi-antigen vaccine against falciparum malaria: progress at the Walter Reed Army Institute of Research.Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors.Effect of celecoxib on cardiovascular events and blood pressure in two trials for the prevention of colorectal adenomas.Use of 5-alpha-reductase inhibitors for prostate cancer chemoprevention: American Society of Clinical Oncology/American Urological Association 2008 Clinical Practice GuidelineThe FDA's Final Rule on Expedited Safety Reporting: Statistical Considerations.Cardiovascular safety of drugs not intended for cardiovascular use: need for a new conceptual basis for assessment and approval.Monitoring the ACTIVE-W trial: some issues in monitoring a noninferiority trial.Use of 5alpha-reductase inhibitors for prostate cancer chemoprevention: American Society of Clinical Oncology/American Urological Association 2008 Clinical Practice Guideline.Outcome measures to assess efficacy of treatments for age-related macular degeneration.What information should a sponsor of a randomized trial receive during its conduct?Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop.First-line treatment of metastatic renal cell carcinoma after COMPARZ and PISCES.New approaches to hyperkalemia in patients with indications for renin angiotensin aldosterone inhibitors: Considerations for trial design and regulatory approval.Effect of Ularitide on Cardiovascular Mortality in Acute Heart Failure.Risk factors for heart failure in patients with type 2 diabetes mellitus and stage 4 chronic kidney disease treated with bardoxolone methyl.Alternatives to Hazard Ratios for Comparing the Efficacy or Safety of Therapies in Noninferiority Studies.Rationale and trial design of Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes: the Occurrence of Renal Events (BEACON).Study design and rationale for the clinical outcomes of the STABILITY Trial (STabilization of Atherosclerotic plaque By Initiation of darapLadIb TherapY) comparing darapladib versus placebo in patients with coronary heart disease.Bias and trials stopped early for benefit.Cost-effectiveness of gemfibrozil for coronary heart disease patients with low levels of high-density lipoprotein cholesterol: the Department of Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial.Assessing correlates of protection in vaccine trials.Times to event: why are they hard to visualize?Principal results of the Controlled Onset Verapamil Investigation of Cardiovascular End Points (CONVINCE) trial.Comment on paper by Crowe et al.
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