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The Boston area has long been home to innovation that leads to impactful new drugs. But manufacturing those drugs for clinical trials often involves international partners and supply chains. The vulne...
Pretreatment fasting plasma glucose and insulin modify dietary weight loss success: results from 3 randomized clinical trials
glucose insulin precision medicine personalized nutrition weight glycemic load glycemic index fiber prediabetes diabetes
2018/11/15
Background: Which diet is optimal for weight loss and maintenance remains controversial and implies that no diet fits all patients.
Statistical design considerations applicable to clinical trials of iodine supplementation in pregnant women who may be mildly iodine deficient
clinical trials iodine supplementation outcomes measurement pregnancy statistical methods
2018/12/14
No large, randomized, placebo-controlled trial of iodine supplementation in pregnant women in a region of mild or moderate iodine deficiency has been completed in which a primary outcome measure was a...
Ethical issues around phase I and phase III clinical trials in cancer
Cancer clinical trials clinical practice drug toxicity
2017/2/22
The results of phase III (randomised) cancer clinical trials underpin evidence-based clinical practice. A standard comparator (control arm) is crucial so that the real value of an intervention can be ...
Ethical issues around phase I and phase III clinical trials in cancer
cancer Ethical issues
2017/4/10
The results of phase III (randomised) cancer clinical trials underpin evidence-based clinical practice. A standard comparator (control arm) is crucial so that the real value of an intervention can be ...
Project Management of Randomized Clinical Trials:A Narrative Review
Clinical Trial Project Management Trial Manager Principal Investigator Study Protocol
2015/11/9
Context: A well-structured protocol for a clinical trial may be able to answer clinical questions, but it cannot be deemed enough to ensure success in the face of incompetent management of time as wel...
A Meta-Analysis of Randomized Clinical Trials Comparing Shorter (Less or Equal Than 6 Months) and Longer (More or Equal Than 12 Months) Dual Anti-Platelet Therapy Following Drug-Eluting Coronary Stents
Drug-Eluting Stents Dual Antiplatelet Therapy Meta-Analysis
2015/11/9
Context: The optimal duration of dual anti-platelet therapy (DAPT) after the implantation of drug-eluting coronary stents (DES) is still the subject of ongoing debate. This meta-analysis was performed...
Investigator initiated clinical trials are critical to the advancement of cancer care in Australia. Cooperative clinical trials
groups in Australia and New Zealand contribute greatly to independent ...
Co-operative Clinical Trials in Cancer – the need for increased capacity
increased capacity Cancer
2015/1/23
In the clinical management of cancer, the
practice of evidence based medicine is
almost totally reliant on the findings of
previous clinical trials
Botulinum Toxin Type A Therapy in Migraine:Preclinical and Clinical Trials
Botulinum Toxin Type A Nitroglycerin Randomized Controlled Trial
2015/10/9
Background: Botulinum toxin type A (BTX-A) has been reported to be effective for the therapy for migraine. The purpose of this study was to investigate the effect of BTX-A on the immunoreactive levels...
Is Certolizumab Pegol Safe and Effective in the Treatment of Patients with Moderate to Severe Crohn’s Disease? A Meta-analysis of Controlled Clinical Trials
Meta-analysis Certolizumab Pegol Crohn’s Disease
2015/10/8
Background: Tumor necrosis factor-α (TNF-α) antibodies are currently used in patients with moderate to severe Crohn’s disease (CD) who are unresponsive to conventional therapies. Certolizumab pegol (C...
Generalized Likelihood Ratio Statistics and Uncertainty Adjustments in Efficient Adaptive Design of Clinical Trials
Hoeffding’s information bound Internal pilot Kullback-Leibler information Modified Haybittle-Peto test Multiparameter exponential family Sample size re-estimation
2011/6/20
A new approach to adaptive design of clinical trials is proposed in a general multi-
parameter exponential family setting, based on generalized likelihood ratio statistics and optimal
sequential tes...
Efficient adaptive designs with mid-course sample size adjustment in clinical trials
adaptive design conditional power futility Kullback-Leibler information sample size re-estimation
2011/6/17
Adaptive designs have been proposed for clinical trials in which the nuisance parameters
or alternative of interest are unknown or likely to be misspecified before the trial. Whereas most
previous w...
Handling Covariates in the Design of Clinical Trials
Balance covariate-adaptive randomization covariate-adjusted response-adaptive randomization effi ciency ethics
2011/3/23
There has been a split in the statistics community about the need for taking covariates into account in the design phase of a clinical trial. There are many advocates of using stratification and covar...
Handling Covariates in the Design of Clinical Trials
Balance covariate-adaptive randomization covariate-adjusted response-adaptive randomization effi ciency ethics
2011/3/22
There has been a split in the statistics community about the need for taking covariates into account in the design phase of a clinical trial. There are many advocates of using stratification and covar...