Correction to: Two-stage Bayesian hierarchical modeling for blinded and unblinded safety monitoring in randomized clinical trials
نویسندگان
چکیده
منابع مشابه
Bayesian Monitoring of Safety Signals in Blinded Clinical Trial Data
Monitoring of patient safety is an indispensable part of clinical trial planning and conduct. Proactive safety signal monitoring using blinded data in on-going clinical trials enables pharmaceutical sponsors to monitor patient safety closely while maintaining the study blind. Bayesian methods, by their nature of updating knowledge based on accumulating data and synthesis of prior knowledge, pro...
متن کاملUsing instrumental variables to disentangle treatment and placebo effects in blinded and unblinded randomized clinical trials influenced by unmeasured confounders
Clinical trials traditionally employ blinding as a design mechanism to reduce the influence of placebo effects. In practice, however, it can be difficult or impossible to blind study participants and unblinded trials are common in medical research. Here we show how instrumental variables can be used to quantify and disentangle treatment and placebo effects in randomized clinical trials comparin...
متن کاملBayesian two-stage designs for phase II clinical trials.
Many different statistical designs have been used in phase II clinical trials. The majority of these are based on frequentist statistical approaches. Bayesian methods provide a good alternative to frequentist approaches as they allow for the incorporation of relevant prior information and the presentation of the trial results in a manner which, some feel, is more intuitive and helpful. In this ...
متن کاملBiased Safety Reporting in Blinded Randomized Clinical Trials: Meta-Analysis of Angiotensin Receptor Blocker Trials
BACKGROUND Cough is listed as an adverse drug reaction (ADR) on the labels of angiotensin receptor blockers (ARB). However, a causal association with cough has also been reported for angiotensin converting enzyme inhibitors (ACEI), which have frequently been used as comparator drugs in the registration clinical trials of ARBs. This prompted us to examine the possible influence of using comparat...
متن کاملRandomized Phase II Trials: a Bayesian Two-Stage Design
Single-arm two-stage designs are commonly used in phase II of clinical trials. However, the use of randomization in phase II trials is currently increasing. We propose a randomized version of a Bayesian two-stage design due to Tan and Machin [2]. The idea is to select the two-stage sample sizes by ensuring a large posterior probability that the true response rate of the experimental treatment e...
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ژورنال
عنوان ژورنال: BMC Medical Research Methodology
سال: 2020
ISSN: 1471-2288
DOI: 10.1186/s12874-020-01114-8