Editorial
Evaluating Drugs from Cradle to Grave—Evolving Systems for a Complex Activity
Are medicines dangerous chemicals or life enhancing agents? The answer is ‘Both of those things, often at the same time, and worse in the wrong hands’.
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Others
The Ethics of Placebo-Controlled Trials in Developing Countries to Prevent Mother-to-Child Transmission of HIV
Placebo-trials on HIV-infected pregnant women in developing countries like Thailand and Uganda have provoked recent controversy. Such experiments aim to find a treatment that will cut the rate of vertical transmission more efficiently than existing ‘gold standard’ treatments like zidovudine.
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Others
Randomisation: Magical Cure for Bias?
There is general consensus that randomised clinical trial (RCT) can provide the most valid conclusions about effects of different treatment as eligible patients are randomly allocated into two or more alternative treatments. Trials using non-randomised comparison groups like historical controls tend to yield more optimistic results than randomised trials.
This...
Others
Estimation of Number of Subjects Required for Comparison of Drug versus Control in Adaptive Designs
Traditional designs for clinical trials make balanced (or 50-50) allocation of patients to treatments. This is done in the past to minimise the variance of different estimators.
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Others
Assessment of Patient Sociodemographic Variables in Clinical Trials—Can Patient Characteristics Make a Difference?
The pathway by which patients enter clinical trials can be a selective, non-random process. In order for patients to enter clinical trials, a set of circumstances must occur exclusive of having the disease being investigated and meeting clinical entry criteria.
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