Volume 29, Number 5

September 2000

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’. This article is available only as a PDF. Please click on “Download PDF” on top to view the full article.

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. This article is available only as a PDF. Please click...

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...

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. This article is available only as a PDF. Please click on “Download PDF” on top to view the full article.

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. This article is available only as a PDF. Please click...