Selected highlights from the 4th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV
Drug safety is an important issue for manufacturers, regulatory agencies and, most of all, the user. One of the problems with HIV clinical trials, according to researcher Andrew Hill from the UK, is that there may not be enough volunteers or research subjects enrolled in studies. When there are relatively low numbers of subjects in a study, certain side effects may not be judged to be significant. This can lead to incorrect conclusions about the safety of a drug. Below are some numbers of subjects calculated by Dr. Hill that are needed for certain measurements or events.
To detect significant changes when comparing two treatment groups in a study, at least 435 subjects in each group (for a total of at least 870) would be needed to detect a 5% vs. 10% incidence of severe or life-threatening increases in cholesterol levels.
Rare events: pancreatitis, hypersensitivity reactions and lactic acidosis
These side effects, though dangerous, are not common. To detect a doubling of the risk of these events, the number of subjects needed for meaningful statistical evaluation would be as follows:
Dr. Hill concluded that most HIV clinical trials are too small to detect differences between two treatment groups when it comes to severe or life-threatening side effects. This is something to bear in mind when reading results from clinical trials, particularly those of new anti-HIV drugs.
REFERENCE
Hill A, James I, McKinnon E and Law M. Statistical power to detect drug toxicity in HIV clinical trials. Abstract 20.
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