The data, all the data and nothing but the data

(Reuters)Unreported data from early trials of experimental medicines in humans can result in harm to future patients and needless costs for health systems, according to scientists writing in the British Medical Journal on Wednesday.

The role of statistics in research leads to obvious risks for the drawing of conclusions about causal relationships between parameters without actually increasing the understanding about the underlying mechanisms. In pharmaceutical and health research such conclusions provide enormous financial benefits for the researchers and their sponsors – and not always in the interests of the patients involved.

In a series of studies for the BMJ on the extent to which clinical trial data are made public, researchers found a large proportion of evidence was unreported and much of what was reported by pharmaceutical firms was inadequate. ….

The BMJ has long been campaigning for greater transparency in clinical trials and has attacked the drug industry for being reluctant and slow to publish data from human trials of drugs in the later stages of development, and from trials of medicines already licensed and on the market.

Drug firms, for their part, have been publishing more data from trials they sponsor, but this is sometimes done on obscure websites rather than in high-profile peer-reviewed journals, and critics say the industry is still far from transparent. …

A third study in the series found that when previously unpublished data are included in meta-analyses of drug trials — studies which seek to collate all the available evidence to come to a more robust conclusion — the results are often different.

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