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Clinical trials should be registered to prevent data manipulation

Defining the protocols for clinical trials in publicly accessible registers prior to commencement of the trials would help identify drugs’ real risk-benefit balance.

Many people who agree to take part in clinical trials do so in the public interest, "to advance medical knowledge". And yet, in practice, the results of many clinical trials on drugs are never published, especially when they are unfavourable to the firm funding the trial. Recent years have seen a mounting body of evidence that companies have been able to manipulate the results of trials with negative results for them, particularly by altering the initial aims of the trial after the event.

To combat these practices that are damaging to patients’ and public health, it is increasingly necessary for the protocols of clinical trials to be defined in publicly accessible registers, before the trials commence. The major international medical journals will now only publish the results of clinical trials on this condition.

This is a welcome development which introduces an element of transparency into clinical trials.

Patients should be encouraged to take part only in trials that are described in a publicly accessible register, and on condition of receiving an assurance that the results will be published.

©Prescrire July 2008

Source: "Registres d'essais cliniques : vers un meilleur accès aux données sur les traitements" Rev Prescrire 2008 ; 28 (297) : 536-541.

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