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Lancet: new rules for Phase I studies

"New rules are urgently needed on the methods of testing drugs in clinical phase I". The appeal is launched by an editorial published in the Lancet. To avoid repeating dramas like that of healthy English volunteers, disfigured to look like "Elephant man" after taking a monoclonal antibody evaluated against diseases such as rheumatoid arthritis and leukemia, the magazine's experts underline the need to "introduce changes in the approval and regulation procedures of the first tests of a new product on humans". Especially if the trials involve "biological active ingredients," warn the scientists. The British agency MHRA (Medicine and Healthcare Products Regulatory Agency) had given the green light to the phase I clinical study on TGN1412 by the German TeGenero, in which six healthy volunteers then reported serious side effects. A report from the same regulatory body recently "acquitted" the trial, explaining that there was no evidence of irregularities or errors, but the review's comment is critical. "Although the risk of massive release of cytokines linked to the administration of the new monolocal antibody had been recognised, and reported in the relevant dossier, no precautions regarding the interval between one administration of the drug and the next were reported". Instead, "as the Academy of Medical Sciences suggests, the most correct strategy for testing this type of product would be to administer a single dose to a single patient, who would then be observed for an appropriate period of time before moving on to another". From medical Florence-SIMeF. Year IV – No. 104.

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco