Digital Pharma: Online trial safety reporting
pharmafile | June 21, 2010 | News story | Research and Development | FDA, MHRA, digital research, drug safety
From September all serious adverse events that occur during clinical trials in the UK will have to be reported electronically to the MHRA.
Its new eSUSAR website is already up and running, but until 31 August the UK medicine regulator will continue to also accept paper reports from sponsors and institutions responsible for trial safety reporting.
Suspected unexpected serious adverse reactions (SUSARs) include those that: result in death, are life-threatening, require hospitalisation or result in persistent disability.
The eSUSAR website will be used to collect all ‘UK-relevant’ SUSARs, that is those that originate in the UK or originate outside the UK but where the sponsor has an ongoing trial in the UK involving the same investigational medicinal product.
From 1 August the MHRA would like to see all UK-relevant SUSARs that would normally be sent to the EMA’s EudraVigilance database to be submitted to both authorities’ systems. Alternatively, the UK regulator says it will upload to EudraVigilance on a daily basis any reports only submitted via its new eSUSAR system.
Meanwhile, at the end of May the MHRA’s US counterpart the Food and Drug Administration (FDA) launched an electronic safety reporting site of its own to collect pre- and post-market safety data.
The regulator collaborated with the US National Institutes of Health on the Safety Reporting Portal, which allows pharma, researchers, the food industry, health officials and the general public to report safety concerns.
The portal is currently limited to accepting problems with foods, animal feed, animal drugs and human gene transfer trials, but in the future will be used for other types of clinical trials and, eventually, a broad range of safety problems.
“The portal will be a key detection tool in improving the country’s nationwide surveillance system and will strengthen our ability to protect the nation’s health,” said Commissioner of Food and Drugs Margaret Hamburg. “We will now be able to analyse human and animal safety-related events more quickly and identify those measures needed to protect the public.”
The FDA also plans to make safety reviews of new products more easily accessible for the public, by posting summary information and a brief discussion of any related safety measures on to its website.
Dominic Tyer is web editor for Pharmafocus and InPharm.com and the author of the Digital Pharma blog He can be contacted via email, Twitter or LinkedIn.
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