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Collecting and reporting safety data

We can receive information on adverse events from several sources such as:

• Unsolicited reports from health professionals and patients.
• Post-marketing trials or observational studies.
• Investigators who submit clinical study reports.
• Regulatory authorities.
• Medical and scientific literature.
• Newspapers and other media.

All this information must be kept and entered in our global safety database. Our staff use this data to analyse, monitor and report on the safety of all our products to regulatory authorities around the world in accordance with the regulations.

Changes to the benefit – risk profile of a product may result in appropriate corrective actions to minimise the risk. This can include carrying out further clinical trials, modifying the prescribing information, communications to physicians and other healthcare providers or establishment of a formal risk management program. In certain cases it may be appropriate to stop a clinical trial or withdraw a product from the market.

Data on adverse events is also being made available to the public via the internet. For example, data for products marketed in the UK is available via the Medicines and Healthcare Products Regulatory Agency. Some safety data is also available in Canada, while in the US the FDA is preparing to make the information in its database more accessible to the public. In 2004, we became one of the first companies to launch an online Clinical Trial Register. This contains results and protocol information from GSK-sponsored trials of marketed medicines.

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