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23 Jul 2010 - GSK rejects misleading media reporting of its clinical trial activity

GlaxoSmithKline (GSK) Australia today rejected misleading reports in several media outlets over the weekend in relation to its conduct of clinical trials (Sunday Telegraph, Sunday Times, Courier Mail).

GSK rigorously adheres to the principals of Good Clinical Practice1 and the National Health and Medical Research Council, National Statement on Ethical Conduct in Research Involving Humans.

GSK does not pay incentives to people (including parents) who volunteer for clinical trials. GSK compensates trial participants for expenses and inconvenience incurred, such as travel and parking as a result of participation in a clinical trial.

GSK does not pay incentives to doctors to conduct a clinical trial. GSK compensates the Institution / Hospital / Research Organisation for the costs incurred in conducting a clinical trial which covers all medical assessments and procedures, patient monitoring, medical/nursing care associated with the trial and all administrative aspects related to the trial.

In Australia, all clinical trials must be approved by an independent ethics committee, including how the trial is conducted and how participants are compensated.

GSK Australia conducts clinical trials in Australia as part of our global effort to bring new and innovative medicines to the community. Clinical trials must be conducted before new medicines and vaccines can be made available to the broader population. The safety of those who participate in our clinical trials is of paramount importance.

GSK works with ethics committees and investigators to achieve an informed consent2 process that informs volunteers about the study and its risks and that they may not receive direct benefit.

1The Good Clinical Practice (GCP) is developed by the International Conference on Harmonisation (ICH) and the principles contained in the World Medical Association Declaration of Helsinki on the 'Ethical Principles for Medical Research Involving Human Subjects (2008)'.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.au

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Enquiries: Lisa Maguire 0449 950 745