The pharmaceutical industry is absolutely committed to the safety of patients and volunteers undergoing clinical trials and it is vital that the appropriate lessons are drawn from the recent unprecedented events at Northwick Park hospital. The Association of the British Pharmaceutical Industry (ABPI) welcomes the measures laid out in the interim report from the Medicines and Healthcare products Regulation Agency (MHRA).
As a joint initiative, the ABPI and the Bio Industry Association (BIA) propose setting up an expert working group to provide industry input to this process. We have also offered to nominate industry experts to work in partnership with the MHRA to assist in its ongoing activities relating to this issue.
While lessons need to be learnt about what went wrong with this particular type of medicine, the basic clinical trial system is robust and has proved itself over decades. And advanced medicines based on monoclonal antibodies have contributed to effective and life-saving therapies for millions of cancer and arthritis sufferers.
Dr Richard Barker, ABPI Director General said: "There will always be some uncertainty in the process of developing new medicines, but we need to balance this with the benefits to the millions of patients in need of appropriate treatments."
For further information, please contact: ABPI Press office: 020 7747 1410