This was the final report from the Expert Scientific Group, chaired by Professor Gordon Duff, which was set up following the very serious adverse reactions that occurred in the first-in-man clinical trial of TGN412 at Northwick Park hospital in March 2006.
Aisling Burnand, Chief Executive of the BioIndustry Association, said:
“The bioscience industry welcomes these recommendations which provide further clarity on the proposed changes. The manner and timing of implementation of these recommendations will now be key. Adequate resourcing and funding for the regulator will be required to ensure that there is no delay to the development of new medicines for patients.”
Karol Sikora, Professor of Cancer Medicine and honorary Consultant Oncologist at Imperial College School of Medicine, Hammersmith Hospital, said:
“This report on the very sad incident makes good sense. The most important recommendation (15) is that the administration of a novel agent to volunteers for the first time should be staggered. This would have avoided the number of men affected and allowed closer monitoring of individuals under study. The concept of creating specialist centres physically located in major hospitals – not just in it’s grounds is also excellent. In this way a wide range of experts can quickly evaluate any emerging problems.”
Dr David R. Glover , an independent consultant in pharmaceuticals and biotechnology (formerly chief medical officer at Cambridge Antibody Technology), said:
“Whilst I welcome the recommendations in Professor Duff’s report which are forward looking and sound science or common sense, it is very regrettable that there has been no independent investigation of the MHRA and its processes that led to the disastrous clinical trial going ahead – without any questions being raised about the drug itself or the trial design, the starting dose chosen etc and no external advice being sought.
“In the aftermath of the trial the MHRA cleared itself of any responsibility for the disaster and has stated repeatedly and incorrectly, in many experts opinions, that the effects of this drug were unexpected. Subsequent laboratory investigations, revealed in today’s report, have shown that, under optimised conditions, that the cytokine storm could be produced in a test tube – thereby confirming what I and others said at the beginning – that the effects of the drug were predictable and expected.
“The MHRA also previously stated that a second assessment team had looked at the trial application and would also have approved it. Amazingly this assessment actually counts as a success in the MHRA statistics because it was approved within the time target set for such applications. In the future the same process and the same people will be used to assess applications to start trials of these novel drugs with the same target time etc unless the MHRA changes its approach in the light of this report.
“Surely the way that the MHRA works should have been independently reviewed and evaluated in order to help restore public confidence in the system as part of Professor Duff’s expert scientific group report. Perhaps now would be a good time to announce a future independent review of MHRA to check that any new systems or processes and the training and education of the staff are fit to meet the challenge of assessing the drugs of the future.”