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In March this year, a Department of Health Expert Scientific Group chaired by Professor Gordon Duff was set up to investigate the serious adverse reaction suffered by six volunteers after they took the novel drug TGN1412 in a clinical trial at Northwick Park Hospital. Today, scientists commented on the release of a preliminary report from the committee, which presents 22 recommendations to tighten regulations on clinical trials.
Karol Sikora, Professor of Cancer Medicine and honorary Consultant Oncologist at at Imperial College School of Medicine, Hammersmith Hospital, said:
“I am broadly in agreement with these recommendations. Putting a new drug into humans for the first time will always have risks. This goes some way to reducing these risks as much as possible.”
Dr Sophie Petit-Zeman, Director of Public Dialogue, Association of Medical Research Charities (AMRC), said:
“The AMRC welcomes all moves to increase public confidence in the safety of clinical trials, which are an essential part of medical progress for patient benefit.
“The particular recommendation that research funders expedite collection and dissemination of information from early stage trials has our full support.”
Neil A. Williams, Professor of Immunology and Head of Department of Cellular and Molecular Medicine University of Bristol School of Medical Sciences, said:
“The recommendations are a sensible way forwards which balance the need to generate new medicines for serious diseases with the need for caution in exposing subjects to risk. Avoidance of a similar occurrence in the future will be dependent on regulators seeking the correct expert opinion and working to ensure a more cautious approach in trial design.”
Jeffrey Aronson, President-elect, British Pharamcological Society and Clinical Pharmacologist, Radcliffe Infirmary, University of Oxford, said:
“My initial reaction to the 22 recommendations in the report is that they are all sensible and achievable.
“The most important recommendation in my view is that the relation between a complete range of doses and concentrations of a new compound and its biological effects should be carefully studied, for example in human cells, before first-in-man administration.”
Dr David Glover, independent consultant to industry and member of ABPI/BIA taskforce, said:
“The report has come up with some sensible recommendations for the future , in particular it has acknowledged that there are more appropriate methods to set the starting dose for the first trial than was used for TGN1412 , and that if those methods had been used a much lower starting dose would have been used.
“The report however does not criticize the MHRA for its role in approving the TGN1412 trial and the dose used, indeed it comments that current guidelines were met – I doubt that this is actually the case as the company does not appear to have either developed a relevant potency assay for its drug, or to have studied relative potency / sensitivity in different species in a meaningful way and this fact seems to have been missed in the regulatory assessment.
“I, and many others, believe that the effects in man of TGN1412 (cytokine release) should have been expected and the disaster could have been avoided. Given the high level of public interest and the fact that the company behind the trial have filed for bankruptcy, it would now be appropriate for the MHRA to release the information that has been withheld for reasons of commercial confidentiality. By so doing a greater understanding of the science underlying this saga can be developed.”
Aisling Burnand, Chief Executive of the BioIndustry Association (BIA), said:
“We applaud the expert group’s recognition of the need to improve the safety of first-in-man trials for certain novel agents without stifling innovation or introducing undue delay which would be against the interests of patients. We believe the introduction of an alternative approach to initial dose calculation is an important first step, and fully support the Minimal Anticipated Biological Effect Level (MABEL), a concept which our joint BIA/ ABPI industry taskforce proposed to the group.
“It is important once again to emphasise the wholly exceptional nature of the shocking events in the TGN1412 trial and highlight the many benefits that patients are experiencing as a result of a wide range of life-saving biopharmaceutical medicines.”