Closer scrutiny for high-risk clinical trials
pharmafile | December 8, 2006 | News story | Research and Development |
Wide-ranging changes will be made to the way clinical trials are conducted in the UK following the final report by the MHRA's expert group into the disastrous Northwick Park clinical trial.
The group's final conclusions mirror those of their interim report, released over the summer, that pre-clinical testing was at fault even though current regulatory requirements were met.
Six men fell critically ill in March during the phase I trial at Northwick Park Hospital for TGN-1412, which was being developed to treat diseases such as rheumatoid arthritis and B-cell chronic lymphocytic leukaemia.
The trial was carried out by contract research organisation Parexel for the drug's manufacturers, the German biotech company TeGenero, which has since filed for insolvency.
Chair of the MHRA's Expert Scientific Group (ESG) Professor Gordon Duff said: "The alarming outcome of the TGN-1412 trial was unprecedented in the history of clinical trials, and we want to record our sympathy for all of the trial volunteers.
"There is certainly a need to develop new medicines for conditions where current treatment is inadequate but, in clinical trials, the well-being of volunteers must always come first. We believe our recommendations would safeguard this in the future."
The report made 22 recommendations covering a number of key areas including:
* The need for scientific advice from independent experts before high-risk trial are approved
* Information about unpublished clinical trials and adverse reactions occurring in trials
* The skills and future specialist training needs of those conducting clinical trials
* The location of trial units and the provision of adequate medical back up
Following Prof Duff's report the MHRA will set up an expert advisory group to review applications for trials of high-risk substances in the new year.
The regulator has already agreed a joint memorandum with the UK Ethics Committee Authority to improve information sharing as well as implementing precautionary measures for the approval and conduct of trials. These will be kept in place until they can be replaced by new European guidance.
Health minister Andy Burnham said: "We believe that implementing the wide-ranging and comprehensive recommendations made in this report could make a significant contribution to improving the safety of clinical trials of high risk drugs such as TGN-1412."
The government will hold discussions with industry and academia about how best to implement the changes proposed by the report.
The BIA's chief executive Aisling Burnand welcomed the report, but said the manner and timing in which its recommendations were implemented would 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.
"In particular, the bioscience industry welcomes the proposed recommendation of European guidance for first-in-man trials and looks forward to working with the regulatory authorities in development of this," she said.
Pharma industry association the ABPI will soon produce new guidelines for clinical trials in human volunteers – something the association has been working on since before the Northwick Park incident.
Prof Duff's report noted several areas of concern from stakeholders that fell outside its terms of reference, including the process of informed consent, insurance cover and clinical follow-up of trial subjects who had experienced an adverse reaction.
The Expert Scientific Group considered these concerns to be extremely important, and recommended they be looked into as a high priority.
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