New report re-emphasises clinical trial safety
left six men fighting for their lives, has re-iterated the call for
scientists to proceed with extreme caution when testing such drugs
in the future.
The report aims to propose a series of recommendations to enhance and clarify the existing guidelines governing the testing of new medicines in humans following the TGN1412 clinical trial at Northwick Park
The clinical trial left patients with organ failure, swelled heads and damage to their immune systems after they became the first human subjects to test the new drug, TGN1412.
It worked by stimulating the immune system. Most other drugs work by inhibiting an action in the body.
The report is the result of a joint taskforce set up by the Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA).
Their aim was to highlight existing guidelines that were important for clinical trials in which novel agents stimulating the immune system are given to humans for the first time.
Within this arena, recommendations cover the whole range of the Phase 1 development sequence, from comments and advice on the compound's mechanism of action and biological activity through to the education and training of those involved in safety assessment.
"As a responsible industry, we were shocked and want to ensure a similar event never occurs again, and that is why we have developed these 'points to consider' for first-in-human clinical studies," said David Chiswell, one of the co-chairmen of the taskforce.
"In order to safeguard patient safety, we want to make the guidelines available to the research-based industry and - if either the UK or the European regulatory bodies find this useful - to help develop them into a more formal set of 'points to consider'."
The aftermath of the drug trial continues even after four months has passed. The company behind the drug, TeGenero, was forced to file for insolvency earlier this month because investors avoided the drug development firm.
Additionally, four of the six men who were involved in the drug trails are still awaiting compensation.
To see the taskforce's report click >here.
