| The lessons learnt since the disastrous TGN1412 trial have been many and varied; Richard Huckle at Constella Group Ltd outlines the implications for drug development
On March 13th, 2006, six volunteers at Northwick Park Hospital in London were given small doses of a new drug, TGN1412, developed by the German biopharmaceutical company TeGenero. The subjects receiving the drug became so seriously ill that they had to be placed in intensive care. At the time there were fears that at least two of them would not recover and while in the end all survived, the potential long-term health effects are unclear. There has already been much discussion about the measures taken to protect the volunteers, so this review will concentrate on lessons learnt and what this could mean to the future of drug development.
Following the final report by an independent expert working group on Phase I clinical trials, Professor Kent Woods, Chief Executive of the MHRA, said: “We welcome today’s report, produced through wide consultation by independent experts. The MHRA has already implemented nationally the recommendations outlined in the report that affect the Agency’s procedures for authorising trials. Some recommendations will need to be taken forward at EU level and the Agency has already started discussions with other European regulators to take these forward as a priority.
Clinical trials in general have an excellent safety record, but it is important that we learn the lessons from the TGN1412 incident to optimise the safety of future Phase I studies, particularly those involving novel medicines.” So, what does this report actually mean for the development of new and novel medicines that need to be tested in humans for the first time? What is being done to prevent something like this happening again?
The MHRA report draws attention to key areas related to early phase drug development and this article will focus on three specific areas:
- The designation of higher risk molecule status by the MHRA and subsequent review by an expert panel before any human studies can be performed
- Non-clinical studies, specifically the second choice of species and in particular the choice of pharmacologically relevant species in safety and toxicological studies
- Human clinical study design and the need for more caution between doses
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