It is traditional to introduce the first issue of a new year with best wishes for success and happiness – and this I most certainly do. And I also have the unusual task of introducing myself as the new editor of The Medicine Maker and wishing my predecessor – Charlotte Barker – all the best in her new role as editor of Texere Publishing’s new magazine, The Translational Scientist (www.thetranslationalscientist.com). And yet, well-wishing and polite introductions seem somewhat out of place given the solemn start to the year. By now, I am sure that everyone is aware of the tragic Phase I clinical trial in Rennes, France, that resulted in the death of one participant and the hospitalization of five others – some of whom may be facing brain damage.
Phase I trial results do not need to be publicly released in Europe or the US, so it is difficult to quantify exactly how many trials fail so dramatically, but clearly, a significant amount of work goes into preclinical development and increasingly strict regulations must be adhered to. A review from 2005 on the risks and benefits of Phase I trials revealed a toxicity death rate of 0.005 percent (1). And some have even suggested that trials are run too conservatively… (2)
Despite the relative safety of clinical trials, recruitment remains difficult, with a lack of volunteers, compounded by ever-expanding inclusion and exclusion criteria. But stated simply, without volunteers for clinical trials, medicine cannot advance – all the more disappointing given the exciting advances being made in cell and gene therapies (some of which are discussed in this month’s cover feature on page 22). The publicity of the latest clinical trial tragedy can only have negative consequences on future clinical trial recruitment.
The sad outcome of the trial may be even more concerning to those of us who understand the emphasis on safety in drug development and manufacture, as it highlights the vast amount that we still do not know about complex molecules and their interactions with the human body – or how these interactions may be affected by manufacturing changes or exposure to contaminants.
But rather than speculate on how the French trial went wrong, I would rather pose a question to you all: where does the industry go from here? This incident – much like the disastrous TGN1412 trial in 2006 – will remain in people’s consciousness for many years. The industry will need to work hard to earn back people’s trust in clinical trial safety – but how?
Stephanie Sutton
Editor
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References
- E. Horstmann et al., “Risks and Benefits of Phase 1 Oncology Trials, 1991 through 2002,” N. Engl. J. Med. 352, 895–904 (2005). R. Kurzrock and R.S. Benjamin, “Risks and benefits of phase 1 oncology trials, revisited,” N. Engl. J. Med., 352, 930–2 (2005).
