Subscribe to Newsletter
Discovery & Development Clinical Trials

A Brave New Year

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 (

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

Receive content, products, events as well as relevant industry updates from The Medicine Maker and its sponsors.
Stay up to date with our other newsletters and sponsors information, tailored specifically to the fields you are interested in

When you click “Subscribe” we will email you a link, which you must click to verify the email address above and activate your subscription. If you do not receive this email, please contact us at [email protected].
If you wish to unsubscribe, you can update your preferences at any point.

  1. E. Horstmann et al., “Risks and Benefits of Phase 1 Oncology Trials, 1991 through 2002,” N. Engl. J. Med. 352, 895–904 (2005).
  2. R. Kurzrock and R.S. Benjamin, “Risks and benefits of phase 1 oncology trials, revisited,” N. Engl. J. Med., 352, 930–2 (2005).
About the Author
Stephanie Vine

Making great scientific magazines isn’t just about delivering knowledge and high quality content; it’s also about packaging these in the right words to ensure that someone is truly inspired by a topic. My passion is ensuring that our authors’ expertise is presented as a seamless and enjoyable reading experience, whether in print, in digital or on social media. I’ve spent fourteen years writing and editing features for scientific and manufacturing publications, and in making this content engaging and accessible without sacrificing its scientific integrity. There is nothing better than a magazine with great content that feels great to read.

Register to The Medicine Maker

Register to access our FREE online portfolio, request the magazine in print and manage your preferences.

You will benefit from:
  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine