The Pharmaceutical Journal
Vol 280 No 7498 p458
19 April 2008

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Early halting of clinical trials for new cancer treatments cuts patient safety data

Clinical trials of new cancer medicines are increasingly likely to be stopped early because new treatments provide statistically significant benefits to patients and this is reducing the amount of safety data available before drugs are launched, Italian and Dutch researchers have warned in a study published online (Annals of Oncology, 9 April 2008).

The researchers examined clinical trials in oncology published between January 1997 and October 2007 and found that the number of trials stopped early had increased by over 50 per cent in 2004–07 compared with the period as a whole.

They argue that however statistically significant short-term benefits are they may not justify the early termination of a trial evaluating the long-term efficacy and safety of medicines for conditions like cancer. Results of trials terminated early for benefit should be viewed with criticism and need to be further confirmed, the researchers stress.

The main effect of decisions to terminate trials early is, they argue, to move along the drug approval path earlier than is ideal, leading to unsafe and ineffective medicines being marketed and prescribed, jeopardising consumers’ health.