Feature Clinical Research

Leaping to conclusions

BMJ 2008; 336 doi: https://doi.org/10.1136/bmj.39589.396840.94 (Published 29 May 2008) Cite this as: BMJ 2008;336:1213
  1. Margaret McCartney, general practitioner
  1. 1Glasgow
  1. Margaret{at}margaretmccartney.com

    Clinical trials are sometimes stopped prematurely if they show early benefit. But this might pose a risk to patients, says Margaret McCartney

    “Major trial stopped early because results so good”—such urgent, feel good headlines about the latest medical breakthrough make for an eye catching health story. Cancer and HIV drug trials seem especially susceptible to a high media profile when there is talk of a newly discovered advantage.

    The impression that this is happening more often is borne out by a recent study published in Annals of Oncology by Trotta and colleagues.1 The research team looked for all published clinical trials of cancer drugs in the past 11 years that were stopped early after an interim analysis found benefits. Over half of the 25 trials they identified were published in the past three years (2005–7).

    Is this something to be concerned about? Surely an effective drug needs to be licensed and made available to as many people as possible, as quickly as possible. People who are seriously ill cannot wait for tedious committees to wait for long clinical trials to end before deciding about effective drugs—at least, that is how the argument goes. Indeed, Trotta and colleagues found that most of the recent trials that were stopped early were used in support of an application for marketing authorisation at the European Medicines Agency or the US Food and Drugs Administration.

    Yet this may be exactly the reason to be concerned. Is the trend for stopping trials early in order to quickly license apparently effective drugs good for patients?

    Trials are often stopped by a data and safety monitoring committee, which is responsible for assessment of the results obtained during the live running of a clinical trial. Part of the role of these committees is to ensure that participants in …

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