Missing clinical trial data
BMJ 2012; 344 doi: https://doi.org/10.1136/bmj.d8158 (Published 03 January 2012) Cite this as: BMJ 2012;344:d8158
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Sir,
In the course of a succinct account of the linked papers relating to the problem of missing data from clinical trials, Lehman and Loder [1] make some sharp, but entirely warranted, criticisms of the state of medical research today.
While the failure to publish data – either in whole or in part – deserves censure, this issue is of secondary importance to the reliability and the value of the conclusions drawn from randomised trials. To their credit, Lehman and Loder allude to this in their opening remarks. But it deserves greater emphasis.
Unreported studies are of concern only if the rest of the research is of value. This, though, is not the case. The so-called advances in medicine delivered by large-scale RCTs and epidemiological studies are based on flawed methods and, in any case, are of little worth to individual patients. [2] In general, the medical profession is unaware of this state of affairs and, needless to say, patients remain totally in the dark.
The BMJ has begun the New Year well. It is to be hoped that it takes a step further and turns the spotlight on the dubious foundations of modern medical research. After all, the rewards on offer are considerable.
James Penston
References
1. Lehman R, Loder E. Missing clinical trial data. BMJ 2012;344;d8158.
2. Penston J. Stats.con – How we’ve been fooled by statistics-based research in medicine. The London Press. London, November 2010.
Competing interests: No competing interests
The editorial about missing data is not only important for the advancement of medicine in general, but has made me consider the potential value of a dedicated, independent Ombudsman (BMJ 2012;344:d8158).
As a rather traditional scientist, I found it hard to understand why a letter of mine with 'missing data' was rejected by one of our mainstream journals, given that it would alert fellow readers that the published claims for the efficacy of graded exercise therapy (GET) in the management of chronic fatigue syndrome (CFS) might have been overstated.
The letter was rejected and thus readers of the journal were unaware that GET had not achieved its principle aim, i.e., to increase activity levels. Based on the results of actigraphy, the change from baseline to follow-up was minimal and close to that documented for the controls. Since then, other researchers using various motion-sensing devices have also shown that any improvements in fatigue and physical functioning in CFS cannot be attributed to an increase in activity. Indeed, it has been posited that most patients do not adhere to the protocol and revert to the alternative strategy of pacing [1].
Does an objective scientist ignore such evidence? The regulatory body covering medical journals judged the rejection of a letter with clinically meaningful but inconvenient data as perfectly acceptable. NICE was also aware of the missing data but ignored the problem when formulating their guidelines for the management of CFS.
How does this approach make us different from the bankers and politicians who, a few years ago, chose to ignore what they didn't like the look of? GET may be appropriate for some patients with CFS, but in light of the 'missing data', we don’t know yet for whom.
1. Goudsmit EM, Nijs, J, Jason LA, Walmann K. Pacing as a strategy to improve energy management in myalgic encephalomyelitis/chronic fatigue syndrome: a consensus document. Disab Rehabil 2011. Online 19th December.
doi: 10.3109/09638288.2011.635746.
Competing interests: No competing interests
Re: Missing clinical trial data
As a graduate student in public health and a patient advocate, I find it ironic that your editorial and series of papers expressing the dangers of not disseminating clinical trial data is not accessible to the public without a charge or subscription to your journal. While I and other researchers may gain access to this important information, those who are most affected by unpublished evidence from clinical trials are again stymied by a system that often seems to be designed to prevent knowledge from reaching consumers. News reports of this article are already being shared, and as a premier medical journal you have the opportunity to make public the extent of the problem. I urge you to make these articles publicly available free of charge.
Competing interests: No competing interests