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Rapid Responses: Rapid Responses published:
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Time for more than tinkering
- James Penston (17 December 2004)
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James Penston, Consultant Physician/Gastroenterologist Scunthorpe General Hospital, Cliff Gardens, Scunthorpe, North Lincolnshire DN15 7BH
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Sir, In your editorial of 11th December 2004, [1] readers were informed that, from the beginning of 2005, authors would be required to include the trial protocol when submitting research papers for publication. This proposal, which is intended to expose deviations from the original protocol, appears reasonable, particularly as the recent publications by Chan et al. [2,3] – which show substantial discrepancies between the protocol and the published paper – are a source of much disquiet. However, your comment that “…identifying deviation from the protocol is another important step in ensuring that the findings of a study are reported with honesty and transparency” rings hollow. What, for example, are the other “important steps”? Is there, for instance, any evidence that such steps taken in the past have made a genuine difference to the reliability of data from clinical trials? Despite the many attempts to address the poor quality of reporting of trials, studies suggest that there has been little improvement in the standard. [4,5] In any case, compelling researchers to include their protocols will have no effect whatsoever on their honesty. If an individual is dishonest and intent on committing research misconduct, then he will do so – preventing him from deviating from the protocol will simply encourage him to seek alternative means to achieve his aims. And, it is not difficult to discover many instances of investigators being willing to manipulate data in other ways: consider the reports of misleading claims in clinical trials that have been discussed in the BMJ over recent months. [6-9] The point is surely this: current clinical research relies upon a methodology that is readily open to abuse. The mechanics of large-scale randomised trials are highly complex, the data opaque and the results marginal – all features which prevent a clear view of any research misconduct. Moreover, the absence of any method to confirm or refute the results means that such behaviour is likely to go undetected. Dishonest researchers exist and randomised clinical trials allow them to flourish. Tinkering with new rules – such as that proposed in your editorial – will do little to improve the reliability of the results of clinical trials. What is needed is a complete re-appraisal of large-scale randomised trials. References 1. Abbasi K & Jones G. Trial protocols at the BMJ. BMJ 2004;329;1360. 2. Chan A, Krleza-Jeric K, Schmid I, et al. Outcome reporting bias in randomised trials funded by the Canadian Institutes of Health Research. CMAJ 2004;171;735-40. 3. Chan A, Hrobjartsson A, Haahr M et al. Empirical evidence for selective reporting of outcomes in randomised trials: comparison of protocols to published articles. JAMA 2004;291;2457-65. 4. Thornley B, & Adams C. Content and quality of 2000 controlled trials in schizophrenia over 50 years. BMJ 1998;317;1181-4. 5. Huwiler-Muntener K, Juni P, Junker C, Egger M. Quality of reporting of randomised trials as a measure of methodologic quality. JAMA 2002;287;2801-4. 6. Wennberg R & Zimmermann C. The PROGRESS trial three years later: time for a balanced report of effectiveness. BMJ 2004;329;968-70. 7. Penston J. Rapid response letters to “Wennberg R & Zimmermann C. BMJ 2004;329;968-70” 29th October 2004. 8. Montori VM, Jaeschke R, Schunemann HJ, et al. User’s guide to detecting misleading claims in clinical research reports. BMJ 2004;329;1093-96. 9. Penston J. Rapid response letters to “Montori VM, Jaeschke R, Schunemann HJ, et al. BMJ 2004;329;1093-96” 8th November 2004. Competing interests: None declared |
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