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British Medical Journal

Clinical Articles, News & Views

Research misconduct persists in the UK…

More than one in 10 (13%) UK based scientists or doctors have witnessed colleagues intentionally altering or fabricating data during their research or for the purposes of publication, while 6% say they are aware of possible research misconduct at their institution that has not been properly investigated, reveals a British Medical Journal (BMJ) survey published recently.1

The survey was emailed to a mixed sample of 9,036 UK based academics and clinicians registered with the BMJ’s manuscript tracking system. 2,782 (31%) responses were received, the results suggesting that research misconduct is alive and well in the UK, highlighting the need for better systems to deter, detect, and investigate research misconduct.

They also reflect previous research2 among newly appointed consultants in seven UK hospitals. One in 10 said they had first-hand knowledge of scientists or doctors intentionally altering or fabricating data, and 6% admitted to past personal research misconduct.

The results will be presented at a high level meeting in London today, hosted by the BMJ and the Committee on Publication Ethics (COPE), which aims to push for a consensus among institutions and funders towards tackling misconduct in the UK.

Dr Fiona Godlee, BMJ Editor in Chief, said: “While our survey can’t provide a true estimate of how much research misconduct there is in the UK, it does show that there is a substantial number of cases and that UK institutions are failing to investigate adequately, if at all. The BMJ has been told of junior academics being advised to keep concerns to themselves to protect their careers, being bullied into not publishing their findings, or having their contracts terminated when they spoke out”.

On a positive note, she says solutions are already being aired in advance of the meeting and she is confident that the meeting will prompt concerted action from the research community. “UK science and medicine deserve better. Doing nothing is not an option,” she says.

COPE Chair, Dr Elizabeth Wager, noted: “This survey chimes with our experience from COPE where we see many cases of institutions not cooperating with journals and failing to investigate research misconduct properly”.

…as does missing trial data

Missing clinical trial data can harm patients and lead to futile costs to health systems, warn experts in reports published recently on bmj.com as part of an in-depth review of the matter.

The BMJ has published several papers3,4,5,6,7,8,9 that examine the extent, causes, and consequences of unpublished evidence. They confirm that a large proportion of evidence from human trials is unreported, and much of what is reported is done so inadequately.

 In an editorial,10 Dr Richard Lehman from the University of Oxford and BMJ Clinical Epidemiology Editor, Dr Elizabeth Loder, describe a “culture of haphazard publication and incomplete data disclosure.”

They call for more robust regulation and full access to raw trial data to allow better understanding of the benefits and harms of many kinds of treatment.

 A study by Beth Hart and colleagues finds that including unpublished data in published meta-analyses of drug trials often changed their results. They argue that access to full trial data is needed to allow drugs to be independently assessed.

Two further studies show poor adherence to requirements for mandatory trial registration and timely sharing of results.

Ross and colleagues show that fewer than half of US National Institutes of Health funded trials are published in a peer reviewed journal within 30 months of completion, while Andrew Prayle and colleagues find that only 22% of trials subject to mandatory reporting had results available within one year of completion.  “When the word ‘mandatory’ turns out to mandate so little, the need for stronger mechanisms of enforcement becomes very clear,” write Lehman and Loder.

The two authors believe that concealment of data is “a serious ethical breach” and that clinical researchers who fail to disclose data “should be subject to disciplinary action by professional organisations”.

They conclude: “These changes have long been called for, and delay has already caused harm. The evidence we publish shows that the current situation is a disservice to research participants, patients, health systems, and the whole endeavour of clinical medicine”.

References

1 Full results available here: http://press.psprings.co.uk/bmj/january/misconductsurvey.pdf

2 Geggie D. A survey of newly appointed consultants’ attitudes towards research fraud. J Med Ethics 2001;27:344–6.

3 Hart B, Lundh A Bero L.  Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses. BMJ 2011;343:d7202 http://dx.doi.org/10.1136/bmj.d7202

4 Ross JS, Tse T, Zarin DA, Xu H Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ 2011;344:d7292 http://dx.doi.org/10.1136/bmj.d7292

5 Prayle P, Hurley MN, Smyth AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ 2011;344:d7373 http://dx.doi.org/10.1136/bmj.d7373

6 Wieseler B, Kerekes MF, Vervoelgyi V, McGauran N, Kaiser T. Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications. BMJ 2011;344:d8141 http://dx.doi.org/10.1136/bmj.d8141

7 Chan AW. Out of sight but not out of mind: how to search for unpublished clinical trial evidence. BMJ 2011;344:d8013 http://dx.doi.org/10.1136/bmj.d8013

8 Ahmed I, Sutton AJ, Riley RD. Assessment of publication bias, selection bias, and unavailable data in meta-analyses using individual participant data: a database survey. BMJ 2011;344:d7762 http://dx.doi.org/10.1136/bmj.d7762

9 Wieland LS, Robinson KA, Dickersin K. Understanding why evidence from randomised clinical trials may not be retrieved from Medline: comparison of indexed and non-indexed records. BMJ 2011;344:d7501 http://dx.doi.org/10.1136/bmj.d7501

10 Lehman R, Loder E. Missing clinical trial data. BMJ 2011;344:d8158 http://dx.doi.org/10.1136/bmj.d8158

Published on: February 7, 2012

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