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Underreporting research is scientific misconduct (Chalmers, 1990)

D

Dolphin

Senior Member
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17,567
Ben Goldacre just highlighted this on Twitter. I know some people here are interested in the area.
Underreporting research is scientific misconduct

JAMA. 1990 Mar 9;263(10):1405-8.

Chalmers I.

Source
National Perinatal Epidemiology Unit, Radcliffe Infirmary, Oxford, England.

Abstract*

Substantial numbers of clinical trials are never reported in print, and among those that are, many are not reported in sufficient detail to enable judgments to be made about the validity of their results.

Failure to publish an adequate account of a well-designed clinical trial is a form of scientific misconduct that can lead those caring for patients to make inappropriate treatment decisions.

Investigators, research ethics committees, funding bodies, and scientific editors all have responsibilities to reduce underreporting of clinical trials.

An extended use of prospective registration of trials at inception, as well as benefiting clinical research in other ways, could help people to play their respective roles in reducing underreporting of clinical trials.

KIE:
Chalmers discusses two phenomena that he regards as forms of scientific misconduct.

The first is the selection of reports for publication on the basis of "positive results" rather than of whether they have been well conceptualized and competently executed.

The second is the failure of investigators to publish results with sufficient detail to allow judgments to be made about their validity.

Chalmers gives examples of underreporting of research in the field of perinatology, and reports on a survey he and colleagues conducted in an attempt to identify unpublished randomized trials.

He discusses ways that the problem of underreporting might be reduced through the efforts of investigators, funding organizations, ethics committees, and journal editors.

Chalmers suggests that these efforts could be aided by wider adoption of prospective registration of trials at their inception.

PMID: 2304220 [PubMed - indexed for MEDLINE]
Click to expand...

*I gave each sentence its own paragraph
 
SilverbladeTE

SilverbladeTE

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yeah, we rely on NEGATIVE studies even ore so actually than postivie (since science works by disproving essentially, and not everything will be positive)
so to leave such out, for fraud (pharma corps!) or because they aren't "sexy" (pay for journals etc) is dangerous
 
D

Dolphin

Senior Member
Messages
17,567
SilverbladeTE said:
yeah, we rely on NEGATIVE studies even ore so actually than postivie (since science works by disproving essentially, and not everything will be positive)
so to leave such out, for fraud (pharma corps!) or because they aren't "sexy" (pay for journals etc) is dangerous
Click to expand...
Yes, agree, although it's not necessarily just drug trials where some researchers may not publish data: researchers can be attached to, and have careers associated with, all sorts of theories e.g. that specific non-pharmacological therapies are useful for condition X.
 
biophile

biophile

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What about the grey area of exclusion of studies from systematic reviews? I am sure everyone remembers the CBT/GET trial by Nunez et al. (2011) which found worsened outcomes on average. Soon after, a meta-analysis was published by Castell et al. (2011) (who are pro-CBT?) which excluded that particular trial from consideration because it involved combination treatment (even though GET is often part of CBT). I can imagine other systematic reviews doing the same, ie Cochrane on CBT, even though GET is often part of CBT. It is possible that some negative studies such as Nunez et al. (2011) will never enter the same literature being used to claim that CBT and GET are safe and effective.
 
alex3619

alex3619

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Logan, Queensland, Australia
I have read there are cases where a pharmacological research might have several studies, and the most favourable one is published. I have not chased this down to confirm it with reliable sources (yet) but its a concern. Clearly all trials need to be pre-registered, and all data needs to be made public. Transparency is necessary for accountability, and a lack of accountability can derail any large system such as a company or even government.

Its why empty assertions need to be challenged when they are of serious public interest. Its why properly functioning FOI is important for democracy. Its why the media needs to reorganize to deal with the internet, because without good information from investigative journalists the truth rarely comes out.

I have almost finished reading The Silent State by Heather Brooke, who clearly shows many problems with transparency and accountability in the UK. She does however have an agenda, and its not always clear where her agenda distorts the book, though in a few places I spotted it. However the facts of many of these issues, presuming she got the facts right, do show systematic failure in accountability and transparency in the UK. Many government agencies seem to be unaccountable, and some have been caught misrepresenting the facts. There is apparently more concern over spinning the facts via public relations than in making them visible and so enabling problems to be solved.

It is clear to me that we need open publishing of scientific papers, we need evidence based medicine to be truly advisory and seen as nothing more, we need full data disclosed for studies, and not just pharmcological intervention - the full data needs to be revealed regarding the PACE trial.

Data can be fraudulently constructed or altered in science, particularly in psychiatry. There have been many instances of this. However having the full data available means many scientists and statisticians can review it, and this is how many frauds are caught.

These problems though are similar to that we face in making government, bureaucracy and big business accountable. I think the same principles often apply. The more we make things transparent, and the more the facts are investigated, the more we improve the science, or government, or the banking sector. Secrecy is the enemy of democracy.
 
biophile

biophile

Places I'd rather be.
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In the dark

New Scientist | Issue 2437

Comment > Comment and Analysis (p19)

06 March 2004

Drug companies should be forced to publish all the results of clinical trials. How else can we know the truth about their products, asks Iain Chalmers:

http://www.newscientist.com/article/mg18124373.100-in-the-dark.html

EFFECTIVE, safe and non-addictive: that is how the new generation of antidepressants was billed in the early days. Now these drugs are the focus of a fierce dispute. Some patients and doctors claim they are of questionable efficacy and can induce suicidal thoughts. Advocates, including the companies that make them, insist these medicines have helped millions of people, and that withholding them would do more harm than good.

It would be easier to judge which side was right if all the relevant information about the drugs were publicly available. But it isn't. Believe it or not, the law does not oblige companies to disclose the findings of their research on licensed medicines, and scientists, doctors, patients and even public organisations have no legal right to inspect the evidence that led regulators to license drugs.

This problem is serious because under-reporting of clinical research is biased and can be lethal. For ...

[To continue reading this article, subscribe to receive access to all of newscientist.com, including 20 years of archive content.]
Click to expand...
 
S

Sasha

Fine, thank you
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UK
Just heard Sir Iain on BBC Radio 4's Today programme, arguing for full publication of all trial data. He said that the MRC signed up to this - I didn't catch when.

I haven't been following the PACE issues in detail but aren't people having to use FOI to try to get at the data? Is there a quick summary of the issues somewhere that someone can link me to?
 
Esther12

Esther12

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