(Free Paper) "How to Get All Trials Reported: Audit, Better Data, and Individual Accountability"

[Tom Kindlon]

Open Access paper:
http://bit.ly/1zZDyqx i.e.
http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001821
How to Get All Trials Reported: Audit, Better Data, and Individual Accountability
Ben Goldacre
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A few extracts:

"In this week’s PLOS Medicine, the World Health Organization (WHO) publishes a landmark position statement, requiring all trials to make their methods and results available [1]. This represents important progress on a long-standing and global structural problem that has a clear, negative impact on patient care. The best currently available evidence shows that the methods and results of clinical trials are routinely withheld from doctors, researchers, and patients [2–5], undermining our best efforts at informed decision making. From this point forward, whenever the methods and results of a trial are withheld, doctors, patients, researchers, campaigners, and health care providers will be able to point at an unambiguous statement from WHO."

"Patient groups, lastly, could write open letters to all companies and researchers withholding methods and results of trials on treatments taken by their members, represent their constituencies by holding individuals to reasonable account, and again help improve compliance."

"Lastly, doctors and patients can act on withheld data exposed by audit and consider avoiding treatments—or indeed whole companies—where there is clear evidence that the data on those interventions is comparatively unreliable."

This contrasts with the way patients and patient groups have been treated and portrayed for looking for data from the £5 million PACE Trial e.g. the primary outcomes and recovery rates using the versions in the published protocol, not the changed versions the investigators published instead.

 

[alex3619]

I think this applies to PACE. We already write open letters. We already avoid treatment. What else can we do?

The focus in the article is on pharmacological interventions, but there is not much difference with psychological interventions, an RCT is an RCT. The debate needs to be expanded to include all of psychiatry.