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"Call to improve transparency of trials of non-regulated interventions" (Ioannidis)

Dolphin

Senior Member
Messages
17,567
(Not open access)

http://www.bmj.com/content/350/bmj.h1323

Call to improve transparency of trials of non-regulated interventions

BMJ 2015; 350 doi: http://dx.doi.org/10.1136/bmj.h1323 (Published 27 March 2015) Cite this as: BMJ 2015;350:h1323
  1. Rafael Dal-Ré, director1,
  2. Michael B Bracken, professor and co-director2,
  3. John P A Ioannidis, professor and director3

The public and clinicians require transparent, quality evidence for all interventions. Trials of non-regulated interventions are common, and efforts to improve their registration and publication compared with drug trials are overdue, say Rafael Dal-Ré, Michael Bracken, and John Ioannidis

Efforts to promote the availability of data from clinical trials have been led predominantly by regulators1 or drug companies2 and tend to focus on regulated interventions—that is, drugs, biologics, and medical devices. By contrast, trials of non-regulated interventions such as diets, exercise programmes, physiotherapy, surgical procedures, behavioural interventions, or complementary medicine have received much less attention.

To determine the benefits and harms of an intervention, randomised trial evidence is needed. These trials should be registered and published in an accurate and unbiased manner. Ideally clinical trial protocols and raw data should be made available to ensure transparency and for further use—for example, in individual patient data meta-analyses. These imperatives are well appreciated for trials of regulated interventions, but practices are lagging for non-regulated interventions.

All of us are likely to experience one or more non-regulated intervention in our lives. Yet many trials in these fields are small, underpowered, and lack quality safeguards such as appropriate randomisation, blinding, or choice of placebo or sham control.3 The results are often spurious. Very large, well conducted, trials on non-regulated interventions are rare, even for common lifestyle interventions such as diet and exercise programmes.4 5 Some trials of non-regulated interventions such as surgical procedures and behavioural interventions have intrinsic difficulties in their conduct,6 7 such as how to standardise the intervention. Non-standardisation leads to more heterogeneity and potential for bias.

Current mandates
In the United States the Food and Drug Administration is responsible for assessing all regulated interventions including drugs, biologics, and medical devices before they are licensed and commercially available. The …

(rest is behind a paywall)
 

Dolphin

Senior Member
Messages
17,567
I wonder have there been unpublished trials of CBT, GET and other non-pharmacological interventions in ME/CFS? The PACE Trial's outcomes appear worse on average than trials that have been published before.
 

Snow Leopard

Hibernating
Messages
5,902
Location
South Australia
I wonder have there been unpublished trials of CBT, GET and other non-pharmacological interventions in ME/CFS? The PACE Trial's outcomes appear worse on average than trials that have been published before.

There is certainly plenty of unpublished clinical data. Not so sure about unpublished trials (though some specific data is almost certainly withheld) as funders tend to get a bit angsty about that...
 

Dolphin

Senior Member
Messages
17,567
There is certainly plenty of unpublished clinical data. Not so sure about unpublished trials (though some specific data is almost certainly withheld) as funders tend to get a bit angsty about that...
True now. But I want whether much external funding is required from some of the early trials of CBT and GET with small numbers of patients.