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Implementational research and clinical trials

Posted by peterbyass on 22 Nov 2010 at 14:18 GMT

Implementation research aims to develop strategies for available or new health interventions in order to improve access to, and the use of, these interventions by the populations in need.

Thanks for this interesting article. I think there is a further aspect here that perhaps deserves exploration - the question of when implementational research becomes a clinical trial? If, for example, a local health authority decides to deliver a particular drug treatment in different ways in two different districts, and then investigate the outcomes, is that something that should conform to ICMJE and Consort guidelines for clinical trials, and which must therefore be pre-registered as such in order to be published? I suspect there is something of a grey area here.

Competing interests declared: PLoS Med editorial board