I want to assess Chloroquine and Primaquine Treatment Outcome among Uncomplicated P.Vivax Malaria: Open Label Clinical Trial.Which Study design is suitable for me?
one deals with clearance study of parasite the other deals with impact of this intervention in reduction of case burden
Which study deals with clearance study on parasite and which ones deals with impact of this intervention in reduction of case burden?
Dear Dinka
please read this:
https://www.nottingham.ac.uk/helmopen/rlos/ebp/rct/page_three.html
and/or arsk the author Dr Amit SIngal for his paper on " A primer on Effectiveness and Efficacy TRials" at amit.singal at utsouthwestern.edu
good luck with your reaearch!
Dear Dinka
Putting it simply, a therapeutic EFFICACY study is one in which the therapeutic agent is investigator administered and a therapeutic EFFECTIVENESS study is one in which the therapeutic agent is self administered by the participants. Effectiveness studies, also known as "pragmatic" studies carry a high risk of protocol violations due to misadministration of treatment, missed follow ups, and regrettably misinformation about what was done given by the participants. The four pragmatic studies we have conducted incorporated so many procedural violations by participants that it was difficult to identify a per-protocol outcome group.
Therefore, my recommendation would be to conduct a relatively small proof of principle efficacy study first so that you have a baseline set of data and follow that up with a larger effectiveness study with as many safeguards for data integrity built into the protocol as it is possible to achieve.
Kind regards
Ian
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