Placebo-controlled clinical trials: how trial documents justify the use of randomisation and placebo

by Tapani Keränen, Arja Halkoaho, Emmi Itkonenet al.
BMC Medical Ethics 2015, 16:2 (11 January 2015)

11 pp. 124 kB:

Randomised clinical trials (RCTs) involve procedures such as randomisation, blinding, and placebo use, which are not part of standard medical care. Patients asked to participate in RCTs often experience difficulties in understanding the meaning of these and their justification. The authors conclude that the justification of placebo control was inadequately described in the RCT study protocols, by principal or national co-ordinating investigators, and in participant-information documents. Furthermore, possible health-related risks associated with the use of placebo were poorly explained in the participant-information documents.

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