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The process study was carried out between January 2003 and April 2004 on 29 out of the first 31 trial consultations.
In this efficacy, safety and pharmacokinetic trial, HIV positive or negative patients presenting with malaria symptoms were recruited from routine clinics and attended trial consultations individually as out-patients until Day 42.
However there were significant differences between the two groups with regards to the cost of training (significantly higher for lay educators) and the cost of delivering the trial consultations (significantly lower for lay educators).
The length of the trial consultations were not recorded during the trial, therefore an assumption was made that the consultations lasted as detailed in the protocol for the two face-to-face consultations (1st consultation 45 minutes, 2nd consultation 30 minutes).
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In this article, we share our perspectives in the consideration of adaptive design clinical trials based on our experiences discussing adaptive design in clinical trial consultation meetings in Japan.
The PHCT member who knew the woman best, often the GP, chaired each trial consultation.
For many patients, the condition underlying their trial consultation was not their only health problem.
Each of the forty seven mothers in the intervention group participated in one trial consultation.
A time and date for the consultation was also arranged to suit all participating in the trial consultation.
At the trial consultation, the Lead Clinician consents and randomises the patient into the 'comparison' or 'intervention' group.
Ninety participants were recruited and, after completing their pilot trial consultation, all participants were then invited to be interviewed.
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