Abstract
Background Blinding is a pre-requisite to high standard clinical trials of medicinal products (CTIMPs), but this requirement, can on occasions, present complex challenges in placebo matching and delivery. OBS2 is a trial evaluating the effectiveness of early fibrinogen administration in the management of complex postpartum haemorrhage. Fibrinogen concentrate is a white powder that froths distinctively on reconstitution and a suitable placebo, that could match these characteristics, could not be identified during the trial design stage.
Highlights
Blinding is a pre-requisite to high standard clinical trials of medicinal products (CTIMPs), but this requirement, can on occasions, present complex challenges in placebo matching and delivery
OBS2 is a trial evaluating the effectiveness of early fibrinogen administration in the management of complex postpartum haemorrhage
The method follows a three stage process of adding dilutant to sleeved ampoules, drawing the reconstituted IMP into black syringes, and excess air expelled into a starch
Summary
Blinding is a pre-requisite to high standard clinical trials of medicinal products (CTIMPs), but this requirement, can on occasions, present complex challenges in placebo matching and delivery. Obvious (once revealed): a novel approach to blinding medicinal products for injection From 3rd International Clinical Trials Methodology Conference Glasgow, UK.
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