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Trials and Tribulations By Annette Keith

Here at Real Science, we are powered by curiosity and we love a pint. The Pint of Science Festival was made for us! Over the past week, we sent some of our intrepid science explorers to investigate some of the fascinating topics that were on offer. We came, we saw, we took notes.

Nothing new for us, the discussion of clinical trials … but not normally in a pub. Actually, that’s not true – I’ve discussed many a clinical trial in a pub, but maybe I shouldn’t admit to that. Anyway, in this thoroughly enjoyable Pint of Science event, Abda Mahmood, Julie Fox and Stephen Nash invited us to learn about their clinical trials in two very different settings.
The first was the CRASH-3 trial of tranexamic acid for traumatic brain injury (TBI; NCT01402882). Previous studies have already demonstrated impressive efficacy in general trauma and now the investigators are evaluating if tranexamic acid can minimise intracranial bleeding and reduce mortality – results of the ~13,000 patient trial are due this year.
The second was an HIV prevention trial, involving nine treatment arms of different PreP (pre-exposure prophylaxis) regimens, 144 foreskins from willing volunteers, and some speedy tissue transport across Sub‑Saharan Africa to determine the risk of infection.
Along with the clinical and biological discussions, we enjoyed the ethical conversations initiated by both the speakers and members of the audience. They included the issue of informed consent, which you can’t typically gain in an emergency (there is an exception in the ICH guidelines – who knew?!), the need for a placebo control even where there is expectation that an experimental treatment will work, and how there is a need for pragmatism when designing trials in challenging settings.
All in all, a great event and one that caused us to think about clinical trials from a different perspective.