It was Guy Fawkes’ Night in the UK here yesterday, 05 November – commonly known as Bonfire Night. Which reminded me of a phrase used by a colleague in the industry last week when we were discussing trial protocols – that there should be a bonfire of eligibility criteria to enable a much wider audience to participate in trials.

The sentiment stems from the fact we’ve both seen protocols that have simply been copied and pasted from earlier protocols for trials in the same therapy area.

Leading to the sometimes ludicrous requirement for such things as a patient needing to have a low Body Mass Index – when the condition in question has a side effect of obesity.

Reviewing a protocol’s eligibility criteria against the specific outcomes you want to measure for your current trial can help remove these unnecessary elements, expanding the target audience and improving your recruitment efforts.