Qualifying patients for trials can cause a lot of headaches. Very strict Inclusion/Exclusion criteria is now the norm for most trials, making it difficult to find people who match exactly with the trial protocol. In my experience, some of this is based on ‘cutting and pasting’ criteria from previous trials, which can lead to irrelevant criteria being included.

The ideal path is to have a pre-screening process – probably online – that filters out people who wouldn’t qualify.

Then, a swift follow-up to confirm or further qualify them against the I/E criteria. Having medically-trained people follow up by phone within an hour of the application has often worked best for optimal results.

And making the informed consent process as simple as possible – perhaps using an explainer video or presentation – is another vital ingredient for success.