Gilad Gilad

How To Write Patient Friendly Inclusion/Exclusion Questions? – TrialX Investigator Manual FAQs

One of the most daunting pieces of information about a clinical trial is the text regarding inclusion/exclusion criteria. The complex trial description and the medical terminology can frighten and deter patients from volunteering to clinical trials. This is particularly true for cancer and other chronic disease trials.

Our recommendation, without disregarding the IRB’s guidance, is to use the simplest English that you can and to keep things to a minimum. Remember that the true screening will be held at your site, and the online screener is there to filter out the obvious patients that will not match the criteria.

In the trial page under the Detailed information section, specify the exclusion/inclusion criteria using at most 3-4 simple to understand question. Here are some examples:

You may be eligible to participate in the study if you meet the following the criteria:

1. Do you have Diabetes?

2. Are you between the age of  18-65?

3. Do you take any insulin?