We’ve analyzed data from 299 studies, comparing sites which were ‘successful’ in enrollment (i.e., randomized 75% or more of targeted patients) with those which were ‘unsuccessful’ (randomized less than 75% of targeted patients).
We asked sites to rate if they had issues with 14 categories (e.g., site compensation, eligibility criteria, CRA personnel) and the presence or absence of 123 attributes (contact me to get a list of the categories and attributes).
‘Unsuccessful’ sites identified 25 attributes as issues far more frequently than did ‘successful’ sites. The 25 attributes can be grouped into four categories:
- Issues with passwords and/or software 8 attributes
- Protocol-related issues 5 attributes
- Issues with site compensation 3 attributes
- Miscellaneous issues 9 attributes
What is the takeaway message? While new software programs are very helpful to sponsors, they frequently cause significant issues for site staff.
Ross H. Weaver, PharmD, MBA