You know your sites need promotional materials for your study, and you hire a vendor to create them. They are authorized by the central IRB and distributed to sites. You discuss them with the study coordinators. You hold a teleconference to answer questions. You remind them in your newsletter. Now, four months later, you find that sites complain they don’t have promotional materials. What is going on?
You realize there are some challenges to site requirements for some of the study subject visits for your protocol. You develop training materials. You provide reminder tools describing what needs to occur during each visit. Three months later, you hear from sites that they don’t know what they are to do each visit and need some support materials. What is going on?
It is easy to get frustrated. After all, haven’t you done everything you can do? Why don’t site staff use what you’ve provided them?
Unfortunately, no, you haven’t done everything you can do. What you can do is repeat your messages. Over, and over, and over. Ten years ago the rule was that messages had to be repeated at least seven times to stick. Now, with the internet and the massive number of messages seen every day by your site staff, estimates are that messages must be repeated as many as 20 times to stick. 20 times!
While the exact number of times messages must be repeated is uncertain, I’m pretty sure the optimal number is more than the number of times you’ve repeated your messages to sites.
- Identify site-based issues that are slowing patient enrollment or randomization (yes, we can help!).
- If training, promotional support, or other materials need to be created, create them.
- If sites have the materials, patiently remind them of the materials and how to use them. Answer their questions.
Ross H. Weaver, PharmD, MBA