Lead CRA Q&A: Investigative Site Recruitment Plan

Have patients lining up to be in your trials

Mumbabe said…

I am a CRA stationed in the Netherlands. I have done a lot of Pre study site visits and I was wondering how do you ask potential investigators about the number of patients they are able to recruit? Which open ended phrases do you use? Here in NL it is really a big problem as most of the data managers have to go to their database to get such info and that takes them months.

The Lead CRA responds…

site director
Don’t roll the dice when it comes to
subject recruitment. Asking targeted questions
will help the  PI or Site Director to better predict
how many subjects they will screen/enroll. 

Investigators can usually tell you whether they will be recruiting primarily from their own patient database, advertising (remember all adverts need to receive prior approval from the sponsor AND IRB/Ethics Committee), or whether they will be sending Dear Physician letters to their known and trusted colleagues in the area.  Ask if they will be using one or a combination of these methods.  You could also bring this up in the context of a budget discussion, “Hey Dr. Jones, you will be paid $300 for each SF but up to $3000 for every subject that completes. How many subjects do you expect your site to contribute?”

Hopefully you will be blessed with enthusiastic sites and they will meet their projections but this is not normally the case. Remember, as the CRA, you are qualifying this site (please see a related post: Selecting Qualified Investigators) so thank them for their enthusiasm but be wary of high projections that are not in line with other sites. Be sure to ask them if they see any barriers to recruitment via protocol design (inc/exc too tight, prohibited con meds will make things difficult) or facility shortcomings (no freezer to hold DNA samples, staff shortage, 5 competing protocols, etc.).

Depending on the protocol, you as a CRA can have a direct impact on the recruitment. Call the site often and check in. Refer to a relevant article that discusses motivating your study coordinators. Also make sure they are adequately supplied and that they are looking at every patient who comes through the door as a potential research subject. MDs have many competing priorities, remind them to keep the study on their radar.

Reader questions may have been edited for spelling or grammar, for reasons of anonymity, truncated, or edited in other ways although the main content remains unchanged.

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About The Author

The Lead CRA

Nadia started The Lead CRA blog in 2007. She is now lead author for ClinOps Toolkit. Nadia is currently working as a Clinical Program Manager at a small specialty pharmaceutical company in the San Francisco Bay Area. You can reach Nadia via email at leadcra@clinopstoolkit.com anytime.