CRO uses site data when new studies begin
Predicted vs. actual results matters
Cato Research, a clinical research organization (CRO) in Durham, NC, maintains a database and metrics on all studies, continually comparing sites' predicted study enrollment with their actual performance.
This information can be very helpful when the CRO is selecting sites to work with on new studies, says Lisa Sanders, PhD, RAC, senior clinical strategy scientist for Cato Research.
"It's more valuable than cold-calling sites we don't know," Sanders says. "I think it is a trend that most CROs now are maintaining historical information on sites they've worked with because they want to go back to sites that are good ones."
Sites that collect data and typically are private and profit-driven have increased in the last five years, and from a CRO's perspective, there is a big difference between their approach to research and the typical approach of the traditional university-type research sites, Sanders notes.
When CROs want a site that is performance-driven with fast enrollment, the professional sites often are the answer, she adds.
However, their past performance cannot be the only criteria for selecting them for a new study.
"We typically will always do a site visit and a little more investigating because things could change," Sanders says. "They could be fabulous on one study, but very driven by a site manager who has left, and on subsequent visits they didn't perform as well."
Some of the other important criteria in selecting sites for studies include these, she says:
- What is the site's prior overall experience, particularly with regard to a study's specific disease or indication?
- How many patients are in database who meet the study's enrollment criteria?
- What are some of the site's other approaches for recruiting outside of the patient database?
- How will the site identify new patients to bring in?
- What kind of support, including advertising support, will the site need during recruitment?
- Have the investigators read the protocol before we get there for the site visit?
- Can the site do the study within the timeframe required?
- Does the site have time to do the study and is the staff available to pay attention to it?