Recruiting for diabetes trials has grown increasingly complicated as more investigators compete to attract a limited population of patients, and face the constant risk of attrition and patients who fail to comply with the treatment protocol. Changes in the regulatory approval process have only added challenges to this process. To meet requirements, including evaluation of cardiovascular risk, investigators are being forced to increase their sample sizes, recruit higher risk (and thus harder to find) patients, and create endpoint-driven, intent-to-treat (ITT) study designs.
It can feel overwhelming, however it doesn’t have to be. When investigators follow these planning tips, they can improve their recruiting efforts, reduce attrition, and improve the probability of success.