Variation in site recruitment performance is a major risk factor for CROs and their sponsors according to new research.
The research by the Tufts Center for the Study of Drug Development revealed that although 90 per cent of clinical trials reach their recruitment goals, signing up the required number of patients usually take twice as expected.
The Tufts analysts looked at 150 clinical trials involving 16,000 sites and found that to attract participants, sponsors and contractor tend rely on traditional recruitment tactics, such as physician referrals and media ads, and “have yet to embrace non-traditional approaches, including social media.”
Tufts research director Ken Getz said: “Patient recruitment and retention are among the greatest challenges that the clinical research enterprise faces today, and they are a major cause of drug development delays.
He added that: “The results of our recent study paint a complex picture of global practices and their effectiveness and characterize a very high level of investigative site performance risk.”
Regional enrollment variation
Trial sites in Western Europe performed the best in terms of study start-up, with 93 per cent achieving ‘site activation,’ with an average of 92 per cent of research centres in Eastern Europe and 91 per cent Asia achieving site activation.
Tufts also reported that: “Enrollment achievement rates vary by region, ranging from 75 per cent to 98 per cent of targeted levels, with Asia/Pacific and Latin America achieving the highest rates.
“11 per cent of sites in a given trial typically fail to enroll a single patient, 37 per cent under-enroll, 39 per cent meet their enrollment targets, and 13 per cent exceed their targets.”