Updated on 9 October 2014
Mr David Horsburgh, associate regional patient and site services lead, Quintiles Asia
With surveys indicating that 70 percent of clinical trials across Asia, Europe, Canada and Latin America experience delays and only 15 percent of Asian trials are completed on time1,2 ─ contributing to higher development costs and delays in getting more efficacious treatments to patients, there are great incentives to isolate the root cause of delays. One key factor is clinical study site selection.
A comprehensive site identification and startup solution is of the essence, considering feasibility, regulatory, documentation, patient recruitment, and perhaps foremost, review of each site's previous trial experience for an indication of how sites are performing.
What about sites without trial experience, called naïve sites in industry parlance. Should a lack of experience be considered a red flag? Quite the contrary, recent analysis using data from 14 studies across Asia conducted by Quintiles suggests that naïve sites could provide a solution to struggling recruitment and reduce the burden of increasing study timelines.
The analysis covered five key therapeutic areas including oncology, diabetes, cardiology, psychiatry, and rheumatology. Based on records in Quintiles internal databases and Clinicaltrial.gov, sites that had conducted protocols were classified as experienced and those that had not conducted prior protocols were classified as naïve. Experienced sites were further grouped according to enrolment performance on their previous studies into high, middle, or low performers.
Results across the 14 studies indicated a vast disparity among experienced sites. While some sites have proven to be capable of high patient enrollment, there are sites that have consistently enrolled at a low level; enrolling 0.28 patients per month or at a rate only 34 percent of what is seen at top performing locations. Most interesting of all however, was naïve sites that were conducting a clinical trial for the first time also regularly enrolled patients at a faster rate than experienced sites with a history of low performance. The average enrollment rate from naïve sites was 0.47 patient per month, which is 68 percent higher than experienced low performers, with this pattern repeated in four out of the five therapeutic areas investigated including oncology, diabetes, cardiology and rheumatology.