Selecting the right site is the single most crucial decision you’ll make about your next clinical trial. And perhaps the single most important consideration in selecting a site is whether it can make its enrollment. Many don’t; in fact, 20-25 percent of all clinical studies close because they fail to meet enrollment targets.
The startup process is often more complicated than either sponsors or sites anticipate. Research from March 2018 finds that:
- Average time from site identification to study start-up completion is 31.4 weeks; that’s a month longer than 10 years ago.
- On average, 11 percent of investigative sites initiated were never activated; what’s more, that figure hasn’t changed in 20 years.
For decades, CROs and sponsors have found their “best fit” sites and returned for future studies. But in the era of precision medicine and adaptive trial designs, that may not always be the best course of action. It is becoming increasingly necessary to turn to untapped resources to find potential enrollees. As research increasingly focuses on rare diseases with highly targeted patient sub-populations, the percentage of new sites is expected to increase.
According to Tufts research released in March 2018, sponsors and CROs report that 28 percent of their sites are new relationships with no prior history or familiarity. Those relationships can be tricky. The overall site initiation cycle time is nearly 10 weeks longer for new sites compared to repeat or familiar ones.
Moreover, sites with insufficient experience are more likely to violate protocols or have low-quality data, which leads to more on-site visits and more request for clarification—even additional training. And all of that takes time and money.
Download this whitepaper to learn how to find the best-fit sites for your clinical trials.