Expedite Study Startup: Four Strategies To Optimize Site Activation

Sluggish study startup affects sponsors, contract research organizations (CROs), sites, and most importantly, patients—but despite incentive from virtually every study stakeholder to hurry up, startup timelines are more prone to delays than any other stage of the clinical trial.

Delayed site activation is a big reason. More than 80 percent of clinical trials miss onboarding timelines, often by months.¹ The National Cancer Institute (NCI), for example, expects protocols to activate in eight to 12 weeks. And yet, roughly 66 percent of NCI-participating centers have fewer than 10 percent of studies running within three months.²

Why is Site Activation a Challenge?

Unfortunately, finding sites is a perennial problem—mostly because it is difficult to identify and connect with sites with the appropriate patient population for a study, or once found, they lack the staffing to take on additional trials. Burnout associated with administrative hassles like redundant trainings or paperwork can drive the phenomenon.

Recently, an Advarra survey among site, sponsor, and CROs found 73 percent of respondents indicated staffing would worsen over the next 12 months.³ Even among the well-staffed sites better equipped for these changes, sponsors can still struggle to activate them. Fierce competition for patient pools in large-scale studies for cancer or heart disease often tap out eligible participants. Similarly, rare diseases can mean fewer patients and thus, fewer principal investigators (PIs). Cumbersome trainings, duplicative, unconnected technologies, and misaligned expectations can all further contribute to bumpy study starts.