Patient recruitment is one of the most critical elements of a clinical trial. Without sufficient participation, studies will lack the power to demonstrate statistical significance and the efficacy of new treatments. Ultimately, poor patient enrollment will delay or prevent new therapies from reaching the market. Not only do such delays cost millions of dollars, but they also deprive patients of effective, potentially life-changing treatments.
Screening and recruitment failures loom large across the industry, with 50 percent of trials delayed due to patient recruitment issues, according to a 2016 report in Pharmafile. Each day of delay costs an average of $600,000 but can go as high as $8 million a day for very complex studies. What’s more, once the trial is underway, up to 30 percent of recruited patients drop out.
Considering that it costs an average of $6,533 to recruit one patient and $19,533 to replace a patient who drops out, study sponsors are motivated to find solutions that optimize enrollment of the right patients from the beginning, and minimize patient dropout after enrollment.