Today’s targeted oncology therapies have the potential to provide patient benefits far beyond those seen in more traditional treatments. Because they are specifically designed to interrupt signals from the oncogenic driver mutations in tumors, they can deliver much higher objective response rates (ORR), leading to prolonged survival.
These mutations are, however, found only in a small fraction of patients, making it extremely difficult to identify eligible participants for clinical studies. Sponsors who rely solely on the timeworn method of asking sites that have performed well in the past to find patients in any given new study run the risk of drawing out the recruitment phase of their trials and adding substantially to their development costs. Regardless of how detailed the feasibility assessment conducted and how capable the selected sites may be, recruiting patients with required mutations via preselected sites can be like waiting for the needle to jump out of the haystack.
It is, therefore, critical to identify from the outset the most appropriate strategies for recruiting patients, to ensure that valuable time is not lost in inefficient efforts. Just-in-time site activation is an approach that has proven successful in studies of targeted therapies/rare diseases and is worth considering as a solution. The following paper explains how just-in-time site activation works, when it is recommended and what factors determine its success.