Many of the delays seen in trials these days originate in the start-up phase. The parties agree to get moving, and then a protocol is untenable, or the investigators can’t find as many patients as expected, or regulatory snafus appear. Chaos ensues. Feasibility studies can be a way to circumvent all that, asserts Javier Revuelta, MDS Pharma Services’ head of clinical operations for Europe and Asia. As more sponsors are taking their trials global, feasibility studies are becoming more common. Dedicated Unit MDS has a unit dedicated to the start-up phase of its clients’ studies—and half of that unit’s resources go toward feasibility studies. What exactly is a feasibility study? A detailed survey, usually of the study sites, “to assess and define how the study will be managed, and whether it is something that can be managed,” said Revuelta. Sometimes the focus is on exactly how many patients an investigator has…more...