22 Jun Flexibility key to clinical trial success

Michael Causey, The Association of Clinical Research Professionals (ACRP)

It’s probably time to remove the cookie-cutter mentality from your clinical trials operational tool kit. Specifically, it’s important to note that not all solutions are “one size fits all,” and each organization or project team needs to implement a “fit for purpose” model for each study, says Vatche Bartekian, president of Vantage BioTrials Inc. He adds, “After all, in my own 23-year career, I’ve never seen two studies which were ever exactly alike.”

However, that doesn’t mean some of the same problems and challenges don’t keep cropping up over and over, Bartekian says. “Clinical trial performance data continue to show, in a not-so-promising and alarming trend, that project success remains out of reach for many sponsors due to a multitude of factors, including lack of process coordination, communication shortfalls, participant recruitment/retention challenges, and loss of budgetary control,” he explains.

Clinical trial practitioners shouldn’t be surprised by these trends, Bartekian says. “Many of us know what to look out for in terms of high-risk indicators for our projects,” he notes. “However, we often get overwhelmed with the amount of risk indicators we have to keep track of and pay attention to on an ongoing basis.” Read more …