Preventing Unintentional Unblinding In Clinical Trials

It’s well known that clinical trials have become increasingly complex and costly over the past few decades. The globalization of trials, the addition of extraneous protocol procedures and complex study designs are some of the main contributors to the escalation in clinical trial spending. In fact, an industry survey published in 2013 reported that the average cost per patient in a Phase II trial has risen to $38,000 and for Phase III that figure is $40,000 to $42,000 per patient. With all the planning and expense required to launch a successful adequate and well-controlled study, attention to every detail, no matter how small, is critical. This includes details that help to make certain that the study is free of any bias. According to ICH E9, the most important controls in avoiding bias are randomization and blinding. Randomization was covered in detail in a previous paper (insert link for Randomization paper) and we will now review topics dealing with preserving the study blind, sometimes called the mask, as well methods of avoiding unintentional unblinding and partial unblinding.