09 Sep 6 key elements to writing a strong clinical trial protocol synopsis

A clinical research protocol is a roadmap. In order to have a clear roadmap, it is important for the investigator to have a succinct and relevant synopsis that others can review at a glance for a general sense of direction. In Lewis Carroll’s Alice in Wonderland, the King says to the White Rabbit, “Begin at the beginning, then go until you reach the end. Then stop.” He could have been telling an investigator about the process of crafting a clinical trial protocol. The synopsis is often used when investigators apply for grants or seek to obtain resources and other support to undertake the study. For medical school residents, a synopsis can be used as a discussion point with an advisor. For investigators...