Considering the concept
Concept protocols offer an excellent opportunity to capture your study design ideas, stimulate discussion with project teams on the fundamental aspects of a study and provide a means of achieving team alignment before investing the resources required to develop a full protocol. They are short, flexible documents that can be reviewed quickly and edited easily. However, this can encourage teams to develop multiple drafts. When do you stop? How many drafts should there be? What should you include?
Artificial intelligence, machine learning and large language models are getting everywhere and influencing everything, to the good and to the bad. We have updated our Insider's Insight to consider the impact that these tools will have on protocol development [1]. One clear takeaway is that in order to accelerate a clinical trial you have to reduce your complexity - also a subject recently considered by our Managing Director, Dr Tim Hardman (here).