This thought piece explores the concept of agile working for the pharma world, delving into the opportunities and challenges that arise for CI teams and managers as working environments adapt to find success in a more dynamic, uncertain, and fast-paced environment.
If agile is the answer, what is the question?
At the heart of pharma stands the monolith that is the clinical trial protocol: three phases; strict regulations governing every aspect of each; enormous quantities of clinical study report data to be captured and translated into coherence. This is the template that pharmaceutical companies have incorporated into every aspect of their decision-making process. Upon these three cascading phased tiers are all pharma workflow decisions made. This structure is immutable, and pharma companies monkey with it at their peril.
Except… recent guidance from the FDA practically begs them to monkey with it. Consider the September 2018 guidance for industry, Adaptive Designs for Clinical Trials of Drugs and Biologics:
“Adaptive designs can provide a variety of advantages over non-adaptive designs. These advantages arise from the fundamental property of clinical trials with an adaptive design: they allow the trial to adjust to information that was not available when the trial began.”1
To anyone familiar with the plethora of modern workflow and productivity systems, that last sentence – allowing the trial to adjust to information not available at the beginning – can only mean one thing:
Somebody at the FDA knows – and cares – about agile.