Embracing Fiction Writing Techniques for Regulatory Submissions

Using Speculative Fiction Techniques to Enhance Regulatory Submissions 

Speculative fiction is a broad genre of literature that explores hypothetical worlds and events that are often set in the future or fantastical places of our imagination. Speculative fiction interrogates the present by imagining possible futures, drawing on hypothetical scenarios like the oppressive theocracy of The Handmaid’s Tale, the tech-driven dystopias of Black Mirror, and the intergalactic political intrigue of Dune. At its core, speculative fiction delves into what could be, prompting us to ask, “What if?” and inviting us to explore the implications of the answers. 

When it comes to crafting regulatory submissions for drug and medical device development, some principles of speculative fiction can be surprisingly relevant. Just as speculative fiction writers use world-building and scenario planning to craft compelling narratives, regulatory medical writers must construct logical, evidence-driven frameworks around nonclinical and clinical data. Behind every submission lies an overarching challenge: anticipating the unknown. By using a little imagination and proactively addressing potential questions from regulators, sponsors and medical writers can create a more robust submission that is well-prepared for scrutiny by regulatory bodies.  

World Building: Defining the Regulatory Space 

In fiction, world-building means crafting a coherent, immersive setting. In regulatory writing, it means fully mapping the complex environment that has been, and what is anticipated to be, the development experience of a drug or device. Questions that the sponsor and medical writer can ask themselves include: 

• What is the regulatory landscape today, and how might it shift? 

• What external pressures (political, social, technological) could have influence? 

  
  

By viewing the regulatory space as an interconnected “world”, writers can better anticipate evolving challenges to pinpoint potential areas of friction and navigate them with a sense of preparedness. 

Character Motivation: Think Like A Reviewer 

In speculative fiction, characters are driven by their motivations, shaping the course of events through their decisions and actions. Similarly, regulatory reviewers are influenced by their own set of priorities: balancing risk management, established precedents, and the paramount goal of protecting patient safety. To think like a reviewer, one can ask:  

• What important risks need thoroughly addressed?  

• Where might the data appear weak or messaging ambiguous? 

  
  

By stepping into the reviewer’s shoes, sponsors and medical writers can map out potential regulatory feedback in order to be proactive in identifying and addressing prospective challenges. 

Crafting “What If?” Scenarios: Play Out Alternate Realities 

A practical example of crafting “What if?” scenarios might involve preparing an Investigational New Drug (IND) submission, perhaps around nonclinical toxicology data. By asking "What if there are concerns about drug-induced liver injury based on high-dose animal studies?", the sponsor can conduct additional studies or risk assessments in advance and work with the medical writer to refine key messaging around the first-in-human dosing strategy. This method of scenario mapping can refine messaging and allows opportunity for building additional needs into critical-path timelines. 

Write Like a Storyteller, Think Like a Scientist 

Good fiction uses effective storytelling to weave together well-developed ideas, plausible scenarios, and foreshadowing to craft compelling and engaging narratives. In regulatory writing, sponsors and medical writers should use the data to tell a story, while also proactively acknowledging concerns. Strong medical writing doesn't just summarize data, it builds trust by guiding the reviewer through a logical, transparent, evidence-based story. 

By incorporating speculative fiction writing techniques into the overall development strategy and regulatory document authoring, the kind that asks “What if?” in order to pressure test hypotheses and sees reviewers as part of the narrative building process, we can create strategic language with clearer messaging. Anticipating potential risks and regulatory feedback through plausible, hypothetical scenarios empowers the team to address challenges proactively, strengthening the submission and increasing its chances of success.