Business Brief: Creating Compliant Content

Business Brief

Creating Compliant Content

by Maria Bavishi, Associate Scientific Director, Axiom

Introduction

Creating sales training content can be one of the most challenging types of medical writing to perfect. Not only does it need to be clear, precise, engaging, and, most importantly, easily understandable for the learner, but it also needs to strike the right balance between scientific knowledge and compliance. Training content helps to build an informational foundation for the learner so that they can accurately and impactfully engage with their customers, who are usually healthcare providers (HCPs). It also provides them with the boundaries for remaining compliant. Engaging with HCPs requires an in-depth understanding of both the drug that they are as well as the disease state targeted by the drug. But to speak with authority on what are often complex disease states and treatments while remaining on-label requires more than just a general knowledge dump. It requires the right knowledge building, so the learner feels confident and empowered when engaging with their customers.

So, what is the best way to ensure that the training curriculum being developed leads to the sales representatives always staying compliant, on-label, and on message? An obvious practice is to have stringent writing and editorial protocols in place. But what else can you do? Some of my best practices when developing content include the following:

  • Identify your audience and their training needs
  • Align on learning objectives at the start of the project
  • Determine how those learning objectives can be grouped in individual assets
  • Decide on the best content modalities to communicate the learning objectives
  • Develop a curriculum map so learners can see where the content falls within the curriculum
  • When writing, determine what’s “need to know” vs “nice to know” content

Identifying the audience might seem obvious, but this goes beyond just identifying the type of learner, but also includes what these specific audiences need to know about the disease state and product. Writing for a sales representative is very different than writing for a medical science liaison (MSL) or healthcare provider (HCP), primarily because the base of knowledge is different for these groups. But when developing content, I try to dig deeper to determine what the audience really needs to know.

Doing this step first leads naturally into the next: developing comprehensive learning objectives for the curriculum. This allows me to 1) focus on what the audience needs to understand the topic at hand, and 2) ensure that I am including all essential information about the topic. I like to take a final step when developing learning objectives for sales representatives—layering in the messaging I know they will need to use when speaking with customers. This ensures that the content is focused, ultimately increasing the learner’s ability to stay compliant. Once complete, the learning objectives can be grouped to help identify specific content topics. Historically, sales training content was developed in a modular format, with each module covering multiple learning objectives and numerous topics. While having a textbook-like resource can be valuable for accumulating a foundation of knowledge, it can also lead to essential information being buried and hard to find. More recently, many companies like mine have taken a microlearning approach to develop content. A comprehensive microlearning curriculum typically includes different modalities, with each asset covering 1-2 learning objectives and taking no more than 10-15 minutes to review. Types of modalities can include:

  • Short digital learning assets
  • Infographics
  • Backgrounders
  • Podcasts
  • Explainer or whiteboard videos
  • Magazine articles

This approach not only accommodates all different learning styles but also allows for creating assets that provide the best “fit” for the information being covered. For example, the MOA of a new drug might best be explained through a short video, while a review of unmet needs might be better suited for a podcast. Regardless of the formats used, a final step in developing compliant content usually includes the development of a curriculum map. This provides the learner with a high-level view of the training and can help them quickly identify where a specific topic might be found within the curriculum. This is critical because if a sales representative can’t easily find a topic they need to refresh on prior to customer calls, they are tempted to look online, which can lead to them presenting non-compliant, or even incorrect information when talking with customers.

I want to talk for a moment about specific content to include in training materials, specifically “nice to know” vs “need to know.” I think I can speak for many scientific writers in that we love to share as much information as possible. I get caught up sometimes in the topic at hand and want to share every cool fact with the learner, especially as interesting content can go a long way in encouraging engagement. However, I’ve learned over the years that less is often more in regards to retention of knowledge. I start by including all the “need to know” and adding only the “nice to know” that is needed to build a strong foundation, and then layer in any specific messaging. This naturally leads to content that is both compliant and on target.

Conclusion

Writing within the pharmaceutical industry can be challenging, primarily due to the numerous regulatory and legal requirements for correctly communicating disease state and brand information. When the challenges of translating highly complex scientific concepts for learners who may not have much of a scientific background are considered, there are many chances for incorrect or even non-compliant content to sneak in. Developing a structured project plan that includes writing and editorial processes, identified learning objectives, and a detailed curriculum map can go a long way toward ensuring compliant content. While remaining compliant is the goal, I think it’s important to recognize that creating engaging and interesting content is equally important. This is where microlearning really comes into play. It’s targeted enough to ensure that compliant content is being accurately covered and engaging enough to interest even the most reluctant learner. And as far as I’m concerned, the biggest compliment to any training I develop is to hear: “That was really fun training! I actually understand [the topic] so much better now.” Any training that is fun while still being knowledgeable and compliant is a success in my books.

“The most compliant training in the world is useless if no one wants to actually review that training.”

Maria Bavishi, Associate Scientific Director, Axiom

About ACTO

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