FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Translational Sciences (OTS) partnered with CDER’s Office of Communications (OCOMM) to create the Guidance Snapshot Pilot Program. The program communicates guidance recommendations to multiple stakeholder audiences using visuals, plain language, and other innovative technologies to increase awareness and understanding of CDER’s often complex guidance documents.

In this CDER Conversation, ShaAvhrée Buckman-Garner, M.D., PhD., director of CDER OTS, and James-Denton Wyllie, director of CDER OCOMM, discuss the Guidance Snapshot Pilot Program and why their offices partnered to help educate stakeholders and increase public awareness of CDER guidance documents.

Let’s first discuss guidance documents. What are guidances, and why are they important to CDER’s work?

Mr. Wyllie:

In general, guidances represent FDA's current thinking on a topic. They are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agency's interpretation of our policy on a regulatory issue and usually discuss specific issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products. When it comes to the development of new drugs and therapeutic biological products, CDER uses guidance documents to provide updates on the necessary study design elements and other data needed in the drug application.

 

What is the Guidance Snapshot Pilot Program?

Dr. Buckman-Garner:

The Guidance Snapshot Pilot Program consists of both guidance snapshots and the Guidance Recap Podcast. Guidance snapshots are visual documents that convey key recommendations from guidance documents using plain language and graphics. They are communication tools and are not a substitute for the guidance document.

The snapshot offers a condensed look at:

• What each guidance recommends
• Why the guidance is important
• Background information about the guidance topic
• When to apply the guidance recommendations during the development process
• Where to submit official comments (for draft guidance documents only)

Each snapshot also includes a link to a Guidance Recap Podcast episode, which provides highlights and background information on guidance documents through conversations with the authors.

Why is it important to ensure multiple audiences have access to the recommendations presented in guidance documents?

Mr. Wyllie:

CDER has a mission to help ensure the availability of safe and effective drugs to improve the health of people in the U.S. To be successful in its mission, CDER must communicate its current regulatory processes to wide-ranging stakeholder audiences to promote a culture of two-way engagement and, ultimately, enhance drug development and safety. Many assume that drug developers are CDER’s only audience for guidance documents. However, the translational science that fosters drug development occurs from bench-to-bedside (from the laboratory to the provider’s office) and involves different stakeholders participating in every step along the development process, including research scientists, academics, policy makers, patients, advocacy groups, and health care professionals.

It is essential that the information presented in CDER’s guidance documents is accessible to multiple audiences. However, due to the nature of the material, our guidance documents tend to be very technical. Plain language communication that our audiences can understand the first time they read or hear it is the key to bringing clarity to guidance recommendations. OCOMM is committed to using innovation to provide:

• Content in written, graphic, and audio formats to reach our stakeholders using their preferred media type
• Reader-friendly information that multiple audiences can easily understand
• Materials that allow multiple audiences to easily find important information they can use and act on

 

Why did OTS and OCOMM partner to launch the Guidance Snapshot Pilot Program?

Dr. Buckman-Garner:

The vision for OTS is to drive advancements in human health through scientific and regulatory innovation. Our core values are communication, creativity, innovation, accountability, leadership, collaboration, and civility. Our office spends significant time developing and clearing guidance documents that represent our best thinking on a regulatory issue.

OTS started developing snapshots to enhance awareness of OTS-led guidance efforts. Over time, the program expanded to support guidance efforts led by other CDER offices that highlight important drug development-related recommendations. As a result, OTS and OCOMM partnered to launch the Guidance Snapshot Pilot Program to increase awareness and understanding of CDER guidance documents on topics that seek to modernize drug clinical trials and accelerate drug development. We hope the Guidance Snapshot Pilot Program will enhance our stakeholders’ understanding of the agency’s thinking on topics that seek to modernize drug clinical trials and help bring safe and effective therapies to the public we serve.

 

Can you tell me more about the process OCOMM uses to innovate the guidance snapshots?

Mr. Wyllie:

While OCOMM’s graphic designers use innovative communication methods to make the snapshots accessible to our audiences, we still must follow specific standards and laws to create the highest-quality design for the snapshots.

When we launched the pilot program, OCOMM developed a template to ensure the snapshots have a consistent look and feel, match the tone of the topic, and allow our audiences to easily find the information they need. To do this, we followed the U.S. Digital Design Standards from the U.S. Web Design System (USWDS). Simply put, digital design is the process of mapping out the look and feel of the content people view and interact with in a digital interface.

We also closely follow the 21st Century Integrated Digital Experience Act, or 21st Century IDEA, a 2018 law that aims to improve the digital experience for government audiences and reinforces existing requirements for all federal public websites. The law requires government agencies to adhere to the U.S. Digital Design Standards and use available technology and innovation to provide cohesive, user-friendly digital services to the U.S. public. OCOMM takes this mandate seriously and works with OTS to ensure the snapshots and all other digital products align with the USWDS best practices.

 

To wrap up, can you share what’s next for the Pilot Program?

Dr. Buckman-Garner:

We are continuing to update and enhance our guidance snapshots and podcasts and now have an opportunity to expand the program to the patient community. We are excited to soon launch the first guidance snapshots and accompanying podcast episodes that are specifically intended for patients. The first two snapshots and podcast episodes will be for the following guidance documents:

• Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs
• Patient-Focused Drug Development Guidance 4: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making

 

Both snapshots are slated to launch soon. Follow @FDA_Drug_Info on Twitter for updates!