Med WritingRegulatory

Lay Summary Development: The Oregon Trail of Regulatory Writing

 Lay Summary Development: The Oregon Trail of Regulatory Writing

The Oregon Trail: one of the most iconic and cherished computer games of all time, filled with boxy graphics, heartache, and the occasional bout of dysentery. Players took on the role of wagon party leader, navigating the unchartered frontier of the Wild West in 1848—all the way to Oregon's Willamette Valley. Gamers found themselves thrown into a world where strategy was essential to choosing how to navigate the trail while preserving resources and supplies.

The world of lay summaries is a bit like the Oregon Trail, where authoring and review processes have yet to be navigated by many study sponsors. Impending regulation throws study teams into the Wild West of regulatory documentation, where they are forced to use available resources to keep up with legislation. What happens when resources are limited or the path is unclear?

A lay summary of results, otherwise known as a plain language summary, is a brief synopsis of a research project or clinical trial that has been written for participants in the study and members of the public. It should be written in plain English, keeping concepts straight to the point and easy to understand.  

Regulation (EU) No. 536/2014 for clinical trials of medicinal products for humans is a recent regulation by the European Commission, which requires that a lay summary be produced for every interventional Phase 1–4 clinical study, set to be published on the coming EU clinical trials portal. Any clinical trial maintaining a study site within the EU, as well as clinical trials submitted for marketing authorization within the EU, will be affected. Summaries should be produced within one year from the end of the clinical trial, or six months if a pediatric study.

The purpose of this regulation is to ensure consistency in the conduct of EU clinical trials, as well as easy establishment of multinational clinical trials. The EU portal will benefit the public greatly, as patients, caregivers, and loved ones will be able to clearly review study information in a consistent format. This enables transparency across the pharmaceutical and biotech industry, supporting greater patient participation and disclosure of trial results irrespective of the outcomes.

Even though this regulation was set to be enforced as of June 2014, the actual period of relevancy does not begin until the EU portal and database is complete. The anticipated start date will likely fall in late 2020. Once the regulation comes into effect, sponsors have only six months until the regulation requires action on their part.

This Wild West world of lay summaries is largely untouched by study sponsors. Lay summaries are newly regulated and difficult to create, especially when teams are accustomed to highly technical material. Teams will have to plan to use resources such as graphic design and illustration, lay-language-trained medical writers, and translation for various countries and cultures.

We’ve mapped out a guide to the major “trading posts” along the trail where you can make sure your lay summary is stocked with the essential resources and processes for a successful outcome:

  1. Start a Task Force: This team should be composed of a medical writer, major members of the study team, and any other personnel assigned to review the lay summary. Team members may include a statistics director, patent attorney, patient engagement lead, and more. 
  2. Train Your Task Force: Build and implement a training program for this task force, covering lay summary regulation, author and reviewer “dos” and “don’ts,” and lay-language best practices.
  3. Create a Template: Develop the lay summary template and content parameters for each section, such as style, language, and literacy level.
  4. Get the Data: Obtain the clinical study report, statistic sources, and any relevant study material.
  5. Make a Timeline: Create a timeline for the lay summary, keeping in mind the number of drafts and review cycles required.
  6. Have a Kickoff Meeting: Start the writing process with a kickoff meeting between the medical writer, study team, and all personnel assigned to review the lay summary.
  7. Write like Your Readers Are 12 Years Old: Develop a lay summary for the general public at a sixth- to eighth-grade reading level, assuming no prior knowledge of the study or research area.
  8. Be Visual: Incorporate graphic design to construct non-promotional infographics and illustrations to make the lay summary interesting and understandable to readers.
  9. Get It Reviewed: Send the lay summary for study team and patient review, to evaluate readability, relevancy, and comprehension.
  10. Repeat Steps to Refine: Repeat cycles of team review, graphic design, and patient input as required until the lay summary is ready for finalization.
  11. Have a Formal Quality Review and Approval Process: Complete a thorough quality control and approval stage.
  12. Localize Content as Needed: Translate and distribute the lay summary to all countries in which the study took place.

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