ICON implements new Lay Protocol Synopsis (LPS) program

Increased trial transparency has been a growing industry trend for many years. The largest recent initiative in this realm is the European Medicines Agency’s (EMA’s) Clinical Trials Information System (CTIS), which went online in January 2022. Among the requirements within the CTIS is the creation of a Plain Language Summary (PLS) of clinical trial results. The CTIS implementation will consist of a 3-year rollout. By the second year of the rollout (beginning in January 2023), PLS will be required for new clinical trials in the European Union (EU). ICON has been proactive in establishing a team of PLS writers and editors who have produced hundreds of these documents well before the CTIS initiative.

However, as part of the CTIS rollout in January 2022, the EMA released a Questions and Answers (Q&A) document that recommends the creation of an LPS, which is a plain language summary of clinical protocols. Current guidelines and required content are murky, as is any possible timeline for LPS becoming mandatory for future EU studies.
However, some sponsors have been proactive in enacting LPS for their studies.

A sponsor hired ICON to create an LPS. This was the sponsor’s first LPS, as well as the first LPS written by ICON. Furthermore, the sponsor requested the LPS be produced within an aggressive timeline (sponsor requested finalised document within 3 weeks, while ICON currently uses a 4-week timeline). As the LPS is a new concept across the industry, ICON Clinical Trial Transparency team had only recently created a process, template, timeline, and internal training program. Furthermore, the EMA LPS guidelines require the document to be within a 2-page limit, despite having robust requirements for included content and lay language best practices. 

The team identified the key activity milestones and timelines required to meet the sponsor’s deadline. In parallel, ICON identified and provided internal training and proactively resourced the LPS for internal reviews to maintain the aggressive deadline. The team was able to quickly identify and concisely summarise the required content to
keep the LPS within the difficult parameter of a 2-page limit.
 

ICON successfully delivered the finalised LPS within the abbreviated timeline to achieve the sponsor’s goals. This was accomplished by proactive internal collaboration between the writer and editors, as well as thorough and clear communication with the sponsor’s review team. ICON’s expertise, adaptation, collaborative mindset, and internal processes enabled timely delivery of the LPS while maintaining high quality and accuracy. Due to the team’s performance and flexibility, the sponsor plans to resource future LPS to ICON.