For patients, finding a clinical trial can be a challenge in and of itself. So imagine the frustration patients feel when they can’t find results of a study in which they have participated.
Many sponsors do post study results on ClinicalTrials.gov. However, patients often are overwhelmed by the sheer number of studies listed, difficulty in navigating the site, and the verbiage used, which can come across as medicalese to non-healthcare professionals.
Here’s where health literacy comes in. Some sponsors also are providing clinical trial plain-language summaries (PLS) on their own websites. These summaries, typically written at a 6th- to 8th-grade reading level, are designed to be easily understood by the public.
Sponsors must be careful to avoid the appearance of any promotional language when it comes to PLS. Regulatory agencies such as the European Medicines Agency (EMA) mandate that PLS be objective and unbiased. That’s why PLS also should be posted on a portal, designed to host PLS, that is open to all sponsors.