The much-anticipated 2014 European Union Clinical Trial Regulation 536 (EU CTR) requiring the sponsors and academic researchers conducting research trials to draft layperson/plain language summaries (PLS) is set to go into effect in 2023. The regulation will most likely flow to other countries and will be adopted by various regulatory organizations such as FDA and TGA.

 

The purpose of a lay summary is to help research participants and the general public better comprehend the findings of clinical studies. This endeavour not only helps to demystify the clinical research procedure but also offers the major conclusions of clinical studies in a manner that is specially tailored to persons with limited health literacy. The intended audience is anybody who is interested in research; as a result, the target audience is diverse and may include study participants, healthcare professionals, carers, and members of the general public.

 

The use of advanced platforms like Clinials to assist researchers in deciphering complex clinical trial procedures and medical language could boost trust, transparency, and collaboration between sponsors, study sites, and participants, as PLS, are intended to improve participants’ understanding of trial process and outcomes.

 

What Impact Does It Have on Researchers?

Researchers often face challenges as they tend to use medical language due to their profession and may experience difficulties translating the complex medical language into plain language summaries (PLS) as they have inadequate resources such as having access to advanced digital platforms that may help with PLS. The upcoming 2023 EU Clinical Trial Regulation 536 requirement for EU layperson/ plain language summaries (PLS) may impose further challenges to the researchers as changing medical language to plain language is not their specialty.

 

The regulation (PLS) will potentially flow to other countries’ jurisdictions and soon become a common practice among the clinical trials sector. Regulatory organizations such as FDA and TGA  are likely to follow suit and continue to broaden the guidelines and regulations to encourage greater patient-focused outcomes from sponsors, etc, Therefore, in order to connect the dots between researchers and the general public, AI and automation can be used to speed up the process and aid researchers and participants in deciphering complicated clinical trial procedures and medical language. 

This is where advanced clinical trials platforms such as Clinials come in. With the aid of Clinials, pharmaceutical researchers can accelerate the participant recruitment for global trial locations and automate the process of determining eligibility. Most importantly, using AI and automation, Clinicals can help researchers communicate medical information to patients in plain language, which will ultimately satisfy the EU Clinical Trial Regulation 536 (PLS) requirement. 

 

The upcoming EU Clinical Trial Regulation 536 requirement will shape the clinical trials and medical industry’s standards. There is no doubt that the regulation will bring a positive impact. Especially to patients and participants who are more likely to benefit due to increased trust, understanding, etc. However, researchers may still have a hard time translating into plain language summaries (PLS).

 

Clinials is a digital platform that utilizes technologies such as AI and automation to aid researchers and participants demystify complicated medical language/ clinical procedures. For more information on how Clinials can help provide plain language summaries (PLS) for your study, use the Clinials plain language starter pack