The European Medicines Agency announced that it would require pharmaceutical companies to provide a “plain language summary” (PLS) when disclosing clinical trial information from next year to promote the participation of patients and the general public in clinical studies.

To meet the requirement, multinational drugmakers started to establish information-sharing platforms.

In Korea, however, the clinical trial information disclosure system was implemented belatedly in October 2019.

Even doctors and pharmacists find it difficult to search and collect information about trials conducted before October 2019 by domestic drugmakers and biotech ventures. Observers said this could widen gaps between multinational players and local pharmaceutical firms in terms of trial information disclosure.

Pfizer recently said it would disclose all its trial results using PLS from 2022.

Although medical terms such as “adjuvant therapy,” “pharmacologic effect,” and “standard-of-care” are not used by most people in everyday conversation, such medical terminology has long been part of clinical trials, and this made it challenging for the public to understand, Pfizer said.

The company is making efforts to change this by releasing results of clinical trial studies to the general public in plain language.

Pfizer has been sharing trial results in plain language with the general public since May, but the company will disclose all global clinical trials from phase-1 to phase-4 in plain language, it said.

Pfizer’s move came after the EMA established the plan for “plain language study results summaries” (PLSRS).

Europe and the U.S. are already sharing detailed information on all clinical trials through the clinical trial information disclosure sites EudraCT and Clinicaltrials.gov, respectively.

However, information on the two sites has been used mostly by experts, and it was difficult for patients and the general public to understand many jargons on the sites.

Pharmaceutical companies provide separate platforms for clinical trial participants, but most of them require the input of specific patient information. They are difficult to search on portals, and the information is provided in technical terms.

The European regulator will mandate pharmaceutical companies to offer clinical results in PLS from next year to tackle this problem.

“Under the new EMA regulation, it is expected that PLS will be required starting in 2022,” Pfizer said. “Pfizer will soon begin translating its plain-language summaries into other languages, such as Spanish, French, and German.”

While multinational drugmakers are quickly adapting to European regulation, Korean drug companies are expected to lag behind the international trend significantly.

The Ministry of Food and Drug Safety introduced the clinical trial information disclosure system in October 2019. So, there is limited access to the information about clinical trials conducted before October 2019.

The Korean system requires the regulator’s input of the information, but the MFDS suffers a staff shortage. This situation makes it extremely difficult for local companies to provide even basic information about the technology used in clinical trials, observers said.

Korean drug companies will have a long way to go from conducting clinical trials to providing trial results in PLS on par with global leaders, they said.