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23 June 2016Big Pharma

Life Sciences Law Forum 2016: Transparency of clinical trial data

After the “EU Summary of Clinical Trial Results for Laypersons” was published for consultation in June, a counsel from Novo Nordisk discussed the importance of providing reliable information for patients at an industry event in London.

Rhianon Ebsworth, senior corporate counsel at the company, was one of the panellists in the “Transparency of clinical trial data” session today, June 23, at the Life Sciences Law Forum 2016.

As was discussed it is a requirement for all clinical trials in the EU to make a lay summary available for participants after the clinical trial has concluded.

A lay summary of a clinical trial is a report written in ‘plain English’ or other languages which is made easily accessible for participants in order to understand the results of the study.

The key issues which were raised by Ebsworth were the challenges of the lay summary’s principles, the preparation process and its distribution after it has been completed.

“One of the main challenges with writing a lay summary is that we are trying to write scientifically for a non-scientific audience”, Ebsworth said.

She added: “It should strike a balance between making sure the audience understands the subject, however without losing the message of the results, which usually are scientifically complex.”

There are many requirements and guidelines laid out for the publication of the lay summary, such as having it written for a reading age of as young as 12 years old, and also written in the native language of the target audience.

There are further challenges which arise in terms of distribution, as it is also a requirement for the summary to not be promotional for any parties, and this further brings up challenges of where the publication should be available.

Ebsworth was also joined by two other panellists, who discussed other aspects of transparency of clinical trial data, namely the European Medicines Agency’s position on clinical trial and regulatory data, and the importance of integrity as well as transparency.