A few years ago, the EU parliament passed EU Regulation 536/2014. Article 37 mandates that the results of pharmaceutical clinical trials need to be easily read and understood. Having easy-to-read information provides more transparency and accessibility for the general public.
The easy-to-read version of the clinical trial report is called a lay summary.
This summary needs to be really understandable. According to the recommendations, lay summaries should be readable by a 12-year-old. In addition, these summaries are expected to be available in the local language of every EU country in which the study took place.
Here at Content Rules, we’ve been focused on readability and global readiness for many years. We have always maintained that the more readable your content is in English, the better translations you will have.
Conveniently, readability and global readiness share the same guidelines. Following these guidelines, you can produce a lay summary that meets the needs of all readers.
1. Use short sentences
The number one thing you can do to make your lay summary easier to read and translate is to shorten your sentences. Long sentences are confusing. They make the summary cumbersome and difficult. The rule of thumb is to keep your sentences to a maximum of 26 words. If you find yourself using a lot of commas, stop and split up your sentence.
2. Say the same thing, the same way, everywhere you say it
In addition to using short sentences, you should use and reuse the same phrases and words. Saying the same thing everywhere reduces ambiguity in the summary. In addition, you save money in translation.
3. Standardize terminology
Standardizing terminology is an even more granular way to say the same thing, the same way, everywhere you say it. For readability and translatability, it is important to pick one term and avoid all of its synonyms. Synonyms can be ambiguous and they are definitely costly to translate.
4. Use consistent grammar and style
As you shorten your sentence length and limit your variety of terms and phrases, pay attention to using correct grammar and consistent style. Avoid nuanced sentence structures and phrases. The simpler your writing, the better it will be for everyone in all languages.
5. Avoid jargon and scientific/medical language
The target audience for lay summaries is not familiar with medical terminology. When you write a lay summary, it can be tricky to avoid medical terms. But it is possible to do. Use simple, commonly understood words to replace “medicalese,” wherever you can. If a medical term is absolutely necessary, add a simple and understandable explanation.
Lay summaries are an important element of clinical trial documentation. Delivering understandable information about the results of your trial is mandated by EU 536/2014. When you keep your lay summaries simple in English, translating them is quicker, cheaper, and faster. Everyone gets content they can understand.
If you need assistance writing or simplifying your lay summaries, we can help!
EU Regulation 536/2014 Explained
Article 37 States: “Within one year from the end of a clinical trial in all Member States concerned, the sponsor shall submit to the EU database a summary of the results of the clinical trial…It shall be accompanied by a summary written in a manner that is understandable to laypersons.”
Annex V. of EU Reg. 536/2014 lists the required contents of this easy-to-understand report:
- Clinical trial identification (including title of the trial, protocol number, EU trial number and other identifiers);
- Name and contact details of the sponsor;
- General information about the clinical trial (including where and when the trial was conducted, the main objectives of the trial and an explanation of the reasons for conducting it);
- Population of subjects (including information on the number of subjects included in the trial in the Member State concerned, in the Union and in third countries; age group breakdown and gender breakdown; inclusion and exclusion criteria);
- Investigational medicinal products used;
- Description of adverse reactions and their frequency;
- Overall results of the clinical trial;
- Comments on the outcome of the clinical trial;
- Indication if follow up clinical trials are foreseen;
- Indication where additional information could be found.
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