Featured Industry: Regulatory

From Syllables to Readability, Preparing for Lay Summaries

Translating medical documents is often the right thing to do from an ethics perspective. In addition, successful outcomes to medical treatment are strongly influenced by linguistic and cultural access to care. Further, the translation of clinical and regulatory documents during the drug approval process is required and regulated by agencies around the globe.

However, medical concepts and language can be difficult to grasp. Patients and subjects should have access to easily understandable health information regardless of age, background or reading level, a concept that is addressed and formalized in the European Medicines Agency (EMA) Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use.

Summary of Clinical Trial Results for Laypersons

The new regulation, which recently was postponed from a 2018 roll-out to 2019, requires a Lay Summary. The goal of the document is to increase the transparency of clinical trial data. Translation into all European languages will be required. There is a guideline document, which includes several strict requirements (e.g. readability tests including syllable count, sentence length, etc.). Below is an overview of the guidelines and requirements for drafting summaries of clinical trial results for laypersons, which are published here. It also includes examples of readability tests by country.

  • Keep the document as short as possible. Don’t copy text from the technical summary, but rather rewrite it. Note: Explaining technical terms in simple language and translation to some languages may increase the number of words and result in longer documents.
  • Text should be understood by people with a low to average level of literacy. The average proficiency level in Europe is 2 -3. According to “Summaries of Clinical Trial Results for
    Laypersons” a proficiency level of 2 is defined as being able to identify words and numbers in a context and being able to respond with simple information.
  • Avoid long and complex sentences.  that include many clauses. These can be difficult to understand.
  • Use vocabulary that will be familiar to non-medical persons. Avoid jargon, technical or medical  language. For example, use the phrase “high blood pressure” rather than the medical term “hypertension.”
  • Reduce the number of unnecessary words. And, remove what could be considered complex words. For example, “use” rather than “utilize”.
  • Be consistent in the use of terms and words throughout the document, and then define them.
  • Ensure that the underlying concepts are clear and easy to understand. Where necessary, explain the underlying concept in further detail.
  • Avoid ambiguous words and phrases. For example, “felt badly” can be subjective and have different meanings from one person to another.
  • Use active, rather than passive, voice. The Summaries of Clinical Trial Results for
    Laypersons” gives this example:

Active voice: “Researchers studied the effect of tamoxifen on breast cancer.”

Passive voice: “The effect of tamoxifen on breast cancer was studied by researchers.”

Production of Summary of Clinical Trial Results for Laypersons

To address the forthcoming requirements and ensure quality, Welocalize Life Sciences has designed a workflow for the translation and validation of Lay Summaries, which includes creation of pre-production project-specific instructions and an internal quality assurance step.

Contact Welocalize Life Sciences for information on translation of summaries of clinical trial results for laypersons and other patient-facing medical and clinical documents.

Globe puzzle and stethoscope

Conducting Clinical Trials in Latin America

Speed is key in getting a drug from discovery through to market. Everything that streamlines the clinical trials process (without sacrificing safety and quality) is a priority to today’s drug developers because it is essential in shortening a product’s time to market. Clinical trials across multiple regions of the world have become common practice, with the goal of bringing new drugs and devices to patients around the world, as fast as scientifically possible.

Conducting clinical trials in Latin America provides sponsors large patient populations within a condensed geographical area. For example, more than 626 million people live in Latin America, with 70% of the population concentrated in urban areas like Buenos Aires, Mexico City, Sao Paulo and Rio de Janeiro.  Additionally, the commercial markets are attractive due to relatively lower cost for greater speed.

Latin America offers patients in medical centers with competent and qualified investigators and established regulatory systems at comparable cost. There are challenges, however, that require forward thinking and strategic planning to optimize timely study start and execution.

Selecting an Outsourcing Partner

One of the most important decisions a sponsor makes is choosing the right outsourcing partner to execute a successful clinical trial program in Latin America. Clinical trials conducted by a Contract Research Organization (CRO) may be completed more quickly than those conducted in-house by pharmaceutical companies, and there are some very compelling reasons for that.

A CRO with representation within the country will possess the expertise to navigate the waters of regulatory submission requirements within each given country, and lack of regulatory harmonization makes it challenging for the novice.  Approval times vary widely and omission of required documents will delay review.

Furthermore, challenges to be expected and managed include status of Intellectual Property protection from country to country, cultural and medical differences, logistical challenges around drug storage depots, patient biologic sample handling, regulatory challenges associated with adaptive trial design, ethic review process, and more.  Site feasibility alone must consider public perception and work to dispel misconceptions in multinational trials and identify and train sites of excellence, both in the private sector and in large metropolitan facilities.

An outsourcing partner must understand issues that affect the conduct of clinical trials unique to each country within Latin America, and be versed at accessing patients. They must have a representative that is a source of local culture, to provide insight to accommodate the diversity that exists within a given region in a country, and to address the challenges and concerns that arise.

Translation and Language Barriers

In addition to outsourcing the study execution, there is a translation component—working with a language services company who not only specializes in local languages and regional variations, but also translation of clinical research and regulatory documents. Only in some countries, the investigator’s brochure and a few other documents can be submitted in English, but these are rare exceptions. It is important to note that even though Spanish is spoken in most countries, except for Brazil, the meaning of certain words and phrases varies between countries.

Addressing language barriers therefore requires an understanding of the patient demographics in each country. Although all regulatory documents must be provided the official and written language of the country, any patient-related materials must be adapted for the target patient population. For example, the people of Peru predominantly speak three different languages: Spanish, Quechua and Aymara. In Colombia there are about 65 indigenous languages and nearly 300 dialects. Colombian Spanish is a mixture of the Caribbean dialect and Peruvian coastal dialect.

Dominant indigenous populations not only influence the way the language is spoken in each of these countries, but they are also responsible for differences in the local culture. Among the most common reasons for delays by ethics committees are problems with informed consent, and these are often associated with poor quality translation. In large part, this can be avoided if linguistic and cultural differences are properly addressed. Experts who are native speakers and have a background in clinical research are best equipped to perform such culturally sensitive translations.

Find Out More

For information on how Welocalize Life Sciences can accurately and efficiently translate and localize clinical research trial documents for Latin American countries, contact us. Listen to our webcast on optimizing outcomes for clinical trials.

For more information on conducting clinical trials in Latin America, consider these research-based papers and reports:

Cancer Clinical Research in Latin America

Doing Clinical Research in South America

Latin American Contract Research Organization Market

Portfolio Items