Translation plays a crucial role in the success of a diverse and inclusive clinical trial, from patient recruitment to retention to the trial’s completion. Making clinical trial content available and understandable in patients’ native languages can help build trust, promote inclusivity, improve the patient experience, and expand patient awareness and engagement.
#1 Communicate Complex Content in the Patients’ Language
Understanding medical information can be challenging, whether clinical trial content or results from an annual checkup. One’s level of health literacy influences their health behaviors and ability to navigate the healthcare system. Studies have found:
- 88% of adults living in the U.S. have inadequate health literacy to navigate the healthcare system and promote their well-being.
- 55% have an intermediate proficiency.
- 22% have a basic proficiency.
- 14% have a below-basic proficiency.
- Only 12% are proficiently health literate.
Given such a low health literacy, clinical trial information must be easy to understand.
Europe addresses complex information through regulation (EU-CTR 536/2014) passed by the European Medicines Agency (EMA) in 2022. This regulation requires pharmaceutical companies to provide a Plain Language Summary (PLS) for European clinical trials. A PLS explains complex information about the trial without medical terminology and industry jargon written at a 6th to 8th-grade U.S. reading level.
The same concept should be applied to U.S. trials and other trial information, especially content for participants. When complex content is written without medical terminology, it makes it easier to translate into other languages, opening up the opportunity to reach more diverse patients.
| Clinical Trial Content for Translation |
| · Marketing Materials
· Website Copy · Informed Consent Forms (ICFs) · Patient-Reported Outcomes (PROs) & (ePROs) · Study Protocols · Case Report Forms (CRF) · Quality of Life (QoL) Measures · Clinical Outcome Assessments (COA) & (eCOA) · Medical Safety Reports & Adverse Events · Questionnaires |
#2 Create Translated Materials and Experiences Along the Patient Journey
Provide translated materials using plain language for all the content along a patient’s journey, from promotional materials to website copy to results. Continuing to speak a patient’s language and providing support during every part of the clinical trial process will help with patient retention.
Provide Interpreters
Providing Interpreters is another crucial way to provide language support throughout the clinical trial process. Many people find it easier to talk, especially about complex subjects. Interpreters offer that human connection that may bring comfort, which in most cases can improve the value of clinical trial feedback. In addition, medical interpretation provides a critical role in patient recruitment and retention by bridging the gap between trial team members and LEP patients. Medical interpreters support patients during the recruitment, trial, and post-trial processes.
#3 Provide Culturally Appropriate Translations
It is not always enough to translate text word for word – the translations must also accurately portray cultural intricacies for the target audiences. Being culturally relevant means ensuring that content, including questions, examples, and other materials, fits the target audience’s culture. So, the materials are created and designed for a specific audience.
For example COVID-19 Vaccine Clinical Trial Localization
In this scenario, a pharmaceutical company conducts a global clinical trial for a COVID-19 vaccine candidate. The trial aims to evaluate the vaccine’s safety and efficacy across multiple countries and diverse populations.
The organizers recognize that the trial demands research from different cultures, which may have varying levels of understanding and acceptance of vaccines. They work with a translation and localization organization to develop culturally sensitive communication materials that address concerns and provide accurate information tailored to each region’s cultural norms and values using native-speaking linguists.
The trial materials, including informed consent forms, patient information sheets, and questionnaires, are translated into the local languages spoken in each participating country, and the text is adapted for cultural nuances. This ensures that participants fully understand the trial procedures, potential risks, and benefits, which could be the difference between whether or not you meet several important ethical and legal principles.
The trial organizers design recruitment strategies that resonate with each region’s population. This may involve using culturally relevant advertising and outreach methods to attract participants. Additionally, they consider local factors that might affect participant retention, such as socioeconomic status, transportation, and access to healthcare.
Localization fosters improved engagement by creating a sense of trust and understanding among participants, leading to better engagement and compliance throughout the trial.
In addition, clear communication, tailored to each region’s language and cultural context, results in more accurate data collection and reduced misunderstandings.
In this example, the pharmaceutical company’s proactive approach to localization resulted in a more effective and culturally sensitive clinical trial for the COVID-19 vaccine, ultimately contributing to the global fight against the pandemic.
Engaging a translation company that works with translators who have a deep cultural understanding of the target audience is essential. Being culturally relevant will promote trust and experience, which helps to recruit and retain patients.
#4 Tap into Patient Advocacy Groups to Recruit Patients
One way to recruit patients is to partner with the right advocacy groups. An advocacy group already has relationships with potential patients, and if the group supports a clinical trial, it will provide more weight and establish more trust. In addition, an advocacy group can open up a new and more focused recruitment avenue, promote the trial through their channels, narrow the search for the trial’s requirements, provide recruitment and retention strategy input, and much more.
Partnering with support groups for patients and their family members is another way to make connections and recruit patients for clinical trials. Support groups work to establish trust with their patients, and if they advocate for a clinical trial, patients will be more likely to research it and participate. For groups that support those with LEP, providing translated information and support will go a long way in recruitment and retention.
#5 Be Accessible for Patient Support
Naturally, people interested in a clinical trial will have questions, so be prepared with patient support, which can come in many forms.
One way to do this is to have a frequently asked questions page on the website and clinical trial documentation translated into all potential languages of interest. In addition, make sure to provide contact information for those with additional questions.
In addition, provide support and call center hours with human interpreters who can talk to interested patients and answer questions live. Having a live interaction with a native speaker may give the trust and comfort that an interested person needs. Keep in mind that potential patients, including international participants, may do their research after hours, so sponsors should provide live support when their audience is available to research the trial.
Reliable Clinical Trial Translation
Through strategies such as simplifying complex medical content into patients’ native languages, providing interpreters, offering culturally appropriate translations, partnering with patient advocacy groups, and ensuring accessibility for patient support, clinical trials can overcome language barriers, promote inclusivity, and enhance patient recruitment and retention efforts. Examples, such as the EU regulation mandating plain language summaries for clinical trials and a scenario depicting a culturally sensitive COVID-19 vaccine trial, illustrate the importance of these strategies in fostering trust, understanding, and engagement among potential participants.
How Morningside Can Help
We are a leading provider of professional translation services, offering comprehensive solutions to support patient recruitment and retention in clinical trials. Specializing in the life sciences industry, we ensure accurate and culturally sensitive translation of all trial materials, including informed consent forms, patient information sheets, and promotional materials. Our expertise in cultural adaptation guarantees that translated content reflects the nuances and sensitivities of diverse patient populations, fostering trust and engagement throughout the trial process.
Moreover, we provide both on-site and phone interpretation services to facilitate effective communication between trial staff and patients with limited English proficiency (LEP). By offering language support during recruitment, trial procedures, and post-trial processes, we enhance participants’ overall experience, ensuring comprehension and adherence to trial protocols. With a commitment to timely delivery and adherence to industry regulations, we enable sponsors to execute their recruitment and retention strategies efficiently, ultimately contributing to the success of clinical trials.
Our dedication to quality, accuracy, and compliance empowers sponsors to engage with diverse patient populations effectively, overcome language barriers, and drive the success of their clinical trials. By leveraging our translation and interpretation services expertise, sponsors can enhance patient recruitment and retention efforts, ultimately advancing medical research and improving patient outcomes.
Download our latest whitepaper for more details on The Role Translation Plays in Clinical Trial Recruitment and Retention.
About Morningside
As clinical trials have become more international in scope, precise translations and rigorous quality controls have become even more essential. That’s why the world’s largest pharma companies and CROs choose Morningside, a Questel Company, to help them deliver better outcomes through reliable clinical document translation and linguistic validation services. Clients trust us to handle their most valuable data and mitigate risk for various clinical trial documents, from patient questionnaires to case report forms (CRFs). Our translators consistently deliver linguistically accurate, culturally adapted documents so our clients can deliver results. Contact us to begin your next clinical trial translation project.
Anna Eisenberg is an Associate Director of Life Science Business Development at Morningside, with 20+ years of experience in the localization industry and a focus on life sciences. She is responsible for Morningside's life science strategy and maintaining relationships with global leaders in the field. Anna expertly advises pharmaceutical and medical device companies on best translation practices and is an expert in implementing workflows that improve quality, reduce costs, and accelerate deadlines.