Global Impact in Clinical Trials: Strategies for Success
Today, medical companies recognize the need for patient cohorts in clinical trials to resemble the affected populations. As these clinical trials become increasingly multicultural and decentralized, linguistic, cultural, and technological considerations add to the complexity of ensuring inclusivity and accessibility.
Effective localization for global decentralized clinical trials starts at the business unit or program level (before the individual trial is even designed) and involves a cross-functional team of experts who deeply understand a global audience’s communication needs. By establishing a system for leveraging the existing content ecosystem within your organization, particularly the glossaries, termbases, user content, translation memories, etc., you can efficiently design more inclusive clinical trials.
Table of Contents
Benefits of a System Approach
The benefits of a system approach to global clinical trials extend far beyond the clinical trial itself:
Safety and Legal Liability
Consistent, clear content that is written in plain language using controlled vocabularies, such as Simplified Technical English, facilitates accurate localization, and improves patient retention, safety, and compliance with clinical protocols. Increased compliance and safety lead to better patient outcomes and improves the fidelity of the data. In addition, consistent terminology reduces the likelihood of technical inaccuracies, mistranslation, or other mistakes, reducing legal liability issues.
Regulatory
The FDA and EU authorities require professional translation of all patient-facing materials into a language the participant understands. The EU-CTR further stipulates that translations be provided in the respective country’s official language (or languages). This includes localizing into English variants when necessary. Regulatory agencies love consistency and process, so handling content systematically helps you meet these requirements while also helping you scale efficiently.
Patient and Physician User Experience
Well-run clinical trials and research depend on physician and patient compliance with clinical protocols. Failure to comply results in skewed or unusable data. Compliance and trust increase when the content provides clear instructions and explanations of what to expect using culturally appropriate examples. When the content is linguistically and culturally appropriate to the audience, physicians and patients stay engaged and committed. Leveraging the existing content ecosystem and managing terminology provides a better, more unified experience, gives you better data, and helps maintain brand integrity both during the clinical trial and after product approval.
Accessibility and Inclusivity
While the World Health Organization lists the U.S. as the top country for clinical trials, even in the U.S., approximately 21.6% of the population are non-native English speakers. This means you need plain language content and a localization strategy, even if you only plan to run clinical trials in the U.S.
In addition, many strategies needed for effective localization also benefit accessibility requirements for screen readers, cognitive disorders, and machine learning (including AI).
Costs
Systems facilitate efficiency, effectiveness, and scalability, which help mitigate the costs and complexities of localization and decentralization when developing a global clinical trial. Leveraging existing systems in the organization helps accelerate timelines and allows for better resource allocation, while automating data collection and reporting can provide improved regulatory compliance, as well as greater efficiency and scalability.
Components of the System
The system includes the people, processes, and technology required to deliver world-class global clinical trials that reflect the diversity of the affected population biologically, linguistically, culturally, and socioeconomically. Most medical organizations already have a robust system of checks and balances in place for managing the flow of content throughout the organization. By leveraging these existing systems, you can more quickly develop and scale a program for conducting global clinical trials while ensuring your physician partners and patients receive the information and care they need.
People
Establishing your expert cross-functional team of advisors is the first step when setting up systems for managing the content and localization for global clinical trials. This team will save you a great deal of time and effort by helping you to leverage existing systems for your needs:
Technical communication: Also known as documentation or content development, this team develops the physician- and patient-facing content that ships with the products, as well as other materials needed by technical support, training, and others. They manage large volumes of content and know how to structure information so that it can be reused in other places. They often work across the organization to develop style guides, templates, controlled vocabularies, and other resources that might be useful to you. Content quality assurance also often resides under their umbrella.
Marketing: These professionals often have insight into market expansion priorities, customer research, a list of high-value customers, and access to graphic designers and others who might help create attractive, culturally appropriate messaging.
Localization: Larger organizations often have a team responsible for liaising between the localization service provider (LSP) and the other internal teams that need localization services. This team understands the organization’s localization maturity level, knows all the players, and can help you determine an effective strategy for your localization needs. In other companies, though, especially emerging global companies, the relationship with the LSP and responsibility for content localization is an add-on or minor part of another role.
Regulatory: Most clinical trial teams already work closely with regulatory teams. This team also typically works closely with the localization team to make sure the organization is complying with local regulations and translation requirements and is typically involved in reviewing product documentation, marketing materials, and other content for compliance.
Clinical Trial Partners: Your investigators and other clinical staff will likely have an intimate knowledge of the local population’s needs and culture. Use that understanding when developing clinical trial materials, particularly physician instructions and patient-informed consent. It’s a good idea to work with these teams to do some usability testing as you prepare for the clinical trial. Establish relationships to easily identify and troubleshoot any issues with the content.
Processes
Documented, repeatable processes are critical, especially in ISO-certified organizations. When it comes to creating, managing, and localizing content for clinical trials, two process areas are particularly important:
Source Content Strategy, Operations, and Quality:
Quality localization starts with quality source content. Quality source content starts with effective content development, quality assurance, terminology management, and change management processes. The technical communication team can assist you in leveraging existing processes, as well as help ensure your content is global-ready and supports localization, and smaller companies sometimes outsource that to a localization provider as a preprocessing step.
Localization Strategy and Process:
When evaluating your localization landscape, you have some decisions to make about the depth of localization, number of locales (combination of language, culture, and geography), budget, tone and style, and so on. Your LSP and internal localization team can work with you to establish a strategy that makes sense for you and to identify areas of special consideration. Leveraging existing localization processes and relationships with your LSP will save you time and money when setting up the program. You will most likely also want to leverage the existing translation memories for your purposes.
Technology
No amount of technology will solve people and process issues, so dial those in before focusing too much on the technology. When thinking about technology as it relates to global clinical trials, there are two areas to think about:
Internal content and data management systems: As much as possible, leverage the existing internal systems for managing content and data. They form the system of record for the product you are evaluating and will help you ensure that you meet the regulatory requirements for your content. In addition, leveraging these existing systems enables you to ensure consistency and to scale more quickly.
Digital Health Tools (DHT): If you are doing decentralized trials, DHTs can facilitate physician and patient-facing communication, improve regulatory compliance, and improve efficiency with data collection, analysis, and reporting. However, these tools also need to be localized to be effective. When designing or evaluating these tools for purchase, make sure that the engineers consider the needs of a global audience so that the functionality and interface work in all languages. For example, field label size needs to accommodate text expansion; the database setup needs to accommodate accent marks, measurement conversions, etc.
Localizing Clinical Trial Content: Lessons Learned
Eliana Riviera Burke joined us on our podcast a few months ago and shared some lessons learned both as a cancer survivor herself and as the Head of Client Engagement and Marketing at GreenLight Clinical. Her unique experiences have solidified her commitment to patient advocacy and professional excellence.
In clinical research trials, accurate and culturally sensitive translations are crucial to ensure that participants fully understand the study and their rights. Here are some things you should make sure you do when translating clinical trial content:
1. Translate for Meaning
The translation should convey the intended meaning rather than just a literal translation of each word. Direct, word-for-word translations can lead to misunderstandings, especially when idiomatic expressions or culturally specific terms are used.
2. Use Only Qualified Translators
Ensure that translators have expertise in both the language and the medical or technical content. Using unqualified translators can lead to inaccuracies and misunderstandings. In addition, such misunderstanding could have serious safety or legal consequences.
3. Understand Cultural Context
It’s important to consider cultural differences in communication styles, health beliefs, and perceptions. Failure to adapt content culturally can result in misinterpretation or offense.
4. Use Consistent Terminology
Ensure that the same terms are used consistently throughout all documents (one word—one meaning). Inconsistent terminology can confuse participants and lead to noncompliance.
5. Always Do Back-Translation
Skipping back-translation (translating the document back into the original language by a different translator) can prevent you from identifying errors or misunderstandings in the initial translation.
6. Minimize Medical Jargon
Participants should be able to understand the information easily. Avoiding unnecessary technical terms helps ensure clarity. Use plain language and controlled vocabularies to help maintain consistency.
7. Plan Ahead and Leave Enough Time for Translation
Rushing can lead to errors and oversights. Adequate time should be given to ensure accuracy and quality.
8. Ensure a Human Review of Machine Translation
While machine translation can be a helpful tool, it should never replace human translators, especially for sensitive and complex medical documents. Always have machine translations reviewed by a professional.
9. Comply with Regulatory Requirements
Ensure that translations comply with local regulatory standards. Neglecting these can lead to non-compliance with legal requirements and result in expensive delays or fines.
10. Include Local Dialects and Variants
In regions where multiple dialects or language variants are spoken, it’s important to use the appropriate version to ensure understanding.
Following these guidelines helps maintain the integrity of the trial and protects the rights and well-being of participants.
Conclusion
Localization in global clinical trials isn’t just about making materials understandable—it’s about making them accessible, culturally relevant, and engaging. As clinical trials become more decentralized and diverse, adopting best practices in content creation and localization is essential to success. By establishing a system for managing this content and working cross-functionally to leverage your organization’s existing people, processes, and technology, you can scale faster and more efficiently while meeting the needs of your stakeholders and regulatory bodies. Together, we can create a more equitable and effective clinical trial experience for your patients, physicians, and clinical researchers wherever they live and work and in whatever language they prefer.
As clinical trials continue to evolve, localization will remain a strategic imperative, directly impacting the patient’s quality of experience and the trial’s overall success.
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