The Role Clinical Trial Translation Plays in Patient Recruitment and Retention

Health equity is an essential goal in modern healthcare, and one pivotal aspect of achieving this goal is ensuring that clinical trials are inclusive and representative of the diverse population they aim to serve. Clinical trials are the backbone of medical research, providing the foundation upon which treatments and medications are developed and approved. However, a glaring issue persists: a lack of diversity in clinical trials. Part of the underrepresentation can be addressed with intentional translation, localization and interpretation. In this blog, we will dive deeper into how clinical trial translation plays a crucial role in health equity. 

'Ensuring people from diverse backgrounds join clinical trials is critical to advancing health equity. Participants in clinical trials should represent the patients that will use the medical products. This is often not the case — people from racial and ethnic minorities and other diverse groups are underrepresented in clinical research. This is a concern because people of different ages, races, and ethnicities may react differently to certain medical products.'

- U.S. Food and Drug Administration

Ensuring full representation in clinical trials is essential to improving health outcomes. Pharmaceutical companies must understand how diverse populations respond to medications before they are approved for use in the general public. However, existing data highlights persistent inequities:

• Racial and ethnic minorities make up nearly 39% of the U.S. population, yet account for only 2–16% of clinical trial participants.
• African American participation is under 5%, despite a 14% higher risk of dying from cancer.
• Latino populations represent 18% of the U.S. population, yet only around 1% participate in clinical trials.
• Approximately 1 in 5 new drugs approved since 2009 have demonstrated differential responses across racial and ethnic groups.
• Additional factors such as age and gender also significantly influence how patients respond to treatments.

To address these gaps, changes are being introduced to ensure more diverse patient inclusion in clinical trials. In this context, clinical trial translation plays a crucial role in improving recruitment and retention, as patients are more likely to engage when materials are available in their native languages. Providing multilingual content and interpreters throughout the clinical process helps build trust, improves the patient experience, and supports more inclusive and representative research outcomes.

New Guidelines: Food and Drug Omnibus Reform Act of 2022

U.S. President Joe Biden signed the Consolidated Appropriations Act, 2023 (H.R. 2617) on December 29, 2022. The legislation includes the Food and Drug Omnibus Reform Act of 2022 (FDORA), which introduces provisions requiring the U.S. Food and Drug Administration (FDA) to issue new guidance on diversity action plans in clinical trials. This represents an important step toward ensuring that clinical trials are evaluated across all relevant patient populations, regardless of race, sex, or ethnicity.

Historically, identifying and enrolling a diverse patient population has been a significant challenge for pharmaceutical companies. Under the new framework, however, sponsors are expected to define and report their goals for diverse representation in clinical studies, including considerations of age, sex, and racial and ethnic demographic characteristics.

Diversity in Clinical Trials Improves Health Equity

Language barriers, both linguistic and cultural, are among the key factors contributing to the historical marginalization of individuals with limited English proficiency (LEP). In healthcare settings, LEP patients often face significant communication challenges, which can lead to poorer health outcomes, reinforce existing health inequities, and limit access to essential health information. Improving language accessibility therefore plays a critical role in advancing health equity for LEP and other underrepresented communities.

For clinical trial sponsors, there is growing demand for clear, consistent, and easy-to-understand materials translated into the target languages of the patient population. To meet the needs of diverse populations and ultimately improve health equity, sponsors must effectively communicate in the languages of LEP communities to support patient recruitment and retention at every stage of the clinical process.

A wide range of clinical trial documents require translation throughout the study lifecycle, including:

• Investigator’s Manual
• Clinical Study Protocol
• Clinical Study Reports
• Case Report Forms
• Adverse Event Source Documents
• Data Sheets
• Development Safety Update Reports (DSURs)
• Regulatory Dossiers
• Drug Registration Documentation
• Informed Consent Forms

The Crucial Role of Clinical Trial Translation in Advancing Medical Research

Clinical trials are a key driver of medical advancement, enabling innovations that improve patient care and transform healthcare systems. In today’s interconnected global environment, where collaboration extends across borders, precise and expert clinical trial translations plays a critical yet often underappreciated role in ensuring that medical breakthroughs are accessible across languages and cultures. From supporting patient understanding to enabling regulatory approvals, clinical trial translation is essential to the success of global clinical research. Recognizing its importance and applying best practices, allows researchers, sponsors, and healthcare professionals to advance medical knowledge while maintaining the highest standards of quality, ethics, and compliance. 

Accurate translation in clinical trials is indispensable, but its value extends beyond simply converting text from one language to another. Its importance can be understood through three key dimensions: 

Expanded Volunteer Pool: Translating key trial documents particularly informed consent forms enables research teams to reach a wider and more diverse participant base, increasing the number of eligible and willing study volunteers. 

Ethical Informed Consent: When Clinical Research Organizations (CROs) engage participants across different regions, accurate translation becomes an ethical requirement. Ensuring that essential information is fully understood allows participants to provide truly informed consent with confidence. 

Global Academic Collaboration: Translating clinical protocols and research findings facilitates the exchange of knowledge across international borders, strengthening collaboration between researchers worldwide. 

This is why many of the world’s leading pharmaceutical companies and CROs rely on professional language service providers, such as Questel, to deliver reliable clinical translation and linguistic validation services. Clients trust these services to manage sensitive clinical data and reduce regulatory and operational risk across a wide range of documents—from patient questionnaires to case report forms (CRFs). Through linguistically accurate and culturally adapted translations, organizations can achieve better clinical outcomes and support more effective global research programs. 

Unlock Further Insights in Our Webinar

If you are interested in unlocking more valuable insights into inclusive research and ethical global engagement, you can watch our experts discuss how to advance healthcare through diverse and inclusive clinical trials. 

Hosted by Morningside, a Questel Company, this webinar is designed to provide a fresh perspective on diversity in clinical trials, aligned with the latest FDA requirements and best practices in clinical trial translation. 

What should you expect from our one-hour presentation:

• Expert speakers: Listen to industry experts Sara Tylosky, CEO of Farmacon Global, and Anna Eisenberg, Director of Business Development for Morningside, a Questel company, as they share their insights, experience, and practical guidance on implementing diversity and translation strategies in clinical research.
• We were thrilled to have Sara Tylosky, MBA, join us. Sara is the CEO of Farmacon Global and brings over 20 years of experience leading teams across both large and small pharmaceutical environments. Over the past seven years as CEO, she has guided Farmacon Global, a strategic CRO of medical consultants, in accelerating clinical trials, improving patient diversity, supporting patient enrollment, and facilitating market access in emerging markets.
• Recognized for her strong cultural intelligence and problem-solving expertise, Sara and her team specialize in Rare Diseases, Immunology, Infectious Diseases, Oncology, and Vaccines. Fluent in Spanish and having lived on four continents, she has a particular focus on Latin America, while actively expanding into other key global markets. Her leadership continues to position Farmacon Global at the forefront of healthcare innovation and global market expansion.
• Farmacon Global accelerates clinical research and market access initiatives in emerging markets through a trusted network of on-the-ground medical experts. Its concierge model enables pharmaceutical and biotech companies to efficiently achieve their goals while saving time and resources. The organization delivers culturally tailored strategies for medical intelligence, market access, site activation, and patient enrollment, while helping navigate complex regulatory and logistical challenges. This extends across clinical sites, investigators, and patients in both the United States and emerging markets, supported by strategic partnerships with technology providers to streamline and accelerate processes.

Don’t miss this opportunity to revolutionize your approach to clinical trials, ensuring they are not only compliant but also genuinely inclusive. Embrace diversity, meet FDA requirements, and elevate your research to new heights. Watch the webinar recording now!

Anna Eisenberg is an Associate Director of Life Science Business Development at Morningside, with over 20 years of experience in the localization industry, specializing in life sciences. She is responsible for Morningside’s life science strategy and for maintaining relationships with global leaders in the field.

Anna provides expert advisory support to pharmaceutical and medical device companies on best practices in translation, and is highly skilled in implementing workflow solutions that enhance quality, reduce costs, and accelerate project timelines.