Last month, we commemorated National Cancer Survivors Day — a day of reflection, celebration, and renewed commitment to improving cancer care. Behind every survivor’s story is a journey shaped by medical innovation, compassionate care, and, critically, clinical research.

Clinical trials are the backbone of cancer treatment progress. From testing novel therapies to developing early detection methods, these studies pave the way for improved survival rates and better quality of life for patients. However, there’s a key factor that often goes underappreciated in the research process: language access.

When clinical trial documents — such as consent forms, patient instructions, or investigator brochures — are only available in English, a significant portion of the global and U.S. population is left out. For patients with limited English proficiency (LEP), this language barrier can mean the difference between participating in a life-saving trial or being excluded entirely.

At DTS Language Services, we believe every patient deserves a voice in research, and that starts with understanding.

The Global Nature of Cancer Research

Cancer knows no borders, and neither should clinical trials. Many studies today are conducted internationally or aim to include diverse patient populations. According to the World Health Organization (WHO), over 70% of cancer deaths occur in low- and middle-income countries, highlighting the urgent need for inclusive global research efforts.

Even within the U.S., language diversity is vast. The U.S. Census Bureau reports that over 67 million people — about 1 in 5 — speak a language other than English at home. For research teams, this means that producing documents solely in English can unintentionally restrict access, especially for immigrant communities, minority groups, and underserved populations who may already face healthcare disparities.

By ensuring that clinical trial materials are accurately translated into participants’ native languages, sponsors and research organizations can foster greater inclusivity, improved retention rates, and stronger data integrity.

Why Translation in Clinical Trials Matters

Effective communication in clinical research isn’t just about language. It’s about clarity, consent, and compliance. Here’s why accurate and culturally sensitive translation is mission-critical:

1. Informed Consent Requires True Understanding

The informed consent process is the cornerstone of ethical clinical research. It ensures that patients understand what they’re agreeing to, including the risks, potential benefits, and their rights throughout the study.

A poorly translated consent form — or one that’s overly technical or culturally insensitive — undermines this process. Participants may unknowingly agree to procedures they don’t fully understand, leading to ethical concerns, legal liability, and potential regulatory repercussions.

2. Improved Recruitment and Retention

Language accessibility can boost recruitment, particularly among populations traditionally underrepresented in trials. Patients are more likely to join and stay enrolled in studies when they feel understood, respected, and confident in their ability to follow study protocols. Removing those barriers helps trials become more equitable and representative, ultimately improving the generalizability of the results.

3. Regulatory Compliance

Agencies like the FDA, EMA, and other international regulatory bodies require that clinical trial sponsors ensure participants receive study materials in a language they understand.

In fact, the FDA’s guidelines state: “The informed consent must be in language understandable to the subject.” Failure to comply with this requirement can result in delays, study rejections, or worse — harm to participants due to miscommunication.

4. Patient Safety

Clear, comprehensible instructions about medication use, follow-up visits, dietary restrictions, or symptom tracking are essential to trial success and patient safety. A single misinterpreted phrase can lead to missed appointments, improper dosage, or adverse events.

With accurate, well-localized translations, trial teams reduce the risk of errors, strengthen patient adherence, and protect the integrity of the data collected.

DTS Delivers Expert Clinical Trial Translations

At DTS Language Services, we specialize in clinical trial translations for oncology and a wide range of other therapeutic areas, supporting global studies with linguistic precision and cultural sensitivity. Our translation process is designed to meet the highest standards of accuracy, compliance, and patient understanding, essential for the success of clinical research in complex, high-stakes environments like cancer treatment. Our process involves:

  • Subject-matter expert linguists – Every project is handled by professional linguists with deep expertise in life sciences, particularly in oncology. They are fluent not only in the target language but also in the specialized terminology used in cancer research, treatment protocols, and pharmacology.
  • Back translation and reconciliation – To maintain the integrity of clinical content, particularly in patient-facing documents such as informed consent forms (ICFs), we offer a rigorous back-translation process. When requested, it provides an extra layer of validation to ensure the translated content accurately reflects the original meaning and intent. Reconciliation, on the other hand, is a standard part of our process—carefully carried out by each translator and editor and overseen by our project managers to maintain consistency and clarity throughout.
  • Cultural adaptation – Language alone isn’t enough. We localize all content to reflect regional norms, healthcare practices, and varying levels of health literacy. This enhances patient comprehension and engagement while reducing dropout rates and regulatory delays.
  • ISO 17100:2015-certified workflows – Quality is at the core of what we do. Our workflows are certified to ISO 17100:2015, the international standard for translation services, ensuring traceable, consistent, and fully auditable processes for each project.

Whether it’s translating clinical trial protocols, investigator brochures, patient-reported outcome measures, or eCOA content, we collaborate closely with sponsors, contract research organizations (CROs), and institutional review boards (IRBs). Our goal is to ensure that every document is not only linguistically accurate but also culturally appropriate and regulatory-compliant, helping to bring life-saving medicines and therapies to market faster and with confidence.

10 Tips For Your Next Translation Project (Video)

10 Tips For Your Next Translation Project (Video)

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