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.'
Ensuring full representation in clinical trials is crucial to improving health. Pharmaceutical companies must study how all types of people respond to medications before they’re approved for use by the general public. There’s no shortage of data to show the inequities:
- Statistics show that racial and ethnic minorities comprise almost 39 percent of the U.S. population, yet they only make up 2-16% of patient populations in clinical trials.
- African American participation rates are less than 5%, yet they have a 14% greater risk of dying from cancer.
- Latinos comprise 18% of the U.S. population, yet only 1% participate in clinical trials.
- Approximately 1/5 of new drugs approved since 2009 have demonstrated responses across different racial and ethnic groups.
Other factors, such as age and gender, also affect how patients react to medications.
Changes are being introduced so that clinical trials include more diverse patient groups. As such, clinical trial translation plays a crucial part in recruiting and retaining patients, as people are more apt to engage when content is in their native languages. Making clinical trial content available in other languages and providing interpreters throughout the process builds trust and improves the patient experience.
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 Act includes the Food and Drug Omnibus Reform Act 2022 (FDORA). FDORA includes provisions through the FDA to provide new guidance on diversity action plans during clinical trials. The guidance is a step forward in ensuring that clinical trials are evaluated based on all relevant patient populations regardless of race, sex or ethnicity.
Finding a diverse patient population has often been a challenge for pharmaceutical companies. Still, they must provide their goals in future clinical studies for a diverse patient population by age, sex, and racial and ethnic demographic characteristics.
Diversity in Clinical Trials Improves Health Equity
Language barriers — both linguistic and cultural—are just one of the many ways people with limited English proficiency (LEP) have historically been marginalized. In healthcare, LEP individuals can face extreme communication challenges, resulting in negative care outcomes, continuously contributing to health inequities, and improving access to health information benefits LEP and underrepresented communities, leading to improved health equity.
For sponsors, providing clear, consistent, and easy-to-understand materials in the target languages of the patient population is growing in demand. To meet the requirements of diverse populations and ultimately improve health equality, sponsors need to speak the language of LEP populations to recruit and retain patients along every step of the process.
There are a number of documents that must be translated throughout a clinical trial:
- Investigator’s Manual
- Clinical Study Protocol
- Clinical Study Reports
- Case Report Forms
- Adverse Event Source Documents
- Data Sheets
- Development Safety Update Reports
- Drug Registration Documentation
- Informed Consent Forms
The Crucial Role of Clinical Trial Translation in Advancing Medical Research
Clinical trials catalyze medical advancements, propelling innovations that enhance patient care and revolutionize healthcare practices. In our interconnected world, where collaboration transcends borders, precise and expert clinical trial translations emerge as the unsung heroes ensuring that medical breakthroughs resonate across languages and cultures. From fostering patient understanding to facilitating regulatory approvals, clinical trial translations pave the way for successful global medical research. By acknowledging their significance and embracing best practices, researchers, sponsors, and medical professionals can continue pushing the boundaries of medical knowledge while upholding the highest standards of quality and ethics.
Accurate translations are indispensable in clinical trials, but the importance of medical translation comes from more than just the need to render words into a different language. Considering this, it becomes evident that clinical trial translation holds significant importance for three key reasons:
Expanded Volunteer Pool: Translating clinical trial documents, particularly informed consent forms, enables research teams to reach a broader audience, increasing the potential number of volunteers willing to participate in a study.
Ethical Informed Consent: When Clinical Research Organizations (CROs) engage volunteers from diverse regions, the accurate translation of forms and protocols becomes an ethical imperative. Preserving essential information in clinical trial translation ensures that volunteers can provide informed consent confidently.
Global Academic Collaboration: Translating clinical trial protocols and research findings facilitates the sharing of information across international borders and fosters collaboration among researchers from different countries.
That’s why the world’s largest pharma companies and CROs choose a professional language services provider, such as Questel, 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.
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 advancing healthcare through diverse and inclusive clinical trials.
Hosted by Morningside, a Questel Company, this webinar is designed to provide you with a fresh perspective on diversity in clinical trials aligned with the latest FDA requirements and translation practices.
What should you expect from our one-hour presentation:
- Insights on FDA requirements: Gain a comprehensive understanding of the latest FDA guidelines and requirements pertaining to diversity in clinical trials. Stay ahead of the curve and ensure your research meets the highest regulatory standards.
- Clinical trial translation best practices: Explore the crucial role of translation in ensuring ethical and effective communication with diverse participant groups. Learn how precise translation can enhance informed consent and contribute to the success of your trials.
- Real-world case studies: Understand the state of enrollment for clinical trials and diverse populations.
- Unlock the possibilities within emerging markets, encompassing more than 50% of the global population, and the potential for increased diagnoses, innovative treatments, and market expansion benefitting patients across diverse regions while simultaneously paving the way for new opportunities in both emerging and developed markets.
- 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, experiences, and practical tips for implementing diversity and translation strategies in clinical research.
We were thrilled to have speaker Sara Tylosky, MBA, join us. Sara serves as the CEO at Farmacon Global, bringing over 20 years of experience leading teams in both large and small pharmaceutical environments. In her seven years as CEO, she has led Farmacon Global, a strategic CRO of medical consultants, in accelerating clinical trials, increasing diversity, supporting enrollment, and paving the way to market access in emerging markets.
Known for her high cultural intelligence and problem-solving skills, Sara and her team specialize in Rare Diseases, Immunology, Infectious Diseases, Cancer, 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 markets globally. Sara’s direction plays a pivotal role in steering Farmacon Global toward healthcare innovation and global market leadership.
Farmacon Global accelerates Clinical Research and Market Access projects in Emerging Markets through its trusted network of on-the-ground medical experts. Its concierge approach ensures Pharma and Biotechs can efficiently achieve their goals, saving both time and resources. It delivers culturally tailored strategies for medical intelligence, market access, site enrollment, and adeptly navigate regulatory and logistical challenges. This extends to sites, investigators, and patients in the US and emerging markets, strengthened by partnerships with technology companies for accelerated 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!