Diversifying clinical trials can accelerate the development of patient-centred treatments, as well as ensure equity and improve patient engagement.
People may have different health outcomes from the same medicine or vaccine depending on their race, ethnicity, age, and sex. Therefore, a diverse group of clinical trial participants is more likely to provide credible knowledge about medical discoveries and new treatments that apply to all populations.
An increased focus on patient-centricity can also help to improve clinical trial outcomes. This approach aims to provide patients with better results by designing healthcare solutions around their needs and preferences.
According to research by The Economist Intelligence Unit, titled The Innovation Imperative: The Future of Drug Development, improving the patient experience leads to faster recruitment and higher retention in clinical trials.
Such improvements can be crucial for biopharma companies that struggle to increase patient participation in clinical research projects. Only 46% of clinical trials fulfilled their enrolment targets, according to GlobalData’s Trials Intelligence database, accessed in May 2023.
In these scenarios, it is crucial to foster transparency, build trust and communicate effectively about the clinical trial process to appeal to a broader representation of patient demographics.
Identifying barriers
While the role of diversity in clinical trial recruitment is important, sponsors must also establish factors that can limit representativeness. Insufficient enrolment was reported to be the leading cause of trials being terminated or suspended between 2003 to 2023 by a GlobalData report, Clinical Trials: Precision and Personalised Medicine.
The report highlighted that when patients are not explained complex protocols properly, it creates a significant barrier to their recruitment and retention in clinical trials. Providing clear information about the research process is pivotal when designing an inclusive recruitment strategy.
“Lack of understanding of cultural differences is one of the biggest challenges that sponsors face,” says Jill Balcerzak, vice president at Global Solutions RWS, a leading provider of technology-enabled language, content management and intellectual property services. “If sponsors don’t understand the cultural differences that exist within their patient population, they may not be able to create a culturally appropriate trial.”
At the same time, designing an inclusive trial can be a resource-intensive and time-consuming process, which may hinder progress. “Sponsors may need to hire cultural experts, translate materials into multiple languages, and create culturally appropriate marketing materials. Some stakeholders may not be supportive of the process of navigating cultural differences. They may believe that it is too time-consuming or too expensive,” Balcerzak adds.
In such a landscape, language inclusivity can go a long way in mitigating some of the reservations among diverse populations regarding clinical research.
Removing language barriers for clinical trials
Multi-faceted communication methods that are mindful of cultural and linguistic differences can encourage patients to participate and engage in studies. This approach can also create health literacy and increase awareness about the purpose of clinical trials.
Learning more about different cultures through books, articles, and websites, as well as connecting with people from other cultures, can go a long way in increasing awareness for sponsors and assisting trial teams in being attentive to differences in communication.
“For example, in some cultures, it can be considered rude to make direct eye contact, whereas, in other cultures, this is considered a sign of respect,” explains Balcerzak. “Be aware of cultural taboos. For example, in some cultures, it’s considered taboo to discuss certain medical conditions, while in other cultures, these conditions are openly discussed.”
In addition, Balcerzak suggests conducting a cultural assessment to identify the factors that may impact the trial, such as language, values, beliefs, and practices. By involving patients from diverse backgrounds in the design and conduct of the trial, it can help ensure that the trial is culturally appropriate and that all patients’ needs are met.
The inclusion of virtual components such as telemedicine, remote patient monitoring and wearable devices, can help reach a broader demographic in different languages to boost participation. These technologies can reduce the logistical and transport issues that often prevent patients from participating in studies and mitigate risk for immunocompromised patients.
While technology can be effective, having an in-person language-support system is essential to capture the cultural and social nuances of a particular community, especially when it comes to collecting and translating clinical outcome assessments (COAs), electronic eCOAs and other documentation.
It is important to ensure COA translations are accurate to avoid challenges that may include copyright issues, submissions being rejected by regulatory authorities, and patients feeling misunderstood or misrepresented. Trial sponsors can avoid these hurdles by adopting a robust linguistic validation process that involves checking translations of COA for accuracy, and cultural and conceptual similarity to the source.
“Implementing linguistic validation is a requirement for pharmaceutical and medical device companies seeking product regulatory approval,” says Balcerzak. “Because of the critical importance of an exacting linguistic validation process and the impact the process has on clinical studies, public health regulatory bodies are diligent in their oversight, issuing recommendations and guidance to ensure that translation, cultural adaptation assessment, and linguistic validation follow good practice methodology.”
How language inclusivity can help design successful trials
As one of the largest language service providers in the world, RWS can help sponsors with their translation, accessibility and compliance needs, as well as enable them to create culturally appropriate communications.
The company’s linguistic validation process adheres to the guidelines outlined by the US Food and Drug Administration and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). With a global network of translators, interviewers, instrument developers, survey researchers, clinicians, and in-country reviewers, the RWS team has accurately translated more than 20,000 COAs in 500-plus languages, covering about 200 therapeutic areas.
To ensure a high level of precision, the RWS translation process within linguistic validation often includes translation and review by at least three translators, a project coordinator or project manager, a survey research analyst, and a client, developer, or copyright holder (if applicable), as well as testing and validation of the translation through cognitive debriefing interviews with either native-speaking subjects or patients (depending on the patient population addressed in the clinical trial and the nature of the questionnaire).
Interpretation and communication services
In an increasingly digital landscape, RWS also offers services that include over-the-phone interpreting, enabling patients to connect with qualified interpreters for instant access to information and quick communications, which is vital in clinical studies.
With more than 8,000 employees spread across 85 offices, RWS has a large in-house team, capable of ensuring all clinical trial translations follow a well-defined process, including:
• Translation and edits, conducted by two highly qualified linguists
• The production of multimedia in multiple languages
• Quality control editing
• Final proofreading
• Certification
According to Balcerzak. “By prioritising language inclusivity within clinical trials, sponsors can improve the chances of success for their trials and can enhance the credibility of their trials. They can also increase the diversity of the study population and improve recruitment rates.”
To learn how RWS can help you create inclusive communications for clinical trials, download the whitepaper below.
