Decentralised clinical trials (DCTs) have long been heralded as the solution to many problems encountered in pharmaceutical research, most notably the issue of attracting and retaining patients. According to GlobalData’s Clinical Trial Database, almost 14,000 clinical trials were suspended, terminated, or withdrawn between 2011 and July 2021, the majority (28%) on account of low accrual rates. Studies have shown that complex, lengthy informed consent forms (ICFs) are one of the principal reasons for low registration levels and patients dropping out before the trial has ended.
DCTs exploded during the Covid-19 pandemic, when stay-at-home restrictions forced the clinical trials industry to implement new methodologies. Beyond the pandemic, DCTs and hybrid trials have emerged as a permanent feature of clinical research, promising to boost patient recruitment, retention, and diversity. If patients participate in a trial from the convenience of their own home, the need for lengthy trips to a site are eliminated. Moreover, as all data is collected virtually, patients can even be recruited from anywhere in the world provided they have access to the right technology.
Yet conducting a DCT, especially across international borders, is not easy. The issue of patient consent is paramount, and DCT platforms must be equipped with the right technology to facilitate understanding across language and cultural differences, education, or disability. When data is collected remotely, it is essential to reduce patient burden and make clinical outcome assessments (COA) as comprehensible as possible to preserve the accuracy and integrity of a trial. The right technology needs to be in place to support the smooth running of a DCT for the decentralised aspect to fulfil its promise.
The information burden
In the running of any trial, there is conflict between the desires of the clinicians and the preferences of the patients. The clinicians want accurate data to support their study, whereas patients are concerned with the potential side effects they may experience and that the trial does not become too inconvenient in their daily lives.
This creates a challenge when organising decentralised trials, because the need to collect data inherently places a large burden on patients to understand the trial’s requirements and provide accurate reports. From the beginning of the recruitment stage, clinicians must make the requirements of the trial clear so patients comprehend their responsibilities. This can be enhanced with the use of clear electronic consent (eConsent) forms, electronic Patient Reported Outcomes (ePRO), and eCOAs.
The ambiguous language and technical jargon that can riddle these forms hinders patients’ comprehension and therefore prohibits the accurate input of data. Errors in data collection in turn can result in inefficiencies, causing a trial to run over budget as time is wasted in rectifying mistakes.
Especially vulnerable to misinterpretations are translations of the complex patient-facing documents, consent forms, ePROs and eCOAs. DCTs have the potential to democratise clinical trials by including people from all backgrounds and all countries, but this opportunity will be wasted if documents are poorly translated or composed without paying attention to cultural differences.
Investing in translation services
To prevent this possibility, all patient-focused documents should be composed in line with plain language principles from the outset. Aside from language barriers, disparities in literacy, and education between patients must be eliminated so everyone has a rounded understanding of their responsibilities in the trial. Readability assessments are also crucial for eConsent, ePRO, and eCOA forms to check that these principles are being executed in practice.
“At the core of a successful DCT is the delicate balance between the need for accurate data and the patient's experience,” says Dan Herron, Vice President of Digital Offerings, Regulated Industries at multinational translation company RWS. “Clear electronic consent forms, patient-reported outcomes, and clinical outcome assessments are essential tools in reducing patient burden while ensuring the integrity of trial data."
It is also essential that patients who do not speak the native language of the documents are provided with a good translation to avoid misunderstandings. According to Herron: "Investing in translation services isn't just about converting text from one language to another; it's about ensuring that all patient-facing documents are clear, culturally appropriate, and accessible to everyone, regardless of their background or where they are in the world.”
An expert in the field, RWS champions linguistic validation to reduce the burden on those participating in a study and can ensure all patient content is localised and accurately translated. Supported by a team of over 1,750 in-house linguistic experts, RWS is rigorous in its approach, as demonstrated by its eCOA Ready Text translation development service. Any translation is undertaken by two individual translators, whose work is then reconciled and translated back into its source language by a third translator blind to the original text. The translation is then proofread alongside native speakers to ensure that it is culturally appropriate and understandable for patients of all ages and educational background, before finally being reviewed by clinicians and copyright holders.
RWS is researching display accessibility issues to support DCTs and hybrid DCTs. Translating into languages with different scripts, such as Arabic and Chinese, can completely change the formatting and with it the simplicity of key documents. With the right partner to facilitate translation, their legibility and accuracy can be improved.
Access for all
Often overlooked are disabled patients, who may have issues with the legibility of certain texts and online technology. "Accessibility extends beyond language and cultural barriers to include patients with disabilities,” says Herron. “Ensuring that digital content in clinical trials is accessible to all is not optional; it's a necessity for inclusivity and ethical research practices."
An estimated 10% of the United States population has an impairment that inhibits their access to digital content, and as populations age this proportion is only going to rise. The right systems need to be in place to ensure digitisation in clinical trials does not exclude this demographic and that they can participate as easily as any other patient.
Language is the key to understanding, but by partnering with experts DCT hosts can aid patient comprehension and ensure inputted data is accurate. When content is localised, cultural differences heeded, and accessibility improved, patients of all abilities, educations, and nationalities can participate in a trial. With the patient pool thus diversified, clinical trials can deliver even more innovative results.
"By partnering with RWS in linguistic validation and translation services, DCT providers can improve patient comprehension and data accuracy,” says Herron. “It's about localising content, acknowledging cultural differences, and enhancing accessibility to democratise participation in clinical trials."
To learn more about how RWS can support clinical trials, download the free whitepaper below.
