Decentralized clinical trials (DCTs) include a broad range of patients, helping studies achieve more comprehensive findings. However, as beneficial as DCTs can be, they face unique challenges other studies may not experience.
Some of those challenges can be bundled together under the umbrella of language and translation. Because study participants are more diverse, there is an increased need for accurate clinical trial translation services that comply with all security and data regulations.
Some trials attempt to solve this need by using decentralized language services—hiring local translators or using various translation services at each location. Unfortunately, this is an unsatisfactory solution that can lead to additional issues with compliance and regulations while also slowing down the time to market.
7 Problems with Decentralized Language Services for DCTs
Decentralized language services can create new problems while trying to solve a trial’s need for language and translation services. Here are a few ways decentralized language services can affect a DCT.
The most significant problem DCTs face when using a decentralized language service is compliance, specifically with data security regulations. Decentralized language services may not be compliant with security regulations because information shared with a decentralized language service is often not encrypted or protected. This leaves sensitive data, such as patents, and personal information at risk.
By using non-compliant language services that do not follow regulatory standards, clinical studies in the U.S. are likely in direct non-compliance with FDA and HIPAA regulations. Not complying with these regulations can lead to a loss of FDA approval (which hinders all marketing and sales), as well as lawsuits and fines.
If a DCT aims to get a treatment approved somewhere other than the U.S., it must meet additional security regulations, like the General Data
Protection Regulation (GDPR), the Personal Data Protection Act (PDPA), and the Personal Information Protection and Electronic Documents Act (PIPEDA). If these international standards are not met, the DCT could face additional fines and legal issues.
As 71% of countries have some form of data protection and privacy legislation, secure language services have become an essential tool for conducting successful clinical trials.
2. Quality of Translation
Decentralized language services lead to each location in a DCT having a different translation solution. Not only is this expensive, it can also create issues with consistency and quality across translated communications.
Language is not a science. There are very few cases where you can simply substitute one word for another during translation. Doing so produces odd phrasing, poorly structured sentences, and missing linguistic nuances.
This lack of consistency and quality is dangerous for a clinical study as it can directly impact the safety of participants along with study results. Consistent, reliable, professional-quality translations must be universal throughout the study to ensure 100% accuracy and data integrity.
3. Language Laws
A newly passed bill in Quebec (named Bill 96) requires all legal documents to be available in French. If a DCT has any patients, employees, or participants who work or live in Québec Province, documents must be available in French.
While Bill 96 specifically applies to Québec, there are other similar laws throughout the global market. When conducting DCTs around the world, it’s important to comply with applicable laws to avoid delays.
4. Irregular Translations
When disparate language service providers handle your translation needs, you end up with inconsistencies in translation style and form. There is no standardized glossary for terms, and some language service providers will have difficulty working with technical and scientific vocabulary.
5. Unmanageable Volume
Small, local translators and translation services have the bandwidth to provide a few translations when necessary; however, many are not prepared for the volume and technicality of documents produced during a clinical trial. This can lead to a language service provider rushing and providing lower quality or inaccurate work, or acting as a bottleneck by taking too long to provide meaningful results.
6. Waste of Time and Money
Because of the low quality and inconsistencies that can come with decentralized language services, they can become a waste of time and money. Translations that take too long and create a bottleneck or are inaccurate and require a second or third attempt at translation hurt the entire trial and speed to market.
7. Slow Speed to Market
Manual translations from a certified translator are accurate and high quality, but it can take days to translate a single document, slowing down all remaining processes. In the life sciences, time means both money and life-saving or -improving treatments, so don’t rely on inefficient methods during the clinical trial process.
Why DCTs Need a Centralized Machine Translation Service
Instead of using decentralized language services, the best option for meeting the unique needs of DCTs is a centralized machine translation service.
Here are five of the most compelling reasons clinical studies should use a machine translation service.
How much control do you have over several different translation teams and their security measures? A centralized language service integrates with existing security measures and provides a translation solution that is just as secure as any of your data. It makes it easier to meet compliance standards and keep sensitive information protected.
Another benefit of having a centralized solution is that your study gains absolute control over the translation glossary. Additionally, machine learning customizes the glossary to tackle even the most complex technical vocabularies to provide accurate translation.
Relying on multiple translation solutions in different trial areas does not yield this flexibility, which leads to awkward or incorrect translations. If technical terminology will be common in your trial documents, choose a service like SYSTRAN that offers this capability.
Relying solely on manual translation can create a bottleneck within a study because of the massive time requirements. A centralized, automated machine translation service from SYSTRAN can provide accurate, professional translations in seconds instead of hours or days.
4. Regulatory Compliance
A centralized solution keeps data contained and protected with existing security measures. Privacy standards are maintained when you don’t transfer information between third-party sites.
Machine translation solutions are available to use around the clock in any circumstance. Because the solution is integrated with the internal security established by the clinical study, anyone on the team can access safe, secure, accurate, and professional translations anytime.
SYSTRAN machine translation servers provide a secure solution that integrates with your existing security and risk management systems to provide fast, accurate translations without risking data leaks or non-compliance issues.
This centralized language service solution allows clinical studies to reap the benefits of decentralization while still protecting sensitive personal data and ensuring compliance and speed to market.