Six Major Challenges Raised by Decentralized Clinical Trials

Decentralized clinical trials allow researchers to reach a broad base of patients and include underrepresented demographics as part of their research. However, the broad potential patient base comes at a cost and presents issues not faced by centralized clinical trials.  

Several of the largest challenges decentralized clinical trials face come directly from the language and communication needs of running a clinical trial. This blog examines those issues as well as how SYSTRAN’s on-site solution can help researchers overcome these challenges.  

Why Do Decentralized Language Services Matter in Decentralized Clinical Trials?  

Decentralized language services are when each location and team in a DCT use a different language service. This is a problem because this can create issues with consistency, quality, timeliness, and compliance.  

Standardized language in clinical trials is essential. If every location has different vocabularies or chooses to translate documents using different glossaries, it creates continuity issues and causes issues when unifying the data. A centralized language service across the entire clinical trial is able to unify a DCT and help guarantee a consistent result for all participants.  

Additionally, the quality of translation matters. Not only does the consistency and reliability of a translation play a role in the success of a trial, but the quality of translation must also meet regulatory standards. A decentralized language service may not meet the quality needed for approval, and also may create risk of non-compliance.  

Finally, using a decentralized language service wastes time and money. Because translations are not centralized, there has to be an additional layer of quality control to ensure that translations are done correctly. In the worst-case scenario, this essentially leads to every translation having to be done twice to make up for any inconsistencies, which leads to doubling your budget and timeline for translation.  

Six Challenges Faced by DCTs  

Here are six of the biggest challenges that affect language matters in decentralized clinical trials.

1. Quality of Translation

Language needs to be consistent throughout a clinical trial to discover significant and meaningful results. Decentralized clinical studies need a language solution that can provide consistent, quality results without mistranslations or errors in language. 

2. Speed to Market

DCTs are often faced with bottlenecks when dealing with language and translation. If each location is using a different translator or translation service, this can create not just differences in the quality of translation, but also in the speed of those translations. Waiting for manual translations can slow down the entire clinical process and significantly impact your speed to market. 

3. Compliance

Data privacy and authentication of data in a decentralized clinical trial is a top issue. While decentralized studies can improve data gathering and even patient compliance, the privacy of patients and their medical information is always a top priority.  

Just within the United States, privacy laws can feel convoluted and complex, but decentralized clinical trials are faced with having to remain compliant with every country they’re working in. This creates unique challenges due to the different regulatory standards and requirements that have to be met for each country, which sometimes can be conflicting or require complex redundancies.  

Compliance is further complicated by language and translation. Mistranslation of a single phrase or word of international regulation can lead a clinical trial to become non-compliant. 

4. Local Language Requirements 

As a trial expands, it is faced with the unique language requirements of each area it is in. For example, Bill 96 in Quebec has been passed requiring all legal documents to be provided by a certified translator in both English and French. If any part of a clinical trial has operations or employees in the province, then there is a direct need for certified translation. 

pexels-edward-jenner-4031824

5. Patient Engagement

Virtual methods can help with creating a diverse and well-rounded sample of participants, but decentralized methodologies struggle to keep those participants engaged throughout the entire clinical study.  

Patients can lose a feeling of connection to the study, especially if they are unable to easily communicate. Decentralized trials empower the study to be done with groups who are underrepresented and reach patients who would typically be unwilling or unable to participate. However, there is still a need for creating ties to various patient populations and maintaining personal interactions.

6. Data Collection, Reliability, and Quality

Decentralized models lead to excessive amounts of data and can make data processing and data management a major hurdle to overcome. Even with standardized data gathering and data entry processes, decentralized studies are faced with gathering and interpreting information from multiple locations simultaneously.  

Data is further complicated by language and the need for language translation. Objective data points like a participant’s weight, height, and age are easily translated and there is little risk of information being lost or misunderstood. However, with more subjective data points like clinician’s notes or participant’s feelings or moods, accurate translation becomes crucial to ensure that the right information is being shared. A consistent and accurate translation solution maintains the data’s integrity across every language and avoids confusion and loss of detail.  

Other challenges that DCTs are faced with include: 

  • An insufficiently detailed description of the justification of decentralized elements in the protocol 
  • Communicating safety information 
  • Inability to assess a participant’s ability and eligibility to participate 

 

Translation Solutions That Resolve DCT Challenges 

For clinical studies, it’s important to research a broad range of patients from various backgrounds and ethnicities, but this brings with it a range of issues with language and translation. 

Slow, but accurate translation can create a bottleneck for your time to market, while fast, but inaccurate translation can lead to misinformation and invalidate key data points. The best translation solution needs to provide fast, reliable, professional, and quality translations every time. 

Here is how translation solutions can help resolve the most common issues of decentralized clinical studies. 

1. Compliance 

By having the right translation solution, you’re able to better meet and maintain compliance standards. International compliance regulations become easy to translate making them easier to understand and enforce. Additionally, the quality of the translations meets all professional standards and compliance needs for translation. 

SYSTRAN’s machine translation solution uses an AI-powered neural network. The neural network is able to identify and establish patterns in language the more it is used. This means that as a DCT continues to use the machine translation solution, it will become better at its job and able to provide even more accurate translations to fit your specific needs.  

2. Patient Engagement

Language barriers can destroy patient engagement. Translation solutions like SYSTAN’s on-premise solution can help break down the language barrier and ensure every patient is able to communicate. By providing service and information to your patients in their native languages, they will be more engaged and connected with the trial. 

3. Data Collection, Reliability, and Quality

Research and patient data should always be protected and secure, and translation can put that information at risk. By using the wrong translation solution, a research team can leak sensitive information, putting them at risk for legal action and potentially even invalidating their study.  
 
SYSTRAN’s on-premise translation solution integrates within your existing system. That means the data in every translation is kept internal and is protected by the same safeguards that are in place for the rest of your study.

national-cancer-institute-NFvdKIhxYlU-unsplash

4. Save Time and Money

SYSTRAN’s machine translation solution provides fast, accurate, and reliable translations every time it is used. There’s no need for second-guessing, and there’s almost no waiting time. This saves you time and money by helping you focus on what matters, rather than being tied up and waiting for translations.  

When streamlining the translation process by leveraging machine translation, translation is no longer the bottleneck of the trial. Not only does this help you have a more efficient trial, but it helps significantly reduce your time to market.  

 

SYSTRAN Solves These Challenges 

With over 50 years of experience, SYSTRAN understands the difficulties that researchers face with translating. We’ve used that knowledge to provide a unique solution that provides fast, accurate, and professional translations every time. It helps clinical studies get the language translation they need while maintaining security and data compliance.  
 
Learn more about how SYSTRAN can solve your DCT translation needs by downloading our ebook today.  

Maria Tola