Driving Global Clinical Trial Success: Four Top Strategies

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By Mark Aiello, General Manager, Lionbridge Life Sciences

The pharma landscape has significantly evolved in the last decade, especially when it comes to clinical trials. One of the biggest trends impacting trials with far-reaching implications for how they should be planned and executed is globalization. As the world becomes smaller with companies doing business across borders, more organizations are looking to conduct clinical trials using a globalized approach. Also, global trials are highly driven by regulatory requirements on patient sample size, and clinical trials having to reflect the patient target population. There are currently more than 250,000 interventional studies registered worldwide, with 47 percent of them being conducted outside of the U.S. This means these trials are being conducted in locations where a variety of languages are spoken by both trial participants and practitioners. Naturally, this can lead to disconnects in communication and creates several challenges for clinical trials, especially around translation.

While the benefits of conducting a clinical trial on a global scale may seem appealing – from the ability to recruit a wider pool of participants to lower operating costs – complications can quickly mount. Take for instance a trial conducted at hundreds of sites worldwide, with thousands of patients speaking a variety of native languages. The coordination necessary in order to effectively communicate critical information around drug treatment regimens and trial procedures is mind boggling. Language plays an important role in driving clinical trial success, and organizations must find a way to manage the translation process in order to effectively communicate to study participants and trial site staff, regardless of location.

For pharma companies and contract research organizations (CROs), streamlining translation practices is important, especially during the initial planning phase of a global clinical trial launch. If not executed properly, organizations risk running into several challenges and barriers in terms of participant recruitment and clinical trial management further down the road.

So how can pharma organizations avoid the pitfalls associated with translation errors and ensure the safety of clinical trial participants? They should start by adopting these four best practices:

 

1. Prepare and Plan

As a first step, pharma leaders must understand the different barriers and complexities that language brings to a clinical trial and prepare to address them. Don’t assume that someone who is multilingual can also be a translator, or that a person who is able to translate product documentation is also equipped to translate clinical trial material. While some team members may be bilingual, they might not be able to transfer content correctly or as accurately as a professional pharma translator. Organizations should work with a trusted translation partner to streamline the communications process. A translation partner offers multiple benefits, from acting as a centralized resource for multi-geography patient locations, to the ability to quickly scale based on project timelines while also providing consistent content across all languages. By working with a trusted partner, organizations can ensure that they have a comprehensive translation strategy that increases efficiency and accuracy.

 

2. Standardize Operations

As a next step, companies looking to conduct global clinical trials would benefit from implementing a standardized process for translation operations. While not every process is one-size-fits-all, some steps that are generally included are: forward and back translation, clinical review, linguistic validation, cognitive debriefing and harmonization. Following these steps will contribute to the accuracy and integrity of clinical trial outcomes, which rely on the patient and site staff’s ability to understand the information and instructions that are presented to them during the trial. These standardized practices will keep the entire translation process organized and efficient, while reducing liability.

 

3. Optimize Review Processes

A challenging area in clinical trials is the final translation review process. In-house staff are usually responsible for conducting the final review, on top of their regular full-time work. This can jeopardize deadlines for clinical trial applications to competent authorities or EC/IRB submissions, and clinical trial approvals are always on critical path of any trial with the review process taking two to several months depending on the country. To shorten the translation timeline, pharma organizations should utilize online tools and digital processes that make for a more seamless review. Alternatively, many companies are partnering with language service providers that have specific expertise in clinical trials. Translation partners are able to employ solutions for version control, labeling and master file management and can significantly decrease the time and resources an organization is required to allocate to reviews and submissions. A global partner can also build translation memory to avoid repeatedly translating the same standard language in multiple documents, therefore reducing costs and increasing productivity as well as consistency in translations.             

              

4. Ensure Regulatory Compliance

Being part of a highly regulated industry, pharma companies must constantly keep pace with shifting regulations to make sure they remain compliant. This comes into play during the clinical labeling process. Managing drug and IMP labeling for multi-site, international studies is complicated and requires a specific set of skills and considerations. Organizations should utilize translation tools that provide a simplified and customizable workflow to efficiently translate drug label content while maintaining adherence to country specific regulatory requirements. Otherwise, they risk running into inconsistencies or incorrect information on labels that could have serious implications for patient safety.

 

What’s Ahead

As the pharma industry continues to be impacted by globalization, launching a successful global clinical trial will be contingent upon preparation, planning and having the right language strategies in place. By embracing these key approaches and prioritizing translation efforts, pharma companies and CROs can overcome challenges and streamline all phases of the clinical trial drug lifecycle.