Clinical trials operate on tight timelines, and a recent article in JAMA Network found that more than 70 percent of clinical trials in its study were delayed. As pharma and biotech professionals, it’s no secret that every milestone, from regulatory submissions to patient enrollment, is mapped against a ticking clock. However, any and all delays should be avoided, as they can compound rather quickly.
One hidden factor that continues to cause costly delays is slow, inefficient clinical trial translation and localization.
Language localization is critical to nearly every clinical trial across the globe. Patient-facing materials, site instructions, regulatory documents, investigator communications, and the like, must all be accurately translated into a variety of languages. When these translations are delayed, the impact is felt across every part of the clinical trial process.
What’s Really at Stake?
Translation delays can stall a clinical trial in ways that are not always obvious, including the following:
- Missed enrollment windows: If patient-facing materials are not ready and available in the required local languages, recruitment often comes to a stop.
- Regulatory rework: Poor or late clinical trial translations can often trigger additional questions, rejections, or back-and-forth with ethics committees and health authorities.
- Site frustration: When investigator brochures (IBs), clinical study protocols, or training documents are not localized on time, site teams are often left waiting, confused, or disengaged.
- Vendor cost overruns: Unplanned delays have the potential to come with expedited fees or added project management hours to catch up.
To help quantify this, the Tufts Center for the Study of Drug Development (Tufts CSDD) recently determined that the “the value of a single day of delay is worth approximately $800,000 in unrealized or lost prescription drug sales and $40,000 in direct daily clinical trial costs.”
A Better Path Forward
Clinical trial sponsors are increasingly turning to technology platforms designed to address these gaps. With AI-enabled localization tools and structured human-in-the-loop (HITL) models, like Athena, sponsors can gain both speed and accuracy to help curb translation delays in clinical trials. The ability to move from core materials to compliant translations with full transparency gives teams a clearer runway to hit their enrollment and submission goals.
Within Cliniphai, experts have seen firsthand how small changes in translation and localization planning can drive measurable gains across clinical study timelines. Based on work with sponsors and global language experts like GRC, here are a few practical strategies for avoiding translation delays:
- Begin localization discussions early to help streamline both regulatory and patient-facing workflows.
- Centralize translation activities on a single platform to prevent disjointed vendor handoffs and manual file exchanges.
- Use specialized linguists who understand clinical content.
Translation delays in clinical trials often fly under the radar until they force a trial stoppage in a given country. By recognizing the impact upfront and adopting a proactive localization strategy, clinical teams can stay on pace and keep these much-needed programs moving forward across borders.
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