By Mark P. Wade, global practice leader, Lionbridge Life Sciences
Pharmaceutical companies have long recognized the complexity of juggling multiple variables at the outset of a clinical trial: selecting a CRO partner with the prerequisite skill sets, identifying PRIs (primary research investigators), and looking for drug-naïve patient populations to meet regulatory obligations. There is, however, another challenge that often appears later in the process. Trial planners realize they need all of their trial documents to be in the native languages of the patient pool, and those documents need to be culturally correct, certified, and, for Quality of Life instruments, validated.
Best Practices for Language Translation in Clinical Trials
Language translation is a critical element of a global clinical trial, but it is typically not a core competency of a pharmaceutical company, a CRO, or the protocol authors. With multiple geographies, there are many variables to manage to ensure certified, on-time translations. There are also scaling issues as studies ramp up and down. Working with a well-established language partner and following a few key guidelines will confirm your trial’s success.
1. Plan for Language
Engage with your language partner early. Take advice on what works culturally even if the documents and the trial sites have not been selected. Be certain your language partner can involve its overseas offices and have resources ready for finalizing documents.
2. Look for a Local Presence
It is fairly common for small translation companies with limited global reach to outsource all or part of a translation project to another small translation company in the target country. This creates significant challenges:
The trial sponsor is far-removed from controlling translation quality.
Harmonizing translations becomes impossible due to differing translation methodologies.
The sponsor’s intellectual property (IP) is shared with unknown parties (clearly not optimal).
Verify that your translation partner has a local presence where your trial is scheduled. Your partner should be marshalling its local offices to directly oversee the translators, and it should not outsource work to unknown translation companies. Keeping the project local protects your IP, ensures consistent translation methodologies, and reduces your trial risk profile.
3. Audit the Managing Translation Site
Always audit the site that’s managing the translation process for you. This is not the same as auditing your translation company’s European or U.S. headquarters. Your audit should focus on the location where the work is performed. Make sure your translation partner is following industry standards (ISPOR and ISOQoL) and that there are robust SOPs around all parts of the translation process. A secure repository should exist for all your documents, and they should not be shared with third parties. Your language partner should also have a well-established version control methodology.
Language translation is on the critical path for today’s clinical trial, yet it is the smallest line item in any trial today. Pharmaceutical companies and CROs that can recruit global patient populations and deliver clean, high-quality data have a huge market opportunity. The fact that language translation is a relatively small part of a trial’s cost should not dilute its value.
The integrity of the data you capture rests firmly in the hands of the participating patients’ trial experience, and it is those patients’ results that the regulatory bodies will scrutinize. Make sure your clinical trial is set up to support the best outcome on both fronts.