Patient reported outcomes (PRO) are a key component in clinical trials involving patients whose informed consent and every piece of feedback matters. Today, Contract Research Organizations (CROs) take on outsourced clinical trials and leverage technology to make data-gathering easier through web and mobile-based electronic patient reported outcome (ePRO). And according to a survey conducted by the Tufts Center for the Study of Drug Development, CROs are increasingly relying on digital technology in clinical trials.
According to the survey, “an overwhelming majority of respondents report that their companies utilize ePRO and agree that ePRO usage is expected to increase in future clinical trials.” This increase in usage spans different medical fields (oncology, more than other fields, has seen an uptick in ePRO usage) and stages of the clinical trial (77% of respondents believe ePRO usage will increase for post-marketing trials).
To put this sort of demand in perspective: there are currently 44,281 open clinical trials going on the world over.
It appears the language services market is set to benefit from the convergence of life sciences and software development, particularly in terms of ePRO.
ePRO systems share much of the same challenges as other software when it comes to translation and localization of the user interface (UI). For instance, there’s limited real estate in the UI, language services providers (LSPs) need to handle the problem of concatenation, and depending on what devices the ePRO systems will run in, character and script support may be limited.
In addition, LSPs need to be able to process the materials which require translation that are unique to ePRO such as:
- eDiary questionnaires – eDiaries are the digital notebooks that patients use to record their feedback. Both the UI and the questions within the eDiaries need to be translated and localized with extra care.
- App UI, including instructions and help manuals – LSPs will encounter many of the difficulties mentioned above when translating UI.
- Subject manuals and / or quick reference guides
- Device stickers
- Site manuals
Beyond ePRO adoption, regulations like the EU 536/2014, which comes into effect on May 2016, also appear to further increase demand for translation in life sciences.