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Featured Article from The ATA Chronicle (January 2013)

How Information Technology Developments Are Changing the Future of Medical Translation
By Erin M. Lyons

The medical field is a discipline undergoing continuous change, both in terms of innovations in treatment and new developments in the information technology and e-documentation used to record patient procedures, therapies, and progress. The wide range of possibilities for subspecialties and the lucrative nature of the industry’s enduring growth, despite a rather lackluster economy, make specializing in medical and life sciences translation an intriguing option. However, translators entering this field will need to embrace technology in order to survive.

Medical translators are already required to be well versed in medical terminology and to keep up with advances in research, technology, procedures, and standard of care, so the ever-changing context of the field presents additional challenges. Translators must remain vigilant to ensure that they acquire and maintain the necessary skill set to stay ahead of the technological curve. By using the appropriate tools, resources, and training,
translators can leverage these technological advantages in what is becoming an increasingly niche-oriented business. One of the ways in which translators can maintain this edge is to understand how innovations in e-documentation used in medical records and clinical trials is transforming the translation process.

What Are the Latest Developments in E-documentation for Clinical Trials and Medical Records?
The internationalization of the pharmaceutical and medical technologies industries has continued to have a far-reaching trickle-down effect as more countries become actively involved in clinical trials, with global teams accessing data at sites around the world in real time. The emergence of new technologies and data workflow
systems represents a multidisciplinary effort to bridge the diverse processing of data collected during clinical trial protocols in order to compile, analyze, and archive study data for the most effective review of the results. Ultimately, the primary goals behind the innovations taking place in electronic data capture include:

• Creating templates and processing data uniformly to leverage for future use.

• Improving the efficacy of data processing to save time and money.

• Standardizing data capture so that modifications can be implemented in real time.

• Providing data that can be retrieved instantly to safeguard patient safety further and improve public health drug safety monitoring (pharmacovigilance).

• Minimizing human error and omissions to ensure data accuracy and prevent data loss.

Essentially, the impact of these latest advancements in e-documentation and data capture has been twofold: 1) the digitalization of the paper-based system, and 2) the consequent reform of the clinical trial workflow process as a result of technological improvements.

“Intelligent” electronic means of data collection and patient reporting in clinical trials include using hand-held devices and tablets to answer patient and quality-of-life questionnaires, completing patient e-diaries for immediate access to information, using digital pens and tablet dispensers for automated drug administration, and employing interactive voice response systems for urgent physician contact. In addition, the embedded and stand-alone medical software used in diagnostic procedures (e.g., electro cardiogram interpretation), apparatus (e.g., radiation therapy administration), or decision-triggering devices (e.g., blood glucose meters) also continue to undergo improvements.

Many medical devices also now have extension mobile applications to control the devices and display, as well as to store, analyze, or transmit patient-specific medical data. Mobile apps include those allowing remote access to the measurements of a patient’s vital signs, ones that calculate the amount of chemotherapy needed based on a patient’s body surface area, and those that monitor a patient’s movements to determine conditions such as sleep apnea, fall detection, or heart rate.

Moreover, medical software is now included in the definition of a medical device under the European Medical Device Directive Amendment of 2010, which states: “Stand-alone software that does not meet the definition of a medical device or of an IVD medical device, but is intended by the manufacturer to be an accessory to a medical device, or an IVD medical device, falls respectively under the scope of Directive 93/42/EEC or Directive 98/79/EC.”1 As a result, new attention is being paid to software by global regulators for validation and verification purposes, creating new opportunities for translation, localization, and validation.

How Have These Developments Affected Clinical Trial Administration?
Data management workflow for clinical trials has clearly been forced to evolve due to these new tools and changes in how, and by whom, data is collected and stored. For the most part, traditional clinical trial management has been overhauled in favor of clinical trial management systems to provide the infrastructure necessary for multi-site clinical trials. The rapid growth and expansion of clinical research has made paper-based collection woefully inadequate and data-based centralized systems essential.

These centralized workflow systems allow data managers and clinicians to work together in a centrally managed database, using the same standard operating procedures and processes, regardless of language or location. Clearly, these types of processes involve translators, who are responsible for translating patient source data and reports and harmonizing and reviewing data collected from multiple sites.

How Are These Technological Innovations Changing the Translation Workflow?
Despite all of these technological advances, translation is still translation, but expectations have changed in terms of productivity, timeliness, and integration. As British physicist, civil servant, and novelist C.P. Snow wrote in The New York Times in 1971, “Technology … is a queer thing. It brings you great gifts with one hand, and it stabs you in the back with the other.”2

Medical translators spend much of their time translating source documentation and case report forms (CRFs) so that international data from multicenter studies can be collected and harmonized. Most medical translators are all too familiar with CRFs, the standardized form used by clinical sites to transcribe relevant data from patient medical charts (the “source documentation”) and compile it with data from other sites around the world to create a statistical pool for study data analysis. The migration from paper-based data collection and medical records to electronic ones has resulted in the development of the electronic case report form (eCRF). As clinical trials expand globally, a properly internationalized and localized eCRF application is essential to provide faster, less expensive, and more consistent translations. The eCRF is basically a means of removing the paper-based step. This makes it possible for data entry to be pushed back to an earlier stage in the data processing protocol and to be performed directly at the clinical sites, rather than being performed internally by one of the sponsor’s subcontractors or a clinical research organization. The key features of the eCRF are that it provides:

• Faster data collection;

• Cleaner data;

• Easy monitoring; and

• The immediate evaluation of results.

For translators, the types of data requiring translation have essentially remained unchanged (e.g., adverse event reports, subject randomization assignments, medical histories, diagnostic reports, laboratory values, etc.), but the platform through which the information is collected and presented has changed, as well as the constraints.

While most medical translators are fairly accustomed to using translation memories (TMs), terminology databases, quality review of document templates, and other reference guidelines, eCRFs call for standardized data input and mapping, as well as classifications such as the Systematized Nomenclature of Medicine – Clinical Terms (SNOMED CT)3 and its related glossaries. All of these systems also tend to use controlled language as part of proprietary systems, which then need to be merged with other systems to compile and cross-analyze data. This means that official regulatory terms (for adverse events, dosing, etc.) need to match up with the translated terms used by the proprietary software platforms at local clinical sites and hospitals. Failing this, automated data processing will be ineffective, with potential duplications of single instances of adverse events that may require additional manual reconciliation. This means that translators and terminologists need to contribute to both the upstream and downstream of software internationalization to ensure that data collection processes remain accurate and effective. Integrated terminology databases and TMs become integral during the initial translation process in order to generate consistent and accurate translations, particularly when there is the added challenge of interlinguistic text expansion and contraction that requires localization and retooling for specific markets.

Data collection and medical records ultimately aid translators because data element attributes have become standardized, creating greater consistency and fewer reporting ambiguities across clinical sites. At the same time, however, the resulting translations are also less “flexible.” Standardized terminology can risk degenerating into “jargon” when linguists are stripped of discretionary translation possibilities and forced to work around rigid terms and controlled language. For medical translators, the global nature of clinical trials means that the use of computer-assisted tools (CATs) has become essential as the process becomes increasingly commodity-driven, with extremely accelerated timelines and data turnover deadlines.

What Tools and Training Are Essential for Translators to Remain Competitive in an Increasingly High-Tech Environment?
Advancements in the field have made continuing education more indispensible than ever for medical translators, who can no longer rely on scientific and medical expertise alone to remain competitive. The complexities of documentation in international clinical studies means that it is no longer enough to be “just” a translator.
While there are not necessarily any gold standards in terms of the specific tools used for clinical trial documentation management, with an abundance of proprietary and open-source systems available, translators can take some key steps to ensure success in working with these new aggregate systems to manage content across diverse linguistic and cultural groups.

1. Become an expert on your CAT/TM. Most translators only have an elementary knowledge of the tools they use on an everyday basis. Learn all of the features of your TM tool of choice, including search functions, terminology “locking” capabilities, terminology plug-ins, and module frameworks. Set tangible goals, such as spending one hour per week to master a specific feature or attending one webinar per month hosted by the tool’s developer.

2. Become a terminologist. Become a master of clinical and technical documentation terminology. Learn the standard terminology for the instructions for use, user manuals, package inserts, labels, etc., for your language and country combinations. For example, the European Medicines Agency Working Group on Quality Review of Documents is a great place to start and is the international multilingual gold standard.

3. Research graphical user interfaces and content management systems. Learn enterprise-level technologies, such as proprietary plug-ins or data transfer systems, used by your end-clients to gain a macro-prospective on quality control and worldwide process
alignment. Under standing the end-use of the translated content (data compilation, regulatory submissions, patient documentation) is key to a translator’s ability to contextualize and tailor translations appropriately.

4. Work your way up the ladder. Start using the information technology interfaces used by your clients, such as database integration tools and XML editors as a linguistic reviewer, before diving into the deep end and mastering them for your own translations. You will find it easier to advance to increasingly integrated support roles if you learn the ins and outs of the client’s proprietary system early on.

Innovation is Key
Although it may seem overwhelming at first, adapting to new innovations in
medical technology should be viewed as an opportunity and business driver for even the less than tech-savvy translator. As in all business sectors, it is vital that translators strategize to find ways to add value to their “product.” Providing quality translations that meet technological expectations is an excellent way for medical translators to find their niche and differentiate themselves from the competition.

Notes
1. European Commission Health & Consumers Directorates-General: Medical Devices, “Guidelines on the Qualification and Classification of Stand-Alone Software Used
in Health Care within the Regulatory Framework of Medical Devices,” http://ec.europa.eu/health/medical-devices/files/meddev_6_ol_en.pdf.    

2. Snow, C.P. The New York Times (March 15, 1971).

3. International Health Terminology Standards Development Organisation – SNOMED, www.ihtsdo.org.

 

Helpful Links for Medical Translators

European Medicines Agency Working Group on Quality Review of Documents
www.ema.europa.eu

European Commission Health & Consumers Directorates-General: Medical Devices
http://ec.europa.eu/health/medical-devices

Food and Drug Administration Guidance for Industry: Electronic Source Documentation in Clinical Investigations
www.fda.gov/downloads/Drugs/NewsEvents/UCM275445.pdf

International Health Terminology Standards Development Organisation – SNOMED
www.ihtsdo.org

MedTerms – Online Medical Terminology Dictionary
www.medterms.com

 

Erin M. Lyons is a full-time French>English and Italian>English translator and medical writer specializing in clinical research, pharmaceuticals, and medical devices. Her experience includes in-house and freelance work as a translator, editor, and project manager in both Europe and the U.S. She has a BA in Romance languages and literature from the University of Chicago and an MA in Italian and French translation from the Monterey Institute of International Studies Graduate School of Translation, Interpretation, and Language Education. She has presented at several ATA Annual Conferences, as well as at the 2011 World Congress of the International Federation of Translators. Contact: elyons08@yahoo.com.