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The next wave: understanding how IT developments are changing the future of medical translation


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Demand is exploding in the field of medical translation with the pharmaceutical, biotechnology, and medical device sectors representing the second-largest market share in the industry. Despite fast-growing demand and higher volumes of translation services in both traditional and emerging markets, the life sciences vertical is set to face new challenges in an expanding geographic environment that has become increasingly regulated and quality-driven.

We will take a closer look at the trends currently driving the medical translation industry, including the recent push towards multilingual harmonization through controlled language and the implementation of common technological applications. Recent changes in the regulatory environment, transitions to e-documentation, and new approaches to terminology management as determinants of quality and consistency will also be explored.

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The next wave: understanding how IT developments are changing the future of medical translation

  1. 1. The Next Wave: Understanding How IT Developments are Changing the Future of Medical Translation © Erin M. Lyons
  2. 2. Introduction Trends and drivers Recent regulatory changes 1 2 3 4 E-documentation 5 Term management
  3. 3. Introduction
  4. 4. “Because things are the way they are, things will not stay the way they are.” - Brecht 1 – Introduction
  5. 5. Diving into the industry 1 – Introduction Growth industry Regulatory opportunities Expanding geographic/linguistic requirements Sustained growth/aggressive vertical 2012 pharma sales = $830 billion despite “patent-cliff” year 25-27% growth in top 17 “pharmerging” countries It takes the FDA an average of 16 months to approve a new product Average cost to bring to market = $500 mn; Average product life cycle = 10 years
  6. 6. 1 – Introduction Pharma Cliff Hanger: Patent Expiration
  7. 7. 1 – Introduction FDA Approvals, 2001 - 2011
  8. 8. 1 – Introduction Geographical Breakdown: Main Markets “Pharmerging” markets: Argentina, Brazil, China, Egypt, India, Indonesia, Mexico, Pakistan, Poland, Romania, Russia, South Africa, Thailand, Turkey, Venezuela, Vietnam, and the Ukraine.
  9. 9. 1 – Introduction Geographical Breakdown: Global Outlook 2011 Global Spending by Segment and Market
  10. 10. 1 – Introduction A Closer Look at the Pharma Pipeline
  11. 11. • The pharma industry is the sector with the highest value-added per person employed • The market continues to be US-dominant, but there is a gradual shift towards emerging economies • Only an average of 1 or 2 per 10,000 substances synthesized in laboratories will become marketed drugs 1 – Introduction The Takeaways:
  12. 12. Trends and drivers
  13. 13. “The secret of getting ahead is getting started.” - Mark Twain 2 – Trends and drivers
  14. 14. 2 – Trends and drivers Research-based activities are particularly economically active in certain countries (i.e. USA, Japan, France) Economic Footprint: R&D vs. Production
  15. 15. 2 – Trends and drivers Economic Footprint: Global R&D Relative density of doctors per 1,000 in population.
  16. 16. 2 – Trends and drivers • Manufacturing and research are not directly linked. •Some countries have little research compared to manufacturing capacity, while others have little manufacturing and considerable research. Economic Footprint: R&D vs. Production
  17. 17. 2 – Trends and drivers Economic Footprint: Technology Transfer Select examples of technology transfer, manufacturing protocols, and entrepreneurial know-how.
  18. 18. Leading Categories of Drug Development 2 – Trends and drivers
  19. 19. Factors promoting technology transfer: 2 – Trends and drivers
  20. 20. Factors Driving Pharmaceutical Innovation 2 – Trends and drivers
  21. 21. Recent regulatory changes
  22. 22. “If you do not change direction, you may end up where you are heading.” - Lao Tzu 3 – Recent regulatory changes
  23. 23. 3 – Recent regulatory changes Continual regulatory lifecycle Regulatory Clinical stage R & D Manufacturing Sales & Marketing
  24. 24. • With the emergence of drug-device and biologic- device combinations, interdisciplinary skills are essential • Products are more complicated and markets are more diverse and challenging • Most companies now have pre- and post-review processes in place 3 – Recent regulatory changes A changing regulatory environment
  25. 25. 3 – Recent regulatory changes An expanding geographic market Regulatory constraints Acquiring linguists Strategic placement Pharmaceutical companies must dive into the new “pharmerging” markets, but they also must build confidence in their brand and products
  26. 26. • Regular and routine review of key websites (FDA site,, EMA, local RA) • Set alerts for updates to ISO – ISO 1455: Good clinical practice in clinical investigations for medical devices for human subjects – ISO 1497: Risk management for medical devices • EC Regulation No. 726/2004: Pharmacovigilance requirements for drug submissions 3 – Recent regulatory changes Gathering regulatory intelligence
  27. 27. 3 – Recent regulatory changes Risk management Risk treatment Risk avoidance Risk retentionRisk transfer Risk management in action
  28. 28. • Pharmaceutical companies are looking for non- scientific justifications to broaden the claims for their medicines • PRO (patient-reported outcomes) are highly subjective and open to “creative” marketing claims • QoL (quality of life) and PRO are expensive and timely when translated well Linguistic validation – measurement tools 3 – Recent regulatory changes
  29. 29. • Define the role a PRO endpoint is intended to play in the clinical trial • Link potential labeling claims to specific trials • A description of challenges related to developing PRO instruments for multiple cultures or languages PRO guidance 3 – Recent regulatory changes
  30. 30. Translation 3 – Recent regulatory changes
  31. 31. • Informed consent forms, patient-reported outcomes Back-translation confirms that content and readability are unaffected • Marketing materials and labeling In-country review guarantees appropriateness for specific markets Back-translation & in-country review 3 – Recent regulatory changes
  32. 32. Back-translation 3 – Recent regulatory changes
  33. 33. E-documentation
  34. 34. “The expectations of life depend upon diligence; the mechanic that would perfect his work must first sharpen his tools.” - Confucius 4 – e-documentation
  35. 35. • It is only a matter of time before all source data is captured in electronic format  Eliminates unnecessary duplication of data  Reduces the opportunity for transcription errors  Promotes real-time entry of source data during visits  Ensures the accuracy and completeness of data • Until then… we have the eCRF! 4 – e-documentation Wave of the future
  36. 36. • A vehicle to assemble data from electronic- and paper-based systems • Captures and organizes diverse data to satisfy the study protocol • Enables the data to be systematically reviewed and analyzed by investigators and other authorized parties 4 – e-documentation What is an eCRF?
  37. 37. 4 – e-documentation Assembling data using an eCRF
  38. 38. • Translation and transfer of medical data to a harmonized format • Translation of eCRF and QA prompts • Translation of site-specific reporting forms for automated import into eCRF • Translation of local proprietary input systems (not global-ready) 4 – e-documentation What does this mean for translators?
  39. 39. 4 – e-documentation Embedded systems Upstream internationalization and localization • Life sciences technology often uses embedded systems as part of diagnostic, monitoring, and reporting tools  Most systems are locally developed, proprietary applications = not global-ready Downstream translation and retooling for international markets
  40. 40. 4 – e-documentation Medical software • According to the European Medical Device Directive Amendment of 2010, software is now included in the definition of a medical device  both integrated and stand- alone applications • New attention to software by global regulators for validation and verification  new linguistic validation opportunities
  41. 41. 4 – e-documentation Localizing embedded systems • Issues faced are similar to those in telecom/software sectors Dynamic resizing Visuals vs. text  Keyboard support  Sorting in non A-Z alphabets Country/health system-specific tags Naming conventions and identifiers
  42. 42. Content repurposing 4 – e-documentation Video content Media syndication Website publishing Your medical translation
  43. 43. 4 – e-documentation Content repurposing • Translators adapt and repurpose content (media syndication, Web publishing, etc.) • Producing e-learning and audio/video training materials • Trans-adaptation and push-button publishing • Consolidation and review in regulated fields
  44. 44. Term management
  45. 45. “Nothing will work unless you do.” - Maya Angelou 5 – Term management
  46. 46. • Terminology investments have an early break- even point • Terminology changes during updates is 200 times more expensive than during authoring Terminology investments 5 – Term management
  47. 47. • Remember that terminology management (unified determinants) is different from TMs (archived examples of translations) • TMs are not an “intelligent” tool • Linguists are essential terminology evaluators in regulated fields • Back-translation is important as a reverse verification term  Terminology is a quality-driver Term management 5 – Term management
  48. 48. • The EMA requires that regulatory dossiers be submitted for simultaneous EU market authorization • Quality Review of Documents (QRD) set terminology, stylistic, and formatting requirements for compliance • Many companies are developing automated tools for QRD control > more efficient top-down control Terminology and QRD 5 – Term management
  49. 49. Quality-driven workflow 5 – Term management Enhanced quality and increased productivity rarely go hand in hand
  50. 50. • EU Medical Device Directive 93/42/EEC requires companies to adopt a specific multilingual documentation process • Multilingual content management has been further complicated by content adaptation to foreign locales/markets • Integration of end-client CMS with vendor TMS for top-down consistency • Back-translation is now an essential benchmarking tool and quality strategy Multilingual harmonization 5 – Term management
  51. 51. Global-ready product lines 5 – Term management
  52. 52. • The technical and simple syntax of medical language makes it friendly to the architectural dimensions of controlled language BUT • The potential consequences of inaccuracies have led to reluctance to using it in essential areas of practice Controlled language 5 – Term management
  53. 53. • Electronic medical terminology databases (i.e.: WHO standard terminology  physician terms  patient terms  billing codes) • Standardized data input for electronic medical records • Mappings to classifications and standard glossaries (Systematized Nomenclature of Medicine – Clinical Terms, SNOMED CT) Applied controlled language 5 – Term management
  54. 54. • Back-translation is an essential benchmarking tool • Development of glossaries and controlled input language for languages/locales • Stakeholder in regulatory review/audits • “Clean” data review Translators and QA 5 – Term management
  55. 55. • Translators link data managers and local clinicians via central database regardless of language or location • Multilingual IVRS integration • Real-time roll-out of protocol changes • Translators on call for out-of-box adverse events A virtual collaborative environment 5 – Term management
  56. 56. • Accelerated timelines and more commodity- driven process • TMs/glossaries are not “intelligent” tools • Technological learning curve for translators • Costly add-on tools? A double-edged sword? 5 – Term management
  57. 57. Erin M. Lyons
  58. 58. 19The ATA Chronicle n January 2013 The medical field is a disci- pline undergoing continuous change, both in terms of innovations in treat- ment and new developments in the information technology and e-documentation used to record patient procedures, therapies, and progress. The wide range of possibilities for subspe- cialties and the lucrative nature of the industry’s enduring growth, despite a rather lackluster economy, make spe- cializing 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, pro- cedures, and standard of care, so the ever-changing context of the field pre- sents additional challenges. Translators must remain vigilant to ensure that they acquire and maintain the neces- sary skill set to stay ahead of the tech- nological curve. By using the appro- priate tools, resources, and training, translators can leverage these techno- logical advantages in what is becoming an increasingly niche-oriented busi- ness. One of the ways in which trans- lators can maintain this edge is to understand how innovations in e-documentation used in medical records and clinical trials is trans- forming the translation process. What Are the Latest Developments in E-documentation for Clinical Trials and Medical Records? The internationalization of the pharmaceutical and medical technolo- gies 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 work- flow systems represents a multidisci- plinary effort to bridge the diverse processing of data collected during clinical trial protocols in order to com- pile, 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. · How Information Technology Developments Are Changing the Future of Medical Translation By Erin M. Lyons Medical translators can no longer rely on scientific and medical expertise alone to remain competitive.
  59. 59. How Information Technology Developments Are Changing the Future of Medical Translation Continued • Improving the efficacy of data pro- cessing 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 moni- toring (pharmacovigilance). • Minimizing human error and omis- sions to ensure data accuracy and prevent data loss. Essentially, the impact of these latest advancements in e-documenta- tion and data capture has been two- fold: 1) the digitalization of the paper-based system, and 2) the conse- quent reform of the clinical trial workflow process as a result of tech- nological 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, com- pleting patient e-diaries for immediate access to information, using digital pens and tablet dispensers for automated drug administration, and employing interac- tive voice response systems for urgent physician contact. In addition, the embedded and stand-alone medical soft- ware used in diagnostic procedures (e.g., electrocardiogram 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 calcu- late the amount of chemotherapy needed based on a patient’s body sur- face 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 soft- ware that does not meet the definition of a medical device or of an IVD med- ical 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, localiza- tion, 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 manage- ment 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 col- lection woefully inadequate and data- based centralized systems essential. These centralized workflow sys- tems allow data managers and clini- cians 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 harmo- nizing 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 integra- tion. 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 docu- mentation and case report forms (CRFs) so that international data from multicenter studies can be collected and harmonized. Most medical trans- lators are all too familiar with CRFs, the standardized form used by clinical 20 The ATA Chronicle n January 2013 Despite all of the technological advances, translation is still translation, but expectations have changed in terms of productivity, timeliness, and integration.
  60. 60. 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 med- ical 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 local- ized 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 sub- contractors 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, diag- nostic 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 data- bases, quality review of document tem- plates, and other reference guidelines, eCRFs call for standardized data input and mapping, as well as classifications such as the Systematized Nomencla- ture of Medicine – Clinical Terms (SNOMED CT)3 and its related glos- saries. All of these systems also tend to use controlled language as part of pro- prietary 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 inef- fective, with potential duplications of single instances of adverse events that may require additional manual reconcil- iation. 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 termi- nology databases and TMs become inte- gral during the initial translation process in order to generate consistent and accu- rate 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 lin- guists are stripped of discretionary translation possibilities and forced to work around rigid terms and con- trolled language. For medical transla- tors, 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 complexi- ties 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 documenta- tion management, with an abundance of proprietary and open-source sys- tems available, translators can take some key steps to ensure success in working with these new aggre- · The ATA Chronicle n January 2013 21 New attention is being paid to software by global regulators for validation and verification purposes, creating new opportunities for translation, localization, and validation.
  61. 61. gate 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 docu- mentation terminology. Learn the standard terminology for the instruc- tions 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 multi- lingual 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. Understanding the end-use of the translated content (data compila- tion, regulatory submissions, patient documentation) is key to a translator’s ability to contextualize and tailor trans- lations 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 increas- ingly integrated support roles if you learn the ins and outs of the client’s pro- prietary 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 technolog- ical 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 Classifica- tion of Stand-Alone Software Used in Health Care within the Regulatory Framework of Medical Devices,” 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 Organisa- tion – SNOMED, European Medicines Agency Working Group on Quality Review of Documents European Commission Health & Consumers Directorates-General: Medical Devices Food and Drug Administration Guidance for Industry: Electronic Source Documentation in Clinical Investigations International Health Terminology Standards Development Organisation – SNOMED MedTerms – Online Medical Terminology Dictionary 22 The ATA Chronicle n January 2013 How Information Technology Developments Are Changing the Future of Medical Translation Continued Helpful Links for Medical Translators