White Paper

One Voice for Medical

Balancing globally consistent answers against local multilingual needs

Written By: Sharon Leighton, Sharon Leighton Consultancy Matthias Heyn, SDL September 2012

Table Of Contents
One Voice for Medical....................................................................................................................1 Introduction...................................................................................................................................1 Globalization of Medical Information..................................................................................................2 Managing Medical Information Content.........................................................................................2 The Center - Affiliate Working Model for Medical Information.........................................................2 Responding to Customer Requirements.............................................................................................2 An Affiliate View of Translating Standard Responses...........................................................................3 The Need for Translations...................................................................................................................4 Medical Information Systems Feeding into Translations...................................................................5 Combining the MIS with a TMS......................................................................................................5 Automated Translations...................................................................................................................5 Summary..........................................................................................................................................6 References......................................................................................................................................7

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Glossary Brazil, Russia, India, China Global Standard Responses Medical Information Medical Information Systems Statistical Machine Translation Translation Management System (E)xtensible Markup Language BRIC GSR MI MIS SMT TMS XML

One Voice for Medical

Balancing globally consistent answers against local multilingual needs.

Introduction
With increased information transparency due to clinical trial disclosure and easy widespread access to published clinical literature, the pharmaceutical industry continues to embrace the concept of One Voice for Medical. In reality, this means providing common regulatory labeling, a common set of clinical data and publications to support promotional claims and consistent answers to healthcare professionals queries for each product released into the market. While there will always be some product labeling variations in different countries, they must be still supported by sound medical and clinical evidence. One Voice for Medical Information (MI) functions. The medical information function is responsible for answering product information requests from healthcare professionals, patients, company sales representatives or marketing staff. In larger countries, these departments have dedicated specialist personnel, but smaller affiliates are often staffed by team members with multiple responsibilities, including MI. These functions have a variety of names, including Medical Information, Medical Affairs, Medical Communications, Scientific Communications or variants5. Providing consistent medical information in response to the same question is a guiding principle of medical communication functions in the pharmaceutical industry. A doctor based in a small town or village should get the same answer to the identical question asked by a doctor living in New York, Paris or Tokyo. However, putting this into practice involves complex business processes and systems, usually supported by a global or regional MI function. By creating and managing standard response documents (or Frequently Asked Questions), these centralized groups are able to maintain consistency. However, this becomes a challenge in global markets. The standard response documents, plus statements to align them to the local product label, must be accessible to Medical personnel in all affiliates, large or small, so they can give consistent answers globally. With widespread use of Global Medical Information management systems to manage content and query fulfilment, how do we manage content translated into multiple languages? Double-digit growth in emerging markets in the BRIC territories forces us to re-evaluate the need to provide responses in multiple languages. If English is the common language of business and medicine, is it good enough to provide a detailed response in English only, with a short summary translated into the local language? If the customer needs content in their own language, how do you ensure that a document in Mandarin is aligned to the response in German when document revisions are commonplace? To uncover how pharmaceutical companies are planning for and managing one voice communications today, SDL and Sharon Leighton Consultancy hosted a round table with representatives from nine pharmaceutical companies. This white paper examines the questions posed above, how pharmaceutical companies put these principles into practice and the solutions necessary to deliver on the One Voice vision.

Globalization of Medical Information

One of the emerging trends in Medical Information (MI) over the last 5 10 years has been the rise of global functions and services. There are several factors that have driven the need for globalization in Medical Information: Common regulatory labels in regions like Europe demand a common response for a given question. Information consistency worldwide is becoming more essential due to the increased regulatory scrutiny of the MI function during inspections or internal audits. Cost drivers for more efficient business operations are rising due to poor economic performance, pressure on healthcare budgets and loss of patent exclusivity from blockbuster medicines. Improved technological solutions to manage customer queries and content compliance across multiple countries, regions and languages. Increased use of regional and national outsourced MI services to maintain customer service levels and reduce costs as internal headcount is cut.

The Global Medical Information function can be a dedicated department, a person acting as a facilitator and influencer, or a virtual organization with regional hubs aligning their services and functions.

Managing Medical Information Content

Global and regional MI departments use Medical Information Systems to manage standard responses and other reference material, such as data on file or clinical articles. Regardless of the software system a company uses, they need to be able to create, approve, publish, update and archive standard response documents so that affiliates can access the most current version. An audit trail of what information was provided for each customer is also necessary for compliance purposes.

The Center - Affiliate Working Model for Medical Information

MI teams based in the United States are often the largest groups, so many companies have tried to leverage local US standard responses for use in other countries. However, this is not always a successful strategy, as US standard responses are often very long (up to 20 pages and more). Busy doctors and pharmacists dont have the time to read long documents, so they prefer more concise information and summary sections. With the expansion of global and regional MI departments, master standard responses can be generated and maintained centrally (by the Global MI team) or through collaboration across regional hubs to create a virtual global solution. Today, many companies are using this top down strategy. However, when Englishonly content is used, the local country affiliates have to focus on custom customer interactions and query fulfilments across multiple languages, so they often do not have the resources to create local, translated standard responses. Some companies have taken a glocal approach. Local affiliates with sufficient experience and expertise are responsible for producing responses that meet their customers needs but also satisfy global standards so they can be used more widely2. Therefore, a more collaborative approach is taken; when resources are tight, the global teams can focus on newly launched products whereas the affiliates may be able to provide content for products that may be significant in their market but no longer have a high priority from the global organization.

Responding to Customer Requirements

As companies have been able to roll out global Medical Information Management Systems to their affiliates, the issue of language and translations has become more prominent. Originally, affiliates were able to provide 2

a bespoke service to healthcare professional customers, answering their queries in their own language and using relevant local clinical studies as well as any global literature they could find. They could closely tailor their approach to meet local needs, although a consistent query management standard may not have been enforced. With the globalization of Medical Information, companies have challenged the status quo and moved towards a core set of languages used for standard responses. In many cases, the global standard responses (GSR) are only offered in English but often the affiliates are encouraged to translate them if the situation demanded it. Some companies planned to translate the GSRs into key languages. For example, in their globalization strategy, GSK3 planned to offer standard responses in 9 languages, while Pfizer4 originally planned to use English only. As affiliates often do not have the resources to translate the whole document and external vendors add a delay (often 2 weeks) for the customer, the solution originally planned by Pfizer is a compromise. For healthcare professional customers, the changes seen with globalization seem to be a retrograde step in service. The question now becomes what language is acceptable for answers to their questions? For many, the case for using English only seems compelling: English is accepted as a common business language worldwide Many physicians and pharmacists speak English very well, especially specialists like oncologists, cardiologists, etc. Nearly all the useful worldwide clinical literature is published in English, so customers have to be able to read and understand English

However, for many markets, English fluency is not as common as we might believe. What if a doctor misunderstands information from a response in English? Where is the liability? For many companies, a compromise situation is that the GSRs are in English and the affiliates send that information along with a translated cover letter with the summary points, product labeling and disclaimers. However, in this scenario, the healthcare professional misses the opportunity to fully understand the data from the detailed GSR. If the customer really wants a translated version, they have to wait. Preferred language content has been researched and published by Eli Lilly. Their market research study with healthcare professionals in Germany5 showed that sending an English language response to doctors, pharmacists or nurses caused confusion and was incomprehensible to some. The recipients also believed the standard response was a formal clinical publication. By comparison, English language material was better understood by hospital based healthcare professionals but they also preferred content in German as it takes less time to read and comprehend because they dont have to translate as they go along. Since the medical information service is perceived to be a value-added service for customers, taking away localization reduces its value for the customer. In a competitive pharmaceutical market, there is a significant opportunity to provide more value to healthcare professionals that are deciding what drugs to prescribe to patients. The next section of this whitepaper discusses the justification for translating MI content, as well as solutions that can streamline the process.

An Affiliate View of Translating Standard Responses

We have previously touched on the center-affiliate working model that is used in many companies. To help articulate the challenges with translation of medical information, below is a summary of how one company and its affiliate offices have approached translation. The German affiliate of a large multinational pharmaceutical company is responsible for translating GSRs into German. 3

Initially, content for translation was prioritized according to the product and query topic so that not all the GSRs needed processing immediately. Of the 700 documents translated, only 66% were effective. The remainder couldnt be used because the teams generating content in the US and UK didnt realize that every little change to the record (and not just the GSR content), meant the versions were out of alignment. As a result, the affiliate did not receive the information necessary to provide an accurate translation. In the case of this company, the architecture for query fulfilment and medical information management was not designed to manage translations. As a work-around, the affiliate had to download each document as a PDF, organize translation (with a delay of about 2 weeks), convert to XML format and then upload. In this process, document tagging was lost so each document had to be re-indexed, causing more work for the affiliate. In some cases, the original content had changed so the translation was redundant and needed to be re-done. Tracking the translations for multiple documents was also time intensive and inefficient. As a result, the affiliate abandoned translating content into German. The affiliate responsible for Spanish translation followed suit. To resolve this issue, the MI team now has to talk directly to customers in their native language (German or Spanish) to explain the key points of the content. They offer the option for a detailed English version immediately, with a German or Spanish translation later. While inefficient, it is the compromise used to address the complexity of translation. The companys Italian and French affiliate colleagues continued to manage this complex process, as their customers wont accept English documents.

The Need for Translations

Many companies are using a compromise of different options to address global medical information. However, there are several reasons to expand the current level of translation activities. Aside from the general, good ethical practice of providing an answer in the language in which a question was asked, the following list summarizes the main reasons: The Eli Lilly study referenced above demonstrates that not providing a local language response may cause confusion. This introduces the potential for litigation. Language expectations and tolerance for English-only replies varies by culture and region. The French healthcare provider community, for example, is more sensitive and outspoken on this topic. Therefore, most major pharma organizations are systematically translating their GSRs into French. In Germany, one major pharma organization reported that some regions more readily accepted English only responses compared to other regions. Providing local language content in MI can be a differentiator for customer service, especially when positioning high value branded medicines. The value of the product today is not only determined by the capacity of the product itself, but by the quality of the information in which the product is embedded. Companies could use medical information to improve the local healthcare community journey with the product. When given the choice of waiting 2 weeks for a translated response or receiving the English response immediately, most requesters will opt for the fast track response in English. However, if there are means to provide the target language with the same immediacy, this changes the situation for the requester. This will be addressed later in this paper.

Medical Information Systems Feeding into Translations

Today, most Medical Information Systems (MIS) make translations very difficult. This is often the case because many of these systems were not designed to handle responses as an entire text, but rather, to use smaller content fragments. Such fragments are typically re-used and re-assembled by the MI authors within multiple responses. While these content components are meant to improve the authoring process, it often complicates the subsequent translation process. There are various reasons for this: It is hard to translate a content component in isolation, so additional context needs to be provided to the translator to ensure an accurate translation. A translator needs to understand all possible contexts for each component during translation (as a component can be used in multiple responses), so multiple contexts may need to be generated for the translator. A change in a content component may impact multiple responses and their respective translations. This requires a sophisticated mapping between source and target language components. Ideally, as soon as there is a content change, translations of the concerned target language components should be triggered.

A well designed multilingual architecture is necessary for a MIS. Unfortunately, today this area is largely underdeveloped. A good way to overcome current challenges for medical information translation is to combine a MIS with a Translation Management System (TMS). A TMS is a well-established class of application which manages the overall translation process. TMS systems have been used in the past to organize translations for pharmaceutical companies, such as European labeling efforts.

Combining the MIS with a TMS

In the combined solution, the MIS manages the content and the TMS automates many of the necessary translation steps, such as: Creating translation projects from the MIS. Preparing the translation by leveraging translations from previous related translation projects. This means that the TMS is memorizing all translations for future reuse, which is especially useful during updates where only the updated text are exposed to translators and translation reviewers. Distributing prepared translation work items to external translation service providers. This is handled either by distributing a translation work item package to the translation vendor which contains the pre-processed document and additional useful information or by having the translation service provider directly translating the content via a browser-based translation editor. Routing of translation work items (or provision of online browser-based translation editors) to internal reviewers. Tracking the progress of the translations and triggering alerts and notifications if the planned timelines are not kept. Automating the handling of financial transactions with external translation service providers.

Automated Translations
Automated translation has improved significantly over the last years because of the scientific advances in statistical machine translation (SMT). The overall quality of an automated translation depends on how well the statistical machine translation engine has been trained on a base set of relevant existing translations. Years ago, large samples of such texts were necessary; today much smaller data sets can yield very good results. Furthermore, there are means to predict the usability of a machine translation automatically. SDL, for example, offers a quality prediction called a TrustScore, which indicates the utility of the translation. If the TrustScore 5

is high, the likelihood that the translation is good enough for the intended audience is high as well. An automated back-translation can provide further evidence that the translation is fit for the intended purpose. These new technical possibilities allow for innovative scenarios. For example, a MI department may immediately generate an automated translation after finalization of the GSRs. The quality can be assessed via TrustScore and back translation. If the quality is good enough, the requester could be serviced with both the English and the translated response. If the translations do not pass the quality requirements, the translations can go into a post-editing stage with an internal or external translation service provider. Alternatively, the requester may receive electronic delivery of the English response as well as access to selfgenerate the automated translation immediately. The health care provider may further request a human postedited translation if necessary. These scenarios are subject to further investigation, but current advances are providing new opportunities to improve the current MI process to better meet customers needs across multiple countries, not just those in the Anglosphere

Summary
This white paper was developed at a Round Table discussion with representatives from affiliate, global or regional MI departments from 9 pharmaceutical companies, representing different size companies, organizational structures with a mixture of global and regional Medical Information senior managers. Following the round table, there were additional interviews and subsequent discussions with participants. The following list provides a summary of the key lessons learned: One Voice for Medical is interpreted as providing a consistent answer for similar questions from healthcare professionals or patients across the world, aligned to the local prescribing information. Most companies achieve this goal by globalizing their Medical Information functions, providing a central point of contact for content creation and management. Some pharmaceutical companies achieve the same goal by regionalizing their operations or creating virtual product information teams. Most companies initially create the content (global standard responses) in English and need to manage these responses as new clinical evidence emerges or the product labeling changes. Affiliates try to provide answers in their local language, where possible. Realistically, this may mean a verbal answer is given in their local language, followed up by a translation of the standard response summary and full response in English. Although most healthcare professionals are highly educated with a good working knowledge of English, these customers may prefer the content in their own language to avoid misunderstandings and possible legal implications. Affiliates aiming to provide standard responses in their own language experience considerable problems in managing version control and overcoming system architecture issues. This leads to delays in providing detailed answers to customers. Translations Management Systems can overcome significant problems with version control and multiple use of content fragments in Medical Information Systems. Automated translations can also help deliver answers to customers questions in their own language rapidly to a high quality, overcoming customer dissatisfaction and avoiding potential errors.

References
1. Leighton S, Davies JE. Surveying Medical Information across Europe: The Present and the Future. Drug Inf. J. 2009; 43(5): 637-654. 2. Andeh, S. Is it possible to have global responses from a local country perspective? Presentation at DIA Clinical Forum, Medical Information & Communications track, Basel, October 2011. 3. Williams, A. Fit for the future a new strategic approach to Medical Information management within GSK. Presentation at DIA Clinical Forum, Medical Information & Communications track, Nice, October 2009. 4. Cockell, A. Driving change & breaking the mould. The journey from a country based operation to regionalization and ultimately globalization. Presentation at DIA Clinical Forum, Medical Information & Communications track, Nice, October 2009. 5. Fett R, Bruns, K, Lischka-Wittmann S. Results of a Qualitative Market Research Study Evaluating the Quality of Medical Letters. Drug Information Journal 2009: 43(6): 697-703. 6. Heyn, M: Optimizing Multilingual Labeling Processes. An SDL Whitepaper, Maidenhead, 2012 7. Heyn, M: Applying Language Technology to Multilingual Labeling, Maidenhead, 2012

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