Found in Translation

How often have you sat in meetings agonizing over the format of a case report form? Most likely, you have devoted many hours and much energy to the layout of your case report forms (CRFs) so that they are most effective in conveying and collecting the information you need.

Photography: Eyewire Illustration: Paul A. Belci

Then, you are reminded that the trial is being conducted in a foreign country or an area in the United States and/or Canada in which a second language is spoken. You begin the search for a translator without a clear concept of what the translation process really is, or the impact it can have on your carefully thought-out design.

Foreign sites are increasingly being used in clinical trials. The additional demands that translation places on the planning process, as well as the implementation of those plans, is a neglected but critical area. Global clinical trials require that you convey your information in a way that can be understood by speakers of other languages. In fact, even clinical trials being conducted solely within the United States frequently require translation.

The non-native-English speaking part of the population is rapidly growing, with Hispanic Americans the fastest growing demographic. According to Census 2000, their number increased by 58 percent since 1990—a gain of about 13 million people. Hispanics made up 12.5 percent of the population in 2000. It is projected that by the year 2025, Hispanic Americans will account for 18 percent of the U.S. population. Moreover, Spanish is the second most common language in the United States. In 2000, about 27.8 million people (or 10.5% of the population) over the age of five spoke Spanish at home, and just under half could not speak English very well.

In addition to the many different dialects within Chinese, there are also two different ways of writing Chinese—simplified in mainland China and traditional in Taiwan, Hong Kong, and other overseas Chinese-speaking communities. In speaking about this group, there should be mention of the many dialects.

In order to effectively communicate, you might think that all you need is someone who can translate your words into the same words in another language. Translation, however, is far more than that. The goal of translation is to not merely convey a series of words, but to convey a message. You want this message to be phrased in such a way as to be responsive to the cultural needs of the foreign-language-speaking populations.

What is translation?

Regardless of the data management system you have chosen, or the software used to create the CRFs, translation of clinical trial documents is a complex process. However, understanding local language translation and planning for the technical aspect of producing translated clinical trial documents will assist you in implementing a successful global trial. You really need a translation expert to make your global trial successful—wherever it is being conducted. Early collaboration with a specialist can help you in not only the physical layout of your CRF and other materials, but also the way the concepts are phrased. The goal of translation of clinical trial documents is to accurately and appropriately communicate your "message" into the local language so that the data you are collecting is equivalent to the data collected in English.

How do you find this expert? What should your expectations be? What questions should you ask?

Translation providers

When you begin the translation process, there are options as to your choice of provider. You can use a freelance translator, or you can use the services of an agency. If you use a freelancer, you would be responsible for coordinating the workflow. You may have to pay extra for editing and proofreading, because the translator will have to pass their work on to additional people for this phase of the process. If you choose to use an agency or project manager, their service will include the selection and supervision of translators, project management, multiple layers of quality control, and consistency between documents translated into many languages.

Once you have selected the providers, it can be very useful to discuss your needs with them in the planning stages of your trial. A consultation at an early point in the planning can have a great impact on the final product, as noted below:

• The creation of copy can be adjusted for cultural appropriateness. Given the nature of the target audience—what country, the educational level—a translation provider can effectively localize your text. In addition, assistance can be provided to determine if there are governmental requirements. Rethinking and rewriting later in the process can prove costly.

• It can be ensured that enough space has been allocated to allow for the expansion of the word count. When translating from English into a foreign language, the word count can increase from approximately 20% for French and Spanish to much more for some of the Asian languages. This can have a significant impact on the layout of your CRFs.

• A specialized vocabulary can be developed so that translators can be aware of any terminology specific to the project.

• Globalization of your clinical trials is going to affect the budget. A translation provider can discuss the cost considerations, which you should be aware of. The cost will fluctuate depending on the language and word count. Additionally, graphics and any desktop publishing techniques will add to the cost. If you wait too long to contact a provider, you will be charged more for rush processing. Cost-effective alternatives can also be explored. For instance, if a document is going to require input from multiple sites, it can be translated in a draft form, eliminating the expense of editing and proofreading

• Timelines can be established so that the necessary translators have scheduled time at the appropriate intervals.

Writing globally

The globalization of your clinical trials can be easier to achieve if you think globally from the beginning. The most significant area in which to think globally is the creation of the text. Discussing how to write for translation with a translation expert would be helpful in controlling both time and cost. Less time will be necessary in back-and-forth communications to clarify meaning, and the English will require less revision to make your message appropriate for foreign-language speakers. Some considerations include using uncomplicated syntax, and few (if any) idiomatic or colloquial expressions. It is also worthwhile to review your text for possible ambiguous terms or phrases. A nonclinical example could be the use of the word "informal." Asian countries closely ally the concepts of formality and politeness. Therefore, referring to the donkey as the informal symbol of the Democrats could be misunderstood as the impolite symbol. In this case, "unofficial" would be a far better word choice.

YOU are not a translator

Even if you are fluent in a foreign language, it is strongly advised to resist the temptation to handle the translation yourself, because speaking a language does not "translate" into writing a language. You run the risk of creating a poor translation, which could result in insulting or inaccurate text.

Translators are primarily writers. They have a linguistic background, knowledge of the culture, knowledge of the subject matter, and experience in accurately conveying the sense of technical words. Translation is an art combined with a decision- making process. The translator is constantly deciding which would be the best terminology to use in each context, so that the message is not just conveyed, but conveyed well. In addition, since you created the text, you would not be as aware of points that need clarification as a professional would. It is part of the translator's job to review the original text for clarity and accuracy, both of which can be missed by people too close to the project. Translators will also check the content for expressions that do not translate well, and then discuss possible alternatives. If you receive questions from your translation provider, be it agency or freelance, you are getting quality work because your documents are being critically examined.

Reasonable expectations

It will help you establish timelines if you understand the way translators work. An experienced translator can translate approximately 3000 words per day. This does not include editing. In addition, more time is needed if it is a complex document with a lot of formatting. The popularity of the target language also has an impact on timing. If it is a frequently used language, such as French or Spanish, the translator will most likely be very much in demand. This obstacle can be encountered even when using a translation company.

While all translators used by a company should have been carefully screened, some are more appropriate for different subject matters. Translators are usually not generalists. Therefore, even though an agency might have several excellent translators, those that specialize in a given area are limited. For this reason, as you schedule your work, it is critical to be aware that translators usually all have previous commitments. Your expectations should be reasonable—remember that translators are not sitting around waiting for your work. They are busy people who will work in 24-hour stretches if that is what is required to honor their commitments.

There are also expectations regarding a translator's credentials. There are frequently requests for a "certified" translator. In the United States, there is currently no certification process for translators. Thus, a certified translator cannot be produced. The American Translators Association accredits translators through a voluntary testing process. A nonaccredited translator, however, can be as excellent as an accredited one.

Be prepared

In order to have a smooth flow of work, there are a few things to keep in mind when reviewing your process, most of which involve timing.

• Is an estimate required before the translation is begun? If so, you will need to provide the word count in a timely manner or submit the document to the translation provider for an estimated word count. This should be done quickly in case negotiation is required.

• Is the text finalized? You should make sure that the text you send to the translator is the final version. If you do not have all the required input, you will be creating a situation that will end up costing you more. If a translator is required to revise their translation, it can cost the minimum charge or much more, depending on the extent of the revision. Do not think that it will be simple if you only revise a few words. This is not necessarily the case. A translator may have to review much more than a few words to make the requested changes. For instance, a change in a noun means that a translator has to go through the text to make sure that there is gender agreement and correct pronouns throughout.

• Do you need time for proofreading of the final text? Most clinical trial managers prefer to have the translation reviewed by their staff, mostly for formatting issues, i.e., are all the check boxes there?

Know what is required

There is certain information that a translation provider will need in order to proceed with the job. For obvious reasons, it is advisable to have this information at the first contact. The provider will need to know in what area of the country or world the translation will be used. Location has a significant impact on the selection of a translator. Within the United States, it is important to know if a Spanish translation will be used in New York, Florida, California or Texas. The location will determine whether a translator skilled in Cuban Spanish or Mexican Spanish is needed. Of course, the Spanish for use in Spain would require a completely different skill set. If Chinese is requested, it would be important to know if it should be simplified or traditional Chinese—or perhaps a dialect?

You should also know the requirements of the IRB regarding back translations, a frequent request. A back translation is a good way of evaluating the accuracy of a translation. There is one critical caveat to understand. A back translation will not be a mirror image of the original English. When you review a back translation, you will see that your message is being conveyed, but not necessarily in the same words you originally used. Many colloquial phrases cannot be translated into another language and so the translator comes as close to the meaning as possible. For instance, the phrase, "pins and needles" might not exist in other languages. Therefore, the translator must come up with a colloquialism that, when back translated, would read differently.

Additionally, many words and concepts do not exist in other languages. The translator might have also rephrased an idea to avoid a cultural taboo or sensibility. Therefore, it saves a great deal of time if it is clear from the beginning that the back translation will differ in phrasing and words from the original. This does not make the translation incorrect. In fact, if you are receiving a back translation that is word for word like the original, you are not getting a valid back translation.

Potential problems

It is necessary to keep certain issues in mind in order to avoid any setbacks in the translation process. Establishing unrealistic deadlines can lead to rushed work that may lead to oversights on the part of the CRF designers. It is not unusual for a translator to pick up a mistake made in the original text because the clients were so rushed to meet the timeline they did not budget enough time for translation.

Another significant problem lies in too many revisions. Of course, the more versions there are, the greater the potential for confusion. In addition, the more a document is revised, the more it will cost. Revising in a foreign language requires much more than exchanging one word for a new one, or changing one sentence. The translator must be sure that everything that follows from that word or sentence follows the correct grammatical rules, such as gender and the use of the singular or plural.

Conclusion

A translation provider can coordinate your project so that you are able to accurately convey your message to your targeted population. When you use such a company, you will be dealing with someone who understands your subject and can help you define your needs. The finished product will be a mirror image of your CRF, translated into the required languages, edited, proofread, and culturally compatible. The earlier you are able to arrange working with such a provider, the fewer problems you are likely to encounter with both the design of the CRF and the collection of the data.

Ellen Boyar is translation manager, custom information services, with Thomson Scientific, 3501 Market St., Philadelphia, PA 19104, email: ellen.boyar@thomson.com.