Being Smart About Global vs. Local During Clinical Research Trials

Donald A. DePalma, PhDChief Research Officer

Copyright © 2008 by Common Sense Advisory, Inc.

About Common Sense Advisory

Syndicated research company based in Boston area Specialized focus on language services (translation,

interpreting, localization) Our research is frequently cited in national media

(Business Week, US News & World Report, Forbes, Time, Associated Press)

Our analysts have published peer-reviewed journal articles in major publications for the medical community (Journal of Health Care Law and Policy, Health Affairs, among others)

Today’s presentation

The demand The terms of the trade – key terminology The role of culture and language in global clinical trials Applying global project management during the clinical

research process Transcending culture and language barriers in the

management process Recommendations

Life sciences goes global – and multicultural

Pharmaceutical project managers need to master management techniques, tools, and measures that transcend– Language– Cultural– Geopolitical barriers

Each stage of the drug’s life cycle is touched by:– Language– Culture– National infrastructure needs

Industry leaders need to employ new technologies to allow their global team members to collaborate better and to manage critical information on local, international, and global levels

Global markets demand change and adaptation

Pharmaceutical and other life sciences companies selling their products internationally typically adapt:– The offer

– The product itself

– The language

– The website

– The marketing collateral

– Its way of selling

– How it delivers the product

– Who supports it to the needs of doctors and other consumers in their target markets.

The terms of the trade

Translation: Taking information in one language and conveying the same details and thoughts in another language

Localization : Adapting a product, code, content, imagery, and other elements of a drug, brand, or experience to the national, linguistic, legal, and logistical needs of a specific market

Internationalization: The behind-the-scenes engineering work that supports localization and translation.

The role of culture and language in global clinical trials

Accuracy Communication challenges

Accuracy

The precision of translated materials and documentation for clinical trials plays a critical role.

Mistakes from poorly done translations can result in product delays and cost overruns

Inaccurate translations can contribute to malpractice or product liability lawsuits

The proper translation of the Informed Consent documents and adhering to a documented process of free and informed consent, are crucial for protecting the subjects’ human rights

Communication challenges

Problems and issues of true and informed consent may arise when a trial involves non-English speaking subjects.

Research subjects, whether inside or outside the home market, may have cultural values different from those of the researcher.

Translation of Informed Consent documents should take the specific culture into account.

In many cultures – especially in global clinical trials – it is important that researchers talk about the trial with – and possibly obtain permission from – the subject’s family and local community before attempting to obtain consent from individuals for participation in a clinical trial.

Applying global project management during the clinical research process

Global project management The money question Project profiling

Global project management process

Following a well-defined global project management process helps you align business goals with your project’s language, culture, and communications infrastructure characteristics.

First and foremost, outline your project’s business goals. Consider revenue expectations, required investment, continuing expense, and financing.

Example: a drug development licensing negotiation necessarily estimates revenues and expenses related to marketing a drug in order to arrive at valuations for debt and/or equity financing.

The money question

Financing and investment considerations include how financiers assess risk, as well as when they expect to distribute funds and receive payback.

Revenue and expense projections may include:– Estimates for patient adherence to therapy (revenue) – Costs for recruiting and retaining foreign-born scientists

(expense)– Building an effective clinical infrastructure (expense).

Project profiling

Remember: Each financial element is influenced by language, culture and communication factors.

Once you have outlined your project’s key financial aspects, the next steps involve analyzing each for where language, culture, and communication will likely affect your estimates.

Then, you can create a project profile based these characteristics, and amend your project budgets and timelines to account for additional resources needed for translation services, travel, equipment, training and education.

Transcending culture and language barriers in the management process

Language and legislative requirements General guidelines The role of culture

Market requirements

To market a drug successfully in the U.S., Europe, and Japan, pharmaceutical companies may have to provide translation in dozens of languages.

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), and Japan's Ministry of Health, Labor and Welfare (MHLW) all have language requirements for documentation and filings.

Reference: Donald A. DePalma et al., “Can’t Read, Won’t Buy: Why Language Matters on Global Websites” (Lowell, MA: Common Sense Advisory, 2006)

Legislative requirements

All recipients of federal funds are also required by federal law (Title VI of the Civil Rights Act) to provide language services. This includes federal grant money.– Recipients of federal funds are required to make information

available in all languages that comprise either 5% of the total population to which a product is marketed or 1,000 people, whichever is smaller.

– Reinforced by President Clinton in 2000 under Executive Order 13166, “Improving Access to Services for Persons with Limited English Proficiency”

Reference: Donald A. DePalma, “When Translation is the Law” (Lowell, MA: Common Sense Advisory, 2007).

General guidelines

Include expense and time estimates for translating documentation to and from languages, especially for clinical trial forms and documents.

Factor in costs and time for developing language strategies that support work in multilingual teams, like replacing words with graphics and producing project glossaries.

Involve the translation team from the beginning, to ensure that materials are well-written, “translatable” across languages and cultures. This will save time and money later in the development cycle.

The role of culture

Culture plays a role not only with the patients, but in developing relationships with international co-workers, diverse development and financing partners, and physicians.

Cultural practices and values can affect a therapy’s successful development and market adoption, influencing everything from disease diagnoses to definitions of life.

– Example: simpatía – concept common among Latinos of “congeniality” or “affection,” influences how satisfied they feel with their care, potentially affecting their willingness to disclose their complete patient history, to adhere to treatment, to report adverse events, and to make follow-up visits.

Reference: Donald A. DePalma, “Developing Multicultural Websites” (Lowell, MA: Common Sense Advisory, 2007)

Think beyond language. Think communication.

Preferences for specific communication channels (telephone, e-mail, Internet, face-to-face) vary based on individual taste and language skill, ease of availability and use, cultural influences, and confidentiality considerations. Preferred channels may vary among project constituents (colleagues, regulators, patients, physicians, etc.)

Example: Asian-Americans are proportionally the most Internet-active ethnic group, but they represent many different language and cultural groups. Hispanics in the U.S. may hail from many countries, but they share the foundation of a common language.

Consider communication preferences and alternate channels when reaching out to diverse groups to recruit clinical trial subjects, to share information on diseases and treatments, or to communicate other key messages.

How to avoid translation and cultural adaptation mishaps

Control and compliance Strategy and benchmarking Partner and process Technology

Control and compliance

Enormous volumes of data and information about drugs flow around any pharmaceutical company. Most of it is in English and is targeted at various information consumers – doctors, nurses, FDA staff, consumers, retailers, and distributors.

To comply with the laws and ensure that people get the right treatment for their ailments, pharmaceutical firms must keep the information they publish correct, current, and consistent across all of their publications, packaging, websites, and marketing materials.

Managing information gets measurably more complicated as the companies add another step – translation into other languages. For each item they publish in English, they now have to guarantee the accuracy, currency, and consistency of the information they publish in French, German, Japanese, Russian, Thai, and perhaps dozens of other languages.

Strategy and benchmarking

Develop a clear strategy. Develop a global management strategy to prepare your company and your product to compete in diverse environments. Match your project’s business goals with its language, culture, and communications characteristics. Hire or appoint a qualified localization manager to oversee your efforts.

Benchmark against those who have gone before you. Many companies have gone down this path. Compare notes with colleagues in other business units and at other firms to gauge your level of localization maturity. Learn from the experiences and mistakes of others.

Reference: Donald A. DePalma et al., “Localization Maturity Model” (Lowell, MA: Common Sense Advisory, 2006)

Partner and process Engage with partners who can help. Create and maintain process for hiring and managing

language and localization suppliers. Identify partners and tools to help you efficiently localize, internationalize, and globalize your projects.

Formalize your processes. Clearly document all processes connected with localization. Use these to develop a system for efficient and effective localization.

Reference: Donald A. DePalma et al., “Language Perspectives 2006: Supply Side Outlook” (Lowell, MA: Common Sense Advisory, 2006)

Technology

Manage content across multiple locations and translation providers via centralized content management systems and translation memory (TM) tools

Centralize translation management via one department, a core contact team, or even a designated project manager, organizations

References: Benjamin B. Sargent et al., “Translation Management Technology” (Lowell, MA: Common Sense Advisory, 2006); Donald A. DePalma, “Developing Products for Global Markets” (Lowell, MA: Common Sense Advisory, 2006).

Recommendations

Remember communication preferences. For some cultures, even groups who speak English natively, such as low-literacy populations, an audio recording may be preferable to written text.

Consider spoken language capacity. Translated marketing materials often generate phone calls from individuals who want to learn more. Add spoken language interpreting partners as needed.

Prepare for web interactions. Many groups obtain their information via internet. Knowing how available your website is in other languages is extremely important.

References: Benjamin B. Sargent et al., “Website Globalization: The Availability Quotient” (Lowell, MA: Common Sense Advisory, January 2008); Nataly Kelly et al., “Telephone Interpretation” (Lowell, MA: Common Sense Advisory, June 2008).

Thank you.

Donald DePalma

don@commonsenseadvisory.com

+1.978.275.0500 x 1001

Research: www.commonsenseadvisory.com Blog: www.globalwatchtower.com

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