Monthly Email Newsletter
May 2005
IN THIS ISSUE:
I. Message from the Editor
II. Articles:
*** FEATURED INDUSTRY: Global Clinical Research
1. Multicultural Issues in Global Clinical Trials
2. Three Ways of Successful Translation Management
*** FEATURED LANGUAGE: Spanish
3. Marketing to the Hispanic Community
III.
*** Helpful Web Tools
4. Useful Tools for Creating a Spanish-Language Website
IV. In Our Next Issue
V. Your Feedback
VI. How to Subscribe
I. MESSAGE FROM THE EDITOR
We came upon this month's Featured Industry from a recent survey we conducted
among our readers in the healthcare and clinical research fields. A significant
response indicated that they would like to see more information on conducting
Global Clinical Trials. What we put together in this issue's first article
subject will shed light on the advantages and challenges faced by companies
trying to embark on clinical trials in other countries.
On a fun note, the survey had a nice prize drawing attached to it. We know how
busy our readers are, but your input is invaluable to us. So, to make it fun
for you we entered all participants in the survey into a drawing for a pass to
a popular industry conference. This was an $800 value! We will be conducting
several more surveys in the near future, so stay tuned and participate because
each survey will have a prize drawing to accompany it.
Our second article this month is on the Spanish language and the hot topic of
marketing to Hispanics. We recently compiled a demographic report on the top 10
foreign languages spoken in each of the 50 states, which shows Spanish to be
the most popular foreign language in almost every state in the nation (copies
of the report are available by sending a request to
mailto:editor@globallanguages.com). With this number continuing to grow, we
thought it was timely to offer our readers some tips and information on
marketing to this demographic.
Once again, this newsletter is meant to create a virtual community where we
share the latest news and advice, we invite you to submit your suggestions,
story ideas, statistics and web site tips to
mailto:newsletter@globallanguages.com.
Thanks again for reading and we look forward to your continued support.
-- Inna Kassatkina, Editor
mailto:editor@globallanguages.com
II. ARTICLES
*** FEATURED INDUSTRY: CLINICAL RESEARCH
1. MULTICULTURAL ISSUES IN GLOBAL CLINICAL TRIALS
Escalating costs and increased restrictions on research and development
(R&D) are widespread across the global pharmaceutical industry. Comprising
two-thirds of development costs, there is an increased focus on reducing the
costs of clinical development. As a result, many companies have turned to other
countries to conduct their trials. Another major factor in the trend for global
clinical trials is the unsatisfactory domestic patient recruitment rates. The
trends seem to point toward a group of clinical trial friendly areas, which
include Latin America, Eastern Europe, Commonwealth of Independent States (CIS)
countries and Asia.
Since 1990, the scope of global research has grown from 28 to 79 countries, and
the number if investigators conducting FDA research worldwide has multiplied
16-fold.
ADVANTAGES OF CONDUCTING GLOBAL CLINICAL TRIALS
The increased complexity of clinical trials and the large pipeline of products
in early clinical development have resulted in increased competition for
clinical trial participants in the U.S. Competition appears to be fiercest for
patients with cancer, neurological and cardiovascular diseases. The slow
patient recruitment in domestic trials has caused significant delays in product
launches with revenue losses mounting during the precious product patent life.
The resulting trend has been that big pharma companies like Pfizer, Eli Lilly,
Novo Nordisk and Aventis are conducting their global studies abroad and even
much smaller drug development companies are being forced to do so.
The potential for cost savings with clinical trials in emerging countries can
be up to 40 percent cheaper than the U.S. and Western European countries. These
cost savings are the result of the following key elements:
-- lower labor costs for clinical operations personnel
-- lower travel costs as patient enrollment is concentrated at few sites and
the domestic travel is cheaper
-- lower costs of support services, such as handling of clinical trial
supplies, printing and local courier services
-- lower data management costs
The combination of availability of participants, motivated investigators and
clinical environments that are different from the U.S. or Western Europe
provide special opportunities for clinical research.
1) Access to Patients:
There are a number of reasons that other countries are able to recruit clinical
trial participants in such a rapid and effective manner. First, most emerging
countries have large numbers of patients with diseases of both the developing
and industrialized world. In addition to widely prevalent infectious and
tropical diseases, rapid and extensive urban development in countries like
India, China, South Africa and Brazil has resulted in disease prevalence
similar to that found in developed countries like North America and Western
Europe.
Link to http://govinfo.library.unt.edu/nbac/clinical/Chap5.html for useful
information on ensuring the protection of research participants in global
clinical trials.
2) Access to Investigative Staff:
Many emerging world countries have highly trained, motivated physicians, well
suited to be investigators for global clinical trials. One reason for this is
that medical education is often delivered in English and is based on a system
similar to that in North America and Western Europe. Physicians at academic
institutions are well trained, fluent in English and computer literate.
3) Special Clinical Environments:
Seasonal differences between the countries in the northern and southern
hemispheres enable year round patient recruitment for disorders with a seasonal
variation in incidence.
GENERAL CHALLENGES IN CONDUCTING GLOBAL CLINICAL TRIALS
1) Infrastructure
Access to cheaper labor, vast numbers of subjects and willing investigators
makes global clinical trials very appealing; however, these benefits do not
come without challenges. Many times, the infrastructure to conduct these trials
is very limited. Most will require significant investment into building
clinics, computer systems and things we take for granted like refrigeration.
Communications, such as email and phone are not as advanced as in developed
countries. Therefore, a good evaluation should take place prior to making any
decisions to conduct trials in a particular country.
2) Translation Issues
As much as we would like to think that English has become a global language,
the subtle nuances of culture and translation are a large part of the clinical
trial process. In fact, about 1.2 billion people may speak English as a second
or foreign language, while only 380 million can be counted as native speakers,
a ratio of 3:1. According to Mary Stober, President of Global Project
Resources, LLC, "Unaddressed misunderstanding could compromise the integrity of
the whole study and result in a multi-million dollar error. Sponsors can avert
misinterpretation by making all definitions explicitly, through the use of a
standard glossary, and through simultaneous interpretation during investigator
training."
(www.globalprojectresources.com)
One of the areas that typically poses a challenge with regard to translation is
the Informed Consent Form (ICF). Problems can originate in the original English
ICF as well as the translated ICF. Inna Kassatkina of Global Language Solutions
offers several tips for making the ICF an effective working document:
a) Aim for a recommended 4-8th grade reading level by using plain English;
replace all legal and scientific terms with simpler terms
b) Use precise translation equivalents for important terminology (e.g., it
would be incorrect to translate "human subject" as "participant" or "patient")
c) Preserve descriptive non-medical terms in the translation for various
conditions and procedures if such terms were used in the original ICF (for
example, "blood pressure" should not be replaced with "hypertension" in the
translation)
For a complete tip sheet on ICF translation, please send your request to
mailto:ICFtranslation@globallanguages.com.
REGIONAL ADVANTAGES & CHALLENGES
The potential for companies to save money and speed up their trials is huge.
Other countries are ready and willing to take on these challenges. A quick
synopsis on a few specific regions will give a better taste of the climate and
what might be right for you.
1) EUROPEAN UNION: The European Union Clinical Trials Directive 2001/20/EC was
instilled in 2001 and was aimed at improving 'the approximation of the laws,
regulations and administrative provisions of the Member States relating to the
implementation of Good Clinical Practice in the conduct of clinical trials on
medicinal products for human use'. The Directive was supposed to simplify the
administrative provisions governing clinical trials by establishing a clear,
transparent procedure for member states. On paper this sounds like a clear
message, however, in practical application it has become a confusing and
complicated practice to instill.
For specific information on the Directive, go to
http://medicines.mhra.gov.uk/ourwork/licensingmeds/types/clintrialdir.htm.
All legislation had been run through a national format with no regional
governance and was a confusing process, to say the least. During 2004, regional
legislation was put into place with a new directive called the EU Clinical
Trial Directive. Basically, the national legislations still plays a major role
in clinical trial regulation but the member states are more responsible for
time lines, documentation and data.
For more information on navigating the complexities of the EU regulations, link
to
http://www.mdsps.com/Science/Articles/EUClinicalTrialDirective.pdf.
2) LATIN AMERICA: This region offers something unique that other areas do not:
a common language. Spanish is spoken across almost all Latin American countries
except Brazil. Additionally, the regulatory environment has evolved with the
clinical trial and pharmaceutical industry at the center. This bodes well for
companies considering conducting trials in that region. Latin America also
boasts approximately 25% of global pharmaceutical sales in 2000. Leveraging the
clinical trial study in Latin America can easily pave the way to a built in
customer base.
For more information on conducting trials in Latin America, link to
http://www.parexel.com/PAREXEL_Experts/Trials_in_LA.pdf#search='clinical%20trials%20in%20latin%20america%20diego'.
3) ASIA: The largest target for most companies in the Asian region is India.
Why? The simple answer is India's huge billion-plus population and cheaper
costs. According to a study by Rabo India Finance, India's huge patient
population also offers vast genetic diversity, making the country "an ideal
site for clinical trials". For example, India has the largest pool of diabetic
patients, with more than 20 million citizens diagnosed. Additionally, many
residents in the Indian population are considered "poor" and are "treatment
naive". This creates an ideal scenario in which most have never received drugs
for a particular diagnosis - a fact that speeds up patient enrollment and trial
management.
Another upside of conducting trials in India is the medical facilities the
country has to offer. Boasting nearly 700,000 specialty hospital beds, 221
medical colleges and skilled English-speaking medical personnel, this becomes
an ideal environment. Yet, as India emerges as a viable and desirable target
for outsourcing clinical trials, the country may also be heading toward
providing the greatest source of human guinea pigs for the global drug
industry. Because of the patient-rich environment, vast amounts of clinical
trials are being conducted and many without GCP (good clinical practice)
standards. Recent legal crackdowns on illegal trials have begun to open the
eyes of local government, patient populations and medical staff. If this is not
curtailed, the willingness and open environment in India may well disappear.
USEFUL LINKS:
We have compiled a list of links that will help you learn more about the
advantages, challenges and specific target regions for conducting global
clinical trials.
European Union info:
http://www.pharmafocus.com/cda/focusH/1,2109,22-0-0-0-focus_feature_detail-0-197449,00.html
http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=129266
Drug Regulation and Clinical Concerns:
http://www.aapspharmsci.org/view.asp?art=ps050427
Ethical Issues:
http://www.georgetown.edu/research/nrcbl/nbac/clinical/execsum.html
SOURCE INFO:
a) Office of the Inspector General Report, The Globalization of Clinical Trials
(OIG, Washington, DC, September 2001).
b) Clinical Trials in Latin America (DataEdge, 1825 South Grant St., Suite 310,
San Mateo, CA 94402).
2. THREE WAYS OF SUCCESSFUL TRANSLATION MANAGEMENT
Inna Kassatkina of Global Language Solutions (GLS) offers several tips for
ensuring translation management success and the quality of translations. They
are as follows:
1)
Work with a professional translation agency. Complete the following
checklist before working with any reputable agency:
-- check the agency's experience and references in the medical/pharma/clinical
research fields
-- request the agency's documentation of the entire translation and QA process
-- evaluate the agency's selection criteria and testing methods for all
translators
-- request that translation memory (TM) tools be used - these tools ensure
consistency of terminology and reduce overall translation costs
-- make sure that the agency's project manager assigned to your account fully
understands and addresses your needs and communicates with you promptly
-- check the agency's ability to meet or beat your project deadlines
2)
Perform an independent translation review by an expert in the
medical/pharma/clinical research field:
-- it can be one of your company representative or the agency's independent
reviewer
-- in addition to the reviewer's expertise in your field, he/she must be a
native speaker of the target language (i.e., the language into which the
translation was done)
3) As an ultimate test of the translation quality,
perform a back translation:
-- make sure the back translation team is completely different from the
translation team and never gets to see the original document(s)
-- back translations are highly recommended for advertisements, product
inserts, labels and other documents intended for the final consumer or research
subject
*** FEATURED LANGUAGE: SPANISH
3. MARKETING TO THE HISPANIC COMMUNITY
Have you noticed a few changes in your local grocery store? For instance, an
entire row devoted to salsa and only a few shelves for Ketchup? In the dairy
section, we now see that "dulce de leche" has become a popular flavor, and
Corona, a household name! What do all of these subtle changes add up to? A
cultural acknowledgment of the power of today's Hispanic influence.
Here are a few quick facts that illustrate the magnitude of the now recognized
Hispanic market:
1) Research by Nielsen NetRatings shows over 14.3 million people online in
Spain (August 2004).
2) 12.25 million people are online in Mexico (source: ITU, December 2003).
3) According to "The Economist", Spanish-speaking people represent US$2.5
trillion of the world's GDP (gross domestic product) and equal 9% of the
overall population. These global statistics are telling, but what is more eye
opening is the growth of the Hispanic influence in the U.S.
For more stats and insider info on the Hispanic Market go to
http://www.sunshinebydesign.com/cgi-bin/gt/tpl.h,content=347&referrer_code=rss&.
The United States is the fifth largest Spanish-speaking country in the world;
Los Angeles is the third largest Spanish-speaking city in the world, behind
Mexico City and Buenos Aires , Argentina. It is no secret that states like
California and Texas have a large Hispanic demographic. However, a lesser-known
fact is that in the majority of other states, ones that most would not identify
with a large Hispanic demographic, Spanish is the most frequently spoken
foreign language. For instance, according the latest report by Global Language
Solutions (the full report is available by emailing a request to
mailto:editor@globallanguages.com), 27% of Hawaii's population speaks Spanish.
Surprising? Illinois has over 2 million Spanish-speaking residents and New
Jersey boasts a 25% Spanish speaking population. Numbers like these have caused
a jolt within the marketing world, making companies stand up and take notice of
their growing Hispanic customer base. Visit the Latino Marketing &
Advertising blog for an inside look on expert opinions on the industry at
http://juantornoe.blogs.com/hispanictrending/hispanic_marketing_advertising/.
The heightened awareness of the U.S. Hispanic Market has rippled through the
advertising community. In fact, leading advertisers have almost doubled their
advertising efforts targeted to Hispanics. Hispanic buying power is increasing
at a rate of 118% per year and currently is rated at $630 billion dollars.
According to the America Online U.S. Hispanic Cyber study conducted in 2003,
44% of Hispanic consumers make regular purchases online, and among Hispanics,
55% of Internet usage is occurring in Spanish. These statistics indicate that
there is a particular way that the Spanish-speaking community likes to
communicate and shop. For more tips on how to market to the Hispanic market
link to
http://www.refresher.com/!garcia.html.
Marketing to the Hispanic community does have its challenges and cultural
nuances. These are best addressed by multicultural experts; however, for those
that want to get a jumpstart on the learning curve, here are a few tips:
1)
Expect to appeal to the idea/concept of family. Family is of the
highest importance to Hispanics, and family members participate in both the
shopping experience and the decision-making process. Appealing to the entire
family or centering your product or service around a wholesome family image,
recognizing the importance given to elders will go far with the Hispanic
audience.
2)
Formality is key. Do not use first names, but rather Mr., Mrs., Sir
or Ma'am unless invited to use familiar names. Respect, especially for elders,
is extremely important.
3)
Hispanics are very relationship and trust oriented. There needs to be
a familiarity or acceptance of trust before engaging in a business proposition.
U.S. based companies typically like to move quickly when garnering new
customers. Expect the lead time and efforts to be greater in the acquisition of
new customers. The upside of this, is that Hispanics tend to be much more loyal
to brands than their English-speaking counterparts.
4)
Because of the strength of family and the close-knit nature of the Hispanic
community, word of mouth or referral-based marketing is a huge asset. Keep
this in mind when marketing to new customers. Maintaining one happy customer is
very likely to lead to many more new customers down the road.
For additional tips on marketing to Hispanics, please send your request to
mailto:HispanicMktg@globallanguages.com
Whether the label Hispanic or Spanish-speaking customer is used, this is a
group of about 45 million, economically diverse people, living in the US with
an approximate spending power of $750 billion per year currently and projected
to reach $1 trillion by the year 2010. It is a market that is clearly demanding
to be addressed and within its own, cultural dynamics. The key is to market
appropriately and to seek out the proper professional advice when embarking on
a cultural campaign. Good Luck and Feliz Comercialización!
III.
*** HELPFUL WEB TOOLS
4. USEFUL TOOLS FOR CREATING A SPANISH-LANGUAGE WEBSITE
If you have already made the decision to market your business to the Hispanic
demographic, there are numerous resources on the web to help you get started!
1) Before embarking on any campaign, you should gather as much information
about your demographic as possible. This article on the Spanish-speaking
marketplace will give you a great background on what to expect
http://searchenginewatch.com/searchday/article.php/3371721.
2) Do you need a quick fix for translation? For that instant translation try
http://world.altavista.com/.
3) Pilnet.net has a great resource of free chat rooms, visitor counters and
much more to help you create that perfect website!
http://www.pliner.net/?r=-39&OVRAW=spanish%20web%20tools&OVKEY=web%20tool&OVMTC=advanced
4) When seeking interesting and targeted news content, try
http://www.hispaniconline.com/. The site has up to the minute news feed about
all things Hispanic.
5) Looking for fun items to add to your website in Spanish? Try this game
resource at http://www.juegorama.com/juegorama/. Here is a greeting card
service in Spanish:
http://www.tarjetas.com/.
IV. IN OUR NEXT ISSUE
*** FEATURED INDUSTRY: Customer Relationship Management (CRM)
*** FEATURED LANGUAGE: Portuguese
V. YOUR FEEDBACK
Have questions? Or a story idea or topic you would like us to address
in a future issue? Let us know by sending a message to
newsletter@globallanguages.com.
VI. HOW TO SUBSCRIBE
