Over the last decade, research programs have expanded offshore into Eastern Europe, Latin America, and Asia-Pacific. This has been driven in large part by escalating costs and difficulties associated with patient recruitment in North America and Western Europe. Between 2005 and 2006, the number clinical trials conducted in the Asian-Pacific region increased by 50%.
This expansion into emerging regions hasn’t stop clinical trials from becoming increasingly complex and dependent on sophisticated technology systems. A study by the Tufts Center found that the median number of procedures per clinical trial increased by 49% between 2000-2003 and 2004-2007, while the total effort required to complete those procedures grew by 54%.1 Trial complexity has been further compounded by the proliferation of digital study systems.
Among the advantages of conducting trials offshore are concentrated populations in urban centers and a relative abundance of investigators who have been educated in the West. This profile has led to the assumation that conducting clinical trials in such regions is similar to working in Western markets. Over time, however, the research community has realized that important differences exist and success can depend on taking these into account.
Culture trumps all
There are profound differences across cultures in how people learn and communicate, and an understanding of these differences is essential for any endeavor in emerging regions. Indeed, the maxim “culture trumps strategy” has recently arisen, and it might be better said, “Culture trumps all.” Study managers must consider the unique cultural landscape of every country in which they operate.
Among many important cultural factors, communicators must consider differences in providing feedback, asking questions, taking tests, group dynamics, individual roles, relationship building, and social hierarchies, to name just a few. Communication programs and training plans need to accommodate a wide range of such cultural dynamics.
Some generalities apply for effective communications within specific countries, but each culture presents communicators with multiple nuanced challenges. It may be unrealistic to expect study leaders to understand the cultural nuances of every country involved in an offshore clinical trial. Instead, study leaders must rely on feedback from members of the study support team, such as regional affiliates of the drug developer or contract research organization (CRO) personnel who are resident within respective countries.
In addition to culture, socio-economic factors play an important role in communicating in offshore trials. In some less affluent countries, large parts of the population may not have access to adequate health services, and clinical trials may be the only way for some patients to gain access to modern healthcare. In such settings, the need to ensure that patients provide their informed consent is one of many clear communications challenges.
Literacy rates tend to vary more widely among emerging countries, and there is even a wide range of literacy rates among regions within countries such as India and China. This requires a partnership among governments, drug developers, and medical providers to protect illiterate patients from potential abuse in clinical trials. In such cases, informed consent may need to be documented by the patient, study site staff, and independent witnesses.
English has become the de facto standard for communications in offshore clinical trials, but the reality is that English fluency varies among global study sites and there are important language factors to consider. Even for study site investigators and coordinators who speak English as a second language, proficiency can vary widely and affect training.
In some offshore countries such as India, Hong Kong, and the Philippines, English is widely spoken among sectors of the population and is even one of the official languages. High rates of English proficiency are helpful, but can cause developers to underestimate the important cultural differences that exist in such countries. And while English proficiency in these countries is excellent among medical professionals, less educated patient populations may not have as reliable English skills.
At a minimum, many countries require that regulatory documents and patient information be translated into all official languages. Patient materials pose special translation challenges in countries with multiple native languages, and this can become a burdensome aspect of communicating in offshore trials.
Modern and traditional medicine
Training and communications plans may be affected by important differences in medical practices within various regions. Direct experience with clinical research and baseline knowledge of good clinical practice may vary widely from country to country, as may the character of general medical training.
The day-to-day roles and interactions between physicians and non-physician healthcare professionals may be very different among countries. To respect the hierarchical sensitivities of some cultures, it may be necessary to train and communicate with physicians separately from non-physicians such as study coordinators. It’s also imperative to understand how duties in the conduct of studies are divided among investigators and their staff.
The attitudes and behaviors of patients with caregivers can also differ markedly among different countries and regions. Trial leaders face the difficult challenge of balancing cultural sensitivity with the absolute need to conform to Western standards such as ICH/GCP.
In many emerging regions, medical practice often combines Western medicine with traditional medical approaches, and study teams need to understand local medical practices, anticipate possible affects on the protocol, and effectively communicate on how to appropriately execute clinical trials in such practice settings.
Many emerging countries are rapidly improving their regulatory regimes, adoption of ICH/GCP guidelines, and standards of transparency. However, it’s important to closely track the state of development in each country and communicate the most current information to all parties, including field monitors and study sites.
Technology and logistic infrastructure can also affect communication plans. As the exchange of information moves into digital media, it becomes important to consider regional issues such as the availability of broadband connectivity, computer hardware, and software resources, and even basic computer skills among study site personnel.
Logistically, travel and face-to-face communications can be constrained by costs, visa requirements, security concerns, and even freedom of movement in some regions. Meeting and training plans need to incorporate these special logistical considerations.
Perhaps the most important element for effective communications is the involvement of nationals from the countries of offshore study sites. Some drug developers have extensive affiliate offices across the globe, with local staff members who can assist with culturally adjusted communications. If that’s not the case, study leaders may gain support from the growing number of CROs that are available in many emerging countries. Local staff or CROs can serve as an important bridge between the goals and processes of a study, and the cultural context in which the study will operate.
Virtual media has the potential to dramatically lower costs, improve availability, and expedite delivery of effective training and communications. This is especially true for emerging regions, where issues of cost, quality, and logistics are accentuated.
Use of both live virtual media (Web conferences) and on-demand virtual media (Web sites) is booming in clinical research. For live Web conferences, it is imperative to use a skillful mix of multimedia and interactive elements to hold audience attention and achieve communications goals. For Web sites and self-learning modules, it’s important to add production elements that contribute to a superior user experience, such as animation effects and navigation tools that let users control the pace and sequence of material. Audiences that speak English as a second language can especially benefit from self-learning modules that include scrolling text of speaker comments, because such audiences often have better reading skills than listening skills.
Culturally attuned communications may be among the most important factors for success in offshore clinical trials. The clinical research community has made important strides in better understanding new cultural settings, and study leaders must incorporate cultural understanding across the full range of their training and communications activities. ?
Bill Cooney founded MedPoint in 1990 and has presided over the growth and transformation of MedPoint into a provider of digital medical communications and information services.
1. March/April 2010 CSDD Impact Report . Tufts Center for the Study of Drug Development. Available from http://csdd.tufts.edu/files/uploads/mayjuneimpactrpt10summary.pdf Accessed on July 15th, 2011.
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