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Adapting to Cultural Differences to Positively Impact Clinical Trials

June 22, 2021

Importance of Cultural Differences in Clinical Trials

Clinical trials is a multinational industry, where teams from different backgrounds come together to collaborate. Cultural differences influence how they work together, and thus how successful the trial is. One aspect of cultural differences is communication style, which is influenced by educational, social, religious, and ethnic background. Given that interpersonal communication is essential for effective teamwork, clinical trial teams should account for cultural communication differences in their multicultural projects.


One way to assess cultural differences is with the 6-D Model of National Culture. This model provides country-level scores of six cultural dimensions: Individualism, Power Distance, Masculinity, Uncertainty Avoidance, Long-Term Orientation, and Indulgence.\(^1\) When working on a multinational project, a tool like this can help establish a better understanding of the cultural communication differences between team members. Leaders of multicultural teams can employ these principles of cultural dimensions to mitigate cross-cultural conflicts,\(^2\) and if incorporated at the beginning of a multicultural project those conflicts may be avoided. 


Power Distance world map
(Power Distance World Map. Geert Hofstede. https://geerthofstede.com/culture-geert-hofstede-gert-jan-hofstede/6d-model-of-national-culture/)


For example, within the European Union (EU) there are international cultural differences, notably with power distance and uncertainty avoidance, which is important to understand when conducting clinical trials in the EU. Beyond communication style, cultural differences can include work schedules, time urgency, decision-making style, work ethics, and team hierarchy. When cultural differences are properly addressed, they can have a positive impact on the success of clinical trials.

Adapting to Cultural Differences with Study Participants

In multinational clinical trials, it is important to enroll a diverse population of patients, because new drugs and devices should demonstrate efficacy in a wide range of patients, representing different ethnicities and backgrounds. Special attention must be paid to groups that were traditionally under-represented in clinical research because they may have additional barriers to participation.\(^3\) Research has shown that by implementing cross-cultural training for physicians, patient-reported trust and satisfaction can be increased,\(^4\) which then helps to mitigate multicultural differences with study participants.


One component of the clinical trial that requires cultural sensitivity adaptation in particular is informed consent, both the document and the discussion.\(^4\) International cultural differences in healthcare and communication must be appropriately captured in the consent form, and therefore a trial may need multiple country-specific consent forms. These can be tailored to their specific audience by involving local stakeholders in the development process, and by utilizing back-translation of the consent form to ensure it retains its meaning when translated from the target language back to the original language. 


Furthermore, the informed consent discussion is most successful when the study team members have undergone cultural sensitivity training, and have particularly focused on the cultural norms of their target patient population. This is important to ensure that patients have a complete understanding of the clinical trial, which ensures their capacity to agree to participate. Ultimately a “one for all” communication method may not be viable in a multinational clinical trial, but rather a country-specific approach to clinical trial communication strategies should be employed.

Adapting to Cultural Differences with Study Teams

The importance of adapting to cultural differences also extends to communications between study teams. Without properly addressing this, teams may succumb to misunderstandings, missed deadlines, and communication complications, all of which pose a challenge to keeping clinical trials on budget and on time. Solutions may include adapting not only the language used in communication, but also the tempo of communicating and the use of slang or local expressions. Multicultural teams should also adapt to different workplace logistics, such as national holidays, work week beginning on Sunday versus Monday, and expectations for length of work day and break times. 


Beyond these logistical adaptations, it is important that study team leaders receive adequate training so they feel comfortable communicating with their multicultural colleagues. There are multiple models of cross cultural training, one of which is the 5 Cross-Cultural Capabilities for Clinical Staff: Self-reflection, Cultural Understanding, Context, Communication, and Collaboration.\(^5\) The goal of such training is to increase awareness of one’s cultural norms and expectations, how those may differ from multicultural colleagues, and how to effectively communicate to bridge that gap. 


One important cultural difference is power distance. Cultures with a high power distance prefer hierarchical team structure with leaders holding greater power, whereas cultures with a low power distance prefer flat team structure and equal power among team members.\(^6\) High power distance is seen in some Western European and Asian countries, whereas low power distance is seen in the U.S., Australia, and Northern Europe. Appreciating these differences allows clinical trials teams to respect the decision-making processes and timelines of their multicultural colleagues. And by setting clear expectations early in the project, they can adjust their expectations for the workflow, communications, and decision-making throughout the project.

Dokumeds as your Cross-Cultural Clinical Research Partner

Dokumeds is a leading CRO service provider, with over 25 years experience in the clinical research industry. Dokumeds is experienced in multinational trials and multicultural teamwork, including clinical trial projects that span dozens of countries and as many different cultures. Dokumeds’ partners and clients hail from all over the globe, including Europe, Israel, North America, South America, Japan, China, and Africa. One example of this is Dokumeds’ work in ophthalmology clinical trials which often target different regions in European Union, Russia, and other CIS countries, where the ophthalmology disease burden is high. Yet another example is in infectious diseases clinical trials, for instance Dokumeds’ experience includes Tuberculosis projects, spanning across several geographical regions with different cultures, including Europe, Africa, Latin-America, and Asia-Pacific, which represents a truly multinational team with various cultural backgrounds.


Through these experiences and partnerships, and through navigating clinical trials during a pandemic, Dokumeds has developed workflows, training, and a company culture of embracing diverse collaboration and communication styles. Adapting to cultural differences is important to Dokumeds, so Project Managers and key staff members are provided cross-cultural training, during which intercultural communication is highlighted. Dokumeds strives to always remain open-minded, flexible, and eager to embrace diversity. Dokumeds has successfully adapted to cultural differences in clinical trial projects thus far, and looks forward to new projects with multicultural partners.

References

  1. The 6-D model of national culture. Geert Hofstede. https://geerthofstede.com/culture-geert-hofstede-gert-jan-hofstede/6d-model-of-national-culture/. Accessed: 03 June 2021.
  2. Rahman A. Leadership for multicultural teams: the challenges in managing cross-cultural conflicts. Journal of Econocmics, Business and Management. 2019 Feb;7(1):41-44. http://dx.doi.org/10.18178/joebm.2019.7.1.578.
  3. Palazzani L, Macioce F, Daverio M, Persampieri L, Ferro V. New strategies for increasing participation of patients from diverse cultural and religious backgrounds in clinical trials. BioLaw Journal – Rivista di BioDiritto. 2019 Jan;1S:101-123. http://dx.doi.org/10.15168/2284-4503-403.
  4. Harmsen H, Bernsen R, Meeuwesen L, Thomas S, Dorrenboom G, Bruijnzeels M. The effect of educational intervention on intercultural communication: results of a randomised controlled trial. Br J Gen Pract. 2005;55(514):343-350. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15904552.
  5. Queensland Health. Five Cross Cultural Capabilities for Clinical Staff. Division of the Chief Health Officer, Queensland Health. Brisbane 2010. https://www.health.qld.gov.au/__data/assets/pdf_file/0034/382696/ccc-clinical.pdf
  6. How to effectively work across cultures in global clinical trials. Clinical Leader. https://www.clinicalleader.com/doc/how-to-effectively-work-across-cultures-in-global-clinical-trials-0001. Accessed: 04 June 2021.


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