Optimizing Outcomes in Multinational Clinical Trials

As drug and therapy development continues to expand globally, pharma, biotech, and medical device companies need to incorporate techniques that transcend language, cultural, and geopolitical barriers. Clinical research industry leaders are deploying new processes and technologies that allow their global team members to collaborate better and to manage critical information at an international level.

Welocalize Life Sciences will launch a webcast at the end of February focusing on global clinical trials and some of the key considerations large life sciences organizations must consider when undertaking clinical trials in multiple geographies. Louise Law, Global Communications Manager at Welocalize, and Marta Motta, Global Sales Director at Welocalize Life Sciences, will lead the discussion, a preview of which is featured in this post. Register for the webcast here.

Louise (LL): Running clinical trials is a complex process made even more complex when you have to consider multiple languages, cultures, and regulatory bodies. Could you quickly sum up what a clinical trial is?

Marta (MM): A clinical trial is simply medical research involving people. Before a new drug or therapy is brought to market, it must go through several tests – that can sometimes take up to 12 years – before it can be launched. New drugs and therapies have to be tested on people in very controlled environments.

LL: The clinical trial market is valued at over $40 billion and is expected to reach $65 billion by 2025 and nearly half of clinical trials are now conducted outside of North America. Statistics show that the pharmaceutical market is one of the largest and most dynamic global industries.

MM: Yes it is – the numbers are large! The pharmaceutical market is highly competitive and with people living longer, the demand will continue to rise. Enterprises are driven to continue to research and launch more pharmaceuticals to market. As Sponsors and CROs look for more diverse and treatment naïve patients, they often need to expand a study into many different countries.

LL: Once you expand a clinical study into a new country or region, the logistics become more complex. And as we mentioned before, new markets mean new languages and diverse cultures. What are some ways that language and cultural impact studies?

MM: Not everyone speaks the same language. For this reason, many government agencies have language requirements for documentation and filings to meet local legal and regulatory requirements.

LL: So each country has their own governing body and set of rules for medicine and pharmaceuticals?

MM: That’s right Louise.  Many different international ethical guidelines exist, as well, such as Good Clinical Practice, that address language and cultural components as they relate to informed consent – which is what companies need from patients who are participating in a trial. As such, to conduct a study or market a drug or device successfully (and legally) in many parts of the world, companies may have to provide content in dozens of languages. Every person taking part in a trial has to fully understand the possible outcomes and implications.

LL: Patients need to do a lot of background reading in their own language before they signup. And as well as language, culture also affects the global clinical trial process.

MM: Yes – in addition to adhering to regulatory guidelines and laws, cultural practices and values can substantially affect a therapy’s successful development and market adoption. Different cultures not only speak different languages, but they have different habits.

For drug development companies to continue to research novel compounds and reach new patient populations, it is critical to understand the unique role that culture plays and how to use this understanding to foster meaningful communication with patients, physicians, project teams, and other stakeholders.

LL: Can you give us an example?

MM: In different cultures, the physician/patient relationship and the meaning of consent may vary. Doctors, patients, and vendors may respond differently to varying levels of formality and also have different priorities or concerns. In addition, study teams should recognize and adapt to cultural differences including identifying the decision-making authority in a community or family.

LL: Let’s look at one country of central importance to global trials: India. India is a diverse and heavily populated country. Many organizations assume that since English is the primary language of medical training and the education system in India, it should suffice as the official language for the trial. Is this the case?

MM: While clinician English fluency is exceptionally high in India, patients may be unable to participate fully in a trial program without linguistic support.

Many local languages in India have over a million speakers. While consent forms and other materials at the screening level are translated into one of the many local languages, once the patient has been enrolled and randomized, the availability of non-English materials in terms of case-report forms, clinician administered scales or even patient-reported outcomes may dwindle.

Language alone cannot resolve all the issues encountered during clinical trials in India. As with many world populations, certain topics may be socially and culturally inappropriate for direct questioning techniques and investigation. Investigators in a trial may be reluctant to broach particular topics with their patients, and patients are unlikely to answer such questions if asked.

To hear the full webcast and learn more about optimizing outcomes in global clinical trials, register here. In this 30-minute conversation, Marta will share how to overcome some of the challenges inherent to running studies in multiple countries. Topics include establishing informed consent, adapting to cultural and language differences, and how to leverage technology to streamline communications and document versions.