In our most recent Clinical Trials Corner post, we examined the lacking global representation of diverse patient populations in the development of new biopharmaceuticals when compared to consumption of developed drugs by country, highlighting the need to expand and grow industry CTs in several emerging markets – ultimately, a task for pharmaceuticals translations. In this post, we will look at how pharmaceutical and clinical trial localization services enable expanded iCT opportunities to underrepresented regions concentrated primarily in Africa, the Middle East, and South Asia. As well as being a crucial mandate for ethical and representative drug development, engaging patients in these high growth regions can help ensure the competitiveness and commercial viability of treatments in world markets, which localization can further support with subsequent pharmacovigilance and medico-marketing translations.
Emerging Markets Consume the Most Total Pharmaceuticals
Many of the potential clinical trial markets that could benefit from increased iCT access, as highlighted by our analysis using LongTaal Clinical Trial Analytics, are emerging markets for pharmaceuticals, like Bangladesh, Saudi Arabia, Algeria, and Indonesia. These emerging markets (sometimes called “pharmerging” markets) had a 5-year annual growth rate of 3.5% based on medicine volumes shipped from 2016 to 2020, faster than the 1.1% of developed pharmaceutical consumer giants like the United States, Germany, and Japan, as shown in a report by IQVIA Institute for Human Data Science. They already consume more total pharmaceutical units than developed countries and are expected to continue growing through 2025 and beyond.
Whether accessing patients who speak Bahasa Indonesia in Indonesia, Arabic in Algeria, or Urdu in Pakistan, translation and localization of clinical trial materials into local languages can assist industry sponsors in accessing these growing markets to address future pharmaceutical needs.
New Trial Sites Start with Clinical Trial Agreement Translations
Expanding clinical trial sites to emerging markets, particularly when language needs vary and a country may not have a long history of iCTs, can be made or broken even before a trial starts during clinical trial agreement negotiation. Clinical Trial Agreement translations help industry sponsors discuss trial operations with proposed sites and researchers to ensure regulatory compliance, as well as set financial and intellectual property terms. Navigating regulations and legislature in new countries requires both pharmaceuticals and legal subject matter experts to accurately translate even the most basic site monitoring responsibilities across languages.
Pharmaceutical Clinical Trial Execution Requires Localized Communication
Prioritizing racial, ethnic, and cultural diversity when expanding pharmaceutical clinical trials to international study sites means that industry sponsors need to maintain the same patient-centric values as in their home country. Combining the local knowledge of in-country linguists with country-specific multilingual desktop publishing and formatting review allows sponsors to connect with local patient populations and reduce the risk of miscommunication. From patient-facing communications such as informed consent form translations, clinical trial website localizations, and patient questionnaire translations, to on-site operations like investigator’s brochure and clinical trial protocol translations, sponsors can be confident that new study sites are representative of these emerging pharmaceutical markets.
Organized Sponsors Access Diverse Markets with Confidence
Taking a pharmaceutical product from safety and efficacy endpoint success into production and distribution and post-market drug safety monitoring, requires coordination across regulatory, legal, and marketing concerns, which can feel especially daunting across languages. Cloud-based technologies for translation memory and terminology management help sponsors efficiently navigate all aspects of entering new emerging markets such as Ghana, Pakistan, or the United Arab Emirates. From trial close-out and endpoint adjudication translations to intellectual property application and prescription label translations and even pharmacovigilance and medico-marketing, ensuring consistency allows faster market access for growing pharmaceutical areas like oncology, immunology, neurology, and more.
CSOFT Health Sciences: Experts in Pharmaceutical Translations
Industry sponsors looking to take advantage of iCT markets in currently underrepresented countries across South Asia, Africa, and the Middle East perform best with the help of a language service provider that understands the complexity of pharmaceuticals, health science law, and local communication needs. Leveraging a global network of over 10,000 in-country native and subject-matter expert linguists, CSOFT Health Sciences, leaders in medical translations, provides a full range of pharmaceuticals and clinical trial translations in 250+ languages. Learn more about our communication services and innovative cloud-based technology at lifesciences.csoftintl.com.