Today, international trials make up the majority (~65% on clinicaltrials.gov) of ongoing clinical trials. For sponsors and patients, the globalization of drug development has shortened the time to commercialization in key markets and expanded the availability of important new treatments. But globalization comes with a number of challenges, not the least of which is mastering logistics across countries, regions, and time zones. PROMETRIKA has formed strategic partnerships with like-minded and similarly sized local CROs in over 80 countries on 5 continents. These relationships optimize the management of key logistic concerns such as time zone differences, supply chain consistency, language barriers, and ethical and cultural considerations.
Challenge: Time Zone Differences
Clinical trials are fast-moving and, often, information is needed in an expedited manner. Delays in communication caused by time zone differences are affected by cultural complexities such as working days and hours, and holiday closures.
Challenge: Supply Chain Consistency
The provision of trial supplies across countries and regions is perhaps the most daunting logistic challenge of international trials. Each country has a specific set of regulations addressing drug importation and distribution. Additional factors in supply chain planning include pharmacy staff experience, storage capabilities, and regional climates and temperatures at various times of the year.
Challenge: Language Barriers
Differences in language pose a couple of challenges to the timely progress of trials. Obviously, the translations of both medical staff-oriented and patient-oriented materials is a major consideration in the planning of study initiation. In most countries, materials must be translated and back-translated, and these translations must be certified to assure that they accurately convey the study’s messages and instructions in the non-English language. Additionally, there may be cultural differences in the way certain procedures are explained and/or performed.
Challenge: Ethical and Cultural Considerations
The challenges listed above have touched on some cultural considerations. In addition to those, a sponsor must consider the level of research experience at a proposed site. Low- and middle-income countries can provide treatment-naïve patients due to limited access to more modern healthcare. But for a site’s participation in a trial of more advanced treatments, sponsors must consider whether research staff is appropriately qualified and whether regulations are in place to protect patients.
PROMETRIKA’s Solutions
Through our international collaborations, PROMETRIKA has created a culture of global community, which ensures that the issues of study management and progress are addressed seamlessly across regions. Having professional colleagues in each region in which a trial is located addresses all of the challenges listed above.
- Study staff and patients have access to local study management at times that are appropriate for them.
- Issues with procurement or distribution of study materials can be handled as quickly as possible by local study managers.
- Local clinical trial experts are sensitive to appropriate medical terms in their language, and to cultural proprieties in conveying study information.
- Experienced local management is aware of the preparedness of sites to manage study requirements and to protect patients.
PROMETRIKA’s model of informed and efficient colleague communication across regions, as determined in a pre-specified communication plan, ensures that all regions involved in a study remain apprised of any situation that may affect the entire study. For a US-based sponsor, PROMETRIKA remains the global management CRO, which ensures that the sponsor’s goals are addressed seamlessly and consistently on the international platform.
For more information, please read our White Paper.
