艾昆纬-将临床试验扩展到新界：探索成功的关键（英）

White PaperExpanding Clinical Trials into New Territories: Exploring the Keys to Success Maximizing geographical reach by leveraging expertise, technology, and local experienceIAN PEMBERTON, Vice President, Head Of Alliance Management, Mid-Size and Emerging Models, Clinical FSP, IQVIA GARY WHITE, Head of Go to Market – Clinical FSP, IQVIATable of contentsIntroduction 3Key drivers of country expansion 3Patient recruitment and diversity 4Regulatory flexibility 4Cost efficiency 4Access to untapped markets 5Technological advancements 5Regulatory harmonization 5Matching countries to trials: the importance of scrutinizing every variable 5Balancing FSO and FSP solutions in country expansion 6Assessing country infrastructure 7Enrollment modeling and scenario planning 7Site intelligence and identification 8Regulatory and startup 8Navigating the logistics, trial supplies, and supply chain 8Finances, contracting, and payments 8Staying on course: patients, sites, and data management 9Customizing—and optimizing—patient recruitment and retention 9Consistency and excellence in data management and compliance 10Conclusion 10About the authors 11 iqvia.com | 3For as long as societies have existed, people from all walks of life have been compelled to travel abroad — for leisure, commerce, education, or perhaps to start a new life in a foreign land. Venturing into new, unfamiliar regions introduces new sights, sounds, languages and cultures, ultimately rewarding us with an enriched understanding of the world in which we live.Yet no matter what the motivating factor is for venturing overseas, one cardinal rule stands the test of time: the more prepared and informed the traveler is about the destination country, the greater the chances of a successful journey. The logic is simple: understanding local norms, laws and attitudes helps ensure the traveler remains on the proper course and avoids precarious setbacks. Sound contingency planning is also necessary as a safeguard in the event the journey doesn’t go as planned.Nowhere are these principles more relevant than in today’s clinical trials, as sponsors and their CRO partners increasingly seek to expand their geographical reach to conduct medical research. Conducting clinical trials in less charted research destinations — for example, within Latin America, Asia, Africa, and Eastern Europe—provides significant opportunities to develop treatments for more diverse patient populations, achieve greater operational efficiencies, maximize flexibility, accelerate overall delivery, and achieve many other potential benefits for medical science. And with today’s increasingly innovative tools, data, capabilities, and technologies, the opportunity to achieve success conducting clinical research overseas has never been greater.That being said, without robust experience, local expertise and planning, sponsors will likely encounter unforeseen issues that can cause delays, added costs, compliance risks, and—in the wors